This Week in Washington: Debt Limit fight continues; Disagreements arise during Senate HELP Committee mark-up of PBM and Generic Drug Competition Bills

Upcoming Hearings

Congress

House

• Debt Limit Fight Continues Amidst Approaching Default Deadline
• Expanding Care in the Home Act Introduced
• MADE in America Act Reintroduced
• Association Health Plans Act Introduced

Senate

• Senate HELP Committee PBM and Generic Drug Competition Bills Markup Falls Apart
• Cutting Medicare Prescription Drug Prices in Half Act Introduced
• PASTEUR Act Reintroduced
• Workforce Legislation Introduced
• Senate Finance Committee Discusses Ghost Networks
• Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act Introduced
• GAO Appoints Six New MACPAC Board Members and Vice Chair

Administration

• White House Announces End of Federal COVID-19 Vaccination Requirement
• CMS Releases Updated Bulletin on Public Display of QHP Ratings Info
• CMS Opens Medicare Promoting Interoperability Program Proposed Measures Period
• CMS Releases Post COVID-19 PHE Test Coverage Fact Sheet
• CMS Releases Additional Innovation Center Model Data
• CMS Releases Report on IDR Process Data
• CMS Releases Fact Sheet on COVID-19 PHE Unwinding
• CMS Releases Hospital Price Transparency Enforcement Update Fact Sheet
• FDA Approves First RSV Vaccine
• FDA Announces Upcoming Public Advisory Committee Meeting
• FDA Releases Draft Guidance on Acute Radiation Syndrome Drug Development
• FDA Releases Updated Draft Guidance on Decentralized Clinical Trials
• FDA Approves Adult Schizophrenia Drug
• FDA Releases Guidance on Nicotine Replacement Therapy Drug Product Development
• FDA Approves the Use of Prevnar 20 in Individuals 6 Weeks to 17 Years of Age
• FDA Approves First Fecal Microbiota Product
• HHS Launches Mental Health and Substance Abuse Disorder Resource Website
• HRSA Awards $147 Million for HIV Epidemic Initiative

Proposed Rules

• CMS Proposed Rule Seeks to Improve Access to Medicaid and CHIP Care Outcomes
• CMS Proposed Rule Seeks to Improve Access to Medicaid Services
• HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule
• HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure
• CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates
• CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates
• CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates
• CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates
• CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements

Final Rules

• CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule
• CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations
• 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
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Releases Report Regarding NIH Drug Development Funding Recognition
• GAO Releases Report Regarding VA Office of Rural Health Communication Practices
• GAO Releases Report Regarding Federal Action on Antibiotic-Resistant Infections
• GAO Releases Report on IRS Oversight of Hospitals’ Tax-Exempt Status

CBO Cost Estimates

• CBO Releases Report Analyzing the Impact of Economic Conditions on the Federal Budget
• CBO Releases Report on Medicare and Medicaid Improvement Funds
• CBO Releases Report on 1984-2021 Outlays Projections
• CBO Releases Cost Estimates for H.R. 2811 Amendment
• CBO Releases Cost Estimate of Medicaid Work Requirements in H.R. 2811
• CBO Releases Cost Estimate on H.R. 2811, the Limit, Save, Grow Act of 2023

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Upcoming Hearings

May 10

Senate Health, Education, Labor and Pensions Full Committee Hearing: “The Need to Make Insulin Affordable for All Americans”
1:00 p.m., Hart Senate Office Building 216

Announced witnesses are:

• David Ricks, Chair and Chief Executive Office at Eli Lilly and Company
• Lars Fruergaard Jørgensen, President and Chief Executive Officer at Novo Nordisk
• Paul Hudson, Chief Executive Officer at Sanofi
• David Joyner, Executive Vice President and President of Pharmacy Services at CVS Health
• Adam Kautzner, President at Express Scripts
• Heather Cianfrocco, Chief Executive Officer at OptumRx

House Committee on Ways and Means Health Subcommittee Hearing: “Examining Policies that Inhibit Innovation and Patient Access”
2:00 p.m., Longworth House Office Building 1100

Witnesses to be announced.

