HHS Issues Guidelines to Address Disturbing Trend of Racial Disparities in COVID-19 Testing and Treatment

Data collected during the coronavirus pandemic shows a disturbing trend of inequities in testing and treatment for COVID-19 among people of color. On July 20, 2020 the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a Bulletin for healthcare providers, hospitals, and state and local agencies that receive Federal financial assistance to address “Civil Rights Protections Prohibiting Race, Color and National Origin Discrimination During COVID-19.”

In this Bulletin, the OCR reminded healthcare providers, hospitals, and state and local agencies that receive Federal financial assistance that they must comply with Title VI of the Civil Rights Act of 1964, which states that “[n]o person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” Continue Reading

DOJ Antitrust Division Grants Green Light for Pharma Companies Sharing COVID-19 Treatment Drug Production Information

By James M. Burns on July 27, 2020 Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without running afoul of the federal antitrust laws. Specifically, in a letter issued on July 23, the Antitrust Division stated that it had no intention to challenge a proposal by a group of pharmaceutical companies to exchange information about the parties’ ability to manufacture monoclonal antibodies that might be used to treat COVID-19. Continue Reading

CARES Act Provider Relief Funds – The Requirements Are Taxing

By Elizabeth F. Hodge, Stefi George and Danielle C. Gordet on July 22, 2020 Posted in Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures, Hospitals & Health Systems, Physicians

The Internal Revenue Service (“IRS”) recently clarified that CARES Act Provider Relief Funds (“Relief Funds”) are considered taxable income for for-profit providers, including physician practices. This news comes as a surprise as many thought such funds would be considered “qualified disaster relief payments” and therefore not includible in gross income under Section 139 of the Internal Revenue Code (the “Code”). As a result, for-profit healthcare providers who accepted Relief Funds need to assess the tax consequences and plan accordingly. Continue Reading

Novartis’ Simultaneous Settlements Break Records

By Jeremy Burnette on July 20, 2020 Posted in Fraud & Abuse & False Claims Act, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an Anti-Kickback Statute lawsuit brought by a whistleblower pursuant to the False Claims Act’s (FCA) qui tam provision, Novartis, a pharmaceutical company based in East Hanover, New Jersey, has agreed to pay $678 million to settle a lawsuit alleging that it made improper payments to physicians through sham physician education programs to encourage them to prescribe its medications from 2002-2011. In a separate but simultaneous settlement, Novartis paid $51.25 million to settle claims that it improperly paid patients’ co-pays through charitable patient assistance programs (PAPs). Continue Reading

As COVID-19 Spreads, Florida Pharmacists’ Scope of Practice Expands

By Marcy Hahn-Saperstein and Martin R. Dix on June 18, 2020 Posted in Health Care Providers, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment

Florida has been contemplating ways to increase patient access to care, especially in light of the COVID-19 pandemic and the anticipated increase in cases. Recognizing the accessibility of pharmacies, Florida is now authorizing certain qualified pharmacists to perform testing, screening, and treatment of nonchronic diseases and specific treatment of certain chronic conditions. Continue Reading

California Legislature Responds to COVID-19 Crisis With Legislation that Would Require State Approval of Healthcare Mergers and Acquisitions

By James M. Burns and Martin G. Burkett on May 22, 2020 Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

As healthcare providers around the country struggle to respond to patient needs during the Covid-19 crisis, many are reportedly struggling financially as well. In the past, this scenario has led to an increase in merger and acquisition activity, and many healthcare analysts are predicting an increase in such activity for the second half of the year and into 2021.

In light of this development, the California Legislature is considering a bill that would require the California Attorney General’s pre-approval of most healthcare transactions in the state. Specifically, the bill, SB 977 (as amended on May 19), would require that when a healthcare system, private equity group, or hedge fund seeks to acquire or affiliate with a hospital or provider in the state, the parties must obtain the prior approval of the California Attorney General to do so. Continue Reading

Limited Stark and Anti-Kickback Sanction Waivers Issued for Provider Payments During the Pandemic

By William J. Spratt, Jr. and Danielle C. Gordet on May 13, 2020 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods and services, creating potential conflicts with the Stark Law (Section 1877 of the Social Security Act) and its regulations and potential Office of Inspector General (OIG) sanctions pursuant to the federal Anti-Kickback Statute. As a result, the Secretary of the Department of Health and Human Services (HHS) and the OIG will not impose certain sanctions during the COVID-19 pandemic. These waivers of sanctions are limited in scope and will expire at the end of the emergency declaration. Continue Reading

CMS Issues Additional Waivers and Guidance on Telehealth

By Amy Jeon McCullough and Sidney S. Welch on May 11, 2020 Posted in Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Technology

To ensure Medicare beneficiaries have access to necessary care without risking exposure to COVID-19, the Centers for Medicare & Medicaid Services (CMS) has further expanded telehealth services and relaxed certain requirements related to the same with the issuance of additional waivers (available here) and an interim final rule (IFR) available here. Continue Reading

Pharmacy Testing Centers: A Prescription for Fighting COVID-19 in Florida

By Martin R. Dix and Danielle C. Gordet on May 4, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

Pharmacists can now engage in a new role in the battle against COVID-19 – testing patients for the virus. Recognizing the advanced health care training that pharmacists receive and the unique consumer access to community pharmacies during the Pandemic, the Florida Department of Health has designated pharmacists as medical professionals authorized to order and provide COVID-19 tests. Additionally, pharmacies, as Community-Based Testing Sites (CBTS) will benefit from the waiving of penalties for noncompliance with the HIPAA Privacy, Security, and Breach Notification Rules (HIPAA Rules) during the public health emergency in the situations discussed below.

SCOTUS Rules Government Must Pay $12 Billion to Unprofitable ACA Insurers

By Jeremy Burnette on April 29, 2020 Posted in Affordable Care Act and Other Healthcare Reform Legislation, Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation

Despite Congress’ efforts to use riders to neutralize a provision of the Affordable Care Act (ACA or Act), the Federal government (Government) owes certain insurers $12 billion. On April 27, 2020, the Supreme Court of the United States (SCOTUS) ruled 8-1 that congressional riders added to appropriations bills that funded the Centers for Medicare & Medicaid Services (CMS) in 2014, 2015, and 2016 did not, in fact, override the Government’s payment obligations pursuant to the ACA’s “Risk Corridors” provision at Section 1342 of the Act (Section 1342).

The Risk Corridors program provided a formula to determine whether health plans participating in the ACA’s healthcare exchanges incurred gains or losses at the end of each of the first three years of Obamacare. Section 1342 states that profitable plans “shall pay” a sum to the Secretary of the Department of Health and Human Services (Secretary), while the Secretary “shall pay” a sum to eligible unprofitable plans. Continue Reading