This Week in Washington: Still No Speaker in the House; 2024 Medicare Part B Premiums and Deductibles to Rise.

Upcoming Hearings

Congress

Senate

• Senate HELP Committee Majority Staff Releases Report on Nonprofit Hospital Charity Care Spending

Administration

• HHS OIG Releases Report Regarding Medicare Hospital Transfer Payment Policy
• ASPR Awards $500 Million and Announces Project NextGen Vaccine Candidates
• CMS Announces Increase in 2024 Part B Premiums and Deductibles
• CMS Reopens IDR Portal for Initial Dispute Submissions
• FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products
• FDA Establishes Digital Health Advisory Committee

Proposed Rules

• CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee
• CMS Extends Comment Period for Proposed Rule Strengthening Coverage of Mental Health Insurance Benefits
• CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards
• DEA Extends Telehealth Flexibility For a Second Time
• 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

Courts

• White House to Appeal U.S. District Court for the Eastern District of Texas Ruling on QPA Methodology for No Surprises Act

Reports

• GAO Releases Report Regarding State and Local COVID-19 Relief Funds Spending

CBO Cost Estimates

• CBO Seeking Research and Information on Anti-Obesity Medication Use

Upcoming Hearings

October 17

House

House Ways and Means Committee Full Committee Field Hearing: “Field Hearing on Access to Health Care in America: Challenges in Rural and Underserved Communities”
9:00 a.m., East Carolina University Heart Institute
Witnesses to be announced.

October 18

House

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Hearing: “Strengthening Biosafety and Biosecurity Standards: Protecting Against Future Pandemics”
10:00 a.m., Rayburn House Office Building 2154
Witnesses to be announced.

Senate

Senate Finance Committee Full Committee Hearing: “Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences”
10:00 a.m., Hart Senate Office Building 216
Announced witnesses are:

• Christina Reeg, Senior Health Insurance Information Program Director at the Ohio Department of Insurance
• Cobi Blumenfeld-Gantz, Co-Founder and Chief Executive Officer of Chapter
• Krista Hoglund, ASA, MAAA, Chief Executive Officer of Security Health Plan

Senate Committee on the Budget Full Committee Hearing: “Improving Care, Lowering Costs: Achieving Health Care Efficiency”
10:00 a.m., Dirksen Senate Office Building 608
Announced witnesses are:

• Matthew Fiedler, Senior Fellow at the Brookings Institution
• Leemore Dafny, Professor at the Harvard Business School and Harvard Kennedy School
• G. Alan Kurose, Chair of the Rhode Island Foundation and Former President of Coastal Medical
• Theo Merkel, Director of Private Health Reform Initiative and Senior Research Fellow at the Paragon Health Institute and Senior Fellow at the Manhattan Institute
• Chapin White, Director of Health Analysis at the Congressional Budget Office

October 19

House

House Energy and Commerce Committee Subcommittee on Health Hearing: “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care and Minimize Red Tape for Doctors”
10:00 a.m., Rayburn House Office Building 2123
Announced witnesses are:

• Meena Seshamani, MD, PhD, Director of the Centers for Medicare and Medicaid Services Center for Medicare
• Leslie Gordon, Director of Health Care at the Government Accountability Office
• Paul Masi, Executive Director of the Medicare Payment Advisory Commission

House Committee on Veterans’ Affairs Subcommittee on Health Hearing: “Emerging Therapies: Breakthroughs in the Battle Against Suicide?”
1:30 p.m., Cannon House Office Building 360
Witnesses to be announced.

Congress

House

House returns from recess.

Senate

Senate HELP Committee Majority Staff Releases Report on Nonprofit Hospital Charity Care Spending

On Oct. 10, the Senate Health, Education, Labor and Pensions (HELP) Committee Majority Staff released a report on nonprofit hospitals and the amount of revenue they directed toward charity care programs. The report examined the revenue of major nonprofit hospitals for fiscal year (FY) 2021, the cost of their charity care and the percentage of revenue they spent on charity programs.

