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

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.”
Continue Reading CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

On June 24, 2019, President Trump signed an executive order that purports to create a more transparent health care market for both patients and providers. The order attempts to decrease the prevalence of opaque pricing, while increasing the amount of health care data available to health care users and stakeholders alike.

The executive order lays out a series of deadlines by which regulations, proposals and recommendations must be completed that intend to generate: (i) more informed patient choices, (ii) enhanced health care analytics, and (iii) greater financial options for individual payment.
Continue Reading More Data. More Choices. Better Care? New Executive Order Relies on Market Principles to Improve American Healthcare

The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated, affordable, and high quality health service to all DOD beneficiaries” and to be “a responsible steward of taxpayer dollars.” Noting that the Department of Justice (“DOJ”) has limited resources to prosecute those who commit fraud and abuse against the TRICARE program, the DOD now seeks to step in and ramp up enforcement.
Continue Reading The Military Health Care Fraud and Abuse Prevention Program: The Department of Defense Issues Proposed Regulations regarding TRICARE and Civil Monetary Penalties

[1] On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand Memo”) which effectively limits the use and enforcement power of guidance documents for the purposes of affirmative civil enforcement cases, a development that could have a significant impact on how certain healthcare cases are handled at the federal level by federal departments, agencies, and administrations, including those that are fixtures of the healthcare marketplace – the Department of Health and Human Services (HHS) and its constituent agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of Inspector General (OIG).
Continue Reading New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions

This past May, the Department of Health and Human Services (HHS) issued a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in the healthcare system. While Section 1557 has been in effect since 2010, the final rule extends additional protections to transgender individuals seeking transition-related health services, which can include gender reassignment surgery. The rule went into effect July 18th, although provisions affecting health insurance plan benefit design will become effective January 2017.
Continue Reading HHS Final Rule Extends Anti-Discrimination Protection to Transgender Patients