This Week in Washington: House elects new Speaker; Senate HELP Committee advances nomination of NIH Director nominee; House and Senate resume appropriations work.

Upcoming Hearings

Congress

House

• House Resumes Work on Appropriations Bills
• House Budget Committee Healthcare Task Force Holds Roundtable to Discuss CBO New Drug Development Model
• Ninety-One Representatives Send Letter Concerning Nursing Home Staffing Requirement Proposed Rule
• House Energy and Commerce Committee Chairmen Warn NIH Over Possible Subpoena

Senate

• Senate Moves Forward with Minibus
• Senate HELP Committee Favorably Reports Nomination of NIH Director Nominee
• Senate Finance Committee Chairman Sends Letter Concerning Deceptive MA Plan Marketing
• Senate HELP Committee Chairman Sends Letter Concerning NIH Exclusive Patent License
• Bipartisan Bill Introduced to Make Permanent Medicaid Option to Treat Adults with Substance Use Disorders in Large Facilities

Administration

• White House Funding Request Includes $1.55 Billion for OUD Support Services
• HHS Holds Roundtable on Healthcare Cybersecurity Challenges and Releases Toolkit
• CDC Issues Advisory Regarding RSV Vaccine Shortage
• CMS Releases Information on 2024 Marketplace Qualified Health Plans
• CMS Seeks Information on Medicare Transaction Facilitator System
• FDA Releases Draft Guidance Regarding Remote Interactive Drug Facility Evaluations
• FDA Approves New Therapy for Myelodysplastic Syndromes
• FDA Releases Guidance Regarding Biological and New Drug Benefit-Risk Assessment
• FDA Releases Guidance Regarding COVID-19 Vaccine Development
• FDA Releases Draft Guidance Regarding SIUU Communications
• FDA Releases Guidance Regarding Non-Invasive Remote Patient Monitoring Devices
• FDA Updates List of AI/ML-Enabled Medical Devices
• HRSA Releases Updated 340B Registration Requirements for Off-Site Facilities

Proposed Rules

• CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards
• FDA Proposes Rule Regarding Laboratory Developed Tests
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• OCR Proposed Rule Strengthens Protections Against Disability Discrimination

Final Rules

• CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties
• CMS Final Rule Streamlines Medicare Savings Program Enrollment Process
• CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date

Reports

• GAO Releases Report Regarding Overseas State Dept. and USAID Mental Health Services
• GAO Releases Report Regarding Native Hawaiian Healthcare System

CBO Cost Estimates

• CBO Releases Presentation on the Federal Budget Process and the CBO’s Role

Upcoming Hearings

Senate

Nov. 1

Senate Committee on Veterans’ Affairs Full Committee Hearing: “Foundation of Care: Examining Research at the Department of Veterans Affairs”
3:30 p.m., Russell Senate Office Building 418
Witnesses to be announced.

House

Nov. 2

House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations Oversight Hearing: “Trust in Transparency: Holding VA Accountable and Protecting Whistleblowers”
10:00 a.m., Cannon House Office Building 360
Announced witnesses are:

• Bruce P. Gipe, Acting Assistant Secretary of the U.S. Department of Veterans Affairs Office of Accountability and Whistleblower Protection
• Eric Calhoun, Director of Investigations Division of the U.S. Department of Veterans Affairs Office of Accountability and Whistleblower Protection
• Ted Radway, Executive Director of Investigations and Acting Executive Director of Compliance and Oversight Directorate of the U.S. Department of Veterans Affairs Office of Accountability and Whistleblower Protection
• Emilee Collier, Chief of the Office of Special Counsel Investigation and Prosecution Division
• Thomas Costa, Director of Education, Workforce and Income Security at the Government Accountability Office
• Tristan Leavitt, President of Empower Oversight
• Tom Devine, Legal Director at the Government Accountability Project
• Joe Spielberger, Policy Counsel at the Project on Government Oversight

Congress

House

House Resumes Work on Appropriations Bills

The House is resuming work on appropriations bills following the election of a Speaker. Speaker Johnson has said that he wants to pass a continuing resolution through Jan. or April 15, because it will take time to conference the House and Senate differences on appropriations.