The report recommends Congress and the Internal Revenue Service (IRS) better monitor nonprofit hospitals’ use of funds and strengthen charity care requirements.

For more information, click here.

Administration

HHS OIG Releases Report Regarding Medicare Hospital Transfer Payment Policy

On Oct. 11, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report in which it analyzed acute-care inpatient hospital claims for Medicare beneficiaries and calculated the savings that the Medicare program would have realized if the Centers for Medicare and Medicaid Services (CMS) expanded the hospital transfer policy to include all Medicare Severity Diagnosis-Related Groups (MS-DRGs).

The OIG determined that Medicare could have saved $694 million between 2017 and 2019 if an expanded policy had been in place.

For more information, click here.

ASPR Awards $500 Million and Announces Project NextGen Vaccine Candidates

On Oct. 13, the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) announced the selection of vaccine candidates who will receive funding through Project NextGen, an initiative led by ASPR and the National Institutes of Health (NIH) that seeks to accelerate the development of innovative vaccines and therapeutics. The vaccine candidates are CastleVax, Codagenix and Gritstone Bio.

In addition, ASPR awarded $500 million in funding to manufacturers of laboratory technologies seeking to improve national preparedness for future COVID-19 outbreaks and strengthen patient access.

For more information, click here.

CMS Announces Increase in 2024 Part B Premiums and Deductibles

On Oct. 12, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare Part B premiums and deductibles will increase in 2024. Standard monthly premiums will increase from $164.90 to $174.70 and annual deductibles will rise from $226 to $240. CMS announced that the increase is due to the rise in general healthcare spending and the $9 billion in lump-sum payments that CMS must direct to 340B hospitals to reimburse hospitals for reductions made in 340B drug reimbursements that have been determined to be improper.

For more information, click here.

CMS Reopens IDR Portal for Initial Dispute Submissions

On Oct. 6, the Centers for Medicare and Medicaid Services (CMS), along with the Department of Labor and Department of the Treasury, announced that the federal independent dispute resolution (IDR) portal would be reopened for the initiation of new single disputes including those involving bundled payment arrangements. The initiation of disputes via the IDR portal had been temporarily suspended since Aug. 3, 2023.

For more information, click here.

FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products

On Oct. 12, the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to the R.J. Reynolds Vapor Company over six flavored Vuse Alto e-cigarette products. The FDA issued the MDOs after it determined that the benefits the e-cigarettes provide to adult smokers did not outweigh the risk they pose to youth.

For more information, click here.

FDA Establishes Digital Health Advisory Committee

On Oct. 11, the Food and Drug Administration (FDA) announced that it had established the Digital Health Advisory Committee. The committee will become fully operational in 2024 and will focus on addressing scientific and technical issues related to digital health technologies such as artificial intelligence, machine learning, augmented reality, virtual reality, remote patient monitoring, software and more.

For more information, click here.

Proposed Rules

CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would increase the administrative fee for disputes initiated within the No Surprises Act independent dispute resolution (IDR) process. The proposed rule would:

• Increase the IDR administrative fee from $50 to $150 per party per dispute;
• Increase the fee range for certified IDR entities by 20 percent for single determinations; and
• Increase the fee range for certified IDR entities by 25 percent for batched determinations.

In addition, the Internal Revenue Service (IRS) and the Employee Benefits Security Administration are proposing the rule.

Public comments will be accepted until Oct. 26, 2023. For more information, click here.

