Healthcare Provider/Provider & Provider/Payer (Reimbursement) Disputes
At the Law Office of Kevin O’Mahony, we represent healthcare providers and businesses in both provider/provider and provider/payer or reimbursement disputes. Providers are the hospital or health system, physician or physician group, laboratory services provider, ambulatory care center, dentist, chiropractor, optometrist, therapist, nurse or other party that provides healthcare services and seeks payment for one or more claims from a payer.
Payers or “payors” (both spellings are often used) are the health insurance companies or other parties responsible for: (1) paying all or part of a claim relating to the rendering of healthcare services; or (2) administering the payment of such a claim for another entity. Included as payers are third parties who administer self-funded plans on the plan sponsor’s behalf. Not included are employers who sponsor benefit plans.
Disputes between providers themselves (not involving payers) can arise in multiple contexts. They include physician disputes with hospitals, health systems, medical staffs, and their own physician groups. We also handle provider/vendor disputes. Many, if not all, of those contexts are discussed on the other individual Practice Area pages of this website. We invite you to review those pages, and contact us if you wish to discuss a dispute in any of those areas. But provider/payer or provider/plan disputes, which are discussed here, have some distinct characteristics, including:
- The provider sector and the payer sector have ongoing, intertwined relationships with disputes that resurface.
- These parties must interact with each other more than most other sectors of the healthcare industry. For example, there are patients who are members of payer plans who need ongoing services from providers such as hospitals and physicians.
- And there are details unique to claims for payment dealing with, for instance, physician reimbursement and treatment coding, that lend themselves to more efficient and less costly handling.
Third-Party Payer & Managed Care Contracting
The United States’ third-party payer healthcare system drives most healthcare providers to enter into contracts with health insurers and managed care organizations. “Managed care” generally describes methods that are intended to lower healthcare costs and improve patient care. Theoretically, managed care delivery systems lower costs and enhance quality of care by providing financial incentives to physicians, other healthcare providers and patients to choose less expensive care options, reduce in-patient hospital stays, increase outpatient surgeries, closely monitor utilization and high-cost patient situations, and share in costs. Unfortunately, managed care also has complicated and created some new problems in our healthcare system, which make it difficult for some physicians and other providers to deliver healthcare profitably without what many consider to be unreasonable (if not unbearable) administrative burdens.
There are multiple types of managed care organizations with varying components, business structures and compensation methods. Some managed care organizations are comprised of only physicians, while others are a combination of hospitals, physicians and other healthcare providers. Specific examples are Independent Practice Associations (“IPAs”), Physician Hospital Organizations (“PHOs”), and Preferred Provider Organizations (“PPOs”) (which also include an insurer or third-party administrator).
Typically, physicians or medical groups enter into a series of contracts (directly or indirectly) with managed care organizations that require the doctors to agree to discounted fees for their services. In exchange for the physicians’ agreement to provide services at lower rates, the managed care entities are responsible for “steering” patients to the physicians or group. A physician or medical group may contract with an IPA or PHO that contracts with a PPO, health insurer or large employer in an arrangement that allows for a third-party payer (an insurer or employer health plan who pays for healthcare) to pay the provider when claims are submitted for patient care. The PPO organizes “networks” of providers that may be included in a health insurance plan pursuant to contracts called “network agreements.”
A hospital, medical group or physician may have multiple contracts in order to participate in a particular network. And a hospital, medical group or physician may participate in multiple networks to obtain additional insured patients. Hospitals, physicians and other healthcare providers may also form “alliances,” as another method of managing and (hopefully) improving care, monitoring utilization, and reducing costs.
While managed care contracts can significantly increase a healthcare provider’s patient volume, participating in networks and other managed care arrangements can be complex and pose risks for providers. Indeed, there are both business and legal risks associated with these contracts.
Providers are in the business of keeping their patients healthy. But confusing contracts filled with complicated provisions and legalese can distract providers from their core mission of improving patient outcomes. Consequently, a provider should obtain the assistance of a qualified healthcare attorney with relevant experience before signing any third-party payer or managed care contract.
Key Terms & Components of Payer Contracts Providers Should Know
Payer contracts define and explain a provider’s reimbursement arrangement for delivering healthcare services to patients covered by a specific health plan. The contracts cover everything from reimbursement rates and provider networks to medical necessity and provider credentialing.
Understanding the terms and provisions in a payer contract is essential to ensure correct and timely reimbursement, prevent claim denials, achieve a smooth revenue cycle, and keep a practice running. Knowing the ins and outs of each contract is crucial to drawing patients to the practice or facility, and being able to offer comprehensive and reimbursable healthcare services to those patients.
Despite the importance of payer contract knowledge, providers (and even their practice administrators and financial advisors) often feel less than confident going up against payer organizations with legal departments, financial analysts and advanced computer software systems. The entire process of contracting and renegotiating with payers is complex, lengthy and time-consuming. And this often causes providers to feel they are at a disadvantage.
However, knowledge is power. And the more providers and their practice administrators know about the terms used in payer contracts, the more effectively they can negotiate and renegotiate contracts to maximize reimbursement and avoid disputes.
But when disputes do arise (as they sometimes unavoidably do), our healthcare, business and litigation law firm can help. Below are some of the key terms and issues involved in contracting and resolving disputes with payers – both private and governmental.
National Provider Identifier
The National Provider Identifier (“NPI”) is a Health Insurance Portability and Accountability Act (“HIPAA”) Administrative Simplification Standard. The NPI is a unique, 10-digit identification number for covered healthcare providers created to help send health information electronically more quickly and effectively. Covered healthcare providers, all health plans, and healthcare clearinghouses must use NPIs in their administrative and financial transactions. As outlined in federal regulations, HIPAA covered providers must share their NPI with other providers, health plans, clearinghouses, and any entity that may need it for billing purposes. The numbers do not carry other information about healthcare providers, such as the state in which they live or their medical specialty.
According to the Department of Health & Human Services (“HHS”), the “allowed amount” on a payer contract is the maximum amount that a payer will reimburse a provider for a covered healthcare service. Some contracts also refer to the allowed amount as an “eligible expense,” “payment allowance,” or “negotiated rate.”
The allowed amount is what the payer will reimburse for services defined as covered or in-network. This rate may not fully cover provider charges. And patients may be responsible for covering the balance between the allowed amount and the provider charges.
Medicare, for example, sets its allowed amounts for specific services in prospective payment systems by care setting and the Physician Fee Schedule (“PFS”). Private payers tend to use Medicare’s rates as the basis for building their own allowed amounts.
A “fee schedule” is a list of fees or payments for specific provider services or supplies, according to the Healthcare Financial Management Association (“HFMA”). Each payer contract should have a fee schedule attached, and providers should push payers to provide a complete fee schedule. The list contained in that schedule should define all covered services and the negotiated rates for each service.
The Centers for Medicare & Medicaid Services (“CMS”) manages the Physician Fee Schedule (“PFS”) for Medicare. Using the PFS, CMS reimburses for physician services under Medicare Part B. Medicare Part A, on the other hand, reimburses for hospital, skilled nursing facility, hospice and home healthcare services provided to Medicare beneficiaries.
Each Current Procedural Terminology (“CPT”) code receives a relative value unit (“RVU”), which then is adjusted for the Geographical Practice Cost Index and the national conversion factor. The result is the Medicare allowed amount for a specific covered service. And other payers (health insurers, etc.) use similar processes to determine the allowed amount for each covered service listed on their fee schedules.
A “clean” claim is a claim that payers can process without needing additional information, according to HFMA. Incomplete clinical documentation and coding, incorrect patient information, missing physician approvals, and other claim errors result in reimbursement delays and claim denials. Failing to ensure a claim is complete and correct, otherwise known as “clean,” can seriously impact provider revenue.
Payer contracts define what a payer needs to ensure timely reimbursement of claims. So, to ensure financial survival and (hopefully) success, providers need to pay close attention to the terms of those contracts to ensure that their claims are clean.
Providers should also track their clean claim rate to evaluate their revenue cycle performance. Higher clean claim rates indicate that medical billing, coding and claim creation processes are running properly and revenue is being collected efficiently.
Payers only reimburse providers for services that are deemed “medically necessary.” Payers define medical necessity in their contracts. So, again, in order to ensure financial survival, providers must pay close attention to and understand what types of services will be covered under their payer agreements.
According to HHS, healthcare services or supplies that are needed to diagnose or treat a condition, illness, disease, injury or related symptoms are considered “medically necessary.” Medically necessary services also must meet generally accepted standards of medicine, according to HHS.
Medical necessity clauses may also limit the number of times providers can perform a procedure or deliver specific care in a specified time period. And for Medicare and Medicaid, the National Coverage Determinations and Local Coverage Determinations impose limits on how many times a provider can deliver a medically necessary service within a certain period.
Providers should be sure they understand each payer’s definition of medical necessity, because definitions may vary (at least slightly) by contract. And the provider’s own definition or understanding may be different than the payer’s. Being on the same page is important not only to receive reimbursement for services. It is also crucial to avoid civil liability and even criminal penalties. That is because billing payers for services that are known to be medically unnecessary can result in healthcare fraud investigations and punishment.
Providers need to keep in mind that what they may consider to be an “innocent mistake” or mere “billing error” may be characterized by the government or a private payer as “fraud.” So, careful attention to submitting clean claims for only medically necessary and appropriately delivered medical services is crucial for providers to survive financially and legally.
It is also important to bear in mind that federal regulations have long barred the routine waiver of coinsurance and copayments for federal healthcare program beneficiaries. Providers who routinely discount or waive patients’ copayments or deductibles (collectively referred to as coinsurance or copayment obligations) can, for example, violate the federal anti-kickback statute (42 U.S.C. § 1320a-7b), or be accused of false billing by private insurers not receiving the discount. Consequently, providers must be careful and take certain steps before offering or allowing any such discount or waiver to a patient.
Although CMS and HHS’ Office of Inspector General (“OIG”) may not react to an occasional waiver of copayment obligations due to financial hardship or uncollectibility, routine waivers of copayment obligations under Medicare is clearly problematic. The federal anti-kickback statute prohibits the offering of any remuneration to induce a person to purchase or order any service for which payment may be made under Medicare. The routine waiver of a patient’s copayment obligations implicates this prohibition because it reduces the amount that the patient pays for services, and may therefore induce the patient to seek more services that are payable by Medicare.
The OIG has promulgated regulations defining and further specifying those payment practices which will not subject providers to penalties under the anti-kickback statute in what are known as “safe harbors.” But when discussing the propriety of discounts, the OIG stated unequivocally that safe harbor protection does not apply to any discount offered to beneficiaries in the form of “a reduction in price offered to a beneficiary (such as a routine reduction or waiver of any coinsurance or deductible amount owed by a program beneficiary).” (See 42 C.F.R. § 1001.952(h)(5)(iv).)
Moreover, private health insurers often take the same position with regard to their beneficiaries, believing that such routine waivers indicate or lead to provision of unnecessary services or services in excess of patients’ needs. Like CMS and the OIG, private insurers and courts are generally not alarmed by occasional waivers, discounts or write-offs for individual patients with documented financial difficulties. But health insurers have successfully challenged routine waivers of copayment obligations in the courts on numerous occasions.
Courts dealing with challenges to discounts of copayment obligations have been concerned with two basic issues. First, a provider who discounts established fees for some patients but not others, without a valid distinction for the differing treatment, can be subject to claims of false billing by a party not receiving the discount or consideration, including claims by insurance carriers. Second, the routine waiver of patient copayment amounts can be viewed as a breach of contract.
Almost without exception, insurers impose a contractual duty on providers to make a reasonable effort to collect applicable copayment amounts from patients, and benefits are only available when the charge for the service submitted by the provider is the actual, and the usual, reasonable and customary charge. The reasoning in these cases is that frequent discounting or waiver of patients’ copayment portion of a provider’s fee shows that the provider really only intends to collect that portion of the fee which is not discounted, making it improper to claim that the fee is the full undiscounted fee.
Therefore, routinely offering discounts to patients is extremely risky and not advised. It can implicate multiple federal and state laws, and may attract the scrutiny of government investigators, as well as private insurance audits. Under certain limited circumstances, providers may occasionally waive or discount patient co-pays, based on legitimate financial need, hardship or uncollectibility. But the individualized circumstances warranting such a discount or waiver must be well documented. And the the provider’s billing practices should be consistent, reasonable and set forth in a written policy.
On January 12, 2021, CMS codified how it defines “reasonable and necessary” coverage for items and services that may be covered under Medicare Parts A and B in a new final rule. The rule updated CMS’s prior definition and applies the definition to National Coverage Determinations and other coverage decisions.
According to the final rule, which took effect on March 15, 2021, the definition has three main elements, including that an item or service (1) be safe and effective, (2) not experimental or investigational, and (3) appropriate for Medicare patients.
The codified definition is similar to one currently published in the Medicare Program Integrity Manual, CMS stated in an announcement. The agency believes the codification of the definition will “bring clarity and consistency” to the coverage determination processes for items and services covered by Parts A and B.
CMS and Medicare Administrative Contractors (“MACs”) have traditionally determined whether items and services are reasonable and necessary on a case-by-case basis, accounting for clinical appropriateness of claims, or through local and national coverage policies, such as Local Coverage Determinations and National Coverage Determinations.
The final rule also stated that CMS will consider coverage for items and services that have insufficient evidence to meet the appropriateness criteria “to the extent the items or services are covered by a majority of commercial insurers.” CMS plans to issue draft sub-regulatory guidance on how it will determine what commercial insurers to consider for national and local coverage determinations in these situations. The agency said it will base its decision on the “measurement of majority of covered lives.”
The American Hospital Association (“AHA”) voiced concern with CMS’ push to consider coverage in the commercial health insurance market when making Medicare coverage determinations. In comments on the proposed rule in November 2020, the AHA said the approach could reduce coverage in Medicare and transparency in coverage determinations. At the time, the rule proposed to codify the Medicare Program Integrity Manual’s definition of “reasonable and necessary” with a modification to the appropriateness factor to allow CMS to refer to commercial coverage.
The rule stated that for an item or service to meet the appropriate criteria, it would need to be:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
- Furnished in a setting appropriate to the patient’s medical needs and condition;
- Ordered and furnished by qualified personnel;
- One that meets, but does not exceed, the patient’s medical need; and
- At least as beneficial as an existing and available medically appropriate alternative; OR
- Covered by commercial insurers, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant.
In the final rule, CMS did not replace the appropriateness criteria completely and addressed the concern by offering to release guidance later regarding how it will determine when and how commercial coverage will be relevant to an item or service’s coverage in Medicare. The complete definition and final rule can be viewed here.
Network requirements are another key component of payer contracts. Such provisions detail the networks in which provider organizations can participate, as well as the credentialing requirements providers must meet in order to join a network.
Providers should ensure that they join appropriate networks for their practice to generate revenue and increase patient volume. Network requirements in payer contracts are becoming even more important as the number of value-based contracts increases.
“Value-based care” (reimbursement that ties payments for care delivery to the quality of care provided and rewards efficiency and effectiveness, as opposed to fee-for-service reimbursement, which pays providers retrospectively for services delivered based on bill charges or annual fee schedules) is producing different networks for different products. And there almost always is language in contracts that pertains to credentialing criteria that providers have to meet in order to be included in a network.
However, a contract may also have language that enables the payer to pick and choose which physicians or individual providers can participate in which networks. From the provider’s perspective, a payer contract should not contain language that allows the payer to select a provider organization’s network. And network changes should be tied to legitimate credentialing criteria only and not arbitrary selection of physicians.
Payer contracts that contain unilateral amendments mean that payers can change contract provisions without the consent of (and sometimes without even notifying) the provider. If a contract contains unilateral amendment language, payers can change anything from reimbursement rates to clean claim definitions, and even network participation.
Most payer contracts state that the payer can amend the contract at any time. In the worst cases, they state that no approval is required from the provider at all. In even the best cases, they usually indicate that a provider has only a limited period of time, typically 10 to 30 days, to object to a proposed amendment in writing.
Otherwise, the amendment automatically goes into effect. Providers should therefore be aware of unilateral amendment language in their contracts, and attempt to negotiate with payers to exclude (or at least improve) such language in future contracts, to the extent possible.
Payer contracts should clearly define the contract’s period and the circumstances under which the provider and payer can terminate the agreement. There can be an initial “term” (typically one year) before the contract automatically expires. Or, it may automatically renew unless specifically terminated. And there usually are both termination “for cause” and termination “without cause” provisions.
With regard to terminations for cause, there normally is a “right to cure” provision, providing a limited time to remedy or fix a material breach or violation of the contract. But for serious enough breaches (such as license suspension or revocation, conviction of a crime, etc.), the termination can be automatic and immediate. Termination without cause provisions normally specify a set number of days (typically anywhere from 15 to 180 days) in which a contract can be terminated for any or no reason at all, by simply providing written notice of termination to the other party. Post-termination duties for both parties should also be specified in the contract, including obligations for the payer to pay any outstanding compensation to the physician or true-up based on a pro rata portion of the performance year, etc.
Statistical analyses have shown that a significant percentage (up to 10% or more) of both hospital and physician charges initially result in claim denials by payers. Therefore, providers need to ensure that their payer contracts have clear dispute resolution processes. Dispute resolution language can include anything from informal resolution processes to formal litigation.
In a payer contract, dispute resolution language normally sets out at least some of the terms for mediating, arbitrating, or (if necessary) litigating in court, provider-payer disputes. In the event of a claim denial or a disputed claim, dispute resolution provisions in the payer contract will direct a provider on how to try to resolve the claim(s) in question, and (hopefully) receive reimbursement if it is owed.
Once again, as the number of value-based contracts increases, dispute resolution language is becoming even more important, because value-based reimbursement criteria often present even more opportunities for claim denials and disputes over claims. In general, providers should try to avoid or negotiate away as much as possible language in a contract that legally binds them to a specific dispute resolution process to the exclusion of others. That is because providers (more than payers) may need the leverage of litigation to get a fair resolution of a dispute.
As the American Medical Association has observed, “in contractual disagreements between physicians and payers, the aggrieved party is often the physician.” “And the absence of language stating that these [alternative dispute resolution proceedings, such as mediation and arbitration] provisions are binding [or mandatory] may give some wiggle room for this leverage. This isn’t the place, therefore, to argue for hard-nosed [mandatory] language.”
Resolving Provider-Payer Disputes & Denied Claims Litigation
In the healthcare industry, providers and payers often have claims for both underpayment and overpayment arising from ongoing contracts or other healthcare services rendered. When claims arise between a provider and a payer, they often are aggregated and combined for purposes of litigation, sometimes totaling thousands of claims in a single action. When the parties are unable to resolve the claims informally, they often become the subject of either a civil action or arbitration proceeding. In either case, the parties usually try to settle those claims and do so often in mediation. But at least occasionally, a trial and even appeals are required to resolve a dispute.
One of the more notable cases occurred in 2021. On Dec. 7, Modern Healthcare (Tepper, Subscription Publication) reported that a Las Vegas jury decided that “UnitedHealthcare must pay $62.65 million in total damages for shortchanging TeamHealth clinicians.” The article said, “The jury unanimously found the nation’s largest insurer guilty of fraud and unjust enrichment, saying it had formed and violated an implied contract with TeamHealth and engaged in unjust and oppressive claims practices.” The article noted, however, that “In this case and others, UnitedHealthcare counters that TeamHealth’s unreasonably high charges led to its removal from the insurer’s provider networks.”
UnitedHealthcare said it plans to appeal the decision on several grounds. For example, the health insurer argues that the jury wasn’t allowed to hear critical pieces of evidence in the case that may have impacted their verdict, including that TeamHealth allegedly sought payment of more than five times the market rate in Nevada, and more than seven times its costs.
More often, cases are brought by payers against providers for alleged overbilling and overpayments. A notable case example in 2021 involved Sutter Health, a California-based healthcare services provider, and several affiliated entities including Sutter Bay Medical Foundation (dba Palo Alto Medical Foundation, Sutter East Bay Medical Foundation, and Sutter Pacific Medical Foundation) and Sutter Valley Medical Foundation (dba Sutter Gould Medical Foundation and Sutter Medical Foundation) (collectively, “Sutter Health”).
In that case, Sutter Health agreed to pay $90 million to resolve allegations that it violated the False Claims Act by knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Medicare Advantage Plans. Specifically, the government alleged that Sutter Health knowingly submitted unsupported diagnosis codes for certain patient encounters for beneficiaries under its care. These unsupported diagnosis codes caused inflated payments to be made to the plans and to Sutter Health. The lawsuit further alleged that, once Sutter Health became aware of these unsupported diagnosis codes, it failed to take sufficient corrective action to identify and delete additional unsupported diagnosis codes.
