Washington Healthcare Update
Oct 23, 2023
Charles Kelley
19 mins
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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
- House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicare Payment Reform
- House Ways and Means Committee Holds Roundtable Regarding Implementation of No Surprises Act
- House Members Send Letter Concerning Home Dialysis for AKI Patients
Senate
- Senate Finance Committee Holds Hearing on Deceptive MA Marketing Tactics and “Ghost Networks”
- Senate HELP Committee Holds Hearing on Nomination of NIH Director
- Bipartisan Bill Introduced to Make Permanent SUPPORT Act SPA Option
Administration
- HHS OCR Issues Telehealth and Health Information Privacy Resources
- HHS Announces Extension of Free Paxlovid Access for Patients
- CMS Releases 2024 Medicare Advantage and Part D Plan Star Ratings
- FDA CDER Seeks Public Comment on Innovative Drug Clinical Trial Design
- FDA to Host Webinar to Discuss Proposed LDT Rule
- FDA Submits Menthol Cigarette Ban Final Rules for OMB Review
- FDA Issues Warning Regarding Compounded Ketamine Products
Proposed Rules
- CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee
- 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
CBO Cost Estimates
- CBO Releases Report on Federal Healthcare Spending
- CBO Releases Report on Alternative Payment Models and Federal Healthcare Spending
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
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
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
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.
- 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.
- 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.
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.
- 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.
- 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.
- 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.
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.
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