On Oct. 26, the House passed the Energy-Water Development funding bill. This week, the House is expected to consider the Legislative Branch, Interior-Environment and Transportation-HUD funding bills.

House Budget Committee Healthcare Task Force Holds Roundtable to Discuss CBO New Drug Development Model

On Oct. 26, the House Budget Committee Health Care Task Force held a roundtable with Congressional Budget Office (CBO) Director Phillip Swagel and drug innovation experts to discuss improvements that could be made to the CBO New Drug Development model. The task force also discussed drug pricing provisions included in the Inflation Reduction Act (IRA).

Task Force Chairman Michael Burgess (R-TX) is concerned that the CBO is not adequately assessing the impacts that drug development and innovation legislation have on federal spending.

For more information, click here.

Ninety-One Representatives Send Letter Concerning Nursing Home Staffing Requirement Proposed Rule

On Oct. 20, Rep. Pence (R-IN) led a group of 90 representatives in sending a letter to Department of Health and Human Services Secretary Xavier Becerra concerning a Centers for Medicare and Medicaid Services proposed rule that would establish minimum staffing requirements and standards for nursing homes. The members are concerned that the rule may limit seniors’ access to care and lead to widespread nursing home closures.

For more information, click here.

House Energy and Commerce Committee Chairmen Warn NIH Over Possible Subpoena

On Oct. 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak.

The chairmen are warning that the committee will issue a subpoena against the agency if it fails to provide documents concerning NIH mpox gain-of-function research by Oct. 31.

For more information, click here.

Senate

Senate Moves Forward with Minibus

On Oct. 24, Senate Appropriations Committee Chairman Patty Murray (D-WA) announced that a bipartisan agreement had been reached to move forward with the mini-omnibus appropriations package, which contains the Agriculture-FDA, Military Construction-VA and Transportation-HUD funding bills. The Senate will consider 40 amendments before holding a final vote, which could occur this week.

Senate HELP Committee Favorably Reports Nomination of NIH Director Nominee

On Oct. 25, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 to favorably report the nomination of Dr. Monica Bertagnolli to become the next National Institutes of Health Director.

Republican and Democratic committee members worked together to pass her nomination out of committee, with Republican Sens. Collins (ME), Murkowski (AK), Romney (UT), Marshall (KS) and Ranking Member Bill Cassidy (LA) voting yes. Chairman Bernie Sanders (I-VT) voted against Dr. Bertagnolli, citing his concern over her decision to decline making commitments to lowering prescription drug prices.

Senate Finance Committee Chairman Sends Letter Concerning Deceptive MA Plan Marketing

On Oct. 25, Senate Finance Committee Chairman Ron Wyden (D-OR) led Democratic committee members in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging CMS to implement stronger Medicare Advantage (MA) plan marketing and transparency requirements.

On Oct. 18, the committee held a hearing to discuss ghost networks and deceptive marketing practices used to target MA beneficiaries during the Medicare Annual Enrollment Period.

For more information, click here.

Senate HELP Committee Chairman Sends Letter Concerning NIH Exclusive Patent License

On Oct. 23, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm concerning a National Institutes of Health (NIH) proposal that would grant an exclusive patent license for a cervical cancer therapy to Scarlet Therapeutics.

The Chairman is urging HHS to investigate the proposal and is calling on the NIH to offer a non-exclusive license to allow other manufacturers to produce the cervical cancer therapy.

For more information, click here.

Bipartisan Bill Introduced to Make Permanent Medicaid Option to Treat Adults with Substance Use Disorders in Large Facilities

On Oct. 19, Sens. Thune (R-SD), Hassan (D-NH) and Blackburn (R-TN) introduced the Securing Advances and a Variety of Evidence-Based (SAVE) Institutions for Mental Disease (IMD) Options Act, a bill to make permanent the Medicaid option for states to treat adults with substance use disorders in facilities larger than 16 beds.