What makes provider-payer disputes unique is that there often are multiple issues or categories of issues involving decision makers from different departments within the same organization (i.e., claims people vs. contracts people vs. case administrators, etc.). Moreover, each issue group may contain hundreds or thousands of separate claims which arise under the same contractual relationship. Because the claims are individually small, the provider usually waits until it has gathered a sufficient number of claims to make filing a legal action or mediating a case pre-litigation worthwhile.
These types of claims fall into several categories, such as lack of authorization, medical necessity, usual and customary rates, and the like. Typically, they span a range of dates of service. Then during the pendency of an action, there may accrue additional claims for additional dates of service or claims that were not part of the original claim(s), but which arose under the same contractual or non-contractual relationship as the original claim(s).
At the same time, the existing contract may be expiring, may have expired, or may be in the process of being renegotiated during the pending action. So by the time of a mediation, arbitration or trial, there are “original” claims, “accrued” claims, “future” claims certain to arise from the relationship, and often contract issues that need to be addressed since the relationship between the parties is ongoing. So the sooner a dispute can be resolved, the better for both parties from a financial and risk management standpoint.
Recoupment Demands by Health Insurers
(This section is adapted from an article titled “When the Insurance Emperor Has No Common Law Clothes: Provider Recoupment Demands, State Contract Law, and the Voluntary Payment Doctrine” by Greg Heller, Esq. of Young Ricchiuti Caldwell & Heller, LLC, which appears in the Feb. 2021 ABA Health Law eSource.)
Practically every day, health insurance companies send recoupment demands to healthcare providers. Insurers generally base their recoupment demands on a contention that payments previously made should not have been paid after all. Recoupment demands are often based on a provider’s alleged failure to comply with the insurer’s documentation rules, and on rules about how claims are to be coded and submitted. The demands come after the providers have already performed or provided healthcare services, paid for the support and professional staff and materials needed to provide the services, and after the insured patient already received the services – in other words, after the insurer’s insured subscriber/member/patient received what the insurance company promised it would cover (pay for) in exchange for premium payments it already received.
The frequency and size of recoupment claims by commercial insurers appear to have increased in recent years. Likely drivers of this increase include the proliferation of technology tools that automate large parts of the audit or review process (which allow, for example, the application of unbundling rules across a wide set of claim records) and widespread use of sampling and extrapolation methodologies within the Medicare and Medicaid programs, which has built out expertise that can also be carried over to commercial health plans and insurers. Another likely driver is the proliferation of narrow provider networks. Narrow networks in the aggregate put more power in the hands of payers because there are more providers than network spots, and providers need to be in-network more than the network needs any particular provider. This dynamic encourages or at least accommodates a more aggressive payer approach to reimbursement. Whatever the reason, recoupment demands are here to stay.
ERISA is Often the Default Framework for Provider-Payer Disputes
When recoupment demands get litigated (either by providers resisting recoupment demands, or by payers pursuing them), that litigation often centers around the Employee Retirement Income Security Act of 1974 (“ERISA”) (29 U.S.C. § 1131, et seq.), a federal law that governs employer-sponsored health coverage and applies to roughly half of all Americans with health insurance coverage. Under ERISA, it is by and large the ERISA plan document (in other words, usually, the insurance policy) that ultimately determines what is and is not covered, and therefore it is (with a few exceptions not relevant here) the plan document that determines whether or not a particular payment from the insurer to a provider was appropriate.
From the insurer’s perspective, litigating provider disputes as ERISA disputes has a lot to recommend it. Plan documents are written by insurers. Those documents generally place considerable discretion in the hands of the insurer, and the insurer’s decisions are reviewed under an abuse of discretion standard. Plan documents also often incorporate (at least by reference) the insurer’s own reimbursement policies and the insurer’s standards for provider audits and reviews, and purport to make those standards a condition of payment under the plan. Under ERISA the fact that a particular provider or insured never saw or agreed to these policies and standards is irrelevant. This places enormous power in the hands of insurers.
ERISA also offers some help to providers. While the discretion granted to insurers is considerable, ERISA does impose some outer boundaries on the substantive standards that insurers apply when they make benefit decisions. There is an extensive body of well-reasoned case law addressing benefit decisions under ERISA, and ERISA is familiar terrain for lawyers who litigate benefit disputes. ERISA also has a statutory fee-shifting provision (29 U.S.C. §1132(g)). The ERISA framework is, therefore, a comfortable one for those who frequently work within it.
For these reasons and others, providers that are either defending against a recoupment demand or affirmatively seeking reimbursement have often sought to pursue their claims as ERISA claims in federal court, generally seeking to pursue claims under ERISA section 502(a)(1)(B), which grants every ERISA plan participant and beneficiary a statutory cause of action “to recover benefits due to him under the terms of his plan, [or] to enforce his rights under the terms of the plan.” (See 29 U.S.C. §1132(a)(1)(B).)
In recent years, courts have often dismissed these claims on the ground that providers are not participants or beneficiaries, and therefore lack standing. Faced with these rulings, providers seeking to proceed under ERISA often claim standing by virtue of assignments received from patients. Managed care companies, in turn, rely on provisions in plan documents that ban such assignments. And providers, again in turn, often assert that plans are estopped from raising anti-assignment provisions, usually because the provider relied on preauthorization communications from the plan. There is an extensive and growing body of case law on these issues. For present purposes, it is sufficient to note that there are opportunities for advocacy and significant rewards for careful analysis on both sides of these issues. A provider seeking to litigate a recoupment claim as an ERISA 502(a)(1)(B) case has a shot at doing so.
But even if providers survive a motion to dismiss on their statutory ERISA claim, they can still face headwinds because the ERISA playing field is often, as a practical matter, tilted in favor of the insurer, as noted above. The insurer’s interpretation of a document written by the insurer will be addressed under a standard that affords substantial deference to the insurer. Consequently, it is fair to ask whether this is the best place for providers to fight.
For Providers, a State Common-Law Framework is Sometimes Better
ERISA, for all its charms, is not the only legal route to challenge a demand for recoupment. The common law also merits consideration. Providers may do better pursuing these cases as state contract claims, because in that framework these cases are analogous to a building owner trying to keep building repairs or improvements, long after receiving and enjoying the benefits of those repairs or improvements, without paying for them.
In other words, imagine a carpenter builds a new deck on a house. The carpenter buys the wood and does all the work, and the owner pays for the deck. The owner has the deck, and the carpenter (at least for the time being) has the money (net of whatever he paid for materials). A year later, the owner comes back to the carpenter and says the carpenter didn’t submit daily progress photographs as required by the owner, and demands a full refund of all the money paid for the deck. That sounds crazy. But that is essentially what happens in many cases in which a health insurer imposes a recoupment demand on a healthcare provider. And that presents some opportunities for providers not necessarily available in ERISA cases. The following are some examples.
Common Law Damages
It is blackletter law that the damages in a contract case are those damages caused by the breach. This means that immaterial, trivial breaches of a contract usually result in immaterial, trivial contract damages, at least in the absence of an express agreement to impose a penalty-style remedy for breaches. For out-of-network providers, such provisions are rarely if ever present in their agreements with health plans. Even for in-network providers, it is the rare contract that would justify a complete forfeiture of payment for a trivial breach of an agreed-upon condition.
This is important, because many recoupment claims are based on documentation and claim submission errors. Managed care plans generally take the position that compliance with documentation and claims-submission standards is a necessary precondition to payment because such compliance is (arguably) a requirement for the payment of benefits under the plan document. But these plan documents have invariably never been seen by the provider, let alone expressly agreed to. It is the rare patient indeed who shows up at the hospital, doctor’s office or other healthcare facility with a copy of his or her insurance policy or plan document. These provisions might be important reference points in a traditional ERISA benefit dispute between an insured and the insurer. But in a contract case between the provider and the payer, any payer arguing that a documentation or claim submission shortcoming is a material breach that essentially forfeits any right to payment has an uphill battle.
Common Law Contract Formation
In actual practice, the requirements that form the basis for a recoupment demand are often not part of the contract between a provider and the insurance company. Even if the provider is in-network, the precise reimbursement policies and other standards are often available only through the internet, if at all, and even then are often so vague that they cannot possibly be part of any contractual agreement.
One national health insurer, for example, purports to make its reimbursement policies available online. But a provider can only see them if the provider clicks on a lengthy disclaimer, which essentially obscures any clarity those reimbursement policies might otherwise provide. The language refers to “provider contract documents” as separate from the “reimbursement policies,” and the provider is forced to agree that the reimbursement policies are not necessarily part of the contract before the provider can even get permission to see the reimbursement policies. A litigant seeking to find an enforceable contract term in the reimbursement policies, therefore, has considerable work to do.
The disclaimer language often refer to other documents not generally available to providers, in-network or otherwise. This means the insurer is attempting to enforce, as a material term of the contract, a set of secret requirements that one party to the contract was not allowed to see. That is generally a heavy lift for an insurer in court. In other words, the basic rudiments of contract formation present significant opportunities for providers defending against recoupment claims in court.
The Insurer’s Failure to Involve the Insured
When insurers seek recoupment from providers, they rarely provide notice to the insured patient. The patient obviously has an interest in the dispute, because a provider with an unpaid bill—including a bill that becomes unpaid after the insurer recovers it by recoupment—often has recourse against the patient. Some of these disputes involve amounts that could bankrupt patients and their families in an instant. From the patient’s standpoint, making these decisions without giving the patient notice or an opportunity to be heard runs counter to basic notions of due process and fair play.
In a traditional ERISA dispute about health insurance benefits, ERISA grants significant procedural protections to insureds. Section 503 of ERISA (29 U.S.C. § 1133(1), (2)) requires insurers to provide notice and “a reasonable opportunity to any participant whose claim has been denied for a full and fair review . . . .” Regulations clarify that these standards apply to any “adverse benefit determination,” a term that includes any “denial, reduction, termination, or failure to provide or make payment.” (See 29 C.F.R. § 2560.503-1.) The regulations mandate that insurers making an adverse benefit determination set forth or make available the bases for their decisions; require insurers to make an appeal available; establish timelines for appeals and decisions on appeal; and establish other procedural requirements.
Federal courts have uniformly held that these procedural requirements do not apply to disputes between providers and insurers because the providers are not participants or beneficiaries under ERISA. Thus, if an insurer’s obligations are defined as consisting only of what is required under ERISA, it is entirely permissible for an insurer to raise and pursue recoupment demands without providing the insured patient an opportunity to be heard, and without affording the provider the procedural protections that otherwise apply to benefit disputes under ERISA.
The common law, however, is a somewhat broader canvas. The insured might or might not be an indispensable party to any recoupment dispute; this is a fact-specific issue that is beyond the scope of this section. Whatever the mandatory procedural requirements, however, the procedural unfairness of an insurer’s intentional decision to disenfranchise the insured and its intentional decision to simply ignore the superstructure already in place for benefit disputes are both issues that can fairly be brought to the attention of the court. These arguments are more likely to find traction in a court deciding a common law contract dispute than a court whose task is limited to interpreting ERISA and its regulations.
The Voluntary Payment Doctrine
A common law doctrine known as the volunteer doctrine or voluntary payment doctrine can also play an important part in these cases when they are presented as simple contract disputes. The voluntary payment doctrine is a long-standing doctrine of law, which provides that one who makes a payment voluntarily cannot recover it on the ground that he was under no legal obligation to make the payment.
A voluntary payment within the meaning of this rule is a payment made without compulsion, fraud, mistake of fact or agreement to repay a demand which the payer does not owe, and which is not enforceable against him, instead of invoking the remedy or defense which the law affords against such demand. This latter component is crucial: the voluntary payment doctrine applies even if a payment should not have been made, provided there is some mechanism to determine whether or not the payment is proper, and the payer decided not to invoke or pursue it. This precisely describes the insurer that has available an ERISA mechanism for raising and resolving benefit determinations with its insureds but has decided not to use it.
Under the voluntary payment doctrine, if an insurer or health plan makes a payment to a provider, it cannot later seek repayment on the grounds that the payment was improper. The insurer is pinioned on the horns of a dilemma of its own making, because the payment was either proper under the applicable policy, or it was not. The common law can recognize that the pay-the-provider decision is the same as the cover-the-benefit-for-the-member decision, even if ERISA’s precise statutory scheme does not treat the two decisions identically. If the payment sought to be recouped was a proper payment in the first place, the recoupment demand vanishes. If the payment was not a proper payment, that means its payment was not required under the applicable policy or plan document. And the insurer runs squarely into the voluntary payment doctrine, because the insurer was under no obligation to make the payment, which makes the insurer a volunteer precluded from seeking repayment.
An insurer that has been deceived can demand repayment, but such deception is rarely present, at least in any material sense that would be recognized under common law or equitable principles. The provider promised to provide services, and the insurer promised to pay for them. If a retrospective audit of hundreds of thousands of claims identifies some documentation discrepancies when measured against the exacting, often inscrutable standards of a multi-state insurer’s computer auditing tool, that is not evidence that the provider misled the insurer unless the provider had expressly agreed to comply with those standards, and that is, as noted above, very often not the case.
It is also helpful to consider the slightly broader context of restitution claims. There is a robust body of case law around an insurer’s right to recover claims paid by mistake. There is some variability in how different states have addressed the issue. For present purposes, it is sufficient to note that the common law of restitution leaves considerable space for equitable and quasi-equitable considerations, which would include the provider’s reliance on payments, and the fact that health insurers have vastly greater access to information about whether or not a particular claim should be paid under any particular insurance policy. One might fairly add to this list the presence, in ERISA, of an express, mandatory scheme for raising and resolving coverage disputes directly with insureds. When an insurer decides to pursue a recoupment claim against a provider instead of a direct restitution claim against its insured, it is choosing to not use this mechanism. Indeed, as noted above, insurers very often oppose any efforts by providers to pursue recoupment claims as ERISA benefit disputes. If a health plan or insurer got the claims-payment decision wrong, that can hardly be the fault of the provider. And the broader truth remains — the insurer got its deck, and can’t fairly keep both the deck and the money.
For a provider who decides to proceed under this common-law approach, the most efficient way might be through a simple declaratory judgment complaint, assuming that option is available under applicable state law. As to adding additional claims and causes of action, note that the theoretical availability of a claim is never the only consideration. When litigating, attorneys endeavor to distill sometimes complicated factual and legal scenarios down to simple, unshakable verities. It’s never too early to begin that work, and sometimes the complaint or answer is the best place to start. It can be hard to convince a court that a case is a simple contract dispute if the complaint includes ERISA and other complex federal claims.
There are also jurisdictional implications. In the absence of diversity jurisdiction, a declaratory judgment action can be filed in, and should remain in, state court, particularly if the applicable plan document has an anti-assignment provision (which would make assignment-based provider standing unavailable). That may well be a more hospitable forum for the provider.
When insurers pursue recoupment claims without engaging the patients they insure through the ERISA process and without following the procedural rules that usually apply to ERISA benefit disputes, they are making an affirmative choice to proceed outside of ERISA. Having made that bed, it is hardly unfair to make them lie in it. Fundamentally it boils down to this: if the insurer refuses to dispute the benefit payment in a benefit dispute, then it can’t dispute the benefit payment in a recoupment dispute. By embracing longstanding common law and contract principles, providers can reframe the conversation in a way that leaves the greatest room possible for substantial justice and common sense, two terms that sometimes do not figure prominently in the stated rationales for ERISA decisions. This approach can also serve the common interest, shared by all, in a functioning healthcare system that provides fair and predictable payment for honest work.
The Medicare Secondary Payer Act
Medicare Secondary Payer (“MSP”) is the term generally used when the Medicare program does not have primary payment responsibility – that is, when another entity (i.e., a health insurer or other payer) has the responsibility for paying before Medicare. When Medicare began in 1966, it was the primary payer for all beneficiaries’ claims except for those covered by Workers’ Compensation, Federal Black Lung benefits, and Veteran’s Administration benefits.
In 1980, Congress passed legislation that made Medicare the “secondary payer” to certain primary plans in an effort to shift costs from Medicare to the appropriate private sources of payment. The MSP provisions have protected Medicare Trust Funds by ensuring that Medicare does not pay for items and services that certain health insurance or coverage is primarily responsible for paying. The MSP provisions apply to situations when Medicare is not the beneficiary’s primary health insurance coverage. The Medicare statute and regulations require that all entities that bill Medicare for items or services rendered to beneficiaries must determine whether Medicare is the primary payer for those items or services.
“Primary payers” are those that have the first responsibility for paying a claim. Medicare remains the primary payer for beneficiaries who are not covered by other types of health insurance or coverage. Medicare is also the primary payer in certain instances, provided several conditions are met. CMS develops Conditions of Participation (“CoPs”) and Conditions for Coverage (“CfCs”) that healthcare organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. These health and safety standards are the foundation for improving quality and protecting the health and safety of beneficiaries. They are a core set of patient health and safety requirements that often represent congressional prerogatives and/or the informed judgment of public health and other policy experts. CMS also ensures that the standards of accrediting organizations recognized by CMS (through a process called “deeming”) meet or exceed the Medicare standards set forth in the CoPs/CfCs.
When there is more than one payer potentially responsible to pay a claim, coordination of benefits (“CoB”) rules decide which one pays first. The “primary payer” pays what it owes on patient bills first, and then sends the rest to the “secondary payer” to pay. In some cases, there may also be a third or “tertiary” payer. The insurance that pays first (the primary payer) pays up to the limits of its coverage. The one that pays second (the secondary payer) only pays if there are costs the primary insurer did not cover. The secondary payer (which may be Medicare) may not pay all the uncovered costs. If the insurance company does not pay the claim promptly (usually within 120 days), a provider may bill Medicare. Medicare may then make a “conditional” payment to pay the bill, but will seek to recover any payments the primary payer should have made.
In providing services to Medicare beneficiaries, providers need to keep these Medicare Secondary Payer rules in mind, to the extent the patient may have other coverage, which may be primary. And disputes over such issues are another area where we, as healthcare counsel, may be of assistance.
Medicare Fee for Service Recovery Audit Program
The Recovery Audit Contractor (“RAC”) program was created through the Medicare Modernization Act of 2003 to identify and recover improper Medicare payments paid to healthcare providers under fee-for-service Medicare plans. Recovery Audit Contractors (“RACs”) are private companies contracted by CMS to identify Medicare overpayments and underpayments and return Medicare overpayments to the Medicare Trust Funds.
RACs do not create payment policies. The payment policies RACs use are determined by Medicare regulations, Medicare billing instructions, National Coverage Determinations and Local Coverage Determinations. RACs detect and correct past improper payments so that CMS, carriers and MACs can implement actions that will prevent future improper payments. RACs attempt to identify improper payments resulting primarily from:
- Non-covered services (including services that are not reasonable and necessary);
- Incorrectly coded services;
- Claims for services provided by unlicensed individuals (even if the individuals are working toward licensure and supervised by a licensed individual); and
- Duplicate services
RACs review claims submitted by hospitals, health systems, physicians, home health agencies and other healthcare providers on a post-payment basis. RACs use proprietary software to identify claims that are likely to contain improper payments. RACs concentrate their reviews on areas identified by the Comprehensive Error Rate Testing as having a high propensity for error. Because they are compensated based upon amounts collected from and/or returned to Medicare by providers or suppliers as a result of improper payments, RACs are highly motivated to identify overpayments and other improper payments.
The RAC process usually proceeds as follows. First, the RAC identifies a risk pool of claims. Second, the RAC requests medical records from the provider. Once the records are received by the RAC, it reviews the claims and medical records. Based on the review, the RAC will make a determination — either overpayment, underpayment or correct payment. If it is determined that an overpayment exists, the RAC sends the file to the MAC to adjust the claim and recoup the payment. The MAC will notify the provider via an overpayment notification letter.
If an overpayment is owed back to the Medicare program, the healthcare provider has several options. The provider can pay by a check, allow recoupment from future payments, request an extended payment plan, or appeal the determination. The Medicare appeals process applies.
After a physician or healthcare provider receives notice of overpayment determination by a RAC, the provider generally has three options: (1) discuss the determination with the RAC, (2) attempt to rebut the determination, and/or (3) request a redetermination. These options are not mutually exclusive.
First, the provider has an opportunity to “discuss” the determination with the RAC. The provider can provide additional information to the RAC, indicating why it contends recoupment should not be initiated. The RAC can also further explain the rationale for the overpayment decision. The provider should contact the RAC directly and supply the additional information within 30 days of the receipt of the Initial Findings Letter (when there has been an Automated Review) or the Review Results Letter (when there has been a Complex Review). Otherwise, offset begins on day 41.
