Washington Healthcare Update

October 23, 2023

This Week in Washington: Still No Speaker in the House; NIH Director Nominee has Hearing; FDA Seeking Feedback on Innovative Drug Clinical Trial Design.

Upcoming Hearings

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

CBO Cost Estimates


Upcoming Hearings

October 24

House

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Hearing: “Reforming the WHO: Ensuring Global Health Security and Accountability”
10:00 a.m., Rayburn House Office Building 2154
Announced witnesses are:

  • Loyce Pace, M.P.H., Assistant Secretary for Global Affairs at the Department of Health and Human Services
  • John Nkengasong, M.Sc., Ph.D, Ambassador-at-Large, U.S. Global AIDS Coordinator, Senior Bureau Official for Global Health Security and Diplomacy at the U.S. Department of State
  • Atul Gawande, M.D., M.P.H., Assistant Administrator for Global Health at the United States Agency for International Development

Senate

October 25

Senate Committee on Veterans’ Affairs Full Committee Hearing: “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans”
3:30 p.m., Russell Senate Office Building 418
Witnesses to be announced.

October 26

Senate Special Committee on Aging Full Committee Hearing: “Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases”
10:00 a.m., Dirksen Senate Office Building 106
Witnesses to be announced.

October 27

Senate Health, Education, Labor and Pensions Committee Field Hearing: “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?”
9:00 a.m., Rutgers University Nicholas Music Center
Witnesses to be announced.

Congress

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicare Payment Reform

On Oct. 19, the House Energy and Commerce Committee Subcommittee on Health held a legislative hearing and considered 23 bills concerning Medicare payment for providers. The witnesses were:

  • Meena Seshamani, M.D., Ph.D., Director of the Centers for Medicare and Medicaid Services Center for Medicare
  • Leslie Gordon, MPP, Director of Health Care at the Government Accountability Office
  • Paul Masi, MPP, Executive Director of the Medicare Payment Advisory Commission
  • Steven Furr, M.D., FAAFP, President-Elect of the American Academy of Family Physicians
  • Debra Patt, M.D., Ph.D., MBA, Executive Vice President of Texas Oncology
  • Joe Albanese, MPP, Senior Policy Analyst of Paragon Health Institute
  • Matthew Fiedler, Ph.D., Joseph A. Pechman Senior Fellow in Economic Studies at the Brookings Institution Brookings Schaeffer Initiative on Health Policy

The bills discussed in the hearing are:

H.R.__, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program
This legislation would extend a policy to increase the work geographic index for Medicare physician payments to 1.00 for any locality where the index would be less than 1.00.

H.R.__, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to improve the accuracy of geographic adjustment factors under such a program
This legislation would extend a policy to increase the work geographic index for Medicare physician payments to 1.00 for any locality where the index would be less than 1.00 and would include reforms to improve the accuracy of geographic data adjustment factors.

H.R. 2377, the Saving Access to Laboratory Services Act
This legislation would direct the Centers for Medicare and Medicaid Services (CMS) to use statistical sampling of private-payer rates when establishing Medicare reimbursement amounts for clinical diagnostic tests.

H.R.__, To amend title XVIII of the Social Security Act to revise the phase-in of clinical laboratory test payment changes under the Medicare program
This legislation would delay changes to how clinical laboratories are paid under the Medicare program until Jan. 1, 2025.

H.R.__, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
This legislation would extend incentive payments for participation in eligible alternative payment models through 2026 and would establish a 5-year cap on payment incentives for qualifying participants.

H.R.__, the Improving Seniors Timely Access to Care Act of 2023
This legislation would require Medicare Advantage plans with prior authorization requirements to establish an electronic prior authorization program.

H.R. 1352, the Increasing Access to Biosimilars Act of 2023
This legislation would create a new pilot program to evaluate the benefits of providing more shared savings payments to biosimilar providers under Medicare.

H.R.__, the Provider Reimbursement Stability Act of 2023
This legislation would increase the Physician Fee Schedule (PFS) budget neutrality threshold, set a limitation on year-to-year conversion fact (CF) variance and require the Secretary of the Department of Health and Human Services (HHS) to update prices and rates for direct cost inputs for practice expense (PE) relative value units (RVUs).

H.R. 5526, the Seniors’ Access to Critical Medications Act of 2023
This legislation would make permanent a CMS waiver that allows Medicare patients to receive medications through the mail and allows family members and caregivers to obtain medications on the patient’s behalf.

H.R. 1406, the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act
This legislation would allow cardiopulmonary rehabilitation services to be furnished via telehealth from a beneficiary’s home permanently.

H.R. 2583, the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023
This legislation would allow nurses and physician assistants to supervise and administer Medicare cardiac rehabilitation care programs.

