Health Care Watch: January 27, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 22 – January 27. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On January 22, Ways & Means Committee Chairman Jason Smith (R-MO) released a statement after the Centers for Medicare & Medicaid Services (CMS) finalized a rule last week to improve the Medicare Advantage (MA) prior authorization processes. Chairman Smith stated that he is pleased CMS has followed the Committee’s example and taken a needed step to improve access to care for America’s seniors by increasing transparency and streamlining prior authorization requirements.
On January 25, Reps. Troy Balderson (R-OH) and Robin Kelly (D-IL) announced that they will hold a briefing with the Consumer Technology Association to announce the launch of the Congressional Digital Health Caucus. The Caucus will aim to inform policymakers of the rapid advancements in digital health innovation, highlight the potential impacts on patients and the health care system, and ensure that all Americans benefit from the transformative power of digital health tools. The briefing will take place at 9:00 AM ET on February 1, 2024.
Senate
On January 23, Finance Committee Chairman Ron Wyden (D-OR) sent letters to the heads of eHealth, GoHealth, Agent Pipeline, SelectQuote, and TRANZACT, seeking information on how the companies use insurance agents, lead generators and other data to target, market to, and direct seniors towards certain MA plans. The inquiry follows previous Committee work aimed to ensure that seniors in Medicare are not being targeted by misleading marketing tactics.
On January 25, Finance Committee Chairman Wyden and Ranking Member Mike Crapo (R-ID) released a white paper outlining interest and ideas the Committee is exploring to address the factors contributing to drug shortages through modifications to the Medicare and Medicaid programs. The Committee is exploring the following areas for legislative development this year: Medicare Part A and B payment reforms to stabilize supply of generic sterile injectable (GSIs) medicines, new incentives for providers and other prescription drug supply chain stakeholders, reforms or new pilot programs in Medicare Part D to bolster incentives for pharmacies to purchase generic medicines, and potential reforms to the Medicaid Drug Rebate Program targeting generic medicines in shortage.
On January 24, Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) introduced a bill to improve access to home medical devices for blind and visually impaired users. The bill would require the Food & Drug Administration (FDA) to develop rules requiring that new medical devices with digital displays, such as glucose monitors or insulin pumps, include accessible features for visually impaired users, unless it would change the fundamental nature of the device.
REGULATORY UPDATE
On January 22, the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) released the newly updated Beneficiaries Dually Eligible for Medicare and Medicaid data book. The data book describes the dual-eligible population’s composition, service use, and spending in calendar year 2021. Additionally, the book includes data on the overlap in Medicaid and Medicare managed care enrollment.
On January 22, the Department of Health & Human Services (HHS) announced that, together with CMS, it will launch a series of actions to educate the public about their rights to emergency medical care and to help support efforts of hospitals to meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). HHS will publish new informational resources, partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA, convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA, and establish a team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.
On January 22, HHS and Pfizer leadership met with health care provider groups, including the American Medical Association, American Academy of Family Physicians, and others to discuss the pathways for a smooth transition of oral antivirals for COVID-19, including Paxlovid, to the commercial market and the importance of provider education and clear communication to consumers. During the call, HHS leadership reminded providers that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status and stated that providers should take steps to ensure patients understand the full range of options when it comes to accessing these treatments.
On January 22, HHS announced a series of new actions to protect and expand access to contraception. HHS outlined how plans and issuers can make sure they meet their contraception coverage obligations. Specifically, HHS announced a new pathway for plans and issuers to meet existing obligations under federal law by covering, at no cost, a broader range of FDA-approved contraceptive drugs and certain devices.
On January 22, HHS released a readout of HHS Secretary Xavier Becerra's meeting with Canadian Health Minister Mark Holland regarding the recent announcement on commercial drug importation from Canada by U.S. states. During the call, they agreed to continue to discuss mechanisms and strategize on finding solutions to combat increasing drug prices to ensure that both Americans and Canadians have access to an affordable and stable drug supply. Secretary Becerra and Minister Holland committed to keeping in close contact to ensure a mutually beneficial path forward.
On January 23, FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) announced the recently accepted new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. The new submission, an automated depression and anxiety severity measurement tool, is the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into ISTAND.
On January 24, HHS announced that 21.3 million people selected an Affordable Care Act (ACA) Health Insurance Marketplace plan during the 2024 Open Enrollment Period. Total plan selections include more than five million people who are new to the Marketplaces and 16 million people who renewed their coverage.
On January 24, CMS announced $50 million in grants for states to connect children to health care services, particularly for mental health, at school. The grants will provide 20 states up to $2.5 million each in funding that can help states implement, enhance, and expand the use of school-based health services through Medicaid and the Children’s Health Insurance Program (CHIP).
On January 24, HHS released voluntary healthcare specific Cybersecurity Performance Goals (CPGs) to help healthcare organizations prioritize implementation of high-impact cybersecurity practices. The goals are divided into two groups: essential goals to help facilities increase basic cybersecurity and enhanced goals to help protect against more sophisticated attacks.
On January 25, HHS’ Office for Civil Rights (OCR) issued guidance to U.S. hospital and long-term care facility administrators, reminding organizations of their independent obligations under CMS regulations to ensure that facility visitation policies, including during a public health emergency, do not unlawfully discriminate on the basis of religion; as well as their obligation not to discriminate on other protected bases under federal civil rights laws, against patients or other individuals receiving care.
On January 25, CMS released a Request for Information (RFI) to solicit feedback from the public on how best to enhance MA data capabilities and increase public transparency. The information solicited by the RFI will support efforts for MA plans to best meet the needs of people with Medicare, for people with Medicare to have timely access to care, to ensure that MA plans appropriately use taxpayer funds, and for the market to have healthy competition. The MA Data RFI can be accessed here. Comments are due May 29, 2024.
On January 26, FDA held the Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO). The town hall discussed the challenges and opportunities switching from EtO to other sterilization methods, the need for forward-looking collaborative activities to support reduced EtO use while assuring patients have access to medical devices, and the creation of a dedicated EtO Tiger Team to advance innovations in medical device sterilization.
WHITE HOUSE
On January 22, President Biden convened a meeting of the Task Force on Reproductive Healthcare Access. The Task Force announced new actions to protect access to reproductive health care. Actions include strengthening contraception access and affordability for women with private health insurance, reinforcing obligations to cover affordable contraception, and educating patients and health care providers on their rights and obligations for emergency medical care.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
Disproportionate Share Hospital (DSH) Third Party Payer (CMS-2445); Final Rule; 12/8/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
OCR
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
UPCOMING HEARINGS
House
Oversight and Accountability Committee
January 31; 10:00 AM; 2154 Rayburn
Overseeing the Department of Health and Human Services’ Compliance with Congress
Energy and Commerce Committee
Health Subcommittee
January 31; 10:00 AM; 2123 Rayburn
Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers
Senate
HELP Committee
February; TBD
Hearing examining high costs of prescription drugs
Witnesses: Robert Davis, CEO, Merck
OTHER POLICY NEWS
On January 22, the Journal of the American Medical Association (JAMA) released a report finding that, when used during the first trimester of pregnancy, buprenorphine was associated with a lower risk of birth defects when compared with methadone.