Second, the provider may attempt to “rebut” the RAC determination. What this actually means is the provider can offer a statement and accompanying evidence indicating why the overpayment action will cause significant financial hardship and should not take place. The rebuttal process is not to be used to submit or request review of supporting medical documentation or disagree with the overpayment decision. A rebuttal should also not to be used to duplicate or preview a redetermination request or process. Providers that wish to exercise the rebuttal option must contact the MAC or Claim Processing Contractor directly. The rebuttal must be filed within 15 days of the date of the Demand Letter.
Third, the provider can request a redetermination. A redetermination is the first level of appeals. The redetermination request should be filed within 30 days from receipt of the Demand Letter to avoid an offset. (It can be submitted up to 120 days afterwards, but to avoid an offset, it should be filed within 30 days). The redetermination request must be submitted to the MAC or Claim Processing Contractor.
It is critical for physicians or other healthcare providers to respond in a timely manner to a demand letter based on a RAC determination that a Medicare overpayment exists. If the time filing requirements are exceeded, the provider’s options and prospects for relief will be limited.
At a minimum, preparation for possible RAC audits should include:
- Establishing and implementing proper coding and billing compliance policies and procedures;
- Monitoring areas that may be subject to RAC review;
- Conducting internal claim reviews and audits;
- Establishing systems to timely respond to RAC record requests within required timeframes; and
- Monitoring and appealing claim denials through the Medicare appeals process.
It is crucial to carefully review any and all claims that have been determined to be overpaid. If an actual overpayment exists, a provider should try to determine how and why the overpayment occurred. In addition to healthcare law firms such as ours, various consulting experts can assist physicians and other healthcare providers in analyzing their claims and determining causes for a RAC audit or Medicare overpayment determination.
It is generally unwise to attempt to defend yourself or your practice without experienced assistance, since the stakes and potential for adverse outcomes are high. Depending on the reason(s) for overpayment, penalties and legal exposure may include not only recoupment of sums improperly paid, but also civil monetary penalties, being placed on OIG’s integrity watch list for Medicare fraud, exclusion from the Medicare program, and criminal charges.
Medicare’s 60-Day Repayment Rule
Hospitals, medical groups, and individual physician practices have long been subject to refunding Medicare payments in response to demand letters from Part A and Part B administrative contractors, and more recently from Medicare Recovery Audit Contractors. Such demands typically resulted from claims reviews or audits, and providers’ refund exposure was generally limited to amounts paid in connection with the disputed claims. Providers also voluntarily work credit balances for Medicare, other payers and patients, and generally reconcile minor over and under payments through routine claims processing adjustments. In certain instances, however, providers face more serious claims under the False Claims Act (“FCA”), initiated by either the government or qui tam “whistleblowers.”
When Congress enacted the Affordable Care Act (“ACA”) in 2010, it increased the obligations and liability exposure for physicians and other Medicare providers and suppliers by including what is generally referred to as the “60-day repayment rule.” That provision requires timely refund of any overpayment which has been identified by the provider. In some circumstances, failure to identify the overpayment or make a timely refund can become grounds for a False Claims Act charge. (42 U.S.C. § 1320a-7k(d)(2).)
Overpayments are typically identified by providers when an employee, staff member, department or service area has systematically made a mistake in billing or documenting a service. Identified errors often span across payer types and normally include both Medicare and Medicaid, as well as possibly other governmental programs.
The ACA requires any person who has received an overpayment from certain defined government health programs to report and return the overpayment within 60 days after the overpayment is identified. If an overpayment is not repaid, or if a self-disclosure is not made before the expiration of the 60-day period, the overpayment amount becomes subject to penalties under the FCA. The FCA imposes damages based on 3 times the actual overpayment, plus a per claim amount of between approximately $11,000 and $22,000.
The damage provisions of the FCA create very strong incentives for providers to self-disclose and/or repay identified overpayments. (See our Stark, Anti-Kickback, Civil Monetary Penalty and FCA Issues webpage for additional information.) The FCA also creates a strong incentive for providers to operate effective compliance programs in order to avoid the imputation of liability based on a “should know” standard. (See the Compliance Plans & Agreements section of our Healthcare & Physician Contracts webpage for additional information.) The “should know” standard assumes that a provider operates an effective compliance program including proactive efforts to identify and audit potential risk areas.
In order to avoid imposition of FCA penalties, repayment must be made within 60 days after the overpayment is identified or a corresponding cost report is due. Regulations provide some assistance for defining when a provider is deemed to have “identified” an overpayment and when the 60-day clock begins to tick. But ambiguities and questions remain. And the stakes are high. So, caution and careful attention are advised.
The statute and corresponding repayment obligation have very broad application. The repayment rules apply to Part A of Medicare, Part B of Medicare, Medicare Advantage, Medicaid Fee-for-Service, and Medicaid Managed Care.
CMS considers the ACA’s statutory requirement to be effective on its face, without implementing regulations. However, CMS published a proposed implementing rule in 2012, and that rule, somewhat revised, was later published as a final regulation on February 12, 2016 (the “Final Rule”). (See 81 Fed. Reg. 7654-7684 (Feb. 12, 2016). CMS issued a separate Final Rule on the 60-day repayment requirement for Medicare Parts C and D overpayments in 2014. See 79 Fed. Reg. 29844 (May 23, 2014). As of this writing, CMS has not issued rules with respect to Medicaid overpayments.)
The Final Rule provided greater clarity to providers on how the repayment requirement is to be interpreted and applied. Key aspects of the Final Rule include the following:
- An overpayment is any Medicare payment received or retained by the provider to which it is not entitled, regardless of the cause. An erroneous payment by the Medicare contractor, through no fault of the provider, is still an overpayment.
- The 60-day repayment clock will begin to run only after the provider has identified the overpayment and quantified the amount, so long as the provider exercises reasonable diligence in doing both.
- Reasonable diligence includes both proactive compliance activities designed to detect overpayments and reactive investigations designed to quantify overpayments in response to credible information.
- Whether a provider had credible information of an overpayment triggering an obligation to investigate, and whether it exercised reasonable diligence in investigating, are both fact specific. They may also be, at least to some extent, resource specific. CMS is not likely to expect the same sophistication, particularly in terms of proactive compliance activities, from a three-person primary care practice as compared to a 20-person single-specialty or 100-person multi-specialty group.
- In nearly all circumstances, investigation and repayment should be completed within eight months—six months to investigate and quantify, and the ACA’s 60 days to refund and report.
- Failure to exercise reasonable diligence causes the 60-day repayment clock to revert back to the date the provider received credible information. For example, if a medical group gets credible evidence and ignores it, or drags its feet in quantifying the repayment, it will be deemed in violation after 60 days, not eight months.
- The obligation to refund, particularly when the overpayment problem is systemic, can go back 6 years. (CMS originally proposed this “lookback” period to be 10 years, so the Final Rule was somewhat of an improvement. But RAC audits have only looked back 3 years, and routine contractor demand letters typically only go back one year, or four for “good cause.”)
- Reporting and refund forms and procedures are determined by the Medicare contractor from whom the overpayment was received.
Overpayments can occur for a variety of reasons. And not all of them are because a provider did anything wrong or was negligent in any way. But the 60-day repayment rule puts the burden on providers to timely identify and refund governmental overpayments, or face increased penalties.
Medicare Provider Reimbursement Review
The Provider Reimbursement Review Board (“PRRB”) is an independent panel to which a certified Medicare provider of services may appeal if it is dissatisfied with a final determination by its Medicare contractor or by CMS. See regulations at 42 C.F.R. § 405, Subpart R.
If you have questions about filing an appeal, the status of a current appeal, etc., you can contact the PRRB via its main telephone line at 410-786-2671 or by e-mail at PRRB@cms.hhs.gov. Or, we would be happy to assist you.
Accountable Care Organizations
Hospitals and health systems continue to test and adopt alternative payment and delivery models besides fees-for-service, such as Accountable Care Organizations. Accountable Care Organizations (“ACOs”) are groups of clinicians, hospitals and other healthcare providers who come together voluntarily to give coordinated high-quality care to a designated group of patients. While some private insurance plans have contracted with ACOs, this section refers mainly to Medicare ACOs.
Coordinated care seeks to ensure that patients, especially the chronically ill, get the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. Under Medicare, when an ACO succeeds both in delivering high-quality care and spending healthcare dollars more wisely, it will share in the savings it achieves for the Medicare program.
The ACO model was included in national healthcare reform legislation as one of several demonstration programs to be administered by CMS. Participating ACOs assume accountability for improving the quality and cost of care for a defined patient population of Medicare beneficiaries. ACOs in turn receive part of any savings generated from care coordination as long as quality was also maintained.
Medicare offers several different types of ACO programs, including:
- Medicare Shared Savings Program (cms.gov) – works to achieve better health for individuals, better population health, and lowering growth in expenditures for fee-for-service beneficiaries
- ACO Investment Model – for ACOs to test pre-paid savings approaches to support Medicare Shared Savings Program in rural and underserved areas
- Advance Payment ACO Model – for certain eligible providers already in or interested in the Medicare Shared Savings Program
- Next Generation ACO Model – for ACOs experienced in managing care for populations of patients; allows providers to assume more financial risk than other ACO programs
- Pioneer ACO Model – for healthcare organizations and providers already experienced in coordinating care for patients across care settings
- Comprehensive ESRD Care Initiative – for beneficiaries receiving dialysis services
Under the Medicare Shared Savings Program (“MSSP”), ACOs are held accountable for the total cost of care and quality outcomes for an assigned beneficiary population. In the one-sided model, ACOs receive a share of any savings, but don’t take on any financial risk if spending exceeds their benchmark. ACOs in the two-sided model have downside financial risk, meaning they must pay Medicare for any losses. At the same time, these ACOs share a larger portion of any savings.
In December 2018, CMS issued a final rule that redesigned the MSSP, including accelerating the pace for participating ACOs to take on financial risk. The final rule lowered shared savings rates from 50% to 40% for one-sided models in the basic track. For all two-sided models in the basic track, the savings rate was set at a maximum of 50%.
In July 2020, CMS announced the release of a new toolkit highlighting strategies used by ACOs to engage providers. Specifically, the toolkit explores how ACOs:
- Communicate with providers about the ACO as a value-based care organization;
- Use data to identify and address opportunities for improving care;
- Offer customized support to primary care providers and specialists; and
- Implement financial incentives.
The provider engagement toolkit is the third in a broader series designed to educate the public about the strategies ACOs use to provide value-based care while also providing actionable ideas to current and prospective ACOs to help them improve or begin operations. CMS released the first toolkit on care coordination in April 2019 and the second toolkit on beneficiary engagement in November 2019. More information on the toolkits, including the previously-released care coordination toolkit and beneficiary engagement toolkit, can obtained by visiting the ACO General Information web page.
On July 24, 2020, House lawmakers introduced a bipartisan bill that would make “commonsense changes” to requirements for Medicare’s Alternative Payment Models (“APMs”) and ACOs in an effort to increase participation in these value-based payment programs. According to a summary of the legislation, the “Value in Health Care Act” would increase the percent of shared savings that new ACOs in the MSSP receive.
“The vast majority of ACOs begin in shared savings-only models before advancing on the path to risk-bearing models, and models need to remain attractive enough to create a pipeline for ACOs to assume risk,” the legislative summary states. The bill would raise the MSSP basic track shared saving rates for one-sided models back to 50% and for two-sided models to between 55% and 60%. It also would modify risk adjustment to “better reflect factors participants encounter like health and other risk variables in their communities”; remove barriers to ACO participation; modify performance metrics so participants aren’t competing against their own successes in improving care; and extend the annual 5% participation bonus for Advanced APMs for an additional six years.
Thirteen national health care groups announced their support of the measure, including the National Association of ACOs, American College of Physicians, the American Medical Association and the American Hospital Association. According to its supporters, the Value in Health Care Act would make sensible modifications to the existing APM parameters and encourage more providers to participate. This ultimately would help patients by improving the quality of care and outcomes.
On May 24, 2021, RevCycle Intelligence (LaPointe) reported that the Next Generation ACO Model “will come to an end at the end of this year as planned despite several calls for an extension, according to an email to model participants.” According to the email, “CMS doesn’t expect to ‘extend or expand’ the model since the model has ‘net-spending increase of $117.5 Million and no net savings for CMS.’”
On October 20, 2021, RevCycle Intelligence (Bailey) reported that “A group of healthcare organizations, led by the National Association of ACOs (NAACOS), has asked CMS to provide” ACOs “with the option to use pre-pandemic years to set Medicare Shared Savings Program (MSSP) benchmarks.” Under CMS’ current policy, “ACOs that renew MSSP agreements and new ACOs that enter the MSSP in 2022 will receive benchmarks that are based on spending targets from 2019 to 2021,” but the group believes “using spending targets from 2020 to set benchmarks for 2022 would be unfair to ACOs” due to spending variations during the COVID-19 pandemic. The request was announced in a press release.
Transparency in Coverage and Prices
In October 2020, the Departments of HHS, Treasury and Labor issued the “transparency in coverage” final rule. This final rule imposes new transparency requirements on group health plans and health insurers in the individual and group markets. HHS also released an accompanying fact sheet and press release. The final rule requires insurers to disclose out-of-pocket cost information, and the underlying negotiated rates, for all covered healthcare items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. This is the companion rule to a 2019 healthcare facility price transparency final rule that became effective on January 1, 2021.
On August 20, 2021, the Departments of Labor, HHS and Treasury issued FAQs regarding implementation of certain provisions of the Affordable Care Act, the No Surprises Act and the transparency rule. Like previously issued FAQs (available at, e.g., http://www.cms.gov/cciio/resources/fact-sheets-and-faqs/index.html), these FAQs answered questions from stakeholders to help people understand the law and promote compliance.
On December 29, 2020, the U.S. Court of Appeals for the District of Columbia Circuit upheld the White House-backed rule requiring hospitals to disclose the prices they negotiate with insurers for many tests and procedures. The American Hospital Association and other hospital groups had challenged the rule, which was issued in November 2019 and became effective on January 1, 2021. Generally, the rule requires hospitals to provide accessible pricing information online about the items and services they provide.
The AHA and other stakeholders argued that the rule violated section 2718(e) of the Public Health Service Act, the Administrative Procedures Act, and the First Amendment. However, the DC Circuit ruled that limiting hospital’s publication of charges to solely Medicare charges would be redundant of Medicare’s statute, and also conflict with section 2718(e), which requires a hospital to publish each of its charges, rather than just charges set by the Secretary of HHS. The DC Circuit also emphasized that the rule “does not require hospitals to disclose all possible permutations of costs based on hypothetical care,” but, rather, hospitals must disclose base rates for an item or service. The DC Circuit affirmed the District Court’s grant of summary judgment, meaning compliance with the rule is required as of the start of 2021. (The case is American Hospital Association, et al. v. Azar, No. 20-5193 (D.C. Cir. 2020)).
After the rule requiring the nation’s hospitals to reveal the rates they negotiate with insurers for various procedures took effect in January 2021, data from the country’s 6,000 hospitals showed that prices vary significantly depending upon who is paying. This, of course, came as no surprise to providers and other industry observers. But it highlights the wide disparity in rates negotiated by insurers, which many experts argue significantly contributes to the affordability crisis in American healthcare.
In March 2021, CMS issued guidance stating that healthcare pricing data must be posted online in a way that does not hide the information from web searches. The guidance followed news reports that found many hospitals used special codes to hide such information from search engines. CMS’ guideline basically requires that all files uploaded by health plans and health insurers must be in formats available to the public without restrictions that would impede the re-use of that information.
In April 2021, ranking members of the U.S. House Energy and Commerce Committee sent a letter to HHS urging it to enforce the rule requiring hospitals to post prices (including the hospital gross charge, discounted rate, and payer-specific negotiated rates) in two formats on their website: a machine-readable file for healthcare stakeholders and a consumer-facing tool that allows patients to search for lower priced care. The letter cited evidence of hospitals’ alleged non-compliance.
By the end of April 2021, after reviewing hospital websites, CMS had begun notifying hospitals it deems are not complying with requirements in the hospital price transparency rule. CMS sent notices, for example, when auditors said they were unable to locate the required machine-readable file on a hospital’s website.
CMS has said the hospital regulation requires the data to be “easily accessible and void of barriers” and that digital files “be digitally searchable.” HHS previously said it expects hospitals to comply with the price transparency guidelines, and it will enforce them. However, on April 27, 2021, CMS issued its proposed rule for the Inpatient Prospective Payment System for fiscal year 2022, which begins October 1. One proposed change would be to no longer require hospitals to report median payer-specific negotiated charges for Medicare Advantage insurers on their Medicare cost reports. If this change is finalized, it would be retroactive to Jan. 1, 2021, when the hospital price transparency rule went into effect despite providers’ efforts to block it.
According to a PatientRightsAdvocate.org study reported by the Washington Post on July 16, 2021, just 5.6% of all U.S. hospitals are fully compliant with CMS’ price disclosure rule. Other notable findings of the study were:
- 80% of hospitals did not publish payer-specific negotiated charges.
- 40% of hospitals published discounted cash prices.
- 52% of hospitals did not publish any negotiated rates.
- 19% of hospitals presented 300 shoppable services in a consumer-friendly format, but a significant number of these presented incomplete data fields, making them ultimately noncompliant.
- 76% of hospitals published a price estimator tool. Out of these hospitals, 11% of them did not allow users to see the discounted cash price.
An Atlanta Journal-Constitution investigation found that as of early July 2021, only one of 14 Georgia hospitals it studied made prices easy to find, and nearly half failed to meet key requirements of the pricing transparency mandate. The hospitals that were found to be fully compliant with the federal price transparency rule had a few strategies in common, including having a good technology partner and beginning their efforts early — in some cases before the rule was even proposed.
Perhaps not coincidentally, on July 19, 2021, CMS issued its Outpatient Prospective Payment System proposed rule for 2022. To improve price transparency compliance, CMS proposed increasing the minimum fine for violations to up to $2 million per year. Specifically, hospitals with more than 30 beds in violation of the rule would pay $10 per day for each bed, up to $5,500 per day. Hospitals with 30 beds or fewer would continue to pay up to $300 per day. This would make the annual penalty at least $109,500, or as high as $2 million a year for large hospitals that fail to make prices public. The proposed rule also would crack down on the use of special coding that prevents search engines from displaying pricing in search results.
The New York Times reported that as of August 22, 2021, many hospitals appeared to be ignoring the price transparency rule and posting nothing. But data from the hospitals that complied showed hospitals were charging patients vastly different amounts for the same basic services. And the data showed numerous examples of health insurers negotiating surprisingly unfavorable rates for their insureds. Indeed, in many cases, insured patients were being charged higher prices than they would be if they had no coverage at all – contrary to what most people expect when they pay for health insurance.
As of July 2021, CMS had sent nearly 170 warning letters to noncompliant hospitals but had not yet levied any fines. Hospitals that do not post prices within 90 days of a warning letter may be sent a second warning letter. And, as noted above, CMS plans to increase the fines in 2022 to as much as $2 million annually for large hospitals.
On November 2, 2021, RevCycle Intelligence (LaPointe) reported, “Starting January 1, CMS will increase penalties for noncompliance with hospital price transparency requirements under the newly released Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule.” The rule “sets the minimum civil monetary penalty of $300 per day for smaller hospitals with a bed count of 30 or fewer, and a penalty of $10 per bed per day for hospitals with a bed count greater than 30.” Still, “the penalty is not to exceed a maximum daily dollar amount of $5,500.”
As of December 2021, CMS had issued noncompliance notices to approximately 335 hospitals and asked 98 hospitals to submit plans for how and when they would comply with the federal rules, according to The Wall Street Journal. As of January 1, 2022, some hospitals and health systems had posted incomplete data and others still had posted nothing at all. CMS is providing hospitals with technical help and information to boost compliance with the rules. CMS hasn’t said when it will begin penalizing hospitals. Please stay tuned for updates.
On April 19, 2022, CMS issued new FAQs regarding compliance with the machine-readable file requirements of the Transparency in Coverage regulations. The Transparency in Coverage final rule, which the Departments of Health and Human Services, Labor and Treasury issued in October 2020, requires most group health plans and health insurance issuers in the individual and group markets to disclose on a public website three separate machine-readable files of in-network provider rates for covered items and services, out-of-network allowed amounts and billed charges for covered items and services, and negotiated rates and historical net prices for covered prescription drugs by January 1, 2022.
In previous FAQs, the agencies postponed enforcement of the requirement to publish machine-readable files for in-network rates and out-of-network allowed amounts and billed charges until July 1, 2022. The agencies also deferred enforcement of the rule’s requirement that plans and issuers publish machine-readable files for prescription drug pricing pending future rulemaking.