H.R.__, To amend title XVIII of the Social Security Act to exempt certain practitioners from MIPS payment adjustments under the Medicare program based on participation in certain payment arrangements under Medicare Advantage
This legislation would allow practitioners who participate in certain Medicare Advantage payment arrangements to be exempted from MIPS reporting requirements and adjustments.

H.R. 4402, To amend title XI of the Social Security Act to clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes
This legislation would clarify that manufacturers of a covered drug, device, biological or medical supply will not be required to submit information regarding educational materials that directly benefit patients.

H.R. 3674, the Providing Relief and Stability for Medicare Patients Act of 2023
This legislation would increase the non-facility practice expense relative value units for certain Medicare services.

H.R.__, To amend title XVIII of the Social Security Act to revise certain physician self-referral exemptions relating to physician-owned hospitals
This legislation would modify the physician self-referral exemptions related to Physician-Owned Hospitals (POHs) for certain rural hospitals.

H.R.__, the Fewer Burdens for Better Care Act of 2023
This legislation would require the HHS Secretary to provide a 30-day public comment period for stakeholders to provide feedback on quality and efficiency measures that should be considered for removal.

H.R. 5395, the SURS Extension Act
This legislation would extend the Quality Payment Program-Small Practice, Underserved, and Rural support program for fiscal years (FYs) 2024-2029.

H.R.__, To amend title XVIII of the Social Security Act to promote provider choice using real-time benefit information
This legislation would require prescription drug plan (PDP) sponsors to provide patients real-time information related to formularies and benefit information within one year of enactment.

H.R. 5555, the DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to provide certain adjustments to Medicare payment for items and medical equipment that were included in round 2021 of the Durable Medical Equipment, Prosthetics/Orthotics and Supplies (DMEPOS) competitive bidding program.

H.R. 4104, the Preserving Patient Access to Home Infusion Act
This legislation would allow nurse practitioners and physician assistants to establish and review home infusion plans of care and require CMS to pay home infusion providers for drugs administered to patients on a daily basis.

H.R. 4878, the EMPOWER Act
This legislation would remove direct supervision requirements for physical therapy assistants and occupational therapy assistants and would require the U.S. Government Accountability Office (GAO) to analyze how the Medicare Part B 15 percent payment differential for services provided by therapy assistants has affected access to therapy services.

H.R.__, the Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from making a physician’s or practitioner’s address of residence publicly available if they choose to provide telehealth services from that address.

H.R.__, To amend title XVIII of the Social Security Act to allow for the use of alternative measures of performance under the Merit-based Incentive Payment System under the Medicare program
This legislation would grant MIPS reporting flexibility to physicians who perform the majority of their work in a facility-based setting.

For more information, click here.

House Ways and Means Committee Holds Roundtable Regarding Implementation of No Surprises Act

On Oct. 18, the House Ways and Means Committee held a roundtable with officials from the Departments of Health and Human Services, Labor and Treasury, regarding the implementation of the No Surprises Act.

On Sept. 19, the committee held a hearing to discuss the ability of small practices to access the system for arbitration, and other issues including network restrictions, payment reductions and dispute resolution process delays.

For more information, click here.

House Members Send Letter Concerning Home Dialysis for AKI Patients

On Oct. 18, Reps. DelBene (D-WA), Miller (R-WV), Cardenas (D-CA) and Bucshon (R-IN) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging CMS to expand access and coverage of home dialysis for Medicare patients with acute kidney injury (AKI).

For more information, click here.

Senate

Senate Finance Committee Holds Hearing on Deceptive MA Marketing Tactics and “Ghost Networks”

On Oct. 18, the Senate Finance Committee held a hearing regarding “ghost networks” and common deceptive marketing practices that target Medicare Advantage (MA) beneficiaries during the Annual Open Enrollment period. The witnesses were:

  • 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

During the hearing, committee Chairman Ron Wyden (D-OR) stressed the importance of eliminating MA “ghost networks.”

In addition, the Chairman and Sens. Bennet (D-CO) and Tillis (R-NC) introduced the Requiring Enhanced and Accurate Lists (REAL) of Health Providers Act. The bill would require MA plans to maintain accurate and updated provider directories and would protect patients from paying for care obtained at providers that were incorrectly listed as being in-network.

For more information on the hearing, click here.

For more information on the bill, click here.

Senate HELP Committee Holds Hearing on Nomination of NIH Director

On Oct. 18, the Senate Health, Education, Labor and Pensions (HELP) committee held a hearing on the nomination of Monica Bertagnolli to be Director of the National Institutes of Health (NIH).

In his questioning of Dr. Bertagnolli, Chairman Bernie Sanders (I-VT) focused on reducing the cost of prescription drugs, which is not in the purview of the NIH. Ranking Member Bill Cassidy (R-LA) asked if Dr. Bertagnolli would apply Reasonable Pricing Clauses to NIH contracts.

