THIS WEEK’S DOSE

• Congress was in session this week, as FY 2024 appropriations bills, the need for a stopgap measure to prevent a government shutdown on October 1, and infighting among House Republicans regarding a path forward continued to dominate the headlines.

• The stalemate had a ripple effect on other legislative business, with the Lower Costs, More Transparency Act (H.R. 5378) abruptly pulled from the House calendar early this week with no forecast for when it may return.

• Congress held hearings on pharmacy benefit managers (PBMs), access to innovative drugs and technology, surprise medical billing, home health, the US Department of Veterans’ Affairs (VA) scope of practice initiative, healthcare workforce and the Inflation Reduction Act (IRA), as well as a Senate Committee on Health, Education, Labor and Pensions (HELP) markup of four healthcare bills.

• The Centers for Medicare & Medicaid Services (CMS) released a final rule to streamline Medicaid and Children’s Health Insurance Program (CHIP) and Medicare Savings Programs (MSPs) enrollment. A proposed rule on the No Surprises Act independent dispute resolution (IDR) process was released by the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury.

CONGRESS

House Oversight Committee Discusses PBMs. The House Committee on Oversight and Accountability held a hearing to discuss the role of PBMs in the health system. Bipartisan consensus was expressed on the need to reform PBMs through increased transparency. Democratic members focused on the broader need to hold pharmaceutical manufacturers accountable for high drug prices. There was also bipartisan concern about patients being steered away from generic drugs toward brand name drugs, as well as discount savings not being directly passed to consumers.

House Energy and Commerce Committee Holds Three Hearings. 

1) The Health Subcommittee legislative hearing on innovation. The witnesses represented CMS and the US Government Accountability Office (GAO).

Members expressed bipartisan enthusiasm for legislation surrounding medical innovation, particularly for the following bills:

• H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act to allow Medicare coverage and payment for US Food and Drug Administration cleared or approved multi-cancer early detection screening tests

• H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 to provide temporary or transitional Medicare coverage of medical breakthrough devices for four years while CMS works to make a permanent coverage determination

• H.R. 1458, the Access to Prescription Digital Therapeutics Act of 2023 to require Medicare and Medicaid coverage of prescription digital therapeutics

• H.R. 3842, the Expanding Access to Diabetes Self-Management Training Act of 2023 to expand coverage for diabetes outpatient self-management training services, remove patient cost-sharing and deductible requirements under Medicare Part B, and create a Center for Medicare and Medicaid Innovation (CMMI) model to cover virtual diabetes outpatient self-management training services

• H.R. 1199, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 to change the Medicare reimbursement structure by establishing separate payment requirements for diagnostic radiopharmaceuticals under the Medicare prospective payment system for hospital outpatient department services

• H.R. 4818, the Treat and Reduce Obesity Act (TROA) of 2023 to expand Medicare Part D coverage of obesity medications and allow additional healthcare providers to offer the intensive behavioral therapy benefit

2) Full Committee Member Day hearing. The committee received testimony from off-committee members on a broad spectrum of topics falling within the committee’s jurisdiction. With respect to healthcare, representatives discussed improving access to care for people facing substance use disorders; a lack of access to care in rural and underserved areas; and solutions to improve healthcare coverage, price transparency and competition in the healthcare marketplace, including the Lower Costs, More Transparency Act.

3) The Oversight and Investigations Subcommittee hearing on IRA implementation of Medicare drug price negotiation. Witnesses and members of the committee discussed concerns that the law could discourage investment in new drug discovery, especially from smaller biotechnology companies, and that this could lead to a decrease in the number of new drugs and treatments available to patients, including those with rare and devastating diseases. Republican members were particularly critical of the IRA, questioning the constitutionality of the law’s drug price negotiation policy and arguing that it would stifle innovation and harm patients. Democratic members defended the IRA, arguing that it would help lower drug costs for Medicare beneficiaries and have minimal impact on the pharmaceutical industry.

House Ways and Means Committee Holds Hearing on No Surprises Act Implementation. The committee met to discuss the implementation of the No Surprises Act, the law addressing surprise medical bills. Witnesses and members emphasized the law’s goal to protect patients from balance bills but discussed the limited knowledge around how the qualifying payment amount is calculated, the need for better transparency of data, and efforts to address problems in the IDR process. Following the hearing, a separate roundtable discussion by the House Doctors Caucus was held on similar issues.