In the latest FAQs, the agencies announced an enforcement safe harbor for satisfying the reporting requirements for plans and issuers that use alternative reimbursement arrangements that do not permit them to derive with accuracy specific dollar amounts contracted for covered items and services in advance—for example, if they contract with an in-network provider to pay a percentage of billed charges. Plans and issuers may instead disclose a description of the formula, variables, methodology, or other information necessary to understand the arrangement, the FAQs said.
The agencies will monitor the implementation of the machine-readable files requirements and may revisit the safe harbor in the future, the FAQs said. The safe harbor does not apply if the agencies determine that a particular arrangement can sufficiently disclose a dollar amount.
On June 7, 2022, CMS issued its first hospital price transparency fines to two Georgia hospitals for failing to make their standard charges available to the public. The first civil monetary penalty (“CMP”) was issued against Northside Hospital Atlanta in the amount of $883,180.
According to the notice posted by CMS, the hospital did not make public a machine-readable file containing a list of all standard charges for all items and services and failed to display shoppable services in a consumer-friendly manner. CMS said the hospital must notify the agency once it has come into compliance or the CMP will continue to accrue. According to CMS, a warning notice was issued to the hospital on April 19, 2021, but the hospital did not respond.
The other CMP was issued to Northside Hospital Cherokee for $214,320 after the hospital failed to make public a machine-readable file containing a list of all standard charges for all items and services and failed to display shoppable services in a consumer-friendly manner. CMS said the hospital received a warning letter dated May 18, 2021, but didn’t respond.
Coronavirus/COVID-19 Pandemic Reimbursement Updates
Provider Reimbursement Review Board Alert 19 Amends Procedures in Light of Coronavirus Pandemic
(This update came from the American Health Law Association’s Regulation, Accreditation & Payment Practice Group, and Kenneth R. Marcus of Honigman LLP.)
On March 25, 2020, in response to the COVID-19 pandemic, the Provider Reimbursement Review Board issued Alert 19 (the numbering is entirely coincidental), which suspends what the PRRB calls “Board Set Deadlines” and provides other special instructions regarding Board procedures during the pandemic. In issuing Alert 19 “[t]he Board recognizes that the immediate focus and priorities of Providers should be on caring for their patients. Likewise, the Board wants to ensure the health and safety of all relevant parties before the Board, while continuing to operate in the most efficient manner possible.” Recognizing the fluidity of the crisis, “the Board plans to continuously reassess its response and will issue additional updates through Board Alerts, as necessary.” Providers and their representatives are well advised to review Alert 19 and, as always, to remain vigilant regarding filing deadlines. Additional details are available here.
On June 16, 2021, the Provider Reimbursement Review Board issued Alert 21, titled “Mandatory Electronic Filing & Revised PRRB Rules, Effective November 1, 2021 and Change of Address, Effective Immediately.” Alert 21 serves public notice of “revisions to the Board Rules, which are effective November 1, 2021 and will supersede all previous rules and instructions.” The Board Order adopts mandatory electronic filing and the revised Board Rules implementing this mandate as well as other revisions. The proposed revisions to the Board Rules supersede Rules 2.0 (August 29, 2018). Comments may be submitted until July 30, 2021.
CMS Promotes Telehealth & Expands Accelerated & Advance Payment Program & Medicare Telehealth Services Benefit
In a March 24, 2020 FAQ, CMS stated that “[t]he widespread availability and usage of telehealth services is vital to combat COVID-19” and expressed support for the promotion of telehealth by issuers, saying: “We strongly encourage all issuers to promote the use of telehealth services, including by notifying policyholders and beneficiaries of their availability, by ensuring access to a robust suite of telehealth services, including mental health and substance use disorder services, and by covering telehealth services without cost sharing or other medical management requirements.“
In the individual and small group markets, CMS will permit “any service provided through telehealth that is reimbursable under applicable state law and otherwise meets applicable risk adjustment data submission standards” to be used for purposes of the risk adjustment program.” (See CMS’s Risk Adjustment FAQ on COVID-19, Apr. 27, 2020, here.) On March 28, 2020, CMS announced an expansion of its accelerated and advance payment program for Medicare participating healthcare providers and suppliers to ensure they have the resources needed to combat COVID-19. CMS’s fact sheet appears here. On April 2, 2020, CMS provided the AHA and hospitals additional details on the accelerated/advanced payment program. See the AHA advisory here for details.
On April 3, 2020, CMS released a video providing answers to common questions about the Medicare telehealth services benefit. CMS is expanding this benefit on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act. (See CMS’s News Alert, Apr. 6, 2020, here.) CMS provided technical guidance including the telehealth codes eligible for inclusion in risk adjustment, such as:
- HCPCS codes G0425, G0426, G0427, G0406, G0407, G0408, G0459, G0508, and G0509;
- Other services may be eligible for inclusion by using modifier codes such as 95, GQ, or GT, or with a place or service code “02”; and
- Six e-visit codes will be designated to expand the use of telehealth and virtual care and valid for risk adjustment purposes—CPT Codes 99421-00423 and HCPCS codes G2061–G2063.
Helpful information about telehealth for both healthcare providers and patients can be viewed at telehealth.hhs.gov. Other telehealth and virtual care guidelines can be accessed at https://www.hhs.gov/coronavirus/telehealth/index.html. The AMA also continues to update its Quick Guide to Telemedicine in Practice, a resource designed to help mobilize remote care with implementation tips, as well as a reference to CPT codes for reporting telemedicine and remote care services.
Georgia Emergency Waivers & Flexibilities to Help Fight COVID-19 Approved by CMS
On March 28, 2020, Governor Kemp and the Department of Community Health (“DCH”) submitted a request to CMS for an 1135 Medicaid waiver. Concurrently, the Georgia Hospital Association (“GHA”) submitted a request to CMS for an 1135 Medicare waiver. These waivers are intended to increase healthcare providers’ ability to care for patients as they fight COVID-19 by reducing federal regulations.
The 1135 Medicaid and Medicare waivers are a significant step toward easing administrative burdens on Georgia hospitals and healthcare providers during the public health emergency without compromising quality of care or patient safety. “Additionally, these requests would make it easier for patients to be treated at home when possible, remove any red tape to allow for transferring patients to appropriate care settings, and expedite credentialing of providers to reinforce the healthcare workforce across the state,” according to Earl Rogers, GHA’s president.
“Pending CMS consideration and approval, Georgia’s 1135 waiver is designed to provide a number of flexibilities for Medicaid and PeachCare for Kids® providers and members. Some examples of requested flexibilities include modifying the Medicaid authorizations process to enhance fee-for-service prior authorization requirements by extending certain pre-existing authorizations; expediting long-term care services and supports process for pre-admission screening and annual resident review; extending fair hearings and appeal timelines for managed care and fee-for-service enrollees; streamlining provider enrollment, recredentialing, and revalidation processes, including for out-of-state providers; modifying reporting and oversight requirements in certain healthcare facilities; and expanding provider settings to help ensure our providers can deliver care in non-traditional settings. These waiver requests, in addition to a recent expansion of telehealth options for patients and providers, will help to promote access to care during this unprecedented public health emergency,” according to DCH Commissioner Frank Berry.
By March 30, 2020, CMS had approved Georgia’s 1135 Medicare waiver request. The list of approved waivers can be viewed here. On April 1, 2020, CMS approved Georgia’s section 1135 waiver request on the temporary checklist, granting the state a number of flexibilities for Medicaid and PeachCare for Kids® providers and members to combat the COVID-19 public health emergency. CMS’s “Coronavirus Waivers & Flexibilities” webpage can be accessed here. And CMS’s Medicaid Telehealth and Substance Use Disorder Prevention Guidance can be viewed here. CMS has also issued new guidance to states to allow temporary COVID-19-related modifications in provider payment methodologies and capitation rates under Medicaid managed care plans. States would be allowed to use directed payments to increase provider payments within managed care arrangements. (See the AHA bulletin.)
On May 20, 2020, CMS approved Georgia’s emergency Medicaid state plan amendment (“SPA”), which modifies certain policies and procedures under Georgia’s Medicaid state plan for the period of the national COVID-19 public health emergency (“PHE”). Among other things, the SPA suspends all copayments for individuals covered by Medicaid for the duration of the PHE; permits telehealth services that are provided via telephone to be reimbursable under Medicaid for the duration of the PHE; and provides for periodic interim payments to be made to skilled nursing facilities for the duration of the PHE.
However, on Dec. 23, 2021, the Biden administration rejected Georgia’s work or activity requirement. CMS only rejected the state’s work requirement and premiums; the coverage expansion to 100 percent of the poverty level was left in place. On January 21, 2022, Georgia filed suit against the Biden administration in the U.S. District Court for the Southern District of Georgia, Brunswick Division, demanding that the state be allowed to impose a work and activity requirement for some Georgians in order to qualify for Medicaid insurance. Courts have ruled that work requirements do not meet the objective of the Medicaid law, which was to provide health coverage. But the Kemp administration has argued that the engagement requirement is not a work requirement. Please stay tuned for updates.
Coverage for COVID-19 Testing & Treatment/Health Insurers Temporarily Waive Treatment Cost-Sharing During Crisis
On March 30, 2020, health insurers Cigna and Humana announced that they would waive consumer costs associated with COVID-19 treatment. And just before that, CVS Health announced a more limited change — that Aetna would waive costs to patients for hospital admissions related to the coronavirus. So far, Aetna and Cigna are pledging to waive COVID-19 treatment costs through qualified medical bills that are incurred until June 1, 2020. As of this writing, Humana’s policy does not yet have an end date.
Anthem announced that effective April 1, 2020, plan members being treated for COVID-19 will have their cost sharing waived. The for-profit Blue Cross/Blue Shield insurer said the expanded coverage would continue through May 31, 2020, and it is encouraging self-funded employers to do the same. “During these challenging times, Anthem stands by our legacy and commitment to living our values and supporting those we serve,” said Anthem President and CEO Gail Boudreaux, in a statement.
Shortly thereafter, UnitedHealthcare became the latest big-name insurer to waive members’ cost-sharing for COVID-19 treatments. UHC said it would waive the associated costs for members in its fully insured commercial, Medicare Advantage and Medicaid plans. The insurer added that it is working with interested self-funded employer plans to offer the same waivers. The UHC waivers will be available through May 31, 2020. UHC also announced that it will waive cost-sharing for in-network telehealth visits that are not for COVID-19-related needs through June 18, 2020. This is in addition to existing waivers for telehealth visits for COVID-19 testing and for virtual visits with the insurers’ preferred partners.
On April 1, 2020, Centene, the parent company of Peach State Health Plan’s Medicaid, Medicare and exchange plans, also announced that it is waiving cost shares for testing and treatment related to COVID-19. Centene also announced a number of efforts to support communities and safety net providers, including FQHCs, behavioral health and long-term care providers. And other health plans are taking similar steps.
On April 1, 2020, the American Hospital Association urged the nation’s five largest private health insurance companies – Aetna, Anthem, Humana, Cigna and UnitedHealthCare – and organizations that represent insurers to support stable cash flow, eliminate administrative processes that delay payment, provide adequate coverage and reimbursement, and expedite processing of outstanding claims. AHA’s letters to the insurers can be viewed here.
On April 11, 2020, it was reported that the Administration said “it will require health insurers to provide free antibody tests that could provide better insight into the scale of the U.S. coronavirus outbreak.” Congress has “required that all Americans, including people without health insurance, receive free diagnostic tests to determine whether they are sick with coronavirus.” The Administration “said it had authority from recent emergency rescue packages to mandate private insurers also provide antibody testing without out-of-pocket costs.”
Also on April 11, 2020, CMS, DOL and the Treasury Department issued guidance to health plans clarifying coverage requirements for private payers in the CARES Act and the FFCRA. Under the bills, commercial health plans are required to provide access to COVID-19 testing and visits for care related to the virus through doctors’ offices, urgent care centers, and emergency departments available at no cost. CMS also said that the mandates will extend to antibody testing once it is made more readily available. And in response to questions, on April 21, 2020, CMS encouraged health insurers to relax otherwise applicable utilization management processes, as permitted by state law, to ensure that staff at hospitals, clinics and pharmacies can focus their limited time and resources on care delivery.
On May 29, 2020, Bloomberg Law reported that “At least five insurers … have decided to lengthen the period for which they would waive out-of-pocket costs related to the coronavirus past the initial June 1 end date, according to America’s Health Insurance Plans (AHIP), an industry trade group.” The insurers’ decisions on whether to continue to waive patient costs came as the nation began to emerge from a months-long lockdown. But starting at the end of 2020 and continuing into the spring 2021, a growing number of insurers ended those fee waivers for COVID treatment on some or all policies. An AHIP summary of how health insurers are responding to the pandemic can be accessed here.
In the wake of large anti-racism demonstrations and increased group gatherings around the country, public health officials have been encouraging protesters and more people in general to get tested for the coronavirus. However, as such precautionary testing has become more common, some health insurers are arguing they cannot pay for everyone who is concerned about their risk to get tested. While the Families First Coronavirus Response Act passed by Congress and effective April 1, 2020, requires health plans to fully pay for testing deemed “medically necessary,” as testing continues to expand to allow people without symptoms to be tested, a “gray area” has emerged. CMS’s guidance says full coverage is required “when medically appropriate for the individual, as determined by the individual’s attending health care provider in accordance with accepted standards of current medical practice.” But that guidance leaves room for argument between payers on the one hand, and providers and patients on the other.
Moreover, according to guidance released by the Trump administration on June 23, 2020, “insurers are not required to cover COVID-19 tests that employers may mandate as they bring employees back to work.” While the Families First Coronavirus Response Act required insurers to cover COVID-19 tests without patient cost-sharing, the guidance clarified that “the law only applies to tests that are deemed ‘medically appropriate’ by a healthcare provider.”
On June 19, 2020, CMS instructed Medicare Administrative Contactors and notified Medicare Advantage plans to cover COVID-19 laboratory tests for nursing home residents and patients. This instruction follows the CDC’s recent update of COVID-19 testing guidelines for nursing homes that provides recommendations for testing of nursing home residents and patients with COVID-19 symptoms, as well as for asymptomatic residents and patients who have been exposed to COVID-19. Original Medicare and Medicare Advantage plans will cover COVID-19 lab tests consistent with CDC guidance.
As of August 2020, COVID care testing and treatment were covered by most payers with no cost sharing. Moreover, nearly all insurance payers continue to cover the costs of virtual visits, and many had no copay for primary care visits performed using synchronous audio-video devices. However, more than a third of people with individual and fully insured group coverage were in plans in which cost-sharing waivers for COVID-19 treatment were scheduled to expire by the end of September 2020. And as of Aug. 19, 2021, most of the country’s largest health plans were no longer waiving out-of-pocket costs for COVID-19 treatment, according to research released by the Peterson-KFF Health System Tracker. Although most private insurers waived cost-sharing for COVID-19 treatment early in the pandemic, some insurers started phasing out these waivers in November 2020. And even more did so after COVID-19 vaccines became widely available in the U.S.
Across the U.S., some physicians have been seeing reimbursement rates so low that they do not cover the cost of the test supplies, jeopardizing access to a tool experts see as essential to slowing the coronavirus’s spread. With new variants of the virus emerging, experts say testing is especially important. But, as the New York Times recently reported, low reimbursements have led some doctors to stop testing certain patients or to forgo testing altogether.
With other health services, physicians sometimes can recoup losses when insurer reimbursements are too low by billing patients directly for the remaining balance. But with coronavirus testing, federal law prohibits such balance billing. Although the law requires insurers to fully cover the cost of a coronavirus test, it does not define what constitutes a “complete” reimbursement. So some payers have been routinely paying test rates that do not even cover the cost of supplies. And, as of this writing, this is a problem that still requires a solution.
Additionally, in late October 2020, the American Hospital Association alleged in a letter to House Democrats that insurers “have been hoarding premium dollars during the COVID-19 pandemic and some have refused to cover emergency care if they ‘unilaterally’ find it isn’t warranted.” According to AHA, “insurers like Anthem are ‘denying coverage of emergency services if the health insurer unilaterally determines that the condition did not warrant emergency-level care.’” Further, “AHA targeted UnitedHealthcare, saying the insurer decided to stop paying back providers who have treated certain inpatient sepsis cases.”
The lack of experience with and knowledge about COVID-19 poses a problem for defining standard care and determining what is medically necessary. Insurers have also refused to pay for some treatments for COVID-19 or aftereffects, determining that they are “experimental” and therefore not covered.
While most health insurers voluntarily waived co-pays, deductibles and other cost-sharing in 2020, many stopped the waivers in early 2021. And, according to a University of Michigan analysis published on Oct. 18, 2021 in JAMA Network Open, Americans who are or were hospitalized with COVID-19 in 2021 may have to pay thousands of dollars in medical bills as insurers lifted waivers.
Without the waivers, patients could owe $3,800 if they have job-related or self-purchased private insurance, or $1,500 if they have Medicare Advantage plans. In total, each hospitalization of a person with private insurance costs about $42,200 on average, and each hospitalization with Medicare Advantage costs approximately $21,400 on average.
The study also found that cost-sharing waivers don’t always cover all hospitalization care. “Many insurers claim that it is justified to charge patients for COVID-19 hospitalizations now that COVID-19 vaccines are widely available,” lead author Kao-Ping Chua, MD, PhD said in an Oct. 18, 2021 statement. “However, some people hospitalized for COVID-19 aren’t eligible for vaccines, such as young children, while others are vaccinated patients who experienced a severe breakthrough infection. Our study suggests these patients could [owe] substantial bills.”
Beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the FDA will be able to have those test costs covered by their plan or insurance. The new federal rules require private insurers to cover the at-home coronavirus tests that Americans buy in pharmacies and other retailers. The goal is to allow millions of Americans to pick up tests at thousands of locations without paying anything out-of-pocket.
However, some health insurers say it probably will take weeks to fully set up the system the federal government seeks. The process will be difficult because over-the-counter coronavirus tests are different from the medical visits and hospital admissions they typically cover. The tests do not, as of this writing, have the billing codes that insurers use to process claims. Moreover, health plans rarely process retail receipts. Instead, they have created digital claims systems with preset formats and long-established billing codes. Consequently, some insurers plan to process the rapid test claims manually, at least for some time.
Under the new rules, consumers who get tests at their health plan’s “preferred” location will have the costs covered upfront, meaning the patient will pay nothing out of pocket. What counts as a “preferred” location will vary from one plan to another, although many expect those facilities to be ones that are already in-network with a given insurer.
Consumers that go to an out-of-network store will need to submit receipts for reimbursement, and the plan will only have to pay $12 per test (or $24 for a kit with two tests). If the price is higher, the patient will be responsible for the additional charges. Health plans that do not designate a set of “preferred” locations will have to cover the full costs of test receipts that their members submit.
The new rules require private insurers to cover eight at-home coronavirus tests for each person, every month. The rules will not apply retroactively to at-home tests that Americans have already purchased, and do not cover patients with public insurance such as Medicare and Medicaid.
But State Medicaid and Children’s Health Insurance Program (“CHIP”) programs are currently required to cover FDA-authorized at-home COVID-19 tests without cost-sharing. In 2021, the Biden Administration issued guidance explaining that State Medicaid and CHIP programs must cover all types of FDA-authorized COVID-19 tests without cost sharing under CMS’s interpretation of the American Rescue Plan Act of 2019. Medicare pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests, with no beneficiary cost sharing when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional. Individuals enrolled in a Medicare Advantage plan should check with their plan to see if their plan offers coverage and payment for at-home over-the-counter COVID-19 tests.
These actions are in addition to multiple steps the Biden Administration has taken to expand access to testing for all Americans. HHS is providing up to 50 million free, at-home tests to community health centers and Medicare-certified health clinics for distribution at no cost to patients and community members. The program is intended to ensure COVID-19 tests are made available to populations and settings in need of testing. HHS also has established more than 10,000 free community-based pharmacy testing sites around the country. And to respond to the Omicron surge, HHS and FEMA are creating surge testing sites throughout the country. (For more information, see FAQs at: https://www.cms.gov/how-to-get-your-at-home-OTC-COVID-19-test-for-free.html. And for additional details, visit: https://www.cms.gov/files/document/faqs-part-51.pdf – PDF.
On January 13, 2022, President Biden announced he was directing his staff to purchase an additional 500 million COVID-19 tests for distribution to Americans, doubling the government’s previous purchase. The president also said the government was working on a plan to ensure that Americans have access to high-quality masks, such as the KN95 and N95 face coverings, so that they are widely available, online and in stores, in ample supply, at affordable prices.
On January 18, 2022, the federal government launched a website where Americans can order free coronavirus rapid tests to be shipped to their homes. The website, called covidtests.gov, requires that users provide their names and addresses to receive the tests. The government purchased 500 million rapid tests that will be available to every household. There is a limit of one order per residential address, and each order includes four individual rapid test kits. Orders will be shipped within seven to 12 days after being ordered and start shipping in late January 2022, the website says. As of Jan. 19 (the original projected launch date), the site appeared to be fully operational, allowing users to input their information and request a kit.