May 11

Senate Health, Education, Labor and Pensions Bill Mark-Up: “Continuation: S. 1067, S. 1114, S. 1214, and S. 1339”
10:00 a.m., Dirksen Senate Office Building 430

House Energy and Commerce Committee Health Subcommittee Hearing: “Preparing for and Responding to Future Public Health Security Threats”
10:00 a.m., Rayburn House Office Building 2322

Announced witnesses are:

• Dawn O’Connell, Assistant Secretary for Preparedness and Response for the Department of Health and Human Services Administration for Strategic Preparedness and Response
• Rochelle P. Walensky, MD, MPH, Director of the Centers for Disease Control and Prevention
• The Honorable Robert M. Califf, MD, Commissioner of the Food and Drug Administration (FDA)
• Tom Inglesby, Director of the Johns Hopkins Center for Health Security, Bloomberg School of Public Health
• Randall Lutter, Senior Fellow at the Manhattan Institute
• Erik Decker, Chair of the Health Sector Coordinating Council Cybersecurity Working Group
• Mary Denigan-Macauley, PhD, Director of Health Care and Public Health and Private Market at the U.S. Government Accountability Office

Senate Finance Committee Hearing: “Cross-border Rx: Pharmaceutical Manufacturers and U.S. International Tax Policy”
10:00 a.m., Dirksen Senate Office Building 215

Announced witnesses are:

• Brad W. Setser, Senior Fellow at the Council on Foreign Relations
• Diane M. Ring, Professor of Law and Distinguished Scholar at the Boston College Law School
• William Morris, Global Tax Policy Leader at PwC
• Daniel Bunn, President and CEO of the Tax Foundation

House Energy and Commerce Committee Oversight and Investigations Subcommittee Hearing: “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains”
10:30 a.m., Rayburn House Office Building 2123

Witnesses to be announced.

May 12

Senate Health, Labor, Education and Pensions Field Hearing: “Roundtable: How Can We Improve Health Workforce Diversity and Address Shortages? A Conversation with Historically Black College and University Leaders and Students”
10:00 a.m., Morehouse School of Medicine, 720 Westview Dr., Building A, Atlanta, GA

Witnesses to be announced.

Congress

House

Debt Limit Fight Continues Amidst Approaching Default Deadline

Despite warnings by Secretary of the Treasury Janet Yellen that the U.S. could default on its federal debt as early as June 1, no debt limit bill has been agreed upon by Congress. On May 1, Secretary Yellen sent a letter to House Speaker Kevin McCarthy (R-CA), urging Congress to suspend or increase the debt limit as soon as possible. In response, Speaker McCarthy issued his own response, stating that House Republicans had done their job by passing the Limit, Save, Grow Act of 2023, H.R. 2811, by a vote of 217-215. McCarthy criticized the Senate and President Biden for not acting promptly in the wake up the bill’s passage. The bill is not expected to pass in the Democrat-controlled Senate. The leaders of the House and Senate are expected to meet with the President on May 9. In addition, House Democrats are exploring the possibility of a discharge petition, which would be a long shot.

Expanding Care in the Home Act Introduced

On April 26, Reps. Dingell (D-MI) and Smith (R-NE) introduced H.R. 2853, the Expanding Care in the Home Act. The bill specifically would:

• Authorize certain Medicare beneficiaries who are not eligible for Medicaid to receive 12 hours of at-home personal care services per week from a personal care worker;
• Increase access and broaden reimbursement for in-home dialysis treatment, advanced diagnostic imaging, lab testing and infusion services; and
• Allow doctors to receive monthly payments for Primary Care Qualified Evaluation and Management Services (PQEM) as an alternative to fee-for-service reimbursements.

For more information, click here.

MADE in America Act Reintroduced

On April 26, Rep. Miller (R-WV), joined by 15 other members, reintroduced the Manufacturing API, Drugs, and Excipients (MADE) in America Act. The bill seeks to decrease the U.S. pharmaceutical supply chain’s dependency on China and would encourage manufacturing of drugs and pharmaceutical supplies such as active pharmaceutical ingredients (APIs) and personal protection equipment (PPE).

For more information, click here.

Association Health Plans Act Introduced

On April 25, Reps. Walberg (R-MI), Foxx (R-NC), Allen (R-GA), Burgess (R-TX), Crenshaw (R-TX) and Good (R-VA) introduced the Association Health Plans Act. The bill would expand healthcare plan options and costs for small businesses by allowing them to offer association health plans (AHPs). This legislation or variations of it have been introduced in past Congresses.

