Health Care Watch: October 22, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 15 – October 22. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
This week, the House held three roll call votes to elect a new Speaker, with Rep. Jim Jordan (R-OH) failing three times to secure the 217 Republican votes necessary to win. With Republicans still unable to unite around a candidate who can achieve 217 votes, next steps on the Speaker election remain unclear. Nine Republicans have now expressed in interest in running for the position and will address the GOP conference on October 23. An internal party vote is expected to occur on October 24.
On October 18, the Ways & Means Committee held a roundtable with Biden Administration officials on “failures” surrounding the implementation of the No Surprises Act, which contained consumer protections against surprise medical billing. Committee members were joined by officials from the Department of Health & Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury.
Senate
On October 17, Sens. Alex Padilla (D-CA), Thom Tillis (R-NC), Tina Smith (D-MN) and Joni Ernst (R-IA) announced the launch of the Senate Mental Health Caucus. The caucus will serve as a forum for Senators to collaborate on and promote bipartisan mental health legislation. The caucus will work to improve prevention and early intervention efforts, expand the country’s mental health professional workforce, enhance the nation’s crisis response services, and increase access to evidence-based mental health treatment.
On October 18, Finance Committee Chairman Ron Wyden (D-OR) and Sens. Michael Bennet (D-CO) and Thom Tillis (R-NC) introduced the Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act. The legislation aims to ensure Medicare Advantage (MA) plans maintain accurate provider directories and protect seniors from unexpected health care costs. Specifically, the REAL Health Providers Act would strengthen requirements for MA plans to maintain accurate and updated provider directories, ensure patients do not pay out-of-network costs for appointments with providers that were incorrectly listed in their plan’s provider directory as in-network, and direct the Centers for Medicare & Medicaid Services (CMS) to publish guidance for plans to maintain accurate provider directories.
On October 18, the Health, Education, Labor & Pensions (HELP) Committee held hearing on the nomination of Dr. Monica Bertagnolli – President Biden’s pick to run the National Institutes of Health (NIH).
On October 18, the Finance Committee held a hearing entitled Medicare Advantage (MA) Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences. The hearing addressed concerns related to aggressive MA marketing practices and the influence of brokers and other third-party entities to sign up Medicare beneficiaries for health plans that don’t meet their particular needs. The hearing also addressed possible reforms and solutions to enhance consumer protection, ensure fair competition, and improve transparency in marketing and compensation practices.
On October 18, the Budget Committee held a hearing entitled Improving Care, Lowering Costs: Achieving Health Care Efficiency. The hearing examined innovate ways to lower U.S. health care costs and discussed Accountable Care Organizations (ACOs), the Centers for Medicare & Medicaid Innovation (CMMI), and primary care.
REGULATORY UPDATE
On October 16, CMS released two Health Equity Confidential Feedback Reports to post-acute care providers: the Discharge to Community (DTC) Health Equity Confidential Feedback Report and the Medicare Spending Per Beneficiary (MSPB) Health Equity Confidential Feedback Report. CMS stated that the reports come as part of the agency’s commitment to advance health equity and strengthen the Medicare Program.
On October 16, the Food & Drug Administration (FDA) announced a webinar regarding its proposed rule Medical Devices; Laboratory Developed Tests (LDTs). The purpose of the webinar is to provide an overview of the proposed rule to amend FDA’s regulations to make explicit that in vitro diagnostics products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory, and the proposed phase out policy under which the FDA intends to provide greater oversight of LDTs to help ensure their safety and effectiveness. The webinar will take place on October 31 from 1:00 to 2:00 PM ET.
On October 17, CMS updated the Skilled Nursing Facility (SNF) Provider Preview Reports. The reports contain provider performance scores for quality measures, which will be published on Care Compare and Provider Data Catalog (PDC) during the January 2024 refresh.
On October 17, CMS released the final evaluation report of the Million Hearts Cardiovascular Disease Risk Reduction Model. The report describes the model’s implementation and includes estimates of the model’s impact on heart attacks, strokes, survival, and spending. Over five years, the model reduced the incidence of first-time heart attacks and strokes by 3 to 4% in all-cause mortality among high- and medium-risk beneficiaries but did not measurably impact Medicare fee-for-service spending.