This legislation comes several weeks after Congress allowed the SUPPORT Act to expire. Without this state plan amendment pathway, states are bound to the so-called IMD exclusion where they cannot use federal funds to pay for a patient’s behavioral health treatment at a hospital, nursing home or other facility that is more than 16 beds.

The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, included a state plan option in Medicaid that allowed federal Medicaid funds to be used for patients in IMD with substance use disorders.

For more information, click here.

Administration

White House Funding Request Includes $1.55 Billion for OUD Support Services

On Oct. 25, the White House sent a supplemental funding request to Congress seeking $56 billion to support disaster recovery, communication infrastructure and child care programs. The request includes $1.55 billion to strengthen opioid use disorder treatment, harm reduction and recovery support services.

For more information, click here.

HHS Holds Roundtable on Healthcare Cybersecurity Challenges and Releases Toolkit

On Oct. 26, the Department of Health and Human Services held a joint roundtable discussion with the Cybersecurity and Infrastructure Security Agency regarding steps healthcare organizations can take to safely store and protect patient medical information and health records.

For more information, click here.

CDC Issues Advisory Regarding RSV Vaccine Shortage

On Oct. 23, the Centers for Disease Control and Prevention (CDC) issued a health advisory concerning the shortage of the new respiratory syncytial virus (RSV) vaccine Nirsevimab. Due to limited supply, the CDC is recommending that clinicians prioritize the vaccination of infants under the age of six months and those with underlying conditions.

For more information, click here.

CMS Releases Information on 2024 Marketplace Qualified Health Plans

On Oct. 25, the Centers for Medicare and Medicaid Services (CMS) released information on the Marketplace Qualified Health Plans (QHPs) that will be offered in 2024, in preparation for the open enrollment period, which will run from Nov. 1 to Jan. 15.

In addition, CMS released a fact sheet that outlines policy changes, enrollment deadlines and plan participation and premiums data.

For more information on the 2024 QHPs, click here.

For more information on the fact sheet, click here.

CMS Seeks Information on Medicare Transaction Facilitator System

On Oct. 23, the Centers for Medicare and Medicaid Services issued a request for information (RFI) to evaluate whether healthcare-related organizations have the technical ability to provide data exchange, customer support and payment facilitation functions related to the Medicare Drug Price Negotiation Program via a Medicare Transaction Facilitator system.

Comments will be accepted until Nov. 13. For more information, click here.

FDA Releases Draft Guidance Regarding Remote Interactive Drug Facility Evaluations

On Oct. 25, the Food and Drug Administration (FDA) issued draft guidance regarding remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities. The draft guidance is intended to clarify how the FDA requests and conducts voluntary evaluations of facilities where drugs are manufactured, processed, packed and compounded.

For more information, click here.

FDA Approves New Therapy for Myelodysplastic Syndromes

On Oct. 24, the Food and Drug Administration (FDA) approved Tibsovo (ivosidenib), a therapy intended to treat adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 mutation. MDS is a rare blood cancer that decreases the amount of healthy blood cells.

For more information, click here.

FDA Releases Guidance Regarding Biological and New Drug Benefit-Risk Assessment

On Oct. 23, the Food and Drug Administration (FDA) released guidance regarding the benefit-risk assessment of new drug and biological products. The guidance is intended to clarify how the FDA considers drug and biological product benefits, risks and risk management options when evaluating new drug applications.

For more information, click here.

FDA Releases Guidance Regarding COVID-19 Vaccine Development

On Oct. 23, the Food and Drug Administration released guidance regarding the development and licensure of COVID-19 vaccines. The guidance is intended to provide an overview of key considerations of investigational new drug licensing, manufacturing and nonclinical and clinical data regulations.

For more information, click here.

FDA Releases Draft Guidance Regarding SIUU Communications

On Oct. 23, the Food and Drug Administration released draft guidance regarding how firms and healthcare providers should communicate scientific information on unapproved uses (SIUU) of approved and cleared medical products. The guidance outlines SIUU communication recommendations and considerations.

For more information, click here.

FDA Releases Guidance Regarding Non-Invasive Remote Patient Monitoring Devices

On Oct. 19, the Food and Drug Administration (FDA) released guidance regarding non-invasive remote patient monitoring (RPM) devices. The guidance clarifies that non-invasive RPM device manufacturers may make minor changes to device hardware or software without submitting a 510(k) premarket submission.