For more information, click here.

Senate

Senate HELP Committee PBM and Generic Drug Competition Bills Markup Falls Apart

On May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee met to mark up a total of four bipartisan bills.

Ensuring Timely Access to Generics Act: Introduced by Sens. Bennet (D-CO), Shaheen (D-NH) and Collins (R-ME), this bill would help increase generic drug competition by strengthening oversight of the Food and Drug Administration’s (FDA) citizen petition process. The bill would grant the FDA permission to reject citizen petitions if the agency determines that the petition has been submitted to intentionally delay the approval of an application.

Expanding Access to Low-Cost Generics Act: Introduced by Sens. Smith (D-MN) and Braun (R-IN), this bill would address an anti-competitive drug practice known as “parking.” “Parking” refers to a practice in which a brand-name drug manufacturer agrees to not sue a generic drug manufacturer in exchange for the delayed release of their generic drug to the market. During this time, no other drug manufacturer may bring their own generic version of the drug to the market until 180 days have passed. This bill would allow a generic drug manufacturer to receive the 180-day market exclusivity if the first generic drug manufacturer does not make their drug available within 75 days.

Retaining Access and Restoring Exclusivity (RARE) Act: Introduced by Sens. Baldwin (D-WI) and Cassidy (R-LA), this bill would specify that the seven-year orphan drug market exclusivity period outlined in the Food, Drug and Cosmetic (FD&C) Act bans only the approval of other drugs with the same approved use or indication, not drugs that seek to treat the same disease or condition.

Pharmacy Benefit Manager Reform Act: Introduced by Sens. Sanders (I-VT), Cassidy (R-LA), Murray (D-WA) and Marshall (R-KS), this bill would seek to ban a practice utilized by pharmacy benefit managers (PBMs) known as “spread pricing,” a technique whereby PBMs charge health insurance plans more for a drug than the amount they reimburse to pharmacies for dispensing it. The bill would require that all rebates negotiated with drug manufacturers and all fees collected by PBMs are passed through to applicable health insurance plans.

Although Committee Chairman Sanders (I-VT) and Ranking Member Cassidy (R-LA) had announced that they had come to an agreement to mark up the bills and to advance certain measures, the markup did not go as planned. Sen. Cassidy accused Sen. Sanders of reneging on the agreement when Sen. Sanders announced that he would allow a number of bipartisan amendments to the RARE Act to move forward. Sen. Cassidy criticized Sen. Sanders for failing to share FDA technical assistance and Congressional Budget Office (CBO) cost estimates for the amendments in question. The committee decided to go into recess, and Sens. Sanders and Cassidy agreed to reschedule the markup for May 11.

For more information, click here.

Cutting Medicare Prescription Drug Prices in Half Act Introduced

On May 4, Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) and Sen. Klobuchar (D-MN) introduced the Cutting Medicare Prescription Drug Prices in Half Act. The bill seeks to cut the Medicare price of prescription drugs by half by requiring Medicare to pay no more for prescription drugs than the U.S. Department of Veterans Affairs (VA). The bill would also require drug manufacturers to make their medicines available to Medicare at the same prices paid by the VA or the Federal Supply Schedule, whichever is lowest.

For more information, click here.

PASTEUR Act Reintroduced

On April 27, Sens. Young (R-IN) and Bennet (D-CO) reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. The bill would encourage the appropriate use of antibiotics, increase domestic availability of antibiotics and support the development of antibiotics that target drug-resistant infections. The bill would specifically:

• Establish a subscription payment model for antibiotic drug developers, whereby developers would be offered an upfront payment in exchange for access to their antibiotics. This payment amount would range anywhere from $750 million to $3 billion. This subscription model is intended to encourage antimicrobial drug development, particularly drugs that target so-called “superbugs” such as Candida auris and Clostridioides difficile. Developers are currently paid through contracts based on the total volume of their drugs. Subscription-based contracts would be valid for a period of five years or up to the point of an antimicrobial drug’s patent life;
• Enhance existing frameworks of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network, the Emerging Infections Program and other programs focused on analyzing and reporting antibiotic usage and resistance data;
• Establish a Committee on Critical Need Antimicrobials, which would be tasked with developing and implementing guidance on how to treat infections of concern. The committee would be made up of federal agency representatives, doctors, patients and outside experts; and
• Offer small subscription contracts to smaller antimicrobial drug developers.

