On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the “Final Rules”), which require non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets to disclose certain information including negotiated rates with providers and estimated out-of-pocket expenses to enable consumers to make informed health care purchasing decisions.
Continue Reading Trump Administration Finalizes The Transparency in Coverage Rule

As the pandemic rages on, and the United States has seen a spike in coronavirus cases in recent days, many healthcare providers are still struggling to care for patients and remain afloat. In response, HHS is continuing support and extending flexibility.
Continue Reading More Relief on the Way for Healthcare Providers: Provider Relief Fund Payment Opportunities and Flexibility in Repayment Requirements

On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic.  The Executive Order focuses on telehealth access for individuals living in rural areas and implements the following mechanisms:
Continue Reading It’s Official: Telehealth Benefits Have Been Expanded For Medicare Beneficiaries

On July 17, 2020, the Department of Health and Human Services (“HHS”) announced it will begin distributing $10 billion in a second round of funding to hospitals operating in high impact COVID-19 areas. The distribution is anticipated to begin as early as today, Monday, July 20, 2020. Hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID-19 admissions (exceeding the average ratio of COVID-19 admissions/bed) will receive funding in this distribution in the amount of $50,000 per eligible admission.
Continue Reading More Money On the Way in COVID-19 Fight: HHS Announces Additional $10B for Hospitals in High Impact COVID-19 Areas

On Friday, April 10, 2020, the Department of Health and Human Services (“HHS”) began distributing $30B of the $100B appropriated in the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to the Public Health and Social Services Emergency Fund (“PHSSEF”), also called the “CARES Act Provider Relief Fund”.  HHS distributed the funds to providers based on their 2019 Medicare fee-for-service (“FFS”) reimbursement.  We understand that $26B of this $30B have already been directly deposited into providers’ accounts. Many providers have questions about what happens next.  We address the top ten questions here.
Continue Reading HHS Distributes First $30B of CARES Act Provider Relief Fund – What Providers Need to Know and Do Next

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) provides many avenues of potential funding relief for health care providers and suppliers who are suffering increased expenses and lost revenues as a result of the coronavirus pandemic.  Some of these funding opportunities may or will require affirmative action by a health care provider or supplier, e.g., the submission of an application for relief.  Other funding mechanisms will go into effect without additional provider action.  Set forth below is a summary description of these opportunities.
Continue Reading Increased Expenses and Lost Revenues? CARES Act Funding Opportunities for Health Care Providers and Suppliers

On March 18, 2020, the President issued an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “EO”). The EO was issued pursuant to the Defense Production Act of 1950 (50 U.S.C. §4501 et seq.) (“DPA”), which allows the President to invoke special Federal Contracting powers to address shortages in medical resources needed to respond to the COVID-19 pandemic. The EO specifically mentions personal protective equipment and ventilators as necessary to curb the spread of COVID-19, but also delegates authority to the Secretary of Health and Human Services (“HHS”) to identify additional necessary health and medical resources such as drugs, medical devices, health supplies, and health services and equipment.
Continue Reading Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources

On December 20, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on program integrity for Affordable Care Act (ACA) exchange plans.  This rule implements a number of provisions from the ACA, including the requirement that each state have the opportunity to establish an Exchange, as well as the steps the Secretary of Health and Human Services (HHS) may take to oversee Exchanges’ compliance with HHS standards, including ensuring their financial integrity, including conducting investigations and annual audits, and the requirement that the Secretary establish procedures to verify the accuracy of information provided by applicants, including eligibility to purchase qualified health plans (QHPs) through the Exchange and for advance payments of premium tax credit (APTC) and cost-sharing reductions (CSRs).
Continue Reading Health and Human Services Exchange Program Integrity Final Rule