House Committee on Veterans’ Affairs Discusses Federal Supremacy Initiative. The Subcommittee on Health Oversight held a hearing on the VA’s National Scope of Practice Initiative. The VA is developing 51 standards, but the hearing focused on two: the optometry national standard and the certified nurse anesthetist national standard. Some witnesses voiced concern over the initiative and noted that team-based care models should be physician-led. Other witnesses highlighted that clinicians other than physicians are also valuable members of the care team.

House Education and the Workforce Committee Examines Workforce Issues. The Subcommittee on Higher Education and Workforce Development met to discuss the Workforce Innovation and Opportunity Act (WIOA) and ways to improve outcomes for jobseekers, employers and taxpayers. This included a brief discussion on why home care workers should receive community college credit.

Senate Finance Committee Examines Home Health. The Health Subcommittee held a hearing on home healthcare. It focused on several key issues, including the adequacy of Medicare and Medicaid reimbursement for home health services, the shortage of home health workers and aides, and the impact of proposed 2024 Medicare payment cuts on home health providers.

Senate HELP Committee Holds Markup on Four Healthcare Bills. Among the four bills marked up, the committee took up S. 2840, the Bipartisan Primary Care and Health Workforce Act. This bill was unveiled last week by HELP Chair Sanders (I-VT) and Senator Marshall (R-KS) to extend funding for community health centers, the National Health Service Corps and Teaching Health Center Graduate Medical Education. The bill would also provide funds to bolster the primary care workforce. During the markup, Chairman Sanders noted he verbally reached an agreement with Senator Marshall to revise certain provisions related to paying for the legislation. An updated version of the bill text with these revisions has not yet been released. The committee advanced S. 2840 by a vote of 14–7, with three Republicans—Marshall, along with Senators Braun (R-IN) and Murkowski (R-AK)—joining Democrats in support of the bill.

HELP Ranking Member Cassidy (R-LA), who issued a statement of opposition when the bill was released last week, reiterated his opposition during the markup about the manner in which the bill was drafted and the lack of a full list of pay-fors. Conversations are ongoing regarding next steps for the legislation.

The committee also advanced three other bills by votes of 20–1:

• S. 1573, PREEMIE Reauthorization Act of 2023

• S. 2415, Preventing Maternal Deaths Reauthorization Act of 2023

• S. 1624, Gabriella Miller Kids First Research Act 2.0

The chairman’s opening remarks can be found here, the ranking member’s opening remarks can be found here, and the full list of amendments can be found here.

ADMINISTRATION

HHS Releases Updated Contingency Plans for Operations During a Government Shutdown. On September 21, HHS updated its Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations. Contingency plans from other federal agencies are also being released as we inch closer to a potential government shutdown on October 1, and all are located on the Agency Contingency Plans page of the Office of Management and Budget. The agency’s contingency plans provide details on staff who will continue work during a shutdown, as well as key programs that will continue without interruption. Details are broken out by each of HHS’ Operating Divisions, all of which are linked to on the main HHS contingency plan page.

Administration Releases No Surprises Act Proposed Rule Revising IDR Fees. On September 20, HHS, DOL and Treasury (the Departments) released the first of two expected No Surprises Act proposed rules related to the IDR process. This first rule proposes increases to the two fees associated with the process: the nonrefundable administrative fee and the refundable certified IDR entity fee. As mandated by the Texas Medical Association IV court decision, the Departments are required to establish these amounts in notice-and-comment rulemaking after stakeholders opposed systematic increases by the Departments.

CMS proposes to increase the nonrefundable administrative fee to the IDR process per party per dispute to $150 effective January 1, 2024. The original fee was only $50 but was then increased to $350, which led to the court ruling that momentarily returned the amount back to $50. With respect to the refundable certified IDR entity fee, on or after January 1, 2024, certified IDR entities would be permitted to charge a fee for single determinations within the range of $200 to $840. For smaller batched claims, the Departments propose a range of $268 to $1,173. For batched disputes with more than 25 line items, the certified IDR entity fee would be able to increase the base amount for every additional 25 line items by a fixed value between $75 and $250.

