Today House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chair Jason Smith (R-MO), and House Education and the Workforce Chair Virginia Foxx (R-NC) introduced the Lower Costs, More Transparency Act. Bipartisan legislation that increases health care price transparency and lowers overall costs for patients and employers. Additionally, the bill would reauthorize community health centers, the National Health Service Corps and teaching health centers and delay around $16 billion in cuts to hospitals serving a disproportionate number of low-income patients through 2025.

On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) entitled Exploring Congress’ Framework for the Future of AI. Cassidy is requesting feedback by Friday, September 22, from stakeholders on the role of government in regulating the AI industry and how to ensure AI technology is designed, developed, and deployed in a responsible manner that protects Americans’ rights and safety.

On Thursday, Ways and Means Committee Chairman Jason Smith (MO-08) released an open letter request for information (RFI) to the healthcare community soliciting stakeholder input on a variety of issues, including improving existing payment methodologies to end the perpetuation of payment inequities and reduce opportunities for abuse, sustainability in provider and facility financing, aligning sites of service, revitalizing the health care workforce, and advancing innovative care models and technology. The input received from this RFI will be used to inform the Committee’s future work to expand and enhance access to health care for Americans residing in rural and underserved areas. Read the press release here.

House Introduces Bipartisan Lower Cost, More Transparency Act, Draft Bill

Today House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chair Jason Smith (R-MO), and House Education and the Workforce Chair Virginia Foxx (R-NC) introduced the Lower Costs, More Transparency Act. Bipartisan legislation incorporating a range of health policies passed by the House committees earlier this year that increases healthcare price transparency and lowers overall costs for patients and employers. The legislation would additionally reauthorize community health centers, the National Health Service Corps and teaching health centers and delay around $16 billion in cuts to hospitals serving a disproportionate number of low-income patients through 2025. The draft bill excludes some provisions from earlier iterations of the bills approved by the respective committees, including limits on cost-sharing for Medicare Part D enrollees and transparency around hospital ownership information. House GOP leadership is considering moving the legislation to the House floor later this month, but there could be further changes prior to the bill reaching the floor. The Senate is working on its own health care package that is expected to be brought up for a vote later this fall. Read the draft bill here and the side-by-side here. 

On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) entitled Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor. Additionally, Cassidy is requesting feedback from stakeholders on the role of government in regulating the AI industry and how to ensure AI technology is designed, developed, and deployed in a responsible manner that protects Americans’ rights and safety. Cassidy hopes to use the feedback to better understand the effects of AI and how potential legislation and regulation could impact the creation and utilization of this technology.  Feedback must be submitted by Friday, September 22, to HELPGOP_AIComments@help.senate.gov. Read the press release here.

Late last week, the Biden administration announced a $450 million effort to strengthen prevention, harm reduction, treatment, and recovery support services and crack down on illicit drug trafficking. Of the $450 million, the White House Office of National Drug Control Policy (ONDCP) will award $20.5 million to 164 new Drug-Free Communities (DFC) Support Program awards and $18.9 million in FY 2023 discretionary funding for its High-Intensity Drug Trafficking Areas (HIDTA) Program. The Centers for Disease Control and Prevention (CDC) will award $279 million in Overdose Data to Action (OD2A) grants. The Health Resources and Services Administration (HRSA) will award more than $80 million to rural communities to support critical strategies responding to the overdose risk from illicit fentanyl and other opioids. Lastly, the Substance Abuse and Mental Health Services Administration (SAMHSA) will award over $57.6 million to connect Americans to substance use treatment and recovery support services. Read the press release here.

On Tuesday, the Centers for Medicare & Medicaid Services (CMS) announced the States Advancing All-Payer Health Equity Approaches and Development Model (“States Advancing AHEAD” or “AHEAD Model”), which aims to better address chronic disease, behavioral health, and other medical conditions. States participating in AHEAD will be accountable for quality and population health outcomes while reducing all-payer avoidable healthcare spending to spur statewide and regional healthcare transformation. CMS will issue awards to up to eight states, and each state selected to participate in the AHEAD Model will have an opportunity to receive up to $12 million from CMS to support state implementation. Read the press release here.

On Friday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), issued a proposed rule establishing comprehensive staffing requirements for nursing homes, including a national minimum nurse staffing standards. The proposed rule would mandate nursing homes participating in Medicare and Medicaid to provide residents with a minimum of 0.55 hours of care from a registered nurse per resident per day and 2.45 hours of care from a nurse aide per resident per day, exceeding existing standards in nearly all states. CMS estimates approximately three-quarters (75%) of nursing homes would have to strengthen staffing in their facilities, but the proposed rule considers rural and underserved communities by staggering implementation and allowing for exemptions. CMS also proposes to require states to collect and report on compensation for workers as a percentage of Medicaid payments for those working in nursing homes and intermediate care facilities. Lawmakers on both sides are pushing back to the proposed rule, issuing concerns with proposed staffing mandates failing to meet the needs of seniors and individuals with disabilities, the risk of reducing access to patient care, the difficulty of rural areas to currently meet sufficient staffing levels, and concern the proposal would worsen staffing shortages. Read the press release here and the proposed rule here.

