Articles Posted in COVID-19

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On May 28, 2021, the Equal Employment Opportunity Commission (EEOC) released guidance indicating that employers could, under certain circumstances, offer incentives to employees to receive the COVID-19 vaccine and offer the vaccine to employees’ family members. The EEOC largely confined its analysis to the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA). However, employers who are also healthcare providers must also consider whether these benefits to employees or their family members implicate prohibitions on payment for referrals.

The Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statutes (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA) all prohibit various forms of payment for referrals. The Stark Law prohibits “physicians” (generally including MDs, DOs, dentists, optometrists, and chiropractors) from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. The AKS is a criminal statute that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. EKRA provides criminal penalties for paying, receiving, or soliciting any remuneration in return for referrals to recovery homes, clinical treatment facilities, or clinical laboratories. All three and can carry stiff penalties, sometimes criminal penalties.

Healthcare employers who provide incentives to receive the COVID-19 vaccine to employees with the ability to make referrals to the employer or that offer benefits to such employees’ family members should account for these statutes. Depending on how the incentive is structured, it may fit into the bona fide employment exception to the Stark Law or one of the other exceptions or safe harbors in these rules. It is also important to note that, due to federal funding, the vaccine itself it available free-of-charge, but that administration of the vaccine and the convenience thereof may still represent things of value, as well as the value of any incentives, in cash or otherwise.

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Two significant areas of the Provider Relief Fund (PRF) are ripe for updates by the US Department of Health and Human Services (HHS): the current June 30, 2021 deadline for recipients to spend PRF payments and the long-awaited reporting requirements. The PRF is a $175 billion fund created by Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS has subdivided the PRF into various general and targeted distributions.

Currently providers who received payments under the PRF generally have until June 30, 2021 to use the funds. The funds must be used in specific ways as specified by HHS and often require careful documentation and accounting. The June 30, 2021 deadline was initially set early in the pandemic, but HHS has released guidance as recently as March 2021 that reinforces the deadline and provides that HHS expects that providers with unused PRF fund after June 30 will return any unused funds to HHS. However, as the pandemic and the corresponding public health emergency declaration appear likely to extend beyond June 30, 2021, providers are likely to continue to have PRF-eligible expenses well after HHS’s deadline. It would therefore likely benefit many providers for HHS to extend the June 30, 2021 deadline. Indeed, the American Hospital Association (AHA) recently penned a letter to HHS requesting providers be allowed to use PRF fund until the end of the declared public health emergency.

Another reason to extend the June 30, 2021 deadline would be that HHS has yet to release when providers will be required to submit PRF reporting. The statutes that created the PRF and the terms and conditions of the payment to which recipients were required to attest both require recipients to file reports with HHS regarding use of the funds. While HHS has released some details on the form and content of reports and set up a reporting portal, HHS has repeatedly pushed back the release of detailed reporting requirements and the due date of reports. The first reports had initially been due on February 15, 2021, but HHS has pushed this date back. HHS has not released a new date when reports are due but has indicated that recipients will receive a notification when reporting must be completed. A concrete reporting timeline that aligns with an extension of the June 30, 2021 deadline to spend PRF funds would likely be welcomed by providers struggling to plan and budget, while also providing critical care during a public health emergency.

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The US Department of Health and Human Services (HHS) has announced a new program to pay healthcare providers for COVID-19 vaccine administration to underinsured patients, the COVID-19 Coverage Assistance Fund (CAF). CAF is administered by the Health Resources & Services Administration and functions as a claims reimbursement program. Where vaccine administration to uninsured patients is covered by HRSA’s Uninsured Program, CAF is intended to reimburse providers for vaccine administration to patients who have insurance, but whose health plan either denied or only partially paid the claim for vaccine administration. CAF reimburses for COVID-19 vaccine administration at the national Medicare rate.

To submit claims to CAF, providers must first enroll in the program and attest that they (1) have submitted a claim to the patient’s primary health insurance plan and there is a remaining balance from that health insurance plan that either does not include COVID-19 vaccination as a covered benefit or covers COVID-19 vaccine administration but with cost-sharing; (2) have verified that no other third party payer will reimburse them for COVID-19 vaccine administration fees for that patient encounter, or other patient charges related to that COVID-19 vaccination, including co-pays for vaccine administration, deductibles for vaccine administration, and co-insurance; (3) will accept defined program reimbursement as payment in full; (4) agree not to balance bill the patient; and (5) agree to program terms and conditions and may be subject to post-reimbursement audit review.

COVID-19 vaccine administrations occurring on or after December 14, 2020 are eligible for reimbursement by CAF. CAF will reimburse for COVID-19 vaccine administration at the national Medicare rate, which is as follows:

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A St. Louis, Missouri based chiropractor has become the first person charged under the new COVID-19 Consumer Protection Act, with the government alleging numerous civil violations and seeking civil monetary penalties. The allegations serve as a cautionary tale for healthcare providers marketing and selling goods and services relating to the COVID-19 pandemic.

