President Joe Biden has some unfinished business on health policy, and the final months of his term in office will feature a flurry of regulations touching areas from Medicare payments to prior authorizations to cybersecurity.
The Biden administration will end in January regardless whether GOP former President Donald Trump or presumptive Democratic nominee Vice President Kamala Harris prevails on Election Day. And while Harris likely would continue along a similar trajectory as Biden, she would put her on stamp on policy from the White House as president, while Trump's record and agenda indicate he would take health policy in a very different direction.
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Earlier this month, the White House Office of Management and Budget released the administration's unified agenda spelling out the regulatory plan for the remainder of 2024. These are the key healthcare rules the administration has planned as Biden approaches political retirement:
July
Starting this week, the Centers for Medicare and Medicaid Services will issue final rules setting Medicare reimbursement rates and modifying policies for inpatient hospitals, nursing homes, hospices, inpatient psychiatric facilities and inpatient rehabilitation facilities. By law, these regulations must be published by early August to take effect at the beginning of fiscal 2025 on Oct. 1.
CMS is also expected to finalize a rule that to toughen enforcement of mental health parity laws, a key priority the White House touted when the agency published a proposed rule last July. The parity rule would mandate that health insurance companies determine whether members have access to mental healthcare that is equivalent to their access to other types of care, and to modify coverage if they do not. Senate Democrats recently pressured the administration to pick up the pace.
CMS has also been working on a proposed rule to update emergency preparedness requirements for Medicare and Medicaid providers and suppliers as part of its response to lessons learned from the COVID-19 pandemic.
August
CMS will issue a proposed rule to prevent insurers from excluding non-physician providers who perform the same services as doctors from their networks or offer them lower reimbursements. This regulation has been delayed since 2022.
September
The Biden administration has made its mark on Medicare Advantage in many ways, including reducing payments and implementing restrictions on prior authorizations and marketing practices. There are a few more regulations coming.
CMS is scheduled to publish its annual update to Medicare Advantage policy in September. That's two months earlier than most years as the administration seeks to get the regulation in place before Biden departs, just as Trump, President Barack Obama and other outgoing chief executives have done with various rules.
Telehealth providers are eagerly awaiting a revised Drug Enforcement Administration proposed rule on remote prescribing of controlled substances. The first draft provoked strong resistance from the telehealth sector, which characterized its requirement that patients get initial prescriptions during in-person visits as excessively restrictive.
October
Federal authorities continue to implement an overhaul of the organ donation system that began last year. This fall, the Health Resources and Services Administration is due to publish a proposed rule to set standards that would allow HIV-positive people to donate kidneys and livers to other HIV patients.
The Homeland Security Department's Cybersecurity and Infrastructure Security Agency is set to publish a final rule that would create stronger reporting requirements regarding cyberattacks and ransom payments. The American Hospital Association has expressed concern that this regulation would duplicate existing reporting mandates.
November
Medicare reimbursement final rules for physicians, hospitals, dialysis and home health for calendar year 2025 are expected near the end of the year, as usual.
The Health and Human Services Department Office of the Inspector General is poised to publish a proposed rule that would create exceptions to anti-kickback laws and enable hospitals, ambulatory surgical centers, community health centers, rural emergency hospitals, rural health clinics and skilled nursing facilities to offer mental health and substance-use disorder treatments to their own doctors and clinical employees.
CMS is slated to issue another No Surprises Act final rule that would restructure the independent dispute resolution process for providers and insurers.
The agency also is set to finalize a regulation governing electronic transactions and file attachments for prior authorizations. Hospital, physician and insurance groups criticized the proposed rule, saying it would conflict with existing data exchange standards.
CMS plans to issue a separate proposed rule to regulate prescription drug prior authorizations for Medicare Advantage and health insurance exchange enrollees, which would build off an earlier rule requiring electronic processing of preapprovals requests.
December
HHS is expected to close out the year with a focus on cybersecurity, data privacy and digital health. For example, the Office for Civil Rights is scheduled to propose a rule that would mandate organizations covered by the Health Insurance Portability and Accountability Act of 1986 upgrade their cybersecurity infrastructure. The draft regulation also would tweak health data privacy standards.
