HHS OIG says “Ditto” to HHS Blanket Stark Waivers for Purposes of the Anti-Kickback Statute

On April 3, the Department of Health and Human Services Office of the Inspector General (HHS OIG) released a policy statement to align its enforcement of the federal Anti-Kickback Statute (AKS) with HHS’s recent Blanket Waivers of Stark (Blanket Waivers) during the COVID-19 pandemic. As previously reported, HHS issued the Blanket Waivers to allow for certain arrangements necessary to give hospitals and providers additional flexibility in providing care during the pandemic. The HHS OIG notes that “some financial relationships that implicate the physician self-referral law also may implicate, and potentially violate, the Federal anti-kickback statute.” Given the “unique circumstances of the COVID-19 outbreak,” HHS “OIG will not impose administrative sanctions . . . [for] the commission of acts described in the Federal anti-kickback statute, with respect to remuneration that is covered by section II.B.(1)-(11) of the Blanket Waivers.” This effectively aligns AKS enforcement with the relevant portions of the Stark Blanket Waivers during this period of public health emergency.

The HHS OIG stressed that its policy statement is intended to avoid the need any “separate legal review under the Federal anti-kickback statute for arrangements protected by the Blanket Waivers.” Thus, it does not apply to “arrangements that implicate the Federal anti-kickback statute that are not covered by the Blanket Waivers (e.g., … direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved).” But “where an arrangement is covered by a Blanket Waiver, this Policy Statement extends to remuneration that relates to referrals for services furnished to all Federal health care program beneficiaries pursuant to the covered arrangement.”

Notably, the policy statement does not automatically extend protection to all of the types of arrangements described in the Blanket Waivers. The HHS OIG still wants parties to submit inquires with additional details for the arrangements numbered 12-17 in the Blanket Waivers. And, for arrangement number 18—which provides a waiver of the requirement of a written agreement or signature—the policy statement says nothing.

Financial Lifelines, Waivers and Other Support for Hospitals and Healthcare Systems Responding to the Coronavirus Pandemic

In just the past week, the federal government has issued a flurry of legislative and regulatory aid packages, programs and rule changes for hospitals and health systems responding to the COVID-19 pandemic. These measures are designed to give emergency financial support and to cut through regulatory roadblocks to delivering care during the crisis. The federal government’s work is not done; as the size and scope of the crisis expands, we expect further legislative and regulatory actions focused on assisting healthcare entities during this national emergency.

See our client alert here for a summary of these measures.  This alert serves as a guide to assist with the details of the various changes announced and to better understand the implications.

Whistleblowers Look To Capitalize On Stimulus

With their insider access to business operations, whistleblowers will follow stimulus money to learn whether the business abides by the strings attached to that money.  Whistleblowers look for an opportunity to cash in on what they consider fraudulent conduct.  What’s a business to do? See our discussion here on the Anticorruption blog.


CMS Expands Accelerated and Advance Payment Program

On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an expansion of its Accelerated and Advance Payment Program (the Program). The Program is designed to help providers with “significant cash flow problems resulting from…unusual circumstances of the hospital’s operation.” 42 U.S.C. § 1395g (e)(3). Usually deployed during times of natural disasters, the recently enacted CARES Act directed CMS to expand the Program to providers who have been adversely affected by the COVID-19 public health emergency.

The Program allows CMS to make what are essentially short-term, zero interest loans to providers and suppliers in the form of advance payments. Providers who receive an accelerated/advance payment will have a 120-day period before they begin repaying CMS. Providers and suppliers will continue to receive full payment for Medicare claims submitted during this 120-day period.  After the initial 120-day period, CMS will recover the accelerated/advance payments via a recoupment and reconciliation process, through which the accelerated/advance payment amounts are deducted from new claims. At a certain date, each provider and supplier who received accelerated/advance payments under the Program will be required to pay back any remaining balance. Eligibility details, payment amounts, repayment timelines, and the application process are explained in more detail below. Continue Reading

CMS Issues Blanket Stark Law Waivers in Connection with COVID-19 Emergency

On March 30, in connection with the national COVID-19 emergency, the Centers for Medicare and Medicaid Services (“CMS”) issued waivers (the “Waivers”) for certain provisions of the federal physician self-referral law, commonly referred to as the “Stark Law.” To ensure there will be sufficient capacity to handle the unique challenges of the COVID-19 pandemic, CMS is permitting certain financial arrangements that would otherwise be prohibited under the Stark Law for entities and physicians acting in good faith and not engaged in fraud and abuse.

The Waivers apply nationwide and require no notice or approval to be used. The Waivers only apply to financial relationships and referrals that are solely related to “COVID-19 Purposes,” which is broadly defined to include arrangements for securing healthcare professionals to ensure the availability of health care services generally, expanding facility capacity, and addressing medical practice or business interruption due to the COVID-19 outbreak. Parties utilizing the Waivers must make records relating to the use of the Waivers available to the Secretary of the Department of Health and Human Services upon request, although CMS does not specify what documentation would be required. Continue Reading

US Department of Labor Publishes Further Guidance Concerning Paid Sick Leave and Paid FMLA Leave under FFCRA; Finally Clarifies Small Business Exemption

Since the Families First Coronavirus Response Act (FFCRA) became law last week, the US Department of Labor (DOL) has been publishing and updating guidance concerning the public health emergency paid sick leave and emergency Family and Medical Leave Act (FMLA) leave required under the law.  See a summary here by Daniel Pasternak in our Employment Law Worldview blog.

The CARES Act Throws a Lifeline to Hospitals and Providers Confronting the COVID-19 Pandemic

On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was enacted into law. The CARES Act provides broad relief to the many sectors of the economy reeling from the effects of COVID-19, including provisions aimed at giving critical financial and operational relief to hospitals and other providers on the front lines of the pandemic.  These health-related provisions, listed below, offer various forms of direct and indirect financial assistance and actions intended to reduce barriers for pandemic response. Several of these measures—such as the $100 billion in emergency funding for hospitals and providers—will be fleshed out by the Department of Health and Human Services (HHS) over the coming days and weeks.

On Capitol Hill, there are already discussions of additional legislative packages to focus on pandemic aid, and we expect the government to take further administrative and regulatory actions to address the increasing needs of the health sector in its response to the coronavirus. Our healthcare team, including attorneys and policy professionals, is assisting all health-related entities in anticipating and complying with these changes.

We have set up a dedicated resource center for business on the legal, regulatory, and commercial implications of COVID-19. You may access it here . Continue Reading

EC’s New State Aid Developments in the Wake of the COVID-19 Outbreak

Both the European Union (EU) and national governments have sought to respond rapidly to the economic impact of the COVID-19 outbreak. The European Commission (EC) is responding to the increasing need for companies to receive urgent financial support by adopting new State aid tools and emphasizing its ability to approve aid quickly.

In recent days, the EC has adopted a State aid Temporary Framework (Framework) and issued a template for the notification of measures that will compensate companies that have suffered damages (Template). The Commission has also set up a dedicated mailbox and phone line for Member States, which is open seven days a week.

The Commission’s reaction to the pandemic is markedly (and intentionally) faster than its response to the 2008-09 financial crisis, when the adoption of a similar Temporary Framework took three weeks. Continue Reading