The COVID-19 Consumer Protection Act was enacted in December 2020 and makes it unlawful, for the duration of the ongoing COVID-19 public health emergency, for any person, partnership, or corporation to engage in unfair or deceptive acts or practices in or affecting commerce that are associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19. The Act is similar to Section 5(a) of the FTC Act, but adds increased penalties for violations relating to the COVID-19 pandemic. The Act authorizes injunctive relief and Civil Monetary Penalties of up to $42,792 per violation.

In this case, the first under the Act, the government alleged that the chiropractor and his company violated the Act by making claims about the efficacy of their products that were not supported by scientific literature. Specifically, that the chiropractor sold various vitamin supplements and claimed that they prevented or treated COVID-19. The government also alleged that the chiropractor claimed the vitamin supplements were more effective that the available COVID-19 vaccines. The government alleged that the chiropractor made these claims in numerous videos posted on various social media and other websites and misrepresented the results of studies concerning the efficacy of the vitamin supplements in treating or preventing COVID-19. According to the allegations, these claims constituted violations of the Act because, even though there are studies showing correlation between vitamin deficiencies and elevated risk from the virus, there are no randomized clinical trials that establish the vitamin supplements caused positive health outcomes in connection with COVID-19.

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In general, liability waivers can be a useful tool for businesses and individuals to avoid personal injury lawsuits and liability. Typically, liability waivers are associated with participating in a dangerous activity, such as skiing, boating, gym classes, or school activities. The individual participating in the activity signs the waiver, acknowledging that he or she accepts the risks associated with the activity and agrees to release the business or individual from liability related to these risks. However, in response to the COVID-19 pandemic, liability waivers by patients for COVID-19 related risks are becoming increasingly common. While these waivers are likely enforceable, providers should be aware of potential legal issues if patients are asked to sign COVID-19 liability waivers.

Each state evaluates the enforceability of liability waivers differently. For example, in some states, such as Louisiana, Virginia, and Montana, personal injury liability waivers are all invalid. However, in most states, including Michigan, these liability waivers are generally enforceable, subject to certain restrictions. In Michigan, parties may contract against liability for harm caused by ordinary negligence, but not gross negligence, or willful and wanton misconduct. Therefore, a party will not be protected from liability if it intentionally or recklessly engaged in the conduct that caused harm. Although not explicitly stated in laws or statutes in Michigan, other important factors for providers to consider in drafting these liability waivers include:

  • Clear language. The waiver should clearly state that the individual is releasing the business or provider from liability. The terms should also be easy for the parties to understand.
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On April 15, 2021, the Department of Health and Human Services Office of Inspector General (OIG) issued a statement reminding providers that the COVID-19 vaccine must be provided at no cost to the public. OIG issued this message as a result of complaints from patients about charges from providers for receiving the COVID-19 vaccine. All supply of the COVID-19 vaccine in the United States has been purchased by the United States Government and is only to be used by providers through the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination Program. Because the vaccine is being supplied by the federal government, any provider participating in the CDC COVID-19 Vaccination Program must comply with the terms of the program and offer the vaccine to recipients for free.

Providers participating in the CDC COVID-19 Vaccination program must sign a CDC COVID-19 Vaccination Program Provider Agreement. Providers are responsible for compliance with the requirements in the agreement. Compliance with the program requires that providers administer the vaccine at no cost to the patient. All organizations and providers enrolled in the program:

  • Must administer the COVID-19 vaccine with no out-of-pocket charges to the patient
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In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) created separate payments for audio-only telephone evaluation and management (E/M) services. E/M billing codes apply to medical services related to evaluating and managing a patient, such as, hospital visits, preventive services, and office visits. Coding for E/M services can be complicated because many variables are involved in selecting the proper code. For example, the type and complexity of history, examination, and decision making, as well as time spent with the patient are often factors to be considered. Audio-only telephone E/M services were not previously covered by Medicare under the physician fee schedule (PFS). However, beginning with the March 2020 Interim Final Rule with Comment (IFC), CMS found these types of visits to be clinically appropriate and began to cover certain audio-only codes. CMS further expanded the list of covered audio-only codes in the April 2020 IFC.

CMS soon found that audio-only health services became far more popular than CMS expected, and many beneficiaries were not using video technology to communicate from their homes. Since the new E/M codes were established, providers were seeing beneficiaries for more complex evaluation and management services using audio-only technology, when they would normally utilize telehealth video or in-person visits to evaluate the patient. According to CMS, the intensity and complexity of providing an audio-only visit to a beneficiary during the unique circumstances of the COVID-19 PHE was not properly valued as established in the March 2020 IFC. This was especially true when considering these audio-only services were often being used as a complete substitute for office/outpatient Medicare video telehealth visits. Therefore, CMS established new RVUs based on E/M codes in existence prior to the PHE and the time requirements necessary for telephone service-related codes. Because these audio-only visits were being used in replacement of office/outpatient E/M visits, they should be considered telehealth services and added to the Medicare telehealth service list while the PHE is ongoing.