A companion bill was introduced in the House by Reps. Peters (D-CA), Ferguson (R-GA), Levin (D-CA) and LaTurner (R-KS).

For more information, click here.

Workforce Legislation Introduced

In the Senate several bills were introduced related to workforce and direct care. The Resident Physician Shortage Reduction Act was introduced on April 27 by Sens. Menendez (D-NJ), Boozman (R-AR), Schumer (D-NY) and Collins (R-MN). The bill would eliminate the cap on Medicare-funded graduate medical education (GME) positions and would increase the number of GME positions by 14,000 over the next seven years. Hospitals in rural areas and those serving Health Professional Areas (HPSAs) would be prioritized. Hospitals in states with new medical schools and those currently training over their caps would also be granted priority.

For more information, click here.

In addition, the Supporting Our Direct Care Workforce and Family Caregivers Act was introduced, led by Senator Casey (D-PA). The legislation would:

• Direct the Department of Health and Human Services (HHS) to award grants to states and eligible entities to be used for the recruitment, training and promotion of direct care workers and family caregivers. The grants would also go towards caregiver education and training support. Grants would be administered through the Administration on Community Living (ACL); and
• Direct the ACL to establish a center that would be tasked with offering technical assistance to grant awardees and direct care workforce development entities. The center would be responsible for establishing direct care career development, advancement strategy, apprenticeship, specialization, certification and on-the-job training programs. Additionally, the center would be tasked with identifying workforce shortages and evaluating the effectiveness of grants.

For more information, click here.

Senate Finance Committee Discusses Ghost Networks

On May 3, Sen. Wyden (D-OR) held a hearing to discuss the findings of a secret shopper study conducted by the committee majority staff. Staff reviewed directories from 12 different plans in a total of six states, calling 10 systematically selected providers from each plan, for a total of 120 calls. Of the total 120 provider listings contacted by phone, 33 percent were inaccurate, nonworking numbers or unreturned calls. Staff could only make appointments 18 percent of the time.

The Chair’s statement on the findings is available here.

The Chair’s hearing on ghost networks is available here.

Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act Introduced

On April 24, 23 Sens. Klobuchar (D-MN) and Welch (D-VT) led 23 senators in introducing the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act. The bill would grant the Department of Health and Human Services (HHS) enhanced authority to negotiate Medicare Part D drug prices and would allow new drugs and biologics approved by the Food and Drug Administration (FDA) to be eligible for price negotiation for a period of five years. The bill would also increase the number of drugs that HHS can negotiate after 2026 and allow Medicare Part B drugs to be negotiated two years earlier than allowed under current law.

For more information, click here.

GAO Appoints Six New MACPAC Board Members and Vice Chair

On May 1, the Government Accountability Office (GAO) announced the appointment of six new members to the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC). They are as follows:

• Timothy Hill, MPA, Vice President for Client Engagement at the American Institute for Research (AIR);
• Carolyn Ingram, MBA, Executive Vice President of Molina Healthcare, Inc.;
• Patti Killingsworth, Senior Vice President of Long Term Services and Supports (LTSS) Strategy at CareBridge;
• John B. McCarthy, MPA, Founding Partner at Speire Healthcare Strategies;
• Adrienne McFadden, MD, JD, Chief Medical Officer of Medicaid at Elevance Health; and
• Jami Snyder, MA, President and Chief Executive Officer at JSN Strategies LLC.

The GAO also announced that Robert Duncan will serve as MACPAC’s new Vice Chair. Duncan serves as Executive Vice President and Chief Operating Officer of Connecticut Children’s Speciality Care Center, and previously served as Executive Vice President of Children’s Wisconsin and the President of Children’s Service Society.

Administration

White House Announces End of Federal COVID-19 Vaccination Requirement

On May 1, the White House announced that the vaccination requirement for federal employees, contractors, international travelers, Head Start educators and Centers for Medicare and Medicaid Services (CMS) certified facilities will end on May 11, simultaneous with the ending of the COVID-19 public health emergency (PHE). The White House plans to release further details related to the termination of the vaccination requirement in the coming days.