Also on January 19, 2022, the FDA issued an emergency use authorization for the MaximBio ClearDetect over-the-counter COVID-19 home test. The test is supposed to be able to deliver results in 15 minutes.
CMS Issues New Guidance for Providers Seeking Payment for Treating Medicare Patients with COVID-19
On August 17, 2020, CMS issued new guidance intended to update how providers get paid for treating COVID-19 starting in September 2020. According to several reports, “providers that want to get Medicare payments for treating a patient with COVID-19 must include a positive test in that patient’s medical record.” “The impetus for the new change is to combat fraud,” the agency said. According to the guidance, “The test must be performed either during the hospital admission or prior to the hospital admission.” The guidance indicates that if the “patient has been diagnosed with COVID-19 and needs to be admitted to a hospital, the payment to the hospital is increased by 20% to reflect the additional costs of treating a patient with COVID-19.” (See, e.g., 8/18/20 articles by R. King in FierceHealthcare and S. Morse in Healthcare Finance News.)
CMS’s updated guidance relates to the 20% add-on to the inpatient prospective payment system (“PPS”) diagnosis-related group (“DRG”) rate for patients diagnosed with COVID-19 for the duration of the public health emergency. In other words, for inpatient admissions occurring on or after September 1, 2020, claims eligible for the 20% add-on will be required to have a positive COVID-19 laboratory test documented in patients’ medical records. Positive tests must be demonstrated using only the results of viral testing. The inpatient PPS Pricer will continue to apply the 20% adjustment based on appropriate diagnosis codes; however, CMS may conduct post-payment medical review to confirm the presence of a positive COVID-19 test in the medical record. If no such test is present, the additional payment resulting from the 20% add-on may be recouped.
In late October 2020, CMS announced that Medicare will cover COVID-19 vaccines approved by the Food and Drug Administration at no cost to beneficiaries. The rule also boosts provider payments.
Federal Government Strengthens Requirements that Insurers Cover COVID-19 Diagnostic Testing & Vaccinations Without Cost Sharing and Ensures Providers are Reimbursed for Administering COVID-19 Vaccines to Uninsured & Underinsured
On February 26, 2021, in accordance with the Executive Order President Biden signed on January 21, 2021, CMS, the Department of Labor and the Department of Treasury issued new guidance removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. The guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health coverage who are asymptomatic, and who have no known or suspected exposure to COVID-19. Such testing must be covered without cost sharing, prior authorization, or other medical management requirements imposed by the plan or issuer. The guidance also includes information for providers on how to get reimbursed for COVID-19 diagnostic testing or for administering the COVID-19 vaccine to those who are uninsured.
On May 3, 2021, HHS announced that providers who administer COVID-19 vaccines to underinsured patients will be compensated through the new COVID-19 Coverage Assistance Fund. The program should ensure that providers get fully reimbursed for vaccinating patients with health plans that don’t cover vaccination fees or require patient cost-sharing. But as of May 2021, some hospitals and health systems were eliminating COVID test requirements for vaccinated patients as vaccination rates rise and positivity rates drop. And federal health officials’ new, more relaxed recommendations on masks have all but eclipsed another major change in guidance from the government: fully vaccinated Americans can largely skip getting tested for the coronavirus in most instances. (To view the CDC’s testing guidance, click here.)
Billing Codes for Coronavirus Vaccines, Antiviral & Monoclonal Antibody Treatments
On November 10, 2020, the AMA announced that COVID-19 vaccines developed by Pfizer and Moderna (both of which have received emergency use authorization from the FDA) had been issued unique CPT codes to clinically distinguish each vaccine for better tracking, reporting and analysis that supports data-driven planning and allocation. On December 17, 2020, the AMA announced immunization and administration codes for reporting on medical claims for the COVID-19 vaccine under development by AstraZeneca and University of Oxford. And on January 19, 2021, the AMA announced CPT codes for reporting the single-dose Janssen (Johnson & Johnson) COVID-19 vaccine and its administration on medical claims if the FDA approves the candidate vaccine or authorizes it for emergency use. The codes are effective for use once that vaccine receives emergency use authorization (“EUA”) or approval from the FDA.
On February 4, 2021, Johnson & Johnson submitted paperwork requesting that the FDA authorize its COVID-19 vaccine for emergency use in adults. The FDA announced that its advisory committee would meet on Feb. 26 to discuss the application, and on February 26th the committee recommended approval. The agency then authorized the J&J vaccine for emergency use on Feb. 27, making it the third available to Americans. After a brief pause to study a small number of serious adverse events potentially caused by the J&J vaccine, the FDA revised its emergency use authorization on April 23, 2021, to include a new warning about the plausible risk of rare but serious blood clots in adult women under 50. Researchers from J&J and AstraZeneca are investigating whether modifying their COVID-19 vaccines could reduce or eliminate the rare blood clot risk associated with those vaccines.
On June 25, 2021, a warning to the literature that accompanies Pfizer/BioNTech and Moderna COVID-19 vaccine shots was added to indicate the rare risk of heart inflammation after vaccine administration. The FDA revised the fact sheets for healthcare providers to include a warning that reports of adverse events suggest increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart), particularly in young males after the second dose, with onset of symptoms within a few days after vaccination.
On July 12, 2021, the FDA warned that the J&J vaccine can lead to an increased risk of the rare neurological condition known as Guillain-Barré syndrome, an immune system disorder that can cause muscle weakness and occasionally paralysis. The CDC said in a statement it had received reports of 100 people who got the shot developing Guillain-Barré. While regulators found that the chances of developing the condition are low, they appeared to be three to five times higher among recipients of the J&J vaccine than among the general population. The FDA updated its vaccine recipient and vaccination provider fact sheets based on this risk. Available data do not show a similar pattern indicating an increased risk of Guillain-Barré with the Pfizer-BioNTech or Moderna vaccine.
Overall, medical experts, government agencies and officials continue to emphasize that the benefits of getting a COVID vaccine far outweigh the very small risks. Moreover, nearly all COVID hospitalizations and deaths are now confined to unvaccinated individuals, with the CDC Director saying the U.S. is becoming “a pandemic of the unvaccinated.” But with the rise of the highly contagious Delta variant, COVID cases, hospitalizations and deaths are growing again for the unvaccinated, and cases are surging in counties with low vaccination rates.
Studies in children younger than 12 have been underway. Vaccine manufacturers began learning and demonstrating by fall 2021 that vaccines provide immunity in children as young as 6 months old. On July 23, 2021, it was reported that Pfizer and BioNTech will supply the U.S. with another 200 million doses of their COVID-19 shot, setting up a stream of vaccine deliveries through April 2022, in a push to protect kids and provide boosters. And Pfizer-BioNTech’s Sept. 20, 2021 announcement that its vaccine is safe and effective for children ages 5 to 11 set the stage for the FDA and CDC to authorize its use for elementary-school-aged kids in November.
All three companies that currently have authorized coronavirus vaccines in the U.S. — Pfizer, Moderna and Johnson & Johnson — have been investigating the administration of boosters. On August 16, 2021, Pfizer and BioNTech said they had submitted data from a Phase 1 study to the FDA supporting the use of a third, or booster, dose of their vaccine. The data showed that the booster dose elicited a significantly higher antibody response against the initial strain of the coronavirus, as well as against the Delta and Beta variants, compared to what was seen among people who got two doses. And data from Israel showed the vaccines’ effectiveness waned over time without boosters, especially in immunocompromised and older people.
On September 1, 2021, Moderna announced submission of its initial data to the FDA for its COVID-19 vaccine booster. Moderna sought FDA endorsement of a half-dose of its vaccine to be administered to patients at least six months after receiving the initial two-dose immunization series. The half-dose booster increased study participants’ antibody levels against the Delta variant by more than 40 times the starting value, Moderna said in a statement.
Data from Israel showed the vaccines’ effectiveness waned over time without boosters, especially in immunocompromised and older people. Reports from other countries battling the Delta variant with similar vaccination rates to the U.S. (including the U.K., Israel and Singapore) also showed the vaccines (without boosters) are less effective at preventing mild to moderate infections, although they still were providing robust protection against severe illness. Worse, data from contact tracing in Singapore showed that vaccinated people were not only getting infected with the Delta variant (so-called “breakthrough” infections), but they also were transmitting the virus. Besides the fact that no vaccine is 100% effective, this helped explain why many high-profile athletes, celebrities and others reported positive coronavirus tests and sometimes mild illnesses, despite being fully vaccinated.
On August 12, 2021, the FDA expanded its emergency use authorization for both the Pfizer and Moderna COVID-19 vaccines to allow third doses for Americans with compromised immune systems, specifically solid organ transplant recipients or those who are considered to be immunocompromised. On August 18, 2021, the Biden administration announced plans to offer boosters to all U.S. adults as soon as the week of September 20, 2021, pending reviews by federal health agencies. U.S. residents 18 and older who received the Pfizer-BioNTech or Moderna vaccines would be eligible for a third shot eight months (and perhaps even 6 months) after their second dose. Because healthcare workers, long-term care residents and individuals over age 65 were generally the first to receive their initial vaccine doses, they generally were projected to be the first eligible to receive boosters.
Federal officials previously said they were waiting for additional data before setting a plan for people who received the one-dose Johnson & Johnson vaccine. On October 5, 2021, J&J announced it had submitted data to the FDA to support the use of a booster shot of its vaccine for individuals ages 18 and older. The company submitted results of a Phase 3 trial that showed that giving a second shot of its single-shot vaccine, given 56 days after the first, provided 100% protection against severe COVID-19 and 94% protection against symptomatic moderate to severe COVID-19. When a booster was given 6 months after the first shot, antibody levels increased to 12-fold higher four weeks after the booster. Studies on the Pfizer-BioNTech and Moderna vaccines found comparable increases in antibody levels.
On August 23, 2021, the FDA granted full approval to Pfizer-BioNTech’s coronavirus vaccine (which is now marketed as Comirnaty) for people age 16 and above, making it the first to move beyond emergency use status in the U.S. Moderna completed its application for full licensure of its vaccine (now brand-named Spikevax) in adults 18 and older the last week of August. On Nov. 24, 2021, Canada gave full approval to Johnson & Johnson’s single-shot COVID-19 vaccine for people aged 18 years and older. And on Jan. 31, 2022, the FDA granted full approval to the Moderna COVID-19 vaccine (marketed as Spikevax) for individuals age 18 and older. J&J is also expected to apply for full approval in the U.S. soon. Full approval of all three vaccines is expected to increase vaccine mandates by employers and universities, and grow the number of inoculations among those who have been reluctant to receive shots.
Another vaccine produced by Novavax was reportedly on track to have its clinical trial results in 2021. Novavax reportedly was to seek FDA and international approval in mid to late 2021. On May 4, 2021, the AMA announced the CPT codes for reporting the two-dose Novavax vaccine and its administration on medical claims if the FDA approves or authorizes it for emergency use. However, on May 10, 2021 Novavax announced that its vaccine would not be authorized in the U.S. or U.K. until at least July, and that it would not reach peak production until the end of the year. Novavax then published results of its U.S. phase 3 trials for its COVID-19 vaccine in mid-June, stating that its shot was over 90% effective overall and 100% effective against moderate and severe disease, roughly in line with Pfizer’s and Moderna’s vaccines. Novavax’s shot was said to be likely to hit the market around Q4 of 2021, with emergency use authorizations likely to be filed in the U.S., U.K. and Europe by the end of Q4. With the emergence of concerning new coronavirus variants and a relatively slow pace of vaccination outside the U.S., demand for Novavax’s shot remains strong.
On May 10, 2021, the FDA announced the expansion of its emergency use authorization for Pfizer’s COVID-19 vaccine to include adolescents ages 12 to 15. Two days later, the CDC also approved the Pfizer vaccine for children 12 and older. The FDA also updated the Pfizer vaccine-specific Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population.
In September 2021, the AMA published eight new CPT codes for providers administering COVID-19 vaccines. The codes are for reporting Pfizer COVID-19 vaccine and immunization administration for the tris-sucrose formulation, Pfizer COVID-19 immunization administration booster doses, and Moderna COVID-19 vaccine and immunization administration booster doses. The CPT codes for the Moderna vaccine booster will be effective upon it receiving emergency use authorization or approval from the FDA.
On October 1, 2021, the FDA announced its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) would meet later in the month to discuss COVID-19 booster shots, mix-and-match boosters, and vaccines for children ages 5-11. The AMA then announced CPT code set updates to include vaccine and administration codes for pediatric doses of the Pfizer COVID-19 vaccine. The provisional codes will be effective once Pfizer’s vaccine receives FDA approval for use in children ages 5-11. The AMA published the code in advance of the FDA’s approval to ensure healthcare providers are prepared when the EUA is approved.
On Oct. 14 and 15, 2021, VRBPAC discussed the use of Moderna and J&J vaccine booster doses, and voted to recommend them for seniors, adults with other health problems, or jobs or living situations that put them at increased risk for COVID-19. On Oct. 20th, the FDA authorized Moderna boosters (at least six months after the second dose) and J&J boosters (at least two months after the first dose). The FDA also approved the use of a booster of a different vaccine than the one used for the primary series (mix-and-match). The FDA is thus allowing Americans to receive a COVID-19 booster made by a different manufacturer than the one that made the vaccine with which they were initially inoculated. The CDC agreed and endorsed Moderna and J&J boosters and possible mixing and matching the next day. A NIH study on mixing COVID-19 vaccine doses showed that people who were vaccinated with J&J’s COVID-19 shot would receive greater protection if they got a booster made by Moderna or Pfizer. The federal government is not recommending one manufacturer’s booster over another, but has said that while it is preferable to use a booster made by the same company that produced a person’s original vaccine, providers can use their discretion to offer boosters made by a different manufacturer. Although booster shots are now available, the CDC has not changed the definition of “fully vaccinated” based on whether someone has received a booster.
CMS released Medicare Part B billing codes and payment allowances for reporting and administering single booster doses of the Moderna and J&J COVID-19 vaccines to eligible adults as authorized on Oct. 20 by the FDA. Authorized COVID-19 booster doses are covered without cost sharing for eligible Medicare, Medicaid, CHIP and commercial health plan beneficiaries.
On October 20, 2021, ahead of the regulatory steps needed to start administering the shots, the White House issued its plan to administer vaccines to kids ages 5-11. The plan includes distributing the shots to more than 25,000 pediatric offices and other primary care sites, over 100 children’s hospital systems, tens of thousands of pharmacies, and hundreds of schools and community-based clinics.
On Oct. 26, 2021, an independent committee of experts advising the FDA met and voted to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old. On Oct. 29th, the FDA issued its authorization. And on Nov. 2nd, the CDC agreed, opening the way to inoculating 28 million more children in the U.S. Following the CDC’s recommendation, the Georgia Department of Public Health and health districts throughout Georgia are offering the Pfizer pediatric COVID vaccine. For children ages 6 months to 4 years old, clinical trials are underway, and COVID-19 vaccines are expected sometime in the first half of 2022.
On November 9, 2021, Pfizer announced that it and partner BioNTech asked the FDA to amend their emergency use authorization and allow booster shots of their COVID-19 vaccine for anyone 18 or older — a move that could increase booster rates at a critical moment in the pandemic. According to a Nov. 8 Washington Post (McGinley, Pager, Sun) report, “the request is likely to win the backing” of the FDA. However, it was unclear how long it would take for the FDA to act on the request.
On November 17, 2021, Moderna announced that it submitted a request to the FDA to authorize booster doses of its coronavirus vaccine for all adults. The 50 microgram dosage in Moderna’s booster is half of the 100 micrograms used for the first two shots for adults. On November 19th, the FDA authorized booster shots of both the Pfizer-BioNTech and Moderna vaccines for everyone 18 and older. And the CDC endorsed them later the same day. In the meantime, many states expanded eligibility for booster shots to everyone 18 and older, six months after their second dose, even before the FDA and CDC gave their recommendations. All recipients of J&J’s one-shot vaccine were already cleared to get a booster shot at least two months after their injection. Any adult may now receive a Moderna or Pfizer booster regardless of which FDA-authorized vaccination course they received previously.
Previously, on October 5, 2021, AstraZeneca announced it had submitted a request to the FDA for an emergency use authorization for its long-acting antibody (“LAAB”) combination for prevention of symptomatic COVID-19. The company stated that Phase 3 data showed a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo. On Dec. 8, the FDA issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms, or about 88 pounds). The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. This drug is the first LAAB to receive an EUA for COVID-19 prevention.
On November 5, 2021, Pfizer revealed clinical trial data on an oral COVID-19 antiviral treatment, Paxlovid, stating that it is highly effective in reducing the risk of hospitalization or death from severe COVID-19. Pfizer said the drug, when administered within five days of the appearance of COVID-19 symptoms, yielded an 89% reduction in deaths or hospitalizations through 28 days. That appears to be even more effective than a similar offering from Merck (Molnupiravir), which is awaiting federal authorization. Pfizer said it will submit the data in support of its rolling submission for an emergency use authorization to the FDA and ask the FDA and international regulators to authorize its pill as soon as possible.
On November 30, 2021, a FDA advisory committee voted in favor of recommending Molnupiravir, the new antiviral pill made by the drug companies Merck and Ridgeback Biotherapeutics, for treating COVID-19. If the FDA agrees with the panel’s recommendation and authorizes it, Molnupiravir would be the first oral antiviral treatment for mild to moderate COVID-19 and use at home. The second antiviral pill, Paxlovid, manufactured by Pfizer, is being vetted by the FDA and authorization could soon follow. Both Molnupiravir and Paxlovid are a series of pills that are taken twice daily for five days. Paxlovid is taken with an additional booster pill of Ritonavir, a drug that helps keep the drug active in the body for longer.
On December 22, 2021, the FDA issued an emergency use authorization for Paxlovid, Pfizer’s COVID-19 antiviral pill regimen, making it the first available at-home COVID-19 treatment. The treatment is intended for COVID-19 patients who are at high-risk of developing severe illness, with the potential to prevent hospitalizations and avert further strain on the healthcare system amid a nationwide surge in cases driven by the highly transmissible Omicron variant.
The FDA said Pfizer’s prescription pills, which were authorized for use in patients ages 12 and older who weigh at least 88 pounds and are at high risk of progressing to severe illness, should be administered as soon as possible after diagnosis and within five days of developing symptoms. It is administered as three tablets (two tablets of Nirmatrelvir and one tablet of Ritonavir) taken twice daily for no more than five consecutive days.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
In a trial involving 2,246 adults, Paxlovid reduced the risk of hospitalization or death by 89 percent in high-risk adults. And Pfizer has said it expects the antiviral to be effective against Omicron.
On December 23, 2021, the FDA authorized a second antiviral pill for COVID but said it should not be a preferred treatment. The FDA cleared the pill, developed by Merck and known as Molnupiravir, for adults who are vulnerable to becoming severely ill from COVID and for whom alternative treatment options authorized by the FDA are “not accessible or clinically appropriate.” The FDA’s decision reflected concerns that Merck’s pill is only modestly effective while also carrying the possible risk of causing reproductive harm. But in the coming weeks, it is expected to be more available in the United States than other treatment options. The U.S. has purchased 10 million courses of Pfizer’s pill and about 3 million of Merck’s antiviral, according to multiple news reports.
Previously, the only FDA-authorized treatments for non-hospitalized COVID-19 patients were monoclonal antibodies, which typically require intravenous infusion in a clinical setting. (For Monoclonal Antibody Therapeutics Resources, please see the federal government’s Monoclonal Antibody Therapeutics Communications Toolkit, Monoclonal Antibody Clinical Implementation Guide, and Treatment Locator.) By contrast, pills are cheaper to make and easier to distribute and take. Many people therefore believe that take-at-home pills could be a game changer for keeping COVID-19 in check and helping people recover from early stages of the disease. But the antiviral drugs are not designed to replace vaccination; rather, they are intended to provide additional support for people who get sick, especially the elderly or immunocompromised who don’t have strong response from the vaccines.
Both drugs are intended to give your body a leg up in fighting off a COVID-19 infection. But “you can’t take the pill until you get sick,” explains Carl Dieffenbach of the National Institute of Allergy and Infectious Diseases, who is leading antiviral development, according to NPR. “So you still want to avoid getting the disease”; “that’s rule No. 1.” Both pills are demonstrated to work best when given early in the course of infection in patients at high risk for disease progression. In clinical trials, both Molnupiravir and Paxlovid were given to patients within only five days of symptom onset. Because both pills work best when given within days of infection, prompt testing and treatment are required. If a person waits a few days to get tested and another few days for results, the period when these pills are most effective has likely passed, according to experts quoted by NPR. And, unfortunately, such prompt testing and treatment is not always feasible.
