RISE summarizes recent regulatory news.

Biden administration makes largest funding award to date to expand staff for marketplace open enrollment

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid services (CMS), announced it is investing nearly $100 million in grant funding to navigator organizations for the 2023 Open Enrollment Period (OEP) to help consumers enroll through the Marketplace, Medicaid, and the Children’s Health Insurance Program (CHIP).

The awards will help navigator organizations retain staff and add to more than 1,500 navigators who were trained to help consumers find affordable, comprehensive health coverage in nearly every HealthCare.gov state and county during the 2022 open enrollment. It is the single largest funding award provided to date. Previously, the White House administration awarded $80 million to the program, quadrupling the number of navigators for the 2022 open enrollment.

“This is a historic investment to connect people to high-quality, affordable health care,” HHS Secretary Xavier Becerra said in the announcement. “Last year, our investments helped result in the lowest uninsured rate in our nation’s history. This year, we’re doubling down on our efforts to ensure people get the insurance they need. Navigators critically help us reach people where they are, educating them on their health insurance options that can be lifesaving.”

The 2022 navigator awards are the second installment of a three-year period of performance agreement funded in 12-month budget periods. HHS said this multi-year funding structure is designed to provide greater consistency for navigator awardee organizations, reducing yearly start-up time and allowing more efficient use of grant funds.

White House directs agencies to make federally funded studies open access

The White House administration has issued new policy guidance to federal agencies requiring them to make federally funded publications and supporting data publicly accessible for free and without an embargo. The current policy, based on a 2013 memorandum, allowed for a 12-month embargo from public access of any publication resulting from federally funded research, which meant only those who were able to pay for it or had access through libraries or institutions, could read the research.

Dr. Alondra Nelson, deputy assistant to the president and deputy director for science and society, who is performing the duties of director, Office of Science and Technology Policy (OSTP), said in the memorandum, that Americans learned about the benefits of immediate public access to federally funded research at the outset of the COVID-19 pandemic. The new policy, which will require academic journals to provide immediate access to publicly funded papers, urges agencies to update their policies as soon as possible but no later than Dec. 31, 2025, so that the guidance will be fully in place by 2026.

“Immediate public access to COVID-19 research is a powerful case study on the benefits of delivering research results and data rapidly to the people. The insights of new and cutting-edge research stemming from the support of federal agencies should be immediately available—not just in moments of crisis, but in every moment. Not only to fight a pandemic, but to advance all areas of study, including urgent issues such as cancer, clean energy, economic disparities, and climate change,” she wrote. “American investment in such research is essential to the health, economic prosperity, and well-being of the nation. There should be no delay between taxpayers and the returns on their investments in research.”

Centene to pay Washington State $19M for overcharging state Medicaid program

Attorney General Bob Ferguson and the Washington State Health Care Authority announced last week that managed health care giant Centene will pay $19 million to Washington state to resolve allegations that the Fortune 50 company overcharged the state Medicaid program for pharmacy benefit management services.

The resolution is the second-largest Medicaid fraud recovery for Washington state.

Ferguson said the Health Care Authority (HCA) contracts with managed care organizations like Coordinated Care of Washington, a Centene subsidiary, to manage its Medicaid program. Coordinated Care of Washington in turn contracts with pharmacy benefit managers, or PBMs, that negotiate prescription drug prices and other pharmacy related costs, including negotiating rebates and discounts on the cost of drugs.

The Attorney General’s Office and HCA’s Program Integrity Team began investigating PBMs in 2019 after a whistleblower provided information that they were failing to disclose true pharmacy benefits and services costs. Centene allegedly failed to pass on discounts it received to the state Medicaid program and inflated dispensing fees. The whistleblower later filed a separate claim against Centene.

The resolution was the result of a joint investigation conducted by the Washington Attorney General’s Office’s Medicaid Fraud Control Division and the Health Care Authority.

“Medicaid dollars are a precious resource meant to fund care for the most vulnerable among us,” Ferguson said in the announcement. “My office works to ensure that these dollars go where they are intended — not toward fraud.”

As part of the resolution, Washington will recover $19 million. Centene will also pay $13 million to the federal government for administration of Medicaid in Washington State.

Ferguson said Centene has resolved cases with 10 other states over the same conduct.

OCR, Massachusetts dermatology agree to $300K settlement over improper disposal of PHI

The Office for Civil Rights (OCR) at the Department of Health and Human Services last week announced a settlement with New England Dermatology and Laser Center, over the improper disposal of protected health information (PHI), a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

Under the settlement, the Massachusetts-based dermatology and laser center agreed to pay the government $300,640 and implement a corrective action plan to resolve this investigation.

The investigation began in May 2021 after New England Dermatology and Laser Center filed a breach report with OCR stating that empty specimen containers with PHI on the labels were placed in a garbage bin in their parking lot. The containers’ labels included patient names and dates of birth, dates of sample collection, and name of the provider who took the specimen. OCR’s investigation, conducted by OCR’s New England Regional Office, found potential violations of the HIPAA Privacy Rule including the impermissible use and disclosure of PHI and failure to maintain appropriate safeguards to protect the privacy of PHI.

“Improper disposal of protected health information creates an unnecessary risk to patient privacy,” Acting OCR Director Melanie Fontes Rainer said in the announcement. “HIPAA regulated entities should take every step to ensure that safeguards are in place when disposing of patient information to keep it from being accessible by the public.”

In addition to the monetary settlement New England Dermatology and Laser Center will undertake a robust corrective action plan that includes two years of monitoring.

Fauci announces plans to retire in December

The nation’s top infectious disease expert will leave his positions as director of the National Institute of Allergy and Infectious Diseases (NIAID), chief of the NIAID Laboratory of Immunoregulation, and chief medical advisor to President Joe Biden in December.

In a statement, Fauci said he will be leaving these positions to pursue “the next chapter of my career.”

He said it was the “honor of a lifetime to have led the NIAID” for the past 38 years. During those years, Fauci served and advised seven Presidents of the United States, beginning with President Ronald Reagan, on newly emerging and re-emerging infectious disease threats including HIV/AIDS, West Nile virus, the anthrax attacks, pandemic influenza, various bird influenza threats, Ebola and Zika, and the COVID-19 pandemic.

“After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field. I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats,” he said in the announcement.