On Thursday, the HHS’ Office for Civil Rights proposed that Section 504 of the Rehabilitation Act, which prohibits discrimination against people with disabilities in such programs, be updated to prevent disability-based bias.

The rule proposed clarifies certain aspects of Section 504 in health and human services settings, including:

Read the press release here, and the proposed rule here.

On Wednesday, the Food and Drug Administration (FDA) released draft guidances to modernize the process of regulating medical devices. The agency published three draft guidelines to improve the predictability, consistency, and transparency of the Premarket Notification 510(k) Program, allowing manufacturers to say that their devices can be marketed through FDA regulation. The draft guidances propose recommendations on best practices for selecting a predicate device, situations when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices. The agency is accepting comments on the guidances until December 6. Read the press release here.

On Tuesday, a new Report from the Government Accountability Office (GAO) analysis found Medicare Part D beneficiaries are spending more on prescriptions than the plans that cover them due to a rebate system that favors more expensive drugs. The report stated Part D plans received $48.6 billion in rebates from drug manufacturers in 2021. The GAO looked at 100 of the most rebated drugs and found for 79 drugs, beneficiaries or Medicare paid more than plan sponsors for drugs after accounting for rebates. The GAO recommended the Centers for Medicare and Medicaid Services perform greater oversight of plan formularies and their use of rebates. The agency responded to GAO that it is statutorily prohibited from interfering with drug manufacturers and plan sponsor negotiations. GAO noted that monitoring rebate and expenditure data would not require CMS to interfere with negotiations and that data will be necessary as the agency implements parts of the drug pricing law Congress passed last year. In Congress, several committees are working on legislation to further regulate pharmacy benefit managers, including those participating in Part D. Read the GAO report here.

On Thursday, the HHS Office of Inspector General (OIG) published a report that determined 55 percent of Medicare home health claims involving falls with major injury went unreported to CMS’ home health assessments. Since 2019, home health agencies have been required to report falls with major injury in their patient assessments to CMS. Fall rates were later included in quality measures for Care Compare, allowing consumers to assess the quality of home health agencies, but the OIG report shows those quality measures were not accurate. The report also found that reporting was lower among for-profit home health agencies, patients under age 65 and Black, Hispanic or Asian patients. CMS said it will crack down on the completion and accuracy of patient assessments, use other data sources to improve quality measures related to falls, and require home health agencies to submit patient assessments when a patient is hospitalized. Read the report here.

Late last week, a three-judge panel of the US Court of Appeals for the District of Columbia upheld a lower court’s rejection of an attack from 200 hospitals against the disproportionate share hospital (DSH) adjustments formula that Medicare used to compensate hospitals for treating low-income patients. In the district court challenge, the hospitals argued the Medicare formula failed to fully account for care for those eligible for Supplemental Security Income benefits. The Department of Health and Human Services uses that formula as a proxy for care provided to low-income patients. In 2022, the lower court sided with the HHS, granting the agency summary judgment. Read the case here.

On Tuesday, Families USA launched “Same Service, Same Price” a campaign to examine the fees hospital-owned physician offices and clinics charge for services. The ads target consumers and local markets that aim to reach key members of Congress, including House Speaker Kevin McCarthy, Senate Majority Leader Chuck Schumer, Senate Finance Chair Ron Wyden (D-OR), and Senator Joe Manchin (D-WV), among 27 others. The campaign comes as Congress contemplates including site-neutral payment policies, requiring hospitals to charge the same for a service regardless of where it is performed, in health care packages moving on Capitol Hill. Advocacy groups are pushing for policies to be included in a year-end package.

On Tuesday, Novartis became the seventh drug manufacturer and ninth plaintiff to sue the Department of Health and Human Services (HHS) over the Inflation Reduction Act (IRA) drug price negotiation program. Novartis is the first drugmaker on the Centers for Medicare and Medicaid’s (CMS) list of the initial ten drugs subject to price negotiation, with the heart failure drug Entresto. The complaint alleges the price negotiation program violates the First, Fifth, and Eighth Amendments, the three constitutional arguments made by most other drugmakers challenging the law. Read the court docket here.

Hearing: "The Inflation Reduction Act: A Year in Review"

Hearing: “Legislative Proposals to Prevent and Respond to Generic Drug Shortages.” 

Hearing: "Oh Doctor, Where Art Thou? Pandemic Erosion of the Doctor-Patient Relationship"