Moreover, the Molnupiravir pill appears considerably less effective than treatment with monoclonal antibodies, which reduce the risk of severe COVID-19 by 70% to 85%. According to Merck’s data analysis, Molnupiravir reduces the risks of hospitalization and death in COVID-19 patients by only about 30% when the pills are started within five days of symptom onset. The results are still significant though, in terms of reducing hospitalizations and deaths. And preliminary results for Pfizer’s Paxlovid indicate it may be considerably more effective, with studies showing it reduces the risks of hospitalizations and deaths by 89%, though these numbers may change once full study results are analyzed.
Healthcare providers can use a checklist to help them decide when to prescribe Paxlovid, the COVID-19 antiviral from Pfizer. The checklist is part of updated guidance from the FDA, which also updated the fact sheet for healthcare providers to include a list of drugs that could potentially interact negatively with Paxlovid.
On November 26, 2021, the World Health Organization categorized the strain, B.1.1.529, a variant of concern. Named Omicron, it is the first new variant of concern since Delta. Preliminary evidence suggests Omicron is even more transmissible than Delta and may increase risk of reinfection. Vaccine makers Pfizer-BioNTech and Moderna have both said they are preparing to reformulate their COVID-19 vaccines to address the Omicron variant if necessary. Scientists expect to have a better understanding of how effective current vaccines are at protecting against Omicron within a few weeks.
Experts have emphasized that it is not clear whether new formulations of the vaccine are needed. In the meantime, however, experts urge all unvaccinated individuals to get vaccinated, and all who have received their initial doses to get boosters after two or six months, depending on whether their initial doses were manufactured by J&J or Pfizer/Moderna. Even if the variant limits the effectiveness of vaccines, it probably will not completely subvert the protections that vaccines provide, experts say. Scientists are working to determine whether Omicron can cause severe illness, if it is more transmissible than Delta, and whether it can erode or evade immunity. Early studies indicate Omicron is more contagious and better at evading vaccines, but less severe, especially with boosters. Regardless, Omicron shows how variants can mutate rapidly amid low vaccination rates.
On December 2, 2021, the White House announced that over-the-counter rapid coronavirus tests will soon become a much bigger part of its response to the pandemic and the Omicron variant. The Biden administration also said it would make 50 million free tests available for uninsured Americans, to be distributed through health clinics and other sites in rural and underserved communities. Under the plan, private health insurers will soon have to reimburse patients for such tests. It was unclear whether the government will limit reimbursements per person. The administration said it planned to issue rules outlining the reimbursement process by Jan. 15, 2022. The arrival of the Omicron variant and continued Delta surge prompted the administration to try to expand testing availability and improve affordability. It also intends to secure additional antiviral pills for use once authorized; work with authorized vaccine makers to develop contingency plans for other vaccines or boosters for the Omicron variant if needed; and accelerate delivery of COVID-19 vaccines to other countries.
On December 3, 2021, the FDA revised the emergency use authorization of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention. Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “While today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorized for children 5 years of age and above.”
On December 9, 2021, the CDC signed off on booster shots of Pfizer’s coronavirus vaccine for 16- and 17-year-olds who are six months past their second shot, clearing the way for booster vaccinations to start in that age group. The CDC’s announcement came just a few hours after the FDA granted Pfizer an expansion of its emergency use authorization, to bolster protection against the Delta and emerging Omicron variant. The FDA said that the benefits of a booster for 16- and 17-year-olds far outweigh the risks of myocarditis, a rare inflammatory heart condition that has been seen primarily in young men after their second dose of Pfizer or Moderna’s vaccine. And a recent study showed that the rare side effect usually is mild and people recover quickly.
On December 16, 2021, the CDC endorsed updated recommendations made by its Advisory Committee on Immunization Practices for the prevention of COVID-19, expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over J&J’s COVID-19 vaccine. The CDC reaffirmed that receiving any vaccine is better than being unvaccinated. And in a statement, J&J said the company remains confident in the overall positive benefit-risk profile of its vaccine. But the recommendation was made due to increasing evidence that J&J’s shots can trigger a rare blood clot disorder. Panel experts said that J&J’s shot still may make sense for people who would have allergic reactions to the Pfizer or Moderna vaccines, or if a patient does not have access to any other shot. And individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to J&J’s COVID-19 vaccine.
On December 17, 2021, the AHA, AMA and American Nurses Association issued a joint statement urging COVID-19 booster shots amid the spread of both the Delta and Omicron variants. The statement reads in part: “As the Delta variant and new Omicron variant contribute to a rise in COVID-19 cases and hospitalizations across the county, we double-down on our call for all eligible Americans to get vaccinated and to get their booster shots. Science has shown that receiving a booster shot decreases your chance of contracting COVID-19, getting severely sick, ending up in the hospital or dying.”
Two reports released on Dec. 30, 2021 showed that people who get booster doses of J&J’s Janssen vaccine are also well protected against severe disease and hospitalization from the Omicron variant of coronavirus. A study from the South African Medical Research Council showed that two doses of the J&J vaccine provided up to 85% protection against hospitalization from the Omicron variant.
On January 3, 2022, Pfizer and BioNTech announced that the FDA expanded the emergency use authorization of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength as that of the primary series (30 micrograms). The FDA is also amending the existing EUA to reduce the time for administration of a booster dose from at least six months to at least five months following the completion of the primary series for individuals ages 12 and older. In addition, the FDA cleared third doses of the vaccine for some children ages 5 to 11 who have weakened immune systems because of solid organ transplants or other medical conditions. The FDA actions are expected to be reviewed by the CDC and its panel of outside vaccine advisers shortly.
On January 4, 2022, the CDC backed the FDA’s approval of a booster dose of Pfizer’s COVID-19 vaccine for individuals ages 12 and older. The CDC also supported giving certain immunocompromised children ages 5-11 an additional dose of the vaccine 28 days after their second shot. CDC Director Dr. Rochelle Walensky stated, “Today’s recommendations ensure people are able to get a boost of protection in the face of Omicron and increasing cases across the country and ensure that the most vulnerable children can get an additional dose to optimize protection against COVID-19.” On Jan. 5, the CDC further recommended Pfizer’s COVID-19 vaccine boosters for children ages 12 and up, expanding protection to adolescents and teens as surging Omicron infections threatened to disrupt schools and workplaces across the country.
The CDC also said on Jan. 5 that it was not changing its definition of “full vaccination” against the coronavirus. But the agency changed its emphasis on the appropriate regimen, tweaking how it referred to the shots, and recommending that Americans stay up to date with their vaccines. The agency said that three doses of Pfizer-BioNTech or Moderna’s vaccines should be considered “up-to-date” inoculations, and that J&J recipients should receive a second dose, preferably of Moderna or Pfizer-BioNTech, to also be considered up to date.
“The technical definition of ‘fully vaccinated’ — two doses of an mRNA vaccine or one dose of the J & J vaccine — has not changed,” a CDC spokeswoman said in a statement. “Individuals are considered fully vaccinated once they have received their primary series.” But she added that the agency recommends that people “stay ‘up to date’ by receiving any additional doses they are eligible for, according to CDC’s recommendations, to ensure they have optimal protection.”
On January 7, 2022, the FDA amended the emergency use authorization for Moderna’s COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months (down from six months) for adults 18 years of age and older. As noted above, the FDA updated Pfizer’s booster authorization to a five-month interval several days before.
Also on January 7, CMS created HCPCS code J0248 for VEKLURY™ (Remdesivir) antiviral medication when administered in an outpatient setting. The FDA previously approved Remdesivir for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization back in October 2020. The drug received full agency approval later that year for people 12 and older. Treatment of younger children is permitted under an emergency use authorization. The outpatient code is available for use by all payers and is effective for dates of service on or after Dec. 23, 2021.
On January 21, 2022, the FDA approved the use of Remdesivir for COVID-19 outpatients at high risk of being hospitalized. The agency said the intravenous treatment, which previously had been limited to patients in the hospital, could be administered to outpatients with mild-to-moderate illness. Because the drug had been approved for inpatient care, physicians are permitted to prescribe it “off-label” for patients not in the hospital. But now that the FDA has explicitly approved use for outpatients, and other approved treatments have been in short supply, more doctors are expected to begin treating outpatients with the medication. The expanded FDA clearance also helps ensure reimbursement from Medicare and private insurers, since payers often resist covering medications used off-label. Updated treatment guidelines issued on Jan. 19 by the National Institutes of Health for outpatients with mild-to-moderate COVID also encouraged use of Remdesivir. However, the FDA said the treatment (which generally requires that patients go to a clinic or hospital three days in a row for infusions) is not a substitute for vaccines, which remain the best protection against coronavirus.
In addition to seven new 2022 ICD-10 procedure codes announced in November 2021, CMS will implement two new ICD-10 procedure codes for reporting COVID-19 therapeutics effective April 1, 2022. The new codes are for describing the infusion of Tixagevimab and Cilgavimab monoclonal antibody (code XW023X7), and the infusion of other new technology monoclonal antibody (code XW023Y7).
On January 24, 2022, the FDA revised the authorizations for two monoclonal antibody treatments – Bamlanivimab and Etesevimab (administered together) and REGEN-COV (Casirivimab and Imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data showed that these treatments are highly unlikely to be active against the Omicron variant, which has been circulating at a very high frequency throughout the U.S., these treatments are not authorized for use in any U.S. states, territories, and jurisdictions as of this writing. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
On January 27, 2022, the Georgia Department of Public Health stated that other therapies such as oral antivirals from Pfizer and Merck, Remdesivir (intravenous antiviral), and Sotrovimab (mAb) have been shown to be effective against the Omicron variant. These treatments are for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for severe illness, hospitalization or death.
On February 1, 2022, Pfizer announced that it had started the EUA submission process for its lower-dose COVID-19 vaccine in children ages 6 months to 4 years old. The company initially provided the FDA with data from the first two vaccine doses. Each dose contains 3 mcg of mRNA. But children in this age group are expected to need three doses as part of their primary vaccination series. That’s because the immune response from two doses in children ages 2 to 4 years old wasn’t as strong as hoped. On Feb. 11, the FDA announced it will wait for data on whether three doses of Pfizer-BioNTech’s vaccine are effective in young children after new, disappointing data. Pfizer plans to submit third-dose data in the coming months.
A study released by the CDC on Feb. 11, 2022 showed that, during the Omicron wave, the Pfizer or Moderna COVID-19 vaccine was 87% effective at preventing emergency and urgent care visits and 95% effective at preventing hospitalizations in adults who received a third dose in the prior two months. The study also found that a third dose was more effective than a second dose but less effective over time. Another study demonstrated that adverse reactions were less frequent after a third dose than a second dose in adults who received the same COVID-19 vaccine for all their doses. Overall, studies continued to show that two or three doses of currently-available vaccines provide excellent protection against severe disease leading to hospitalization or death.
New vaccine eligibility categories in Georgia, in addition to groups already eligible under Phase 1A+, became effective on March 8, 2021. Currently, all Georgians age 5 and over are eligible to receive a COVID-19 vaccine. The FDA has also posted a booster eligibility chart to assist providers and patients in determining who is eligible for a COVID-19 vaccine booster, which one, and when.
As providers began vaccinating the new groups, they did not need to notate the individual criteria that the patients meet within each category. However, it was recommended that providers have patients attest, either in writing or by a digital appointment scheduling questionnaire, that they fit into one of the eligibility categories. For an example, providers can visit the Georgia Department of Public Health vaccine scheduling website at www.myvaccinegeorgia.com.
GHA updated its COVID-19 Vaccine Consent Form template to reflect recent revisions to the FDA fact sheets for the Pfizer and Moderna vaccines. The fact sheets and GHA template now include a screening question about whether the vaccine recipient has had myocarditis or pericarditis. Recent updates added screening questions based on revisions to the CDC Prevaccination Checklist for COVID-19 Vaccines and removed references to previous limitations on vaccine eligibility. As additional information becomes available or as new vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to continue to be revised.
Per CDC guidance, all organizations and providers participating in the CDC’s COVID-19 Vaccination Program:
- must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay COVID-19 Vaccine administration fees or coverage status;
- may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient; and
- may not seek any reimbursement, including through balance billing, from the vaccine recipient.
For additional information on filing claims for reimbursement of COVID-19 vaccine administration fees, go to:
- HRSA COVID-19 Uninsured Program – https://www.hrsa.gov/CovidUninsuredClaimexternal icon
- CMS Guidance – https://www.cms.gov/covidvax-providerexternal icon
On March 15, 2021, CMS announced its average payment for COVID-19 immunizations increased from $28 to $40 for single-dose vaccines and from $45 to $80 for two-dose vaccines. However, exact reimbursement rates vary depending on what type of provider administers the immunization and where the provider is located.
Early on, FEMA stated that costs incurred as of Jan. 21, 2021 through Sept. 30, 2021 relating to vaccinations will be reimbursed at 100% Federal share for eligible cost. Costs incurred prior to Jan. 21, 2021 will be reimbursed at 75% Federal share of eligible cost. The policy was set to expire Dec. 31, 2021. But on November 9, 2021, President Biden announced that funding to support all eligible COVID-19 work will continue at a 100% federal cost share through April 1, 2022. The funding will be available for eligible costs associated with ongoing COVID-19 recovery efforts and vaccine initiatives. Hospitals and other providers have been encouraged to submit documentation of both the costs they already have incurred, as well as estimated future costs, so that funding can be approved and obligated.
On March 2, 2022, the White House released a National COVID-19 Preparedness Plan as a roadmap to help fight COVID-19 as Americans return to more normal routines. The plan focuses on protecting against and treating COVID-19; preparing for new variants; preventing economic and educational shutdowns; and continuing to vaccinate the world. One key item is a new “test to treat” plan to provide free antiviral pills at pharmacies to people who test positive for the virus. This comes as the national outlook improves, with new cases, hospitalizations and deaths declining.
On March 4, 2022, the White House issued a COVID-19 Test to Treat Fact Sheet, noting that that the program allows individuals to access free lifesaving treatment for COVID-19. People who test positive for COVID-19 and are eligible for certain therapies will be able to receive a prescription for the treatment and have it filled in the same location. The “One-Stop Test to Treat” locations are available at hundreds of locations nationwide, including pharmacy-based clinics, federally qualified community health centers and long-term care facilities. Allocations for this new program began on March 7. The program builds upon the existing distribution of oral antivirals and does not affect the amount of product already made available for free to jurisdictions. Direct allocations made through the Test to Treat program is in addition to what states receive. More information is on HHS’ ASPR website.
On March 15, 2022, Pfizer and BioNTech applied for emergency use authorization of a second booster shot of their coronavirus vaccine for people 65 and older, in an effort to bolster waning immunity that occurs several months after the first booster, Pfizer announced. The companies’ submission to the FDA “includes ‘real world data’ collected in Israel, one of the few countries that has authorized a second booster for older people.” An FDA decision “could come relatively quickly,” “if officials conclude the data is straightforward and does not have to be reviewed by a panel of outside vaccine experts.” Two days later, Moderna announced it is seeking FDA approval for a fourth dose or second booster of its COVID-19 vaccination shot for people ages 18 and up. The company said its request to include all adults was made so that the CDC and healthcare providers can determine the appropriate use of an additional booster dose, including those at higher risk of contracting COVID-19. Moderna is also conducting clinical trials for an Omicron-specific booster shot.
On March 29, 2022, the FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. A second booster dose of the Pfizer or the Moderna vaccine may be administered to individuals 50 years of age or older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. Following the FDA’s authorization, the CDC updated its recommendations to allow the two groups mentioned above to be eligible for a second booster of an mRNA vaccine. A second booster dose of the Pfizer vaccine may be administered to individuals 12 years of age or older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise. A second booster dose of the Moderna vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same kinds of immunocompromise.
On April 4, 2022, CMS announced that Medicare Part B beneficiaries, including those enrolled in a Medicare Advantage plan, can obtain up to eight over-the-counter COVID-19 tests per month at no cost. Beneficiaries will have access to the tests through eligible health care providers and pharmacies for the duration of the public health emergency.
On April 6, 2022, CMS announced it will pay for a second COVID-19 booster shot for eligible enrollees. People with Medicare can receive a COVID-19 vaccine at no cost. People with Medicaid coverage can also get COVID-19 vaccines, including boosters, at no cost.
Meanwhile, cases of BA.2, a new subvariant of Omicron, have been rising. BA.2 led to a surge in Europe and is now the dominant version of the coronavirus in the U.S. and around the world. On April 5, 2022, the FDA announced that Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to its ineffectiveness against BA.2 and increases in the proportion of COVID-19 cases caused by that subvariant.
As of early April 2022, the CDC estimated that about 50% of COVID-19 cases in the U.S were caused by BA.2. As the BA.2 variant advances, scientists are learning more about it. But they still don’t know exactly how it will affect the trajectory of the pandemic. FDA said it will continue to monitor the variant and will provide updates when needed.
On April 14, 2022, the FDA authorized for emergency use the first COVID-19 breathalyzer test for adults, which can detect the virus in breath samples in under three minutes under the supervision of a healthcare provider licensed or authorized to prescribe tests. Positive results should be confirmed with a molecular test. More information is in a Fact Sheet for Healthcare Providers.
Also on April 14, 2022, CMS released CPT codes for reporting a second Moderna COVID-19 vaccine booster dose on medical claims. In March, the FDA authorized a second Pfizer or Moderna booster dose for adults aged 50 and older and certain immunocompromised adults.
As of mid-April 2022, COVID-19 cases were on the rise again in the U.S. and experts said the case wave will be bigger than it looks, because reported numbers are vast undercounts as more people test at home without reporting their infections or skip testing altogether.
On April 25, 2022, the CDC issued a health advisory on the use of recommended therapies for COVID-19 and to advise against using unproven treatments that have known or potential harm for outpatients with mild to moderate COVID-19. The advisory states that systematic corticosteroids and antibacterial therapy are not recommended for patients in certain situations.
Also on April 25, 2022, the FDA expanded its approval of Remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.
On April 26, 2022, Pfizer and BioNTech announced they submitted an application to the FDA for an emergency use authorization of a booster dose of the companies’ COVID-19 vaccine for children ages 5-11. The submission included data from the Phase 2/3 clinical trial in children ages 5-11 who received a booster dose six months after a second dose of the vaccine.
On April 28, 2022, Moderna announced that it had asked the FDA to authorize its coronavirus vaccine for children 6 months to 6 years old, making it the first manufacturer to do so. Moderna had previously requested authorization of its vaccine for 6- to 11-year-olds and 12- to 17-year-olds, and a spokeswoman said that it would submit data supporting and updating those requests in about two weeks. The FDA reportedly was leaning toward considering all three of the company’s applications to vaccinate children simultaneously.
Moderna proposed a two-dose regimen for children up to 6 years old, using one-fourth the strength of an adult dose. Pfizer and BioNTech proposed a three-dose regimen for those 6 months to 5 years old, at one-tenth the strength of the adult dose. The Pfizer-BioNTech vaccine was already authorized for children five and older.
On May 5, 2022, the FDA announced it was limiting the authorized use of the J&J COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible or not clinically appropriate. The FDA analyzed reported cases of rare but potentially life-threatening blood clots with onset of symptoms one to two weeks following the administration of the vaccine and determined the risk warrants limited use of the vaccine. However, FDA stated the benefits of the J&J vaccine for the prevention of COVID-19 still outweigh the risks for adults who cannot receive the Pfizer or Moderna vaccines.
On May 12, 2022, the AMA, AHA and ANA issued a joint statement on the grim milestone of 1 million U.S. deaths from COVID-19 during the nearly two-and-a-half years of the pandemic. The groups urged everyone who is eligible to get vaccinated to protect themselves from the virus and to continue taking health precautions like wearing masks.
On May 17, 2022, the FDA announced it had granted emergency use authorization for a booster dose of the Pfizer-BioNTech Covid-19 vaccine in children ages 5-11. The EUA is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 vaccine primary series in that age group. On May 19th, the CDC’s Advisory Committee on Immunization Practices also recommended a booster dose of the Pfizer-BioNTech COVID-19 vaccine for everyone ages 5 and older. The committee now recommends that children ages 5-11 receive a booster shot five months after their initial Pfizer-BioNTech vaccine series.
On May 19, 2022, the AMA announced it had updated the CPT code set to include CPT codes for the Moderna COVID-19 vaccine for children aged six months through five years. The AMA created the provisional CPT codes to help ensure that healthcare organizations and electronic systems are prepared if the FDA grants the Moderna pediatric COVID-19 vaccine an emergency use authorization.