For more information, click here.

CMS Releases Updated Bulletin on Public Display of QHP Ratings Info

On May 2, the Centers for Medicare and Medicaid Services (CMS) released an updated information bulletin regarding the public display of qualified health plan (QHP) ratings on all federally facilitated exchanges (FFEs), state-based exchanges (SBE-FPs) and state-based exchanges (SBEs) that operate their own eligibility and enrollment platforms. The bulletin outlines the requirements needed to display QHP quality rating information and also explains what exchanges should display if a QHP did not receive a rating.

For more information, click here.

CMS Opens Medicare Promoting Interoperability Program Proposed Measures Period

On May 2, the Centers for Medicare and Medicaid Services (CMS) announced that it was opening the Annual Call for Measures period for hospitals participating in the Medicare Promoting Interoperability Program. Hospitals may submit a measure proposal by July 1, 2023. Measures submitted by the deadline will be considered for future rulemaking.

For more information, click here.

CMS Releases Post COVID-19 PHE Test Coverage Fact Sheet

On May 1, the Centers for Medicare and Medicaid Services (CMS) released a fact sheet explaining how Medicare, Medicaid, Children’s Health Insurance Program and private health insurance plan coverage of COVID-19 tests will change after the COVID-19 public health emergency (PHE) comes to an end on May 11.

For more information, click here.

CMS Releases Additional Innovation Center Model Data

On May 1, the Centers for Medicare and Medicaid Services (CMS) announced that it was releasing new participation data and research identifiable files (RIFs) for some CMS Innovation Center models. New participation data is now available for the Value in Opioid Use Disorder Treatment Demonstration (VIT) model and the Home Health Value Based Purchasing Model (HHVBP). Additionally, new research identifiable files (RIFs) are available for the Million Hearts: Cardiovascular Disease Risk Reduction (MH) model.

For more information, click here.

CMS Releases Report on IDR Process Data

On April 27, the Centers for Medicare and Medicaid Services (CMS) released a report outlining the independent dispute resolution (IDR) process data for IDR disputes submitted between Oct. 1 and Dec. 31, 2022. The report reveals the total number of IDR disputes submitted, as well as the number of IDR disputes for which a final determination was made, during the fourth quarter (Q4) of 2022. It also reveals the amount of administrative fees and compensation that were paid, as well as other information.

For more information, click here.

CMS Releases Fact Sheet on COVID-19 PHE Unwinding

On April 27, the Centers for Medicare and Medicaid Services (CMS) released a fact sheet on the upcoming COVID-19 public health emergency (PHE) unwinding. The fact sheet answers a number of frequently asked questions regarding what impacts the PHE unwinding is expected to have on Medicare, Medicaid and Children’s Health Insurance Program (CHIP) programs. The fact sheet also answers some questions surrounding the unwinding’s anticipated impact on private health insurance’s coverage of COVID-19 vaccines and treatments.

For more information, click here.

CMS Releases Hospital Price Transparency Enforcement Update Fact Sheet

On April 26, the Centers for Medicare and Medicaid Services (CMS) released a fact sheet that outlines recent updates it made to its enforcement of the hospital price transparency rule. CMS announced that it was tightening certain aspects of the rule by shortening the hospital compliance deadline for corrective action plans (CAPs), increasing the number of civil monetary penalties (CMPs) it issues for violations and replacing warning notices with CAP requests.

For more information, click here.

FDA Approves First RSV Vaccine

On May 3, the Food and Drug Administration (FDA) approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved in the U.S. Arexvy is only authorized for use in adults 60 years and older. The FDA decided to approve the vaccine after a randomized, placebo-controlled clinical study showed the vaccine reducing the risk of developing RSV-associated lower respiratory tract disease (LRTD) by 82.6 percent, and the risk of developing severe RSV-associated LRTD by 94.1 percent, in trial participants who received the vaccine.

For more information, click here.

FDA Announces Upcoming Public Advisory Committee Meeting

On May 3, the Food and Drug Administration (FDA) announced that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public advisory committee meeting on June 15. The committee will discuss what COVID-19 strains will be included in the updated COVID-19 vaccines for the 2023-2024 fall and winter seasons. The meeting will be held virtually. Public comments will be accepted until June 14.

For more information, click here.