For more information, click here.

FDA Updates List of AI/ML-Enabled Medical Devices

On Oct. 19, the Food and Drug Administration (FDA) added 155 devices to the list it maintains of artificial intelligence and machine learning (AI/ML)–enabled medical devices. The list is intended to provide insights into the FDA’s work surrounding AI technologies.

For more information, click here.

HRSA Releases Updated 340B Registration Requirements for Off-Site Facilities

On Oct. 26, the Health Resources and Services Administration (HRSA) released updated 340B registration requirements for off-site, outpatient hospital facilities.

The requirements reverse a 2020 guidance that permitted hospitals to use and prescribe 340B drugs at off-site locations before they were reported on a Medicare cost report and registered in the 340B Office of Pharmacy Affairs (OPAIS) database.

For more information, click here.

Proposed Rules

CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards

On Sept. 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would establish minimum nursing staffing standards for long-term care (LTC) facilities and implement provisions aimed at increasing transparency of Medicaid institutional payments. The proposed rule would:

• Require nursing facilities participating in Medicare and Medicaid to provide at a minimum, 0.55 hours of care from a registered nurse (RN) per resident per day and 2.45 hours of care from a nurse aide per resident per day;
• Require nursing facilities to maintain at least one nurse on-site at all times;
• Implement new nursing facility assessment requirements; and
• Require states to publicly report on the percentage of Medicaid payments for home and community-based services that are spent on compensation for direct care workers.

Public comments will be accepted until Nov. 6, 2023. For more information, click here.

FDA Proposes Rule Regarding Laboratory Developed Tests

On Sept. 29, the Food and Drug Administration (FDA) released a proposed rule that would amend regulations and classify in vitro diagnostic products (IVDs) as medical devices under the Federal Food, Drug and Cosmetic (FD&C) Act. The proposed rule also clarifies that the FDA will phase out the general enforcement discretion approach for laboratory developed tests (LDTs) and states that LDTs will fall under the same enforcement approach as other IVDs.

Public comments will be accepted until Dec. 1, 2023. For more information, click here.

FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

On May 30, the Food and Drug Administration (FDA) released a proposed rule that would amend human prescription drug product labeling regulations for medication guides. The proposed rule would require prescription drug and biological product applicants to include a new one-page medication guide known as the Patient Medication Information (PMI) along with products that are used, dispensed or administered in an outpatient setting. Blood and blood components transfused in an outpatient setting would also require a PMI. The PMI would include essential information such as the product’s name, important safety information, common side effects and directions for use.

Public comments will be accepted until Nov. 27, 2023. For more information, click here.

OCR Proposed Rule Strengthens Protections Against Disability Discrimination

On Sept. 7, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to strengthen access to healthcare and human services for individuals with disabilities. It also aims to prohibit discrimination on the basis of a disability among healthcare and human services programs. The proposed rule would:

• Clarify the application of Section 504 and ensure its consistency with the Americans with Disabilities Act, the Rehabilitation Act and case law;
• Clarify obligations for mobile, web and kiosk accessibility;
• Establish standards for accessible medical equipment;
• Prohibit the use of value assessment methods that negatively assess individuals with disabilities and limit their access to aids, benefits and services; and
• Clarify obligations to provide services to disabled persons in integrated and appropriate settings.

Public comments will be accepted until Nov. 13, 2023. For more information, click here.

Final Rules

CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties

On Oct. 11, the Centers for Medicare and Medicaid Services (CMS) released a final rule that specifies how and when it will calculate and impose civil money penalties (CMPs) when group and non-group health plan responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting requirements. It also outlines CMP amounts and clarifies under which circumstances penalties will and will not be imposed.

The final rule will go into effect on Dec. 11, 2023. For more information, click here.