In the CY 2021 PFS proposed rule, CMS elected not to continue covering the audio-only codes when the PHE ends. This is because, outside the circumstances of the COVID-19 PHE, telehealth services generally must be provided using interactive, two-way audio and video technology. Commenters on the proposed rule broadly supported maintaining payment for audio-only provided services. Commenters stated that many beneficiaries may not have access to two-way audio and video technology and that continuing to pay for these E/M services will help vulnerable populations and those with less access to quality healthcare. However, CMS declined to finalize payment of these E/M codes beyond the PHE. The Social Security Act requires telehealth services to be furnished using a telecommunications system. CMS maintains that there is a longstanding policy of interpreting “telecommunications system” to include technology that allows the telehealth visit to be analogous to an in-person visit. Outside the COVID-19 PHE, CMS continues to believe that the longstanding interpretation of telecommunications system excludes the use of audio-only technology for Medicare telehealth services. The PHE declaration must be renewed in 90-day increments and is currently slated to end April 20, 2021. However, HHS and the Biden administration have signaled that they are likely to repeatedly renew the PHE through at least the end of 2021, thereby allowing Medicare telehealth waivers to continue until the end of the year.

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On February 10, 2021, the United States Department of Justice filed the first criminal charges relating to a alleged violation of the terms the Provider Relief Fund (PRF). The allegations contained in the indictment illustrate some of the pitfalls of the PRF and the importance of compliance with its terms. It may also provide insight into coming enforcement actions.

The alleged defendant was a resident of southeastern Michigan who owned and operated a home health agency in Indiana. The home health agency closed in January 2020 and filed a notice of voluntary termination with Medicare in March 2020. However, despite the filing of this notice, when the first wave of payments under the PRF were automatically deposited into providers’ accounts in April, the defendant’s home health agency received approximately $38,000. The defendant then allegedly submitted an attestation to the terms and conditions of the PRF payment and allegedly distributed the funds to family members in a series of checks, all just under $10,000. The indictment charged the defendant with one count of Theft of Public Money, Property, or Records.

This indictment touches several possible areas of enforcement or audits of PRF payments, including eligibility criteria, attestations, and use of the funds. The first wave of payments under the PRF consisted of $30 billion that was automatically deposited in providers’ accounts in amounts based on a provider’s 2019 Medicare billing. Providers did not make requests or applications for this funding. However, simply because a provider received money did not mean they were entitled to keep it, a provider also had to meet the eligibility criteria, such as the requirement that it provided services after January 31, 2020.

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On March 15, 2021, the Centers for Medicare & Medicaid Services (CMS) announced it will increase the amount Medicare pays providers for administering the COVID-19 vaccine. For vaccines administered on or after March 15, 2021, the new national average payment rate for physicians, pharmacies, hospitals, and other providers who administer the vaccine of $40 per single-dose vaccine and $80 per two-dose vaccine. The exact payment rates will be based on the type of provider offering the vaccine and will be adjusted based on the location of the provider. For vaccines administered prior to March 15, 2021, Medicare rates will remain $28.39 per single-dose vaccine and $45.33 for both doses of a two-dose vaccine.

These changes in Medicare payment rates are based on new information regarding the costs of vaccine administration for different types of providers and more resources needed to safely administer the vaccine. The goal of CMS is to increase the number of providers offering the vaccine and further emphasize that no beneficiary, whether a beneficiary with private insurance, Medicare, or Medicaid, should pay cost-sharing to receive the COVID-19 vaccine. The new payment rate is effective for COVID-19 vaccines given on or after March 15, 2021.

In order to receive COVID-19 vaccines at no cost from the federal government, providers cannot charge patients for administration of the vaccine. Providers that receive federally purchased vaccines during the public health emergency must contractually agree to administer COVID-19 vaccines to patients regardless of their ability to pay; Providers are therefore prohibited from charging a patient any amount for administration of the vaccine, including a copay, coinsurance, or deductible, including seeking reimbursement from patients, such as balance billing. CMS provides payment information for various programs, to ensure consistent coverage across payers, such as:

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On March 11, 2021, President Biden signed  the $1.9 trillion American Rescue Plan, a legislative package to help fund vaccinations, provide immediate relief to families during the COVID-19 pandemic, increase COVID-19 testing and identify new and emerging strains of COVID-19.  The final bill includes several sources of funding for COVID-19 response and other healthcare programs:

Development of a national vaccination program

  • The bill includes $20 billion for a nationwide vaccination program, in partnership with state and local authorities. The vaccination program will include the creation of community vaccination centers as well as mobile vaccination units. Under the plan, the Biden Administration will work with Congress to expand the Federal Medicaid Assistance Percentage (FMAP) to 100%, to ensure all Medicaid enrollees will be vaccinated.
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