Additionally, on September 21, the Departments directed certified IDR entities to resume processing all single and bundled disputes submitted on or before August 3, 2023. The Departments stated that they will provide guidance in the near future about other issues associated with these decisions.

CMS Holds Webinar on AHEAD Model. On September 18, CMS held a webinar to provide an overview of a recently announced new payment model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. CMS discussed elements of the model’s design, goals, eligibility criteria and key components. This payment model will test the concept of global budgets for participating hospitals as well as enhanced primary care services, with the goal of controlling costs, improving quality of care and promoting health equity. The presentation also highlighted that CMMI intends to support state start-up costs such as recruiting providers, engaging stakeholders, building behavioral health infrastructure and supporting Medicaid alignment.

The webinar slides will be posted on the AHEAD Model overview website.

CMS Releases Final Rule to Streamline Medicaid, CHIP and MSP Enrollment. CMS finalized the rule on September 18, noting that it should reduce Medicare premiums and out-of-pocket costs for an estimated 860,000 eligible people by helping them to enroll in Medicare savings programs that cover premiums and some cost sharing for lower income Medicare beneficiaries. This rule also aims to ease enrollment barriers by automatically enrolling certain individuals into the Qualified Medicare Beneficiary (QMB) program and better leveraging Medicare Part D Low-Income Subsidy data in these efforts.

Concurrently, CMS and the Social Security Administration are preparing to implement provisions of the Administration’s prescription drug law that expand eligibility for the full Medicare Part D Low Income Subsidy, allowing an estimated 300,000 people to have lower drug costs starting January 1, 2024. The final rule also clarifies that individuals who owe a premium for Part A and live in certain states can get QMB coverage of Parts A and B premiums and cost-sharing.

The CMS press release can be found here, and the fact sheet can be found here.

QUICK HITS

• CMS Identifies 500,000 Children and Families Wrongly Terminated from Medicaid. HHS announced that it has helped 500,000 children and families regain their Medicaid and Children’s Health Insurance Program (CHIP) coverage after CMS issued a call to action to states about a potential issue where state systems were inappropriately disenrolling children and other enrollees. A preliminary overview of state assessments regarding compliance with Medicaid and CHIP automatic renewal requirements at the individual level can be found here.

• HHS Awards Grants to Expand Access to Care for People with Long COVID. HHS, through the Agency for Healthcare Research and Quality, announced nine grant awards of $1 million each for up to five years to support existing multidisciplinary long COVID clinics across the country.

• HHS Improves Healthcare Access for Individuals with Disabilities and Limited English Proficiency. HHS, through the Health Resources and Services Administration, announced more than $8 million through 18 awards to train primary care medical students, physician assistant students and medical residents in providing culturally and linguistically appropriate care for individuals with limited English proficiency and individuals with physical or intellectual and developmental disabilities.

• HHS Announces Resumption of the Free COVID-19 Tests via Mail. HHS, through the Administration for Strategic Preparedness and Response, announced that COVIDTests.gov will reopen on September 25 to enable people to order up to four free tests.

• MACPAC Hosts September 2023 Meeting. The Medicaid and CHIP Payment and Access Commission (MACPAC) met September 21–22 to discuss Medicaid payment policy, managed care denials and appeals, Medicaid unwinding, nursing facility staffing, behavioral health services and MSPs. View the full MACPAC agenda and presentation slides here.

• GAO Releases Two Reports on Provider Relief Fund and Medicaid Program Integrity. The first report highlights HRSA’s continued efforts to recover remaining Provider Relief Fund payments due from providers. The second report highlights opportunities for CMS to strengthen use of state auditor findings in Medicaid program oversight.

• CFPB Announces Rulemaking Process to Remove Medical Bills from Credit Reports. The Consumer Financial Protection Bureau (CFPB) announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often inaccurate. More information can be found in a CFPB press release.

NEXT WEEK’S DIAGNOSIS

As the deadline to avert a government shutdown nears, the main focus next week will remain on whether lawmakers can negotiate a stopgap continuing resolution prior to the end of the current fiscal year on September 30. Healthcare activity may continue at the committee level next week, with a potential Senate Finance Committee hearing on Medicare trustees.