On October 18, HHS’s Office for Civil Rights (OCR) issued two resource documents to help explain to patients the privacy and security risks to their protected health information (PHI) when using telehealth services and ways to reduce these risks. The first resource for health care providers is titled Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth. The resource supports the continued and increased use of telehealth by providing information to help health care providers who choose to discuss telehealth privacy and security with patients. OCR also issued a resource for patients called Telehealth Privacy and Security Tips for Patients. This resource provides recommendations that patients can implement to protect and secure their health information.
On October 19, FDA’s Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.
On October 19, FDA published guidance on its standards recognition program for regenerative medicines. The guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy products.
On October 19, FDA published guidance on its enforcement policy for noninvasive remote monitoring devices. The guidance includes updates to enforcement policies and outlines continuation of certain COVID-era policies.
WHITE HOUSE
On October 20, President Biden asked Congress to provide $1.2 billion in supplemental funding for FY 2024 to stop the flow of fentanyl at America's southwest border.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/29/23
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities (CMS-6084); Final Rule; 9/19/23
CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1780); Final Rule; 9/27/23
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1786); Final Rule; 10/2/23
CY 2024 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1782); Final Rule; 10/10/23
FDA
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Final Rule; 9/7/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule’ 10/19/23
REPORTS
Office of Inspector General (OIG)
On October 17, OIG released a report examining the National Strategic Stockpile and its positioning to respond effectively to the COVID-19 pandemic. OIG found that the Stockpile was operationally effective in distributing its limited inventory in response to the pandemic, based on established policies and procedures and consistent with its statutory obligations. However, the Stockpile's strategic effectiveness and its ability to meet COVID-19 demands was impacted by external and internal factors outside of its control. OIG made several recommendations, including that the Administration for Strategic Preparedness and Response (ASPR): 1) mitigate the risk presented by relying on foreign supply chains and just-in-time inventory strategies when determining annual Stockpile purchases; 2) develop a strategic plan for the Stockpile that clearly defines the goals and objectives of the Stockpile and the Stockpile's roles and responsibilities for responding to emergency events, including pandemics; and 3) work to increase the Stockpile's annual funding to keep pace with the Stockpile's increased responsibilities.
UPCOMING HEARINGS
House
Ways & Means Committee
TBD
Markup of drug and device legislation and hearing on the status of CMMI
Energy & Commerce Committee
Health Subcommittee
October 25; 2:00 PM; 2123 Rayburn
Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care
Senate
Finance Committee
Week of 10/30 or 11/6
Markup up legislation extending existing health care policies under the committee’s jurisdiction, including mental health and pharmacy benefit manager policies
HELP Committee
October 27; 9:00 AM; Nicholas Music Center, Rutgers University; New Brunswick, NJ
Field Hearing: Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?
October 25; 10:00 AM; 10:30 Dirksen
Nominations: Including the nomination of Monica Bertagnolli to be Director of the National Institutes of Health
October; TBD
Nonprofit Hospital Business Practices
OTHER POLICY NEWS
On October 12, the Urban Institute released a report entitled Post-Acute Care (PAC) and Medicare Solvency: Reducing Excessive PAC Payments Can Promote Financial Sustainability. The report considers payments to PAC providers for services to enrollees in traditional Medicare and examines the spending of the four types of PAC providers, their payments in relation to cost, and proposals to reduce Medicare spending for PAC.
On October 16, the Medicare Payment Advisory Commission (MedPAC) announced that it will hold its November meetings on November 2 and 3. The topics and times of each meeting have yet to be announced.
On October 18, the Journal of the American Medical Association (JAMA) released a report, backed by NIH, that examined telemedicine buprenorphine initiation and retention in opioid use disorder treatment for Medicaid enrollees. The report found that enrollees who initiated buprenorphine treatment via telemedicine had higher odds of retention in treatment but no change in the odds of opioid-related nonfatal overdose.
On October 20, MedPAC announced the release of the updated 2023 Medicare Payment Basics series. The updated versions are available here.