CORRECTED: Health Care Checkup: March 1, 2024

Health Care Checkup

March 1, 2024

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

Last week, Speaker Mike Johnson and Democratic Leader Hakeem Jeffries announced the establishment of a bipartisan Task Force on Artificial Intelligence (AI) to explore how Congress can ensure the US continues to lead the world in AI innovation while considering guardrails that may be appropriate to safeguard the nation against current and emerging threats.

What to Expect Next Week:

Appropriations negotiations will continue next week, with the new funding deadline of March 8 for six bills. The text of the six fiscal 2024 spending bills, including funding for the Food and Drug Administration, is expected to be released Sunday.

On Wednesday, the Senate Budget Committee will hold a hearing examining primary care and health care efficiency.

DEEP DIVE

Congressional:

House and Senate Pass a Continuing Resolution to Avoid Partial Government Shutdown

On Thursday, the House and Senate passed a continuing resolution (CR) to avoid a partial shutdown this weekend. The CR extends funding deadlines for six of the twelve appropriations bills until March 8 and the remaining six bills until March 22. The six bills with a March 8 deadline include Energy and Water, Interior, Transportation-HUD; Commerce-Justice-Science; Milcon-VA; and Agriculture-FDA. The CR now heads to President Biden, who is expected to sign it into law Friday.

The CR does not include additional health policies or extenders. We expect the March 8^th package to include an extension of expiring health programs as well as a policy to partially address the physician payment conversion factor. Read the CR text here.

House Energy and Commerce Committee Holds Hearing on Rare Diseases

On Thursday, the Energy and Commerce Health Subcommittee held a hearing to consider legislation aimed at improving access to drugs for people with rare diseases, but there was division on proposals that would broaden exemptions to President Joe Biden's drug pricing law under the Inflation Reduction Act. The majority of the 18 bills discussed were largely bipartisan, apart from three bills that made updates to the Inflation Reduction Act, which Democrats stated were attempts to undermine the law:

H.R. 5539, the Optimizing Research Progress Hope and New (ORPHAN) Cures Act, would allow an orphan drug to be excluded from Medicare price negotiation if it has been approved to treat multiple rare diseases.
H.R. 5547, the Maintaining Investments in New Innovation Act, would allow gene therapies an extra four years of market time before they are subject to price negotiation if they meet the FDA definition of genetically targeted technologies.
H.R. 6465, the Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act, would include plasma-derived medicines in a phase-in process for the Part D redesign of the IRA.

Read more on the legislation at the hearing and the witness testimonies here.

Senate Blocks Measure to Protect Access to In Vitro Fertilization

On Wednesday, Republican Senators blocked legislation, the Access to Family Building Act intended to extend federal protections to vitro fertilization in the wake of an Alabama Supreme Court decision that frozen embryos used in IVF are considered unborn children under the state constitution's personhood rights. Senator Cindy Hyde-Smith (R-MS) opposed the bill, saying it went too far and could violate hospitals’ religious freedoms. Senators Tammy Duckworth (D-IL) and Patty Murray (D-WA), who sponsored the bill, tried to fast-track the legislation through unanimous consent, which requires only one senator to block action on the measure. Republicans in the Senate, for now, have passed on any federal legislative action and have said the responsibility for addressing the court ruling lies with the Alabama legislature.

Reps. Johnson, Jeffries Announce Establishment of Bipartisan Task Force on Artificial Intelligence (AI)

Last week, on Feb 20, Speaker Mike Johnson and Democratic Leader Hakeem Jeffries announced the establishment of a bipartisan Task Force on Artificial Intelligence (AI) to explore how Congress can ensure the US continues to lead the world in AI innovation while considering guardrails that may be appropriate to safeguard the nation against current and emerging threats. Speaker Johnson and Leader Jeffries have each appointed twelve members to the Task Force. The Task Force members represent key committees of jurisdiction and will be jointly led by Chair Jay Obernolte (R-CA) and Co-Chair Ted Lieu (D-CA). The Task Force will seek to produce a comprehensive report that will include guiding principles, forward-looking recommendations, and bipartisan policy proposals developed in consultation with committees of jurisdiction. Read the press release here.