On May 24, 2022, the CDC issued a Health Alert Network (“HAN”) Health Advisory about the potential for patients to experience a recurrence of COVID-19 or “COVID-19 rebound” after receiving Paxlovid treatment. Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among high-risk patients; however, COVID-19 rebound has been reported to occur between two and eight days after initial recovery. It is characterized by the return of COVID-19 symptoms or a new positive viral test after having tested negative.
On June 15, 2022, the FDA Vaccines and Related Biological Products Advisory Committee unanimously recommended the agency authorize Moderna’s COVID-19 two-dose vaccine for children aged 6 months through 5 years old and Pfizer’s three-dose COVID-19 vaccine for children aged 6 months through 4 years old. Based on the scientific evidence available, the committee agreed that each vaccine’s benefits outweigh its risks in these age groups. The committee also voted to recommend FDA authorize Moderna’s vaccine for children ages 6-17. On June 17th, the FDA authorized emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for children ages 6 months and older. And, for the Pfizer-BioNTech COVID-19 vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age.
On June 18, 2022, the CDC also recommended that all children 6 months through 5 years of age also receive a COVID-19 vaccine. Scientific advisers to the CDC unanimously decided the benefits outweigh the risks, despite some reservations about relatively little data on efficacy for children under 5. Federal regulators now have authorized the Moderna vaccine for children ages 6 months through 5 years, and the Pfizer-BioNTech vaccine for children ages 6 months through 4 years. (Pfizer-BioNTech’s vaccine has been available to children ages 5 and older since November 2021.) All children 6 months and older, including those who have already been infected with the coronavirus, should get a COVID-19 vaccine, the CDC’s director said in a media statement.
On June 30, 2022, the Washington Post (Johnson) reported that in the fall, “vaccine makers will begin rolling out coronavirus booster vaccines better tailored to fight the current phase of the pandemic.” The FDA “announced that the fall shots would include a component from BA.4 and BA.5, the Omicron subvariants gaining ground in the United States.” Though “the precise formula has not been tested in people yet…studies showed that vaccines tuned to fight a previous version of Omicron modestly increased the short-term immune response in people compared with more shots of the original.” The New York Times (Weiland) reported that this “decision came just two days after the agency’s committee of independent vaccine experts overwhelmingly voted for regulators to adopt more advanced vaccines tailored to forms of Omicron.” The FDA “recommended that manufacturers produce a so-called bivalent vaccine targeting BA.4 and BA.5 along with the original coronavirus.”
COVID-19 Coding Guidance & Telehealth Toolkit
The American Medical Association released two CPT codes (86328 and 86769) for reporting antibody testing for COVID-19 and revised its CPT code for SARS-CoV-2 nucleic acid tests (86318). Providers can manually upload the code descriptors into their EHR systems. (See additional guidance on the CPT codes.) And on April 23, 2020, CMS announced that the Trump Administration released a new toolkit for states to help accelerate adoption of broader telehealth coverage policies in Medicaid and CHIP during the COVID-19 pandemic. The objective was “to make it easier for Medicaid and CHIP enrollees to receive health care at home rather than at a doctor’s office or emergency room, where they could become exposed to – or pass along – the virus.”
On April 27, 2020, HHS, through the Health Resources and Services Administration (“HRSA”), launched a new COVID-19 Uninsured Program Portal, allowing healthcare providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement. Providers can access the portal at COVIDUninsuredClaim.HRSA.gov. Providers can request reimbursement starting May 6, 2020 if they have treated or tested an uninsured patient for COVID-19, but only if they agree not to balance bill the patient. (For discussions of federal and state restrictions on balance billing as conditions for receiving or keeping COVID relief funds, see here and here.)
Providers can register on HRSA’s website. The program is being administered by United Health Group, so providers must have an Optum ID to register. (See Optum’s summary of key points for claims submission.) HRSA has a program to reimburse providers for COVID-19 testing, treatment and vaccination for uninsured patients. The list of billing codes that will be accepted is shown in the Billing Codes section of HRSA’s website. More information is available in the COVID-19 Uninsured Program FAQs.
Also, the American Health Information Management Association published an article explaining coding for COVID-19 testing and diagnoses that answers many questions about the codes that will be recognized as shown in the Billing Codes section of HRSA’s website. And CMS has developed two HCPCS codes that healthcare providers and laboratories can use to bill for certain COVID-19 diagnostic tests. (See more information and updates on these codes.)
CMS continues to amend and update its lengthy guidance on Medicare Fee for Service Billing as it relates to the COVID-19 pandemic. On May 27, 2020, CMS added language that addresses questions regarding the CARES Act and how it affects the Inpatient Prospective Payment System (“IPPS”). The update included information on how discharges for individuals with COVID-19 should be identified, including different diagnosis codes for discharges between January 27 and March 31, and for discharges occurring on or after April 1 through the duration of the public health emergency period. CMS also clarified that the CARES Act “directs the Secretary to increase the IPPS weighting factor of the assigned diagnosis-related group by 20 percent” for diagnosed COVID-19 patients discharged during the public health emergency period.
On June 1, 2020, CMS provided an update that clarifies when providers must use modifier CR (catastrophe/disaster related) and/or condition code DR (disaster related) when submitting claims to Medicare. The update includes a chart of blanket waivers and flexibilities that require the modifier or condition code.
In its June 2, 2020 update, CMS added or revised nine new provisions to the guidance contained in the FAQ. The revisions include clarifications regarding national coverage determinations and when telehealth may satisfy certain face-to-face requirements. CMS stated that as it continues to thoroughly assess the CARES Act, new and revised guidance will be released as implementation plans are announced. Therefore, additional updates from CMS are expected. Providers should carefully monitor the guidance contained on the COVID-19 FAQ page to evaluate the impact of new guidance on facility operations and finances.
Telehealth Coding Tips
Below are some tips healthcare reimbursement experts suggest for coding various types of telehealth services so as to help ensure compliance.
Telephone (Audio-Only) Services
When social distancing is needed, telephone (audio-only) services have become a practical way to improve patient access and prevent spread of COVID-19. Telephone services (which generally require a minimum of five minutes of medical discussion) can be ideal for minor health problems that don’t require visual examination by a healthcare provider, such as medication refills, etc. For audio-only services, consider the codes listed below that Medicare accepts during the current public health emergency. Commercial payers may accept these codes, as well. Once the PHE has concluded, Medicare may only accept G2012 (virtual check-in) for telephone services.
- Document verbal consent, including patient acknowledgement and acceptance of any copayments or coinsurance amounts due.
- Only count time spent on the phone engaging in medical discussion with the patient or caregiver. Do not report these codes for conversations lasting less than five minutes.
- Clearly document what was discussed, as well as the outcome of the conversation (e.g., medications prescribed, referrals to specialists, additional steps for the patient to take).
- Don’t report these codes when the telephone service ends with a decision to see the patient in 24 hours or the next available appointment.
- Don’t report these codes when the telephone service relates to a related E/M service performed within the previous seven days or within the postoperative period of a previously completed procedure. (“E/M” stands for “evaluation and management.” E/M coding is the process by which physician-patient encounters are translated into five digit CPT codes to facilitate billing.)
- Only use or provide 99441-99443 and 98966-98968 for established patients. During the PHE, Medicare permits providers to bill G2012 for new and established patients.
- To operationalize these codes, set up a process in your practice management system that flags or pends claims for manual reviews to determine whether and which services are ultimately billable.
Telehealth (Audio-Visual) Services
In the last few months, providers have adopted telehealth to improve patient access and generate revenue during COVID-19. Among the services physicians can render via telehealth to patients with Medicare during the current PHE are Medicare annual wellness visits, new and established patient office visits, prolonged services, smoking and tobacco cessation counseling, annual depression and alcohol screenings, advanced care planning and more. Medicare covers more than 200 services via telehealth, many of which were added for temporary coverage during the current PHE. Commercial payer coverage of these services may vary. So, providers should check individual payers’ policies and requirements.
Reimbursement experts advise the following steps for billing telehealth services:
- Check audio-only vs. audio-visual requirements. Medicare requires the use of audio-visual technology for certain telehealth services and permits audio-only for others. For example, physicians can render a telehealth visit for advanced care planning using audio only, but they must use audio-visual technology for a new patient telehealth office visit. Private commercial payers may also have their own specific requirements.
- Do not render Medicare’s Initial Preventive Physical Exam via telehealth. Medicare does not permit it.
- Document verbal consent for telehealth, including patient acceptance of any copayments or coinsurance amounts due.
- Use place of service (“POS”) code 11 and modifier -95 when billing Medicare. Note that commercial payers may require a different POS code (e.g., POS 2 or POS “other”) and modifier.
- Document, document, and document some more. Physicians and other providers need to be able to prove via proper and adequate documentation that they met all of the code requirements, even when rendering a service via telehealth. For example, experts counsel against ever submitting a problem list if you did not treat or manage all of the problems on the list, and say physicians need to link diagnoses with assessments and treatment plans. Another caveat is that during the current PHE, physicians can bill 99201-99215 rendered via telehealth based on time or medical decision-making. But documenting the total time spent in direct medical discussion with the patient is extremely important.
Online Digital E/M Services
Though online digital evaluation and management (“E/M”) services are relatively new, they also can help practices increase patient access during COVID-19 for non-urgent medical issues. Generally, such services are provided as follows: an established patient initiates a conversation through a HIPAA-compliant secure platform (e.g., electronic health record portals, secure email, secure texting, etc.). A physician or other qualified healthcare professional reviews the query, as well as any pertinent data and records. Then the healthcare provider(s) develop a management plan and subsequently communicate that plan to the patient or their caregiver through online, telephone, email or other digitally supported communication.
To maintain compliance in coding for such services, experts suggest the following:
- Use these codes when physicians or other qualified healthcare professionals make a clinical decision that would otherwise occur during an office visit. Do not use them for scheduling appointments or non-evaluative communication of test results.
- Use these codes only for established patients.
- Do not use these codes for fewer than five minutes of E/M services.
- Document verbal consent, including patient acknowledgement and acceptance of any copayments or coinsurance amounts due.
- Do not report these codes when the online digital E/M service ends with a decision to see the patient in 24 hours or the next available urgent visit appointment.
- Do not report these codes when the online digital E/M service relates to a related E/M service performed within the previous seven days or within the postoperative period of a previously completed procedure.
Effective January 1, 2021, the CPT Evaluation and Management (“E/M”) Office or Other Outpatient and Prolonged Services Code and Guidelines were overhauled for the first time in more than 25 years. E/M documentation guidelines for new and established office and outpatient services (99202 – 99215) have gone through substantial revisions. New guidelines include eliminating history and physical exam as elements for code selection, and allowing physicians to choose the code level based on medical decision-making or total time.
Practitioners have the choice to document office/outpatient E/M visits via medical decision making (“MDM”) or time. CMS is adopting the CPT’s revised guidance, including deletion of CPT code 99201. CMS has also finalized separate payment rates for the remaining nine E/M codes. (An AMA summary of the code and guideline changes appears here.) Additional information regarding the 2021 adjustments to the E/M CPT codes, and how to assess potential impacts on physician compensation and productivity, can be viewed here and here.
Remote Patient Monitoring
Remote patient monitoring (“RPM”) is a relatively easy way for providers to keep track of patients’ status or progress without requiring patients to come into the office. Medicare covers RPM for patients with one or more acute or chronic conditions, and private payer coverage may vary. Normally, Medicare permits RPM only for established patients (whom the provider has previously examined in person). But during the PHE, physicians can initiate RPM for not only established, but also new patients.
RPM consists of two forms: monitoring data through either a non-manual or manual data transfer. For example, physicians can remotely monitor a patient’s pulse oximetry, weight, blood pressure or respiratory flow rate using a device that transmits daily recordings or programmed alerts. Physicians can purchase them directly from manufacturers or patients can purchase the devices themselves. Patients are advised to use Bluetooth-enabled devices or devices that include a built-in Global System for Mobile Communications (“GSM”) transmitter. The former requires an Internet connection, while the latter automatically transmits data to an internet cloud service through an encrypted bandwidth. Physicians may be able to bill for the initial setup, cost of the device itself (when applicable) and data monitoring.
Another example is self-measured blood pressure monitoring. When patients supply their own blood pressure device that a physician calibrates, physicians may be able to bill for patient education, device calibration, reviewing the data that the patient provides, and communicating a treatment plan to the patient or caregiver.
Monitoring patients’ physiologic data remotely through such devices can substantially reduce exacerbations of patients’ chronic conditions, emergency room visits, and hospitalizations. It can also be a good source of revenue for providers, especially during a pandemic, when in-person patient visits are reduced.
Experts suggest the following for compliant RPM billing:
- Document patient consent. Patients must opt in for these services.
- Document total time spent rendering these services to support time-based requirements.
- Know when these codes are appropriate. It is unclear whether Medicare will pay physicians for monitoring physiologic data derived from internal devices (devices placed within the patient’s body) or data derived from wearable fitness devices.
- Only bill 99457 when the provider renders at least 20 minutes of live, interactive communication with the patient or caregiver.
CMS 2021 & 2022 Medicare Physician Fee Schedules Boost Telehealth, Use of Non-Physician Practitioners, Vaccines & Equity
In an article by Eric Wicklund dated August 14, 2020, mHealth Intelligence reported that CMS planned “to eliminate most of the temporary codes created during the coronavirus pandemic to expand connected health.” The proposed 2021 Physician Fee Schedule included “nine codes added during the COVID-19 crisis” and 13 new codes, but 74 codes were “slated to end when the public health emergency is over.” According to the article, “The 13 new codes proposed for inclusion in the Physician Fee Schedule are grouped in a new category, Category 3 (the Category 1 codes are slated to remain in place, and the Category 2 codes are scheduled for elimination).”
However, on December 1, 2020, CMS signed off on numerous proposed physician fee schedule changes. The final rule rule permanently expands telehealth services, reworks payments and coding for physicians, and expands the scope of practice for some clinicians. It adds a number of telehealth services to the PFS and creates a new category for temporary coverage for telehealth services. It also makes broad reimbursement policy changes concerning the use and supervision of non-physician practitioners and auxiliary personnel. With these changes, there will continue to be significant expansion in the use of telemedicine during the pandemic and afterwards, as well as greater use of non-physician practitioners when treating Medicare beneficiaries.
On January 5, 2021, it was reported that “after a lobbying frenzy that pitted primary care providers against specialty physicians, Congress decided to recalibrate the Medicare Physician Fee Schedule in its latest stimulus and government funding bill.” Ultimately, lawmakers “decided to give providers an across-the-board 3.75% pay increase for the 2021 calendar year.”
On March 12, 2021, CMS issued a notice correcting technical errors in its final rule updating physician fee schedule payments for calendar year 2021. Among other changes, the notice removed four codes from the newly created Category 3 list of approved telehealth services, which CMS says were inadvertently included on the list.
On November 2, 2021, CMS published the 2022 Physician Fee Schedule Final Rule (“Final Rule”), which includes a permanent expansion of telehealth services for behavioral health care beyond the duration of the public health emergency related to the COVID-19 pandemic. The Final Rule also extends CMS’s physician supervision requirements for telehealth so that direct supervision may continue to be provided via real-time audio-visual communications. Finally, the Final Rule extends reimbursement of Category 3 telehealth services (services that CMS deems to have clinical benefits on a temporary virtual basis) until the end of 2023.
As RevCycle Intelligence (LaPointe) reported on Nov. 2, 2021, “CMS has finalized the calendar year (CY) 2022 Medicare Physician Fee Schedule to promote greater telehealth utilization, boost reimbursement rates for vaccine administration, and improve health equity, among other initiatives,” according to the federal agency. The rule “will implement ‘a series of standard technical proposals’ as part of CY 2022 rate-setting, CMS said.” According to the article, “The conversion factor for next year will be $33.59, a decrease of $1.30 versus the CY 2021 conversion factor.”
Because coding rules for healthcare services change constantly, reimbursement and coding experts advise providers to check CMS’s and commercial payers’ websites on an almost daily basis for updates. Providers should also seek expert advice or legal counsel whenever they are uncertain about how to properly document, code or bill for a particular service – preferably before a dispute with a payer arises.
New Regulatory Waivers and Rule Changes to Support U.S. Healthcare System During COVID-19 Pandemic
On April 30, 2020, CMS issued another round of regulatory waivers and rule changes to support healthcare providers during the COVID-19 pandemic. Changes included increased access to telehealth for Medicare and Medicaid patients and expanding at-home and community-based testing to minimize COVID-19 transmission among Medicare and Medicaid beneficiaries. (See details of the new waivers and the interim final rule.)
Under the temporary waivers and rule changes, Medicare beneficiaries can be tested for COVID-19 without a physician’s order. Instead, Medicare will cover COVID-19 tests when ordered by any healthcare professional authorized to do so under state law.
CMS also is allowing pharmacists to perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory. According to CMS, the changes will open the door for more “point-of-care” testing. Medicare and Medicaid also will cover antibody tests that are authorized by the Food and Drug Administration.
Beyond its efforts to expand testing, CMS is waiving limits on the types of practitioners who can provide telehealth services and is allowing hospitals to bill Medicare as the originating site for services furnished remotely by hospital-based practitioners to registered outpatients, including when the patient is at home. CMS will now also allow nurse practitioners, clinical nurse specialists, and physician assistants to provide home health services, as mandated by the CARES Act.
On May 19, 2020, CMS authorized local Medicare Administrative Contractors (“MACs”) to set the payment amount for COVID-19 testing, both diagnostic and serology, until Medicare establishes national payment rates. CMS noted that for dates of service on or after April 14, Medicare has established a $100 payment rate for laboratory tests using high throughput technologies for rapid results.
Many services for behavioral health and patient education may now be conducted by audio-only telephone between beneficiaries and clinicians, CMS said. The agency also is increasing payments for telephone visits from the current $14-$41 to $46-$110, in line with payments for similar office and outpatient visits. The payments are retroactive to March 1, 2020.
CMS Finalizes Changes for Medicare Advantage, Part D Plans
On May 22, 2020, CMS finalized changes to the Medicare Advantage (“MA”) and Part D programs aimed at expanding access to telehealth and increasing plan options for beneficiaries in rural communities. CMS finalized only certain provisions from the February proposed rule so they would be in place before MA and Part D 2021 plan year bids, which were due on June 1. The agency plans to issue subsequent rulemaking to address the remaining proposals—including policies to lower seniors’ out-of-pocket expenses for pricey prescription drugs—which will apply no earlier than January 1, 2022.
“We understand that the entire healthcare sector is focused on caring for patients and providing coverage related to coronavirus disease 2019 (COVID-19), and we believe this approach provides plans with adequate time and information to design the best coverage for Medicare beneficiaries,” CMS said in a fact sheet.
Network Adequacy, MLR
The final rule gives MA plans more flexibility to count telehealth providers in certain specialties towards network adequacy standards. The policy is aimed at encouraging use of telehealth services and increasing plan choices for beneficiaries, particularly in rural areas.
In rural areas, CMS is reducing the required percentage of beneficiaries that must reside within the maximum time and distance standards from 90% to 85%. CMS also is giving MA plans a 10% credit towards the percentage of beneficiaries that must reside within required time and distance standards for specialty areas such as Dermatology, Psychiatry, Cardiology, Ophthalmology, Nephrology, Primary Care, Gynecology, Endocrinology, and Infectious Diseases, the fact sheet said.
CMS also finalized its proposal to allow MA organizations to broaden the definition of “incurred claims” for purposes of the medical loss ratio (“MLR”). In addition, the final rule adds a deductible-based adjustment to the MLR calculation for MA medical savings account (MSA) contracts receiving a credibility adjustment. CMS said the adjustment “removes a potential deterrent to the offering of MSAs by MA organizations that may be concerned about their inability to meet the MLR requirement as a result of random variations in claims experience, the risk of which is greater under health insurance policies with higher deductibles.”
On June 10, 2020, the Centers for Disease Control and Prevention also issued guidance entitled “Using Telehealth to Expand Access to Essential Health Services During the COVID-19 Pandemic.” It describes the landscape of telehealth services and provides considerations for healthcare systems, practices, and providers using telehealth services to provide virtual care during and beyond the COVID-19 pandemic.
COVID-19 Public Health Emergency Extensions
On June 29, 2020, an HHS spokesperson indicated that HHS intended to extend the COVID-19 public health emergency that was set to expire on July 25. And on July 23, 2020, HHS officially extended it for another 90 days. Additional extensions have occurred since then. For example, on January 7, 2021, HHS announced another renewal of the COVID-19 national public health emergency declaration, effective Jan. 21, 2021. And, in a January 22, 2021 letter to governors, acting HHS Secretary Norris Cochran said that the public health emergency likely will remain in place through 2021. According to the letter, HHS will provide states with 60 days’ notice before terminating the PHE. (Links to HHS’s Public Health Emergency Declarations and extensions are here.)
