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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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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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On December 16, 2020, the Department of Health and Human Services (“HHS”) announced that it would begin Phase 3 of general distributions under the Provider Relief Fund (“PRF”) and that Phase 3 would be larger than initially planned. The PRF is a $175 billion fund created Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. The PRF is administered by HHS through the Health Resource Services Administration (“HRSA”). HHS has subdivided the PRF into various general and targeted distributions.

Earlier in 2020, HHS had made two general distributions under the PRF. The Phase 1 general distribution consisted of $50 billion in financial payments, released in two successive tranches of $30 billion and $20 billion, to healthcare providers based to providers who billed Medicare. The Phase 2 general distribution consisted of an additional $18 billion in financial payments to providers that billed Medicaid, dentists, assisted living facilities, and providers that were not eligible under the terms of Phase 1 due to a change in ownership.

On October 1, 2020, HHS announced the Phase 3 general distribution. The Phase 3 general distribution was initially planned to consist of $20 billion on financial payments to providers who were either excluded from the initial two phases, or who were eligible under the first two phases but required additional funding to cover ongoing financial losses accrued during the pandemic. The following providers are eligible for Phase 3 General Distribution funding: (1) Providers who have previously received, rejected, or accepted a General Distribution PRF payment; (2) behavioral health providers, including those that have previously received funding; and (3) healthcare providers that began practicing January 1, 2020 through March 31, 2020. All providers who receive payments must attest to receiving the payment and accept the associated Terms and Conditions.

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Wachler & Associates is pleased to announce the appointment of two of our attorneys to leadership roles within the American Bar Association’s Health Law Section.

Amy K. Fehn will serve as Vice Chair of three ABA Health Law Sections, including the Health Law and Policy Coordinating Committee, the ABA Health eSource Editorial Board, and the ABA Health Law Section Publication Committee. Ms. Fehn has represented healthcare organizations for 15 years, focusing on HIPAA, Stark Law and the Anti-Kickback Statute, and other regulatory compliance matters. She also serves on the ABA’s Accountable Care Organization (ACO) task force.

Reesa N. Handelsman received her first ABA Health Law Section leadership appointment. Ms. Handelsman will serve as Vice Chair of the Business & Transactions Interest Group. Ms. Handelsman has significant experience counseling healthcare entities in a variety matters, including Stark law and Anti-Kickback Statute compliance, hospital and physician contracting, and all types of healthcare transactions.

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Michigan Lawyers Weekly, an independent newspaper that covers the legal profession in the State of Michigan, recently quoted Wachler & Associates partner Amy K. Fehn on the use of blogs by law firms.

The article, “Blogging: Making the words work,” surveyed legal experts from around the state on the proper uses and benefits of a well-run legal blog. Ms. Fehn discussed the role of our blog in keeping our attorneys on the cutting edge of legal developments related to health law as well as keeping our clients informed of changes that may impact their health care related businesses.

To subscribe to Wachler & Associates’ Health Law Blog, please add your email address and click subscribe in the window on the top right of this page. As always, check back here for continuing updates on health law developments around the country.

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This Thursday, February 21, 2013, Wachler & Associate’s Founder, Andrew Wachler, will present Medicare Appeals & Reimbursement Impacted by New OIG Report for the RAC University’s Live Webcast. Recently, the Office of Inspector General (OIG) released a report entitled Improvements are Needed at the Amdministrative Law Judge Level of Appeal. Sign up for the webcast to learn what impact the OIG’s findings and recommendations to CMS could have on your Medicare appeal strategy.

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Wachler & Associates partner, Amy K. Fehn, was recently quoted in Home Health Line regarding an agency’s liability for a business associate’s HIPAA violations. She explains that even though business associates are separately liable for HIPAA violations, an agency will also be liable for the business associate’s noncompliance. An agency should notify affected patients of any HIPAA breach caused by a business Associate.

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Last year, the American Board of Internal Medicine (ABIM) suspended 139 doctors following an investigation into the practices of the Arora Board Review test-prep company. ABIM claimed that the doctors violated ethical and conduct standards by providing test questions to the company.

Wachler & Associates represented over 40 doctors that were suspended without regard to their individual behavior and circumstances. The story, however, has gained national traction and appeared today on the front page of CNN’s website.

CNN traveled to our offices in Royal Oak, MI to interview Andrew Wachler, managing partner of Wachler and Associates. The following is an excerpt from the article:

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