Senator Grassley Releases Reply Letter from FTC on PBM Investigation

On Monday, Senator Chuck Grassley (R-IA) released a letter from the Federal Trade Commission (FTC) to himself, Senator Maria Cantwell (D-WA), and 10 other senators who called for the agency to complete its investigation into PBMs in late January. The FTC initiated the investigation in June 2022 and then expanded it in May and June 2023. In the FTC response, Chair Lina Kahn stated none of the six companies targeted in the FTC have turned over enough documents to fully comply with the agency’s orders, but they expect to have all the materials very soon. She added that if some companies fail to fully comply with the orders or engage in any actionable delaying tactics, the FTC can take them to court to compel compliance. Grassley said the FTC letter prompted concerns with the agency and the industry it oversees. Read the FTC reply letter here.

Senator Cassidy Releases Report on Proposals to Improve Health Data Privacy

Last week, on Feb 19, Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report outlining ways to improve privacy protections for Americans’ crucial health data. This comes after Cassidy requested information from stakeholders last year on how to enhance health data privacy protections covered by the Health Insurance Portability and Accountability Act (HIPAA) framework, in addition to considering privacy protections for new sources of health data. In the report, Cassidy outlines several proposals to modernize the HIPAA framework, safeguard health data not covered by HIPAA, and how to consider data that cannot be clearly defined as health or non-health. Read the press release here and the report here.

Notable Bills Introduced:

Sens. Tillis, Kelly Introduce Bipartisan Legislation to Increase Access to Non-Opioid Treatments

On Thursday, Senators Thom Tillis (R-NC) and Mark Kelly (D-AZ) introduced the Alternatives to Prevent Addiction in the Nation (Alternatives to PAIN) Act, bipartisan legislation that would provide greater access to non-opioid treatments for pain management for seniors. The legislation would limit patient cost-sharing for patients receiving non-opioid based pain relief under Medicare Part D plans, prohibit the utilization of step therapy and prior authorization for these drugs, and encourage the continued dialogue between patients and their healthcare professionals about preferences in pain management choices. Read the press release here and the bill here.

Sens. Gillibrand, Casey Introduce Strategic Plan for Aging Act

On Wednesday, Senator Kirsten Gillibrand (D-NY), member of the Senate Committee on Aging, and Senator Bob Casey (D-PA), chair of the Senate Committee on Aging, introduced the Strategic Plan for Aging Act. The legislation would create a new, nationwide grant program under the Older Americans Act (OAA) to incentivize and support states’ efforts to create their own strategic plans for aging. The bill would award grants to states, territories, and tribes to create their own multisector plans for aging and provide awardees with resources to work on a cross-agency plan to improve the lives of older adults and older people with disabilities. Up to 65 states, territories, and tribes could receive grants, each worth up to $500,000. HHS would be able to lower the grant amount depending on the awardee. Read the press release here and the bill here.

Sens. Cassidy, Warner, Klobuchar Introduce Legislation to Create Easier Access to Supplemental Oxygen for Medicare Beneficiaries

On Wednesday, Senators Bill Cassidy (R-LA), Mark Warner (D-VA), and Amy Klobuchar (D-MN) introduced legislation to ease access to supplemental oxygen for Medicare beneficiaries. The Supplemental Oxygen Access Reform (SOAR) Act of 2024 would establish a new payment methodology for non-liquid oxygen, allowing for most Medicare beneficiaries to be covered under the base payment levels. Read the press release here and the bill here.

Sens. Cassidy, Cantwell Introduce Legislation to Protect Patients, Health Care Providers Against Unnecessary Electronic Fees

On Tuesday, Senators Bill Cassidy (R-LA) and Maria Cantwell (D-WA) introduced the No Fees for EFTs Act to protect patients and health care providers against fees imposed by electronic fund transfers (EFTs) and payment transactions. Currently, the Affordable Care Act requires health plans to offer medical practices the option to receive reimbursements electronically. However, insurers impose charges between 2-5% on health care providers for EFTs. Companion legislation was introduced in the House by Reps. Greg Murphy (R-NC), Kim Schrier (D-WA), Marianette Miller-Meeks (R-IA), Derek Kilmer (D-WA), and Ami Bera (D-CA). Read the press release here and the bill here.