The committee will vote on whether to send Dr. Bertagnolli’s nomination to the Senate floor on Oct. 25.

For more information, click here.

Bipartisan Bill Introduced to Make Permanent SUPPORT Act SPA Option

On Oct. 19, Sens. John Thune (R-SD), Maggie Hassan (D-NH) and Marsha 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 has 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 disorder.

For the text of the legislation, click here.

Administration

HHS OCR Issues Telehealth and Health Information Privacy Resources

On Oct. 18, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued two resource documents intended to assist patients in understanding the privacy and security risks that may arise when using telehealth services. The documents outline a number of security and privacy best practices.

For more information, click here.

HHS Announces Extension of Free Paxlovid Access for Patients

On Oct. 13, the Department of Health and Human Services (HHS) announced that it would assist Pfizer with the transition of Paxlovid to the commercial market beginning next month and that it would continue providing free access to Paxlovid for Medicare and Medicaid beneficiaries and the uninsured via a patient assistance program through the end of 2024.

For more information, click here.

CMS Releases 2024 Medicare Advantage and Part D Plan Star Ratings

On Oct. 13, the Centers for Medicare and Medicaid Services (CMS) released the 2024 Star Ratings for Medicare Advantage and Part D plans ahead of the Medicare Open Enrollment period, which began Oct. 15 and will run through Dec. 7. The star ratings are intended to help beneficiaries compare their plan and coverage options.

For more information, click here.

FDA CDER Seeks Public Comment on Innovative Drug Clinical Trial Design

On Oct. 17, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) announced that it is seeking public comment on the barriers that impact the incorporation of innovative clinical trial approaches in drug development programs. Comments will be accepted until April 19, 2024.

For more information, click here.

FDA to Host Webinar to Discuss Proposed LDT Rule

On Oct. 17, the Food and Drug Administration (FDA) announced that it will host a webinar on Oct. 31 to provide additional information on the proposed laboratory developed test (LDT) rule that it recently released. The proposed rule would classify LDTs as medical devices and restore the FDA’s authority to regulate them.

For more information, click here.

FDA Submits Menthol Cigarette Ban Final Rules for OMB Review

On Oct. 13, the Food and Drug Administration (FDA) announced that it had submitted two final rules to the White House Office of Management and Budget (OMB) for review that, if approved, would ban the sale of menthol cigarettes and flavored cigars. The prohibition of tobacco flavoring is intended to reduce the appeal of smoking products among children and youth.

FDA Issues Warning Regarding Compounded Ketamine Products

On Oct. 10, the Food and Drug Administration (FDA) issued a warning to patients and healthcare providers regarding the use of compounded ketamine products. The FDA noted that ketamine is not approved for the treatment of any psychiatric disorder and that no compounded ketamine products have received FDA approval.

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 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 Medicare Quality Payment Program and Physician Payment Geographic Adjustments

On Oct. 19, the Government Accountability Office (GAO) released a report regarding the Medicare Quality Payment Program and geographic adjustments to physician payments. The report summarizes previous findings on the Merit-based Incentive Payment System (MIPS) and the Advanced Alternative Payment Model (Advanced APM) that the GAO released in Oct. and Nov. 2021.

The GAO found that between 2017 and 2019, at least 93 percent of providers under MIPS earned a positive adjustment while 5 percent qualified for a negative adjustment. The GAO also found that the proportion of providers who participated in Advanced APMs was lower among providers located in rural or shortage areas compared to other areas and that modeling for geographic variation generally accounted for physician earnings in most localities.

For more information, click here.

CBO Cost Estimates

CBO Releases Report on Federal Healthcare Spending

On Oct. 19, the Congressional Budget Office (CBO) released a report analyzing the long-term projected outlook of federal healthcare spending and the recent decline in spending growth. The report outlines the CBO’s predictions for total outlays and revenues for major healthcare programs through 2053 and the estimated growth in total federal subsidies for health insurance through 2033.

For more information, click here.

CBO Releases Report on Alternative Payment Models and Federal Healthcare Spending

On Oct. 18, the Congressional Budget Office (CBO) released a report regarding alternative payment models and slowdowns in federal healthcare spending, that was submitted as testimony by CBO Director of Health Analysis Chapin White during a Senate Committee on the Budget hearing.

The report describes how accountable care organizations (ACOs), the Center for Medicare and Medicaid Innovation (CMMI) and alternative payment models have contributed to the unexpected slowdown in federal healthcare spending. It also examines the budgetary effects of CMMI activities and explains how the CBO estimates the effects of legislative proposals that would impact the CMMI.

For more information, click here.