CMS Final Rule Streamlines Medicare Savings Program Enrollment Process

On Sept. 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would streamline enrollment into the Medicare Savings Program (MSP) and align it with other public program requirements and processes. It would:

• Automatically enroll the majority of Supplemental Security Income (SSI) recipients into the Qualified Medicare Beneficiary eligibility group;
• Require states to use Medicare Part D low-income subsidy (LIS) program data when making QMP eligibility determinations;
• Eliminate duplicative paperwork; and
• Reduce the cost of prescription drugs.

The final rule will go into effect on Nov. 17, 2023. For more information, click here.

CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting

On Aug. 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would establish mandatory state reporting requirements for the following quality measures:

• Core set of Children’s Health Care Quality measures under Medicaid and the Children’s Health Insurance Program (CHIP);
• Behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and
• Core Sets of Health Home Quality Measures for Medicaid.

The final rule will go into effect on Jan. 1, 2024. For more information, click here.

CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize the calendar year (CY) 2024 payment policies for the Medicare Advantage (MA) and Medicare Part C and D programs. The final rule implements several changes that were made with regard to the Medicare programs listed above, which are outlined in a Rate Announcement released by CMS. The final rule will:

• Finalize technical changes and updates made to the MA risk adjustment model, which include transitioning the model to reflect International Classification of Diseases 10 (ICD-10) condition categories and updating the model with recent Medicare data years. CMS intends on phasing in the updated model over the next three years.
• Finalize changes to the Medicare Part C and D Star Ratings. CMS will provide a list of the eligible disasters for the extreme and uncontrollable circumstances adjustment and of non-substantive updates made to several measure specifications.

CMS’ rate announcement update reflects a 3.32 percent increase in MA payments, equivalent to approximately $13.8 billion. Additionally, the update reflects a 2.28 percent increase in the MA payment effective growth rate, a 1.24 percent decline in star ratings and a 4.4 percent increase in the MA risk score trend.

The rule will go into effect on Jan. 1, 2024. For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

• Improve the delivery of mammography services;
• Strengthen communication of healthcare information;
• Require mammography facilities to provide patients with additional health information;
• Ensure the availability of qualified mammography personnel;
• Bolster medical outcome audits;
• Modernize technological aspects of mammography services; and
• Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule will go into effect on Nov. 6, 2023. For more information, click here.

Reports

GAO Releases Report Regarding Overseas State Dept. and USAID Mental Health Services

On Oct. 26, the Government Accountability Office (GAO) released a report that identifies factors and challenges that impact mental health services offered by the Department of State (DOS) and the U.S. Agency for International Development (USAID) to overseas employees. The GAO reviewed DOS and USAID documents and interviewed agency officials and overseas psychiatrists.

The GAO discovered that the lack of local providers and electronic health records in addition to mental health stigma and medication delivery delays has negatively impacted DOS and USAID mental health services. It also discovered that the DOS does not collect ongoing feedback from overseas employees. The GAO conducted this study because it was asked to review DOS and USAID mental health services for employees based overseas.

For more information, click here.

GAO Releases Report Regarding Native Hawaiian Healthcare System

On Oct. 23, the Government Accountability Office (GAO) released a report regarding the funding, services and oversight of the Native Hawaiian Healthcare System. The GAO reviewed Health Resources and Services Administration (HRSA) data and interviewed HRSA and Papa Ola Lokahi officials. Papa Ola Lokahi oversees the system alongside HRSA.

The GAO found that in 2022, the system’s revenue ranged from $3.5 to $9.7 million and that its revenue primarily came from federal grants. It also found that program funding for individual parts of the system ranged from $2.8 to $3.4 million.

In addition, the GAO found that HRSA utilizes annual operational and financial reviews, in-person operational visits and monitoring calls to oversee the system. The GAO conducted this study because a provision in House Report 117-96 required it to review healthcare services available to Native Hawaiians living in Hawaii.

For more information, click here.

CBO Cost Estimates

CBO Releases Presentation on the Federal Budget Process and the CBO’s Role

On Oct. 25, the Congressional Budget Office (CBO) released a presentation regarding its role in the federal budget process. The presentation clarifies how the CBO is structured and the methods it uses to prepare baseline budget and economic projections and cost estimates of legislative proposals.

For more information, click here.