Senators Hassan, Tillis Introduce Bipartisan Legislation to Support Seniors and Caregivers by Strengthening 1-800 MEDICARE Hotline

Late last week on Feb. 20, Senators Maggie Hassan (D-NH) and Thom Tillis (R-NC) introduced the Connecting Caregivers to Medicare Act, bipartisan legislation to increase outreach and education to Medicare beneficiaries and simplify access to information for family caregivers through the 1-800 MEDICARE hotline. Read the press release here and the bill here.

Executive Branch:

Biden-Harris Administration Issues Final Guidance to Help People with Medicare Prescription Drug Coverage Manage Prescription Drug Costs

On Thursday, the Centers for Medicare & Medicaid Services (CMS) released the final part one guidance for the new Medicare Prescription Payment Plan. The final part one guidance focuses on outlining the necessary operational requirements for Medicare Part D plan sponsors as they prepare for the Medicare Prescription Payment Plan program. The Medicare Prescription Payment Plan, which begins in 2025, will give people with Medicare prescription drug coverage (Medicare Part D) the option to pay out-of-pocket costs in monthly payments spread out over the year rather than requiring they pay in full at the pharmacy counter each time they fill a prescription. The guidance addresses topics such as identifying Medicare Part D enrollees likely to benefit from the program, the opt-in process for Part D enrollees, program participant protections, and the data collection needed to evaluate the program. Read the press release here and the part one guidance here.

FTC Releases Agenda for Virtual Workshop on Private Equity in Health Care on March 5

On Wednesday, the Federal Trade Commission (FTC) released the agenda for Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care, a virtual workshop on March 5, 2024, examining the role of private equity investment in health care markets. The workshop will be livestreamed on the FTC’s website and will take place from 12:30 p.m. to 4:00 p.m. The event will examine private equity’s impact on health care and include a presentation and several panel discussions featuring government officials, academics, economists, practitioners, and members of the public. Read the FTC event press release here.

Health Sector Coordinating Council publishes Five-Year Health Industry Cybersecurity Strategic Plan

On Tuesday, the Department of Health and Human Services (HHS) designated group, the Healthcare and Public Health (HPH) Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG), released its “Health Industry Cybersecurity Strategic Plan” (HIC-SP) to deal with growing cybersecurity threats in the health care sector. The five-year plan includes “feasible” and “harmonized” cybersecurity requirements in the sector, plus “911 cyber civil defense” capabilities to ensure early warnings. Read the press release here.

HHS Announces a Multi-Pronged Effort to Strengthen Direct Care Workforce

On Tuesday, the Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the shortage of direct care professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders, and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. These initiatives support the comprehensive set of actions and investments included in the President’s executive order to improve care. Read the press release here.

Biden-Harris Administration Announces New Funding to Increase Capacity for Behavioral Health Services

On Monday, the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines. Read the press release here.

VA Expands Health Care Eligibility to Millions of Veterans

On Monday, the VA announced that all Veterans who were exposed to toxins and other hazards while serving in the military, at home, or abroad will be eligible to enroll directly in VA health care beginning March 5, 2024. All Veterans who served in the Vietnam War, the Gulf War, Iraq, Afghanistan, the Global War on Terror, or any other combat zone after 9/11 will be eligible to enroll directly in VA health care without first applying for VA benefits. Additionally, Veterans who never deployed but were exposed to toxins or hazards while training or on active duty in the United States will also be eligible to enroll. As directed by President Biden, this expansion of VA health care eliminates the phased-in approach called for by the PACT Act, and millions of Veterans will be eligible for VA health care up to eight years earlier than written into law. Read the press release here.

Legal & Other:

Mississippi House Passes Medicaid Expansion Bill

On Wednesday, the Mississippi House of Representatives passed House Bill 1725, which would expand Medicaid coverage to thousands of low-income adults in the state. The bill passed the Republican-controlled chamber 96-20 with bipartisan support. The bill will now be considered by the state Senate, where GOP leadership has also introduced a bill to expand Medicaid. The House bill includes language on work requirements, which the Biden administration opposes, but would allow for expansion to proceed if the waiver is not obtained.