On February 24, 2021, President Biden continued the national emergency for the COVID-19 pandemic beyond March 1, 2021. And on April 15, 2021, HHS Secretary Xavier Becerra renewed the nationwide public health emergency again as a result of the ongoing pandemic. The public health emergency that was originally declared Jan. 31, 2020 was then scheduled to remain in effect until at least July 20, 2021, at which time it could be renewed again. On July 19 and October 18, 2021, HHS renewed the COVID-19 public health emergency declaration for another 90 days. Administration officials previously told governors that the emergency declaration will last at least through December 2021.
On January 14, 2022, HHS Secretary Becerra extended the COVID-19 public health emergency again, continuing the declaration for another 90 days. An HHS spokesperson said that HHS will provide states with 60 days’ notice prior to any possible termination or expiration in the future. This was the eighth time the declaration was extended since it was announced Jan. 27, 2020.
On February 23, 2022, President Biden released a notice extending the national emergency declaration for the COVID-19 pandemic beyond March 1. The notice did not indicate an end date for the emergency declaration.
On April 12, 2022, the Federal Public Health Emergency was renewed, effective April 16, and currently expires July 15, 2022. The associated federal flexibilities, including current waivers issued by CMS, will remain in place for now.
The renewed national emergency, along with the recently renewed public health emergency, allow HHS to continue Section 1135 waivers and other flexibilities to ensure sufficient healthcare services and items to respond to the pandemic. Significant funding and regulatory relief for hospitals and other healthcare providers are tied to the emergency, so the extensions are important for both health and financial reasons.
Several key policies linked to the public health emergency are the Medicare inpatient 20% add-on payment for COVID-19 patients, increased federal Medicaid matching rates, requirements that insurers cover COVID-19 testing without cost-sharing, and waivers of telehealth restrictions. Adjustments CMS made to the Medicare Shared Savings Program for accountable care organizations are also tied to the length of the public health emergency. The number of months the emergency lasts affects the amount of shared losses an ACO must pay back to CMS. (Links to HHS’s Public Health Emergency Declarations and extensions are here.)
Even with the public health emergency extensions, some changes the administration has made to help healthcare providers are also dependent on a separate Stafford Act national emergency declaration remaining active. These changes include CMS Medicaid waivers that allow bypassing some prior authorization requirements, temporarily enrolling out-of-state providers, delivering care in alternative settings, and pausing fair hearing requests and appeal times. But the renewal gives the healthcare industry at least some certainty through the fall and early winter to assist with the COVID-19 response.
CMS Assessing Telehealth Reimbursement Rates to Potentially Make Medicare Telehealth Expansions Permanent
On July 21, 2020, in an article by Jacqueline LaPointe, RevCycle Intelligence reported that “Telehealth reimbursement rates is one area CMS is assessing in order to make Medicare telehealth expansions permanent after the COVID-19 pandemic, according to the agency’s administrator.” Recently, in a “Health Affairs blog post, CMS Administrator Seema Verma indicated that Medicare telehealth expansions implemented during the pandemic, including payment for telehealth services delivered to non-rural patients and the delivery of telehealth care in patient homes, may be made permanent.” However, three areas will need to be examined by CMS “before finalizing any permanent telehealth expansions, including telehealth reimbursement rates.”
“During the public health emergency, Medicare paid the same rate for a telehealth visit as it would have paid for an in-person visit, given the unique circumstances of the pandemic,” wrote Administrator Verma. “Outside the pandemic, by law Medicare usually pays for telehealth services at rates similar to what professionals are paid in the hospital setting for similar services.” “Further analysis could be done to determine the level of resources involved in telehealth visits outside of a public health emergency, and to inform the extent to which payment rate adjustments might need to be made,” Verma said.
For instance, CMS will need to determine supply costs for telehealth services in order to decide on telehealth reimbursement rates. Medicare reimbursement rates for in-person care take into account the costs for patient gowns, cleaning, disinfectants, and other supply expenses. Telehealth services do not have these costs. But new processes and workflows created to facilitate telehealth visits do have associated costs. Those costs would need to be examined in order for CMS to reimburse providers appropriately for permanent Medicare telehealth expansions, Verma indicated in her blog post.
Other areas CMS would need to examine to make Medicare telehealth expansions permanent included patient safety and clinical appropriateness, as well as healthcare fraud and Medicare program integrity. “We are monitoring program integrity implications such as practitioners who may be offering shorter telehealth visits with patients to maximize payment, or billing more visits than are possible in a day,” Verma wrote. “We know the path forward to expanding telehealth relies on CMS addressing the potential for fraud and abuse in telehealth, as we do with all services.”
On August 3, 2020, the president signed an executive order, seeking to expand the use of telehealth visits, and make some of the changes made when the coronavirus pandemic struck permanent. The order directs HHS to issue rules within 60 days making some of the revisions permanent. The order also calls on HHS to propose a new model that can be tested for how Medicare will pay for some health services in rural areas, with the goal of improving care in rural areas. It is unclear when any of the changes proposed by the order will take effect, however, given that there are still regulatory processes that will take time to play out. (CMS’s announcement that it is proposing changes to expand telehealth permanently, consistent with the Executive Order, can be viewed here.) The agency is also simplifying billing and coding requirements for office and outpatient visits.
Telehealth has been a critical part of COVID-19 response strategies. Through telehealth and telephonic care, providers have been able to keep seeing patients without exposing them or their staff to the highly contagious novel coronavirus. Remote or virtual care has also been key to ensuring patient and provider safety within hospitals and other healthcare facilities. With the use of smartphones, tablets, and other mobile technology, hospitals and physician practices have been able to minimize contact with infected patients while still examining and rendering care to patients.
Temporary payment flexibilities enabled providers to deliver telehealth services in a short period of time. Early in the pandemic, Medicare implemented a wide range of payment flexibilities to spur greater telehealth utilization. The flexibilities included temporarily expanding the scope of Medicare telehealth to allow more beneficiaries to benefit from virtual care services and the scope of providers eligible to bill for telehealth services.
CMS also added 135 allowable services, more than doubling the number of services that providers could bill via telehealth. The services included telephonic care for beneficiaries with limited access to video capabilities. But Congress must sign off on any broader expansion of telehealth coverage, including expanding the types of providers who may bill Medicare for telehealth services and amending the originating and distant site requirements.
Telehealth utilization among Medicare beneficiaries has surged during the pandemic. Over 9 million beneficiaries received a telehealth service between mid-March through mid-June, according to Medicare fee-for-service claims data. According to Verma, that number could grow, since providers have 12 months after they furnish a service to submit claims to CMS.
Telehealth utilization has similarly skyrocketed among the privately insured as private payers implemented similar telehealth expansions. A recent analysis of the privately insured population found that telehealth claim lines increased by 8,336 percent between April 2019 and April 2020, and the presence of telehealth claim lines nearly doubled the 4,347 percent increase observed from March 2019 to March 2020.
In light of such significant growth in utilization of telehealth services, CMS will consider making some temporary Medicare telehealth expansions permanent to encourage innovation while also ensuring “gold standard, in-person care.” “During these unprecedented times, telemedicine has proven to be a lifeline for health care providers and patients,” Verma said. “The rapid adoption of telemedicine among providers and patients has shown that telehealth is here to stay. CMS remains committed to ensuring that the government supports innovation in telehealth that leverages modern technology to enhance patient experience, providing more accessible care.”
In January 2021, a bipartisan group of U.S. representatives reintroduced a bill aimed at expanding access to telehealth beyond the COVID-19 pandemic. The Protecting Access to Post-COVID-19 Telehealth Act of 2021 legislation, which was first introduced in July 2020, would help safeguard access to virtual care after COVID-19 via four main provisions. According to a press statement, it would:
- Eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and establishing the patient’s home as an eligible distant site.
- Authorize CMS to continue reimbursement for telehealth for 90 days beyond the end of the public health emergency.
- Make permanent the disaster waiver authority, enabling HHS to expand telehealth in Medicare during all future emergencies and disasters.
- Require a study on the use of telehealth during COVID, including its costs, uptake rates, measurable health outcomes, and racial and geographic disparities.
The bill avoids some of the key issues associated with telehealth, such as coverage parity and interstate licensing issues, while making permanent broadly popular policies such as eliminating geographic and originating site restrictions. The widely praised earlier version of this bill was endorsed by a wide range of industry groups, who applauded it as an effort to keep patients from falling off a telemedicine “cliff” after the pandemic. But despite the support, the bill lost momentum in July 2020 after being referred to committee. Similarly, the Telehealth Modernization Act also failed to pass the Senate in 2020.
On March 18, 2021, the Senate confirmed Xavier Becerra as the next HHS secretary. During his Senate confirmation hearings, Secretary Becerra indicated his support for permanent telehealth expansions. Secretary Becerra said he wants to boost technology accessibility and is committed to permanently expanding payment policies that have increased virtual health during the COVID-19 pandemic.
On September 15, 2021, Psychiatric News reported that “The federal government is proposing to permanently allow payment under the Medicare program for ‘audio-only’ telehealth mental health services,” which have “been temporarily reimbursed as part of the government’s response to the COVID-19 public health emergency.” In addition, the government “would retain other temporarily reimbursed telehealth services through 2023 in order to evaluate whether those services should be permanently added to the list of covered Medicare services.” These “recommended changes are part of the proposed 2022 Physician Fee Schedule” by CMS and are seen as “a victory for psychiatrists and their patients.”
An HHS report issued on December 3, 2021 revealed that the number of Medicare visits conducted through telehealth surged 63-fold during the pandemic, from about 840,000 in 2019 to 52.7 million in 2020. Overall healthcare visits for Medicare beneficiaries declined in 2020; however, telehealth was particularly helpful in offsetting potential foregone behavioral health care, comprising a third of total visits to behavioral health specialists compared with 8% of visits to primary care providers and 3% of visits to specialists. Most beneficiaries (92%) received telehealth visits from their homes, which was not permissible in Medicare prior to the pandemic. And on Dec. 6, 2021, Modern Healthcare (Devereaux, Subscription Publication) reported that “Since the start of the pandemic, mental health conditions have remained the top diagnosis seen in telehealth nationwide, recently reaching 61.2% of all virtual care claims,” according to “FAIR Health’s Monthly Telehealth Regional Tracker.”
On Dec. 8, 2021, Kaiser Health News (Appleby) reported on the “increasingly heated debate” regarding coverage for audio-only telehealth visits, an issue that “has drawn outsize interest from physician groups.” “Cutting off or reducing audio-only payments could lead providers to sharply curtail telehealth services, warn some physician groups and other experts,” while “other stakeholders, including employers who pay for health coverage, fear payment parity for audio-only telehealth visits could lead to overbilling.”
- Before the pandemic, Medicare generally only reimbursed telehealth visits for rural patients, who were required to go to a healthcare setting to make the telehealth call. Under the legislation, patients would be able to make telehealth calls from home and would not be restricted to certain zip codes, even after the end of the public health emergency.
- The legislation also includes a two-year temporary extension of emergency telehealth waivers, such as allowing certain providers like speech language pathologists, occupational therapists and physical therapists to provide telehealth services.
Telehealth has become so popular that an increasing number of private insurers have launched “virtual-first” plans, requiring patients to consult with a primary care doctor virtually before they come in for an in-person visit. As incentives, such plans often do not require patients to pay co-pays to visit their virtual doctors, saving enrollees on healthcare costs. But while the rates Medicare pays for telehealth and in-person services are currently the same, that arrangement and other telehealth waivers expire at the end of the public health emergency absent Congressional action. Consequently, providers are urging Congress and CMS to maintain payment parity, or something close to it, even after the pandemic ends.
CMS has updated its COVID-19 webpage with toolkits for providers, partners and health plans/issuers. Reimbursement rules and guidance from regulators and payers continue to evolve as the situation develops. To the extent possible, providers should stay informed and monitor for updates. Please see our Medical & Professional Licensing Board Matters webpage for additional details regarding COVID-19 Emergency Practice, Telehealth & Teleprescribing Measures. See our HIPAA, Health Information Privacy & Security Compliance webpage for details regarding HIPAA Compliance & Waivers During the COVID-19 Pandemic. And see our Stark, Anti-Kickback, Civil Monetary Penalty & False Claims Act Issues webpage for details regarding COVID-19 Fraud Enforcement & Telehealth. (A summary of CMS’s blanket waivers of certain self-referral prohibitions contained in the federal Stark Law also appears here. And a summary of all of CMS’s COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers is here.)
In Georgia, during the 2021 legislative session, HB 307 was enacted, revising the Georgia Telehealth Act (O.C.G.A. § 33-24-56.4). The bill authorizes healthcare providers to provide telemedicine services from home and patients to receive telemedicine services from their home, workplace or school. Insurers are not allowed to require a deductible or an in-person consultation before providing coverage for telemedicine services. Additionally, the bill places restrictions on utilization review and requires insurers to allow open access to telehealth and telemedicine services, including the provision of prescription medications. Governor Kemp signed HB 307 into law on May 4, 2021.
CMS Approves Plan to Streamline Prior Authorization & Improve Patient & Provider Medical Records Access
On January 15, 2021, CMS approved its plan to streamline prior authorization and improve patient and provider access to medical records. The “final rule requires payers – including Medicaid, the Children’s Health Insurance Program and exchange plans – to build application program interfaces to support data exchange and prior authorization.” According to CMS, “the changes would allow providers to know in advance what documentation each payer would require, streamline documentation processes, and make it easier for providers to send and receive prior authorization information requests and responses electronically.”
However, on February 17, 2021, FierceHealthcare (R. King) reported that the Biden Administration appeared to have withdrawn the rule finalized at the “last minute” by the Trump administration. CMS did not say why the rule appeared to be withdrawn, but the prior press release no longer appears on CMS’ website, and the rule does not appear in the Federal Register. An agency spokesperson is quoted as saying that “this matter is currently under CMS review and we look forward to sharing additional information about this program soon.” Shortly after President Biden was inaugurated on January 20th, the White House issued a memo calling for a freeze on any last-minute regulations finalized by his predecessor. CMS did not say that the withdrawal was due to the memo and the rule could still survive, as any regulations affected by the freeze must be reviewed and approved by an agency or department head.
In Georgia, during the 2021 legislative session, SB 80 was enacted, amending O.C.G.A. § 33-46-1, et seq., the “Ensuring Transparency in Prior Authorization Act,” to provide new standards for prior authorizations by a utilization review entity. This bill establishes rules for the prior authorization process that include reporting and disclosure requirements, timeline guidance, and qualifications of decision-makers. SB 80 also requires prior authorization standards to be listed on an insurer’s website. Prior authorization approvals must be granted within 72 hours in urgent cases and 15 days for elective procedures. In 2023, the number of days for elective services drops to seven. And a peer-to-peer conversation must take place before a provider has to file an appeal. SB 80 was signed into law by Gov. Kemp on May 10, 2021.
Congress reportedly is also considering changes to Medicare Advantage that would crack down on prior authorization tactics insurers use to reduce healthcare costs but can affect how providers care for patients. As reported by Modern Healthcare (5/13/21, Hellmann and Tepper), Rep. Susan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA) and Larry Bucshon (R-IN) “reintroduced a bill…that aims to quicken the prior authorization process and require more transparency about how often plans deny providers’ requests.” Physician groups insist the requirements of prior authorization have become increasingly burdensome. But insurers claim they only use it for “a small percentage of medical services and products, which are considered experimental or at risk of overuse,” and argue that removing the system could put patients at risk.
Audits in the Wake of COVID-19
Most payer audits have been suspended or postponed during the public health emergency. (OIG’s COVID-19 FAQs can be read here.) But according to its July 2020 FAQ document on provider burden relief, CMS is ending its suspension of Medicare claims audits effective August 3, 2020, regardless of the status of the federally declared COVID-19 national emergency. The department suspended most fee-for-service claims audits on March 30 due to the pandemic. The suspension applied to prepayment medical reviews conducted by MACs and post-payment reviews. CMS cited changes in states’ reopening policies and the importance of the reviews as reasons for resuming the audits.
CMS’s FAQ states that if providers impacted by the pandemic are selected for review, they should discuss with their MAC any COVID-19 related hardships that may affect the timeliness of their audit response. Since CMS permitted several exceptions to its regulatory compliance rules for healthcare providers during the pandemic, CMS will apply any waivers and flexibilities in place at the time of the dates of service.
Healthcare coding and reimbursement experts have been predicting that once the pandemic is no longer raging, “audits will be coming fast and furiously.” For one thing, with spending soaring and revenue plummeting during the emergency, the government and health insurers will need money more than ever once the pandemic abates. And both reimbursement consultants and government enforcers agree that virtually all providers will be in the cross hairs.
For example, one retired HHS-OIG Senior Special Agent warned online: “CMS put out an FAQ this month advising it will stop audits during the PHE. Understand that when that is lifted, audits will commence, and likely at a feverish pace. Are providers prepared for the audits to come, particularly with some of the ‘relaxed’ telemedicine and telehealth rules? Probably not. Be proactive and do internal probe reviews to ensure compliance, so in three years you do not see an overpayment letter for hundreds of thousands of dollars. Getting the education needed to stave off a large overpayment [allegation] is a basic compliance measure.”
In short, it is never too soon to assess your risks and determine how best to mitigate those that could lead to damages (civil or criminal). Do not assume your practice won’t be a target. Be proactive and audit both retrospectively and prospectively. If you have sufficient staff to conduct internal audits, do them. If not, hire a reputable firm to help. Be sure you can fully support with adequate documentation any claims you submit for reimbursement. Adequate documentation is crucial. Even when rules seem more relaxed, documenting properly now can save you in an audit down the road. Also be sure that your audit is conducted under the supervision of an attorney, so as to protect privileged communications and work product to the extent permitted by law.
The regulatory landscape continues to change rapidly. During the onset of the pandemic, agency enforcement discretion allowed for a more relaxed regulatory approach. However, the same enforcement discretion can shift quickly to the return of a more rigid regulatory framework. It now appears that pre-pandemic enforcement practices are resuming, even as the public health emergency continues. Providers therefore need to be prepared.
How We Can Help & Services We Provide
Certain provisions in third-party payer contracts and governmental rules can have a great impact upon a provider’s revenue stream and financial viability. Hospitals and physicians often write off tens of thousands – sometimes even millions — of dollars due to payers improperly denying or underpaying claims. Our healthcare and business law firm can help by:
- Negotiating and reviewing health insurer plan documents.
- Negotiating and reviewing IPA, PHO and PPO network agreements.
- Negotiating and reviewing provider contracts with third-party payers.
- Negotiating with plan sponsors regarding potentially unlawful plan terms.
- Representing providers in disputes that arise under documents such as those listed above.
- Representing providers in disputes with insurers, including terminations of provider agreements.
- Evaluating denied claims against the terms of provider-payer contracts and government regulations, and helping clients determine next steps in proceeding against payers’ improper denials.
- Reviewing and evaluating fact questions like prior authorizations and legal questions like potential violations and penalties.
- Enforcing insurer and payer compliance with preferred provider arrangements, third-party network contracts and treatment agreements.
- Challenging payers who violate the MSP Act and other coordination of benefits rules.
- Challenging audit findings, overpayment demands and recoupment actions issued by third-party administrators, insurers and health plans.
- Challenging plan fiduciaries for failing to follow proper claims and appeals procedures.
- Representing providers in investigations, audits, pre-suit claims, mediations, arbitrations and lawsuits.
- Helping providers recover damages caused by improperly denied or underpaid claims.
Claims denied improperly by managed care payers fall within the scope of the provider participation agreement signed by the provider and payer. Therefore, any wrongly denied claims are subject to the terms of the signed agreement, as well as applicable laws relating to contract breaches. A health plan’s breach of its own contract is subject to the dispute resolution terms of the signed contract, which allow for either an arbitration demand or a lawsuit to be filed against the payer.
Even if the contract or related provider manual contains specific terms not met by a provider, some denials may be unenforceable as illegal penalties. Therefore, healthcare providers who have rendered valuable services to a health plan’s members should not give up on improperly denied claims without first consulting legal counsel. (For discussion of Georgia and federal laws governing so-called “Surprise Billing” and disputes between providers and payers over proper out-of-network payment amounts, please see the Billing & Collection Agreements section of our Healthcare & Physician Contracts webpage.)
Our healthcare and business law firm helps healthcare providers by reviewing, negotiating and drafting contracts. We assist hospitals, physicians, physician groups and other providers in negotiating and contracting with health insurance payers, plans and managed care entities. And we represent healthcare providers in investigations, audits, administrative proceedings, mediations, arbitrations and lawsuits when disputes arise with payers, managed care plans or other entities over reimbursement or other matters. Please call or email us if you need assistance in any of these areas.