CMS Extends Comment Period for Proposed Rule Strengthening Coverage of Mental Health Insurance Benefits

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) announced that it would extend the comment period for a proposed rule that would implement amendments relating to the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The proposed rule would:

• Clarify that the MHPAEA ensures an individual’s right to access mental health and substance use disorder benefits in parity with medical/surgical benefits;
• Provide examples that make clear that plans and issuers may not use restrictive prior authorization and other medical management techniques or standards related to network composition for mental health and substance use disorder benefits;
• Clarify that certain factors may not be used to determine out-of-network reimbursement rates for mental health and substance use disorder providers;
• Require plans and issuers to gather and analyze outcomes data and take action to resolve material differences in access to mental health and substance use disorder benefits and medical/surgical benefits;
• Codify a requirement that directs plans and issuers to conduct meaningful comparative analyses to measure the impact of nonquantitative treatment limitation (NQTL); and
• Implement a sunset provision adopted in the Consolidated Appropriations Act of 2023, that allows self-funded, non-federal government plan elections to opt out of compliance with MHPAEA.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comments and information on proposed new data requirements for limitations related to the composition of a health plan’s or issuer’s network.

Public comments will be accepted until Oct. 17, 2023. For more information, click here.

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.

DEA Extends Telehealth Flexibility For a Second Time

On Oct. 6, the Drug Enforcement Administration (DEA) decided to extend for a second time current telemedicine flexibilities through Dec. 31, 2024. The DEA had previously extended those flexibilities through Nov. 11, 2024.

These rules, established during the COVID-19 pandemic, are an exception to the conditions of a law known as the Ryan Haight Act, which require at least one in-person medical examination before a doctor can prescribe a controlled medicine, including stimulant medications for attention-deficit hyperactivity disorder, benzodiazepines for anxiety and drugs for opioid use disorder, sleep or pain.

The DEA received more than 38,000 public comments on two proposals designed to keep some flexibility in the telehealth framework post public health emergency. The proposals would allow telehealth practitioners to prescribe one 30-day supply of buprenorphine—a medication for opioid use disorder—or Schedule III-V non-narcotic controlled medications, without doing an in-person exam first. A patient would have to do an in-person exam before the second prescription of either type of medication, according to those proposals.

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.

Courts

White House to Appeal U.S. District Court for the Eastern District of Texas Ruling on QPA Methodology for No Surprises Act

On Oct. 6, the White House announced that it would appeal a ruling issued by the U.S. District Court for the Eastern District of Texas that invalidated the methodology for calculating the qualifying payment amount (QPA) used to determine individual cost sharing for items and services covered under No Surprises Act billing protections.

In addition, the White House announced that it would not take enforcement action against insurance plans that continue using the invalidated methodology for calculating QPA until May 2024 at the earliest, and hinted that it may allow plans to continue using the methodology past May to give them more time to come into full compliance with the ruling.

For more information, click here.

Reports

GAO Releases Report Regarding State and Local COVID-19 Relief Funds Spending

On Oct. 11, the Government Accountability Office (GAO) released a report that analyzes how states and localities have been spending $350 billion in COVID-19 recovery funds they received through the Coronavirus State and Local Fiscal Recovery Funds (SLFRF) Program. The GAO analyzed Department of the Treasury SLFRF project and expenditure data, interviewed Treasury officials and reviewed laws and regulations applicable to the SLFRF program.

The GAO found that as of March 31, 2023, states reported obligating $118.3 billion and spending $88.2 billion of the SLFRF awards they received. In addition, localities reported obligating $67.5 billion and spending $47.9 billion of their awards. The GAO conducted this study because a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act directed it to monitor the use of federal funds to respond to the COVID-19 pandemic.

For more information, click here.

CBO Cost Estimates

CBO Seeking Research and Information on Anti-Obesity Medication Use

On Oct. 5, the Congressional Budget Office (CBO) published a blog post announcing that it is seeking additional research and information on the use of anti-obesity medications (AOMs). The CBO is monitoring trends in the use of AOMs and is analyzing their prices, effects on health and coverage by insurance plans but noted that it is in need of more information regarding the near- and long-term clinical impacts of AOMs, their impact on patients’ use of other medical services and patients’ adherence to them.

For more information, click here.