FDA Releases Draft Guidance on Acute Radiation Syndrome Drug Development

On May 3, the Food and Drug Administration (FDA) released a draft guidance for industry on the development of drugs designed to prevent and treat acute radiation syndrome. The draft guidance outlines the FDA’s recommendations regarding the development of clinical safety and efficacy trials for such drugs. The draft guidance also explains how postmarketing evaluation studies should be conducted.

For more information, click here.

FDA Releases Updated Draft Guidance on Decentralized Clinical Trials

On May 2, the Food and Drug Administration (FDA) released an updated draft guidance for industry, investigators and other stakeholders on the use of decentralized clinical trials (DCTs) for drugs, biologics and devices. The updated draft guidance builds on recommendations the FDA issued in 2020 regarding the use of DCTs and outlines how DCTs can be implemented to advance medical product development and research. The draft guidance outlines recommendations regarding the design of DCTs, the role of DCT sponsors and investigators, and more.

For more information, click here.

FDA Approves Adult Schizophrenia Drug

On April 28, the Food and Drug Administration (FDA) approved UZEDY (risperidone), an extended-release injectable suspension drug that is used to treat adults with schizophrenia. The FDA decided to approve the drug after data from two phase 3 trials indicated the drug reducing the risk of schizophrenia in 80 percent of adults who were administered the drug versus those given a placebo.

For more information, click here.

FDA Releases Guidance on Nicotine Replacement Therapy Drug Product Development

On April 28, the Food and Drug Administration (FDA) released a guidance for industry on the development of nicotine replacement therapy (NRT) drug products. The guidance examines NRT drug development and drug trial design issues and outlines the FDA’s current recommendations regarding NRT drug product development programs. This guidance also incorporates feedback the FDA received on a notice it recently published in the Federal Register regarding NRT drug product safety, efficacy, usage and labeling.

For more information, click here.

FDA Approves the Use of Prevnar 20 in Individuals 6 Weeks to 17 Years of Age

On April 27, the Food and Drug Administration (FDA) approved the use of Prevnar 20 in individuals 6 weeks to 17 years of age. Prevnar 20 is a vaccine that, up to this point, was exclusively used to prevent invasive disease and pneumonia caused by different serotypes of the Streptococcus pneumoniae bacterium in individuals 18 years of age and older. It was originally approved in 2021. Prevnar 20 may now be administered to individuals 6 weeks through 5 years of age, to prevent otitis media, and individuals 6 weeks through 17 years of age, to prevent invasive disease.

For more information, click here.

FDA Approves ALS Treatment

On April 25, the Food and Drug Administration (FDA) approved Qalsody (tofersen), an antisense oligonucleotide drug used to treat patients with amyotrophic lateral sclerosis (ALS). The FDA decided to grant Qalsody approval after results of a 28-week, randomized, double-blind, placebo-controlled clinical study showed the drug reducing plasma neurofilament light (NfL), a blood-based biomarker indicating axonal injury and neurodegeneration in ALS patients.

For more information, click here.

FDA Approves First Fecal Microbiota Product

On April 26, the Food and Drug Administration (FDA) approved Vowst, the first fecal microbiota product for the treatment of Clostridioides difficile (C. difficile) infection. C. difficile is a bacterium that causes serious intestinal tract infection in individuals. It is one of the most common healthcare-associated infections and can lead to organ failure and death. Individuals who recover from a C. difficile infection (CDI) are typically at risk for recurrent infections. However, it is believed that fecal microbiota can prevent reinfection. Vowst, an orally administered fecal microbiota product, was shown to lower the rate of CDI recurrence in participants of a randomized, placebo-controlled clinical study.

For more information, click here.

HHS Launches Mental Health and Substance Abuse Disorder Resource Website

On May 4, the Department of Health and Human Services (HHS) launched a new website intended to inform individuals with mental health and substance abuse disorders about available treatment options and resources. The website explains how individuals can find healthcare professionals and set up appointments. It also explains the differences that exist in treatment and support opportunities based on insurance status.

For more information, click here.

HRSA Awards $147 Million for HIV Epidemic Initiative

On April 27, the Health Resources and Services Administration (HRSA) awarded approximately $147 million to states and metropolitan areas in support of the Ending the HIV Epidemic in the U.S. (EHE) initiative. The funding will help improve access to medical and support services and will implement care intervention strategies for people living with HIV. HRSA also awarded $8 million to two nonprofit organizations that help provide training and resources to EHE fund recipients.

For more information, click here.

Proposed Rules

CMS Proposed Rule Seeks to Improve Access to Medicaid and CHIP Care Outcomes

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to strengthen and improve access to care, quality and health outcomes for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees. The proposed rule would:

• Establish national maximum standards for certain appointment wait times for Medicaid and CHIP managed care enrollees;
• Establish stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid and CHIP managed care plans;
• Establish a quality rating system for Medicaid and CHIP managed care plans;
• Require states to conduct annual enrollee experience surveys for Medicaid managed care plans;
• Implement new standards for states that use in lieu of services and settings (ILOSs) to promote effective utilization; and
• Specify medical loss ratio (MLR) requirements.

Public comments will be accepted until July 3, 2023. For more information, click here.

CMS Proposed Rule Seeks to Improve Access to Medicaid Services

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to improve access to Medicaid fee-for-service (FFS), managed care delivery system, and in-home and community-based services (HCBS) programs. The proposed rule would:

• Increase program transparency and accountability;
• Standardize program data and monitoring;
• Create opportunities for states to promote active beneficiary engagement; and
• Strengthen how states use state Medical Care Advisory Committees.

Public comments will be accepted until July 3, 2023. For more information, click here.

HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule

On April 12, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that would modify the Standards for Privacy of Individually Identifiable Health Information “privacy rule” under the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The proposed rule would limit the use and disclosure of an individual’s protected health information (PHI) if it relates to an individual accessing lawful reproductive healthcare services. It would specifically prohibit the disclosure of such information for criminal, civil or administrative investigations or proceedings against individuals or regulated entities.

Public comments will be accepted until June 19, 2023. For more information, click here.

HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure

On April 11, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would make several changes to the nationwide health information technology infrastructure. The proposed rule would:

• Implement the Electronic Health Record Reporting Program and make it a requirement for health information technology (Health IT) developers who are seeking certification;
• Modify and expand exceptions in information blocking regulations;
• Make revisions to the ONC Health IT Certification Program criteria;
• Adopt the United States Core Data for Interoperability (USCDI) Version 3 as standard for the ONC Health IT Certification Program; and
• Update implementation specifications and standards.

Public comments will be accepted until June 20, 2023. For more information, click here.

CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the hospital inpatient prospective payment system (PPS) and long-term care hospital PPS for fiscal year (FY) 2024. The proposed rule would:

• Increase inpatient PPS payment rates by a net 2.8 percent;
• Increase the cost outlier threshold by 4.8 percent;
• Increase the federal capital by 4.5 percent;
• Exclude “dual reclass” hospitals from the rural wage index policy;
• Consider rural reclassified hospitals as geographically rural when calculating the wage index;
• Support graduate medical training in rural areas by allowing graduate medical education payments to go toward rural emergency hospitals;
• Restore program integrity restrictions on “high Medicaid facilities”;
• Add 15 and remove 16 Medicare Severity Diagnosis Related Groups (MS-DRGs);
• Allow web-based surveys to be used for Hospital Consumer Assessment of Healthcare Providers and Systems; and
• Seek public comment and information on supporting safety-net providers.

Public comments will be accepted until June 9, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Psychiatric Facility (IPF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IPF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 1.9 percent (approximately $55 million) payment increase for IPFs in FY 2024, based on a 3.0 percent increase in the IPF PPS payment rate;
• Adopt a 2021-based IPF market basket;
• Update and increase the labor-related share (LRS) to 78.5 percent;
• Make it easier for hospitals to open new IPF units, by allowing them to open new units at any time during the cost reporting period, so long as they notify their CMS Regional Office and Medicare Administrative Contractor within 30 days; and
• Make changes to the IPF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Skilled Nursing Facility (SNF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the SNF Quality Reporting Program (QRP) and SNF Value-Based Purchasing (VBP) Program, for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.7 percent (approximately $1.2 billion) Medicare Part A payment increase for SNFs in FY 2024, based on a 2.7 percent market basket update; a 3.6 percent increase in the market basket forecast error adjustment; a 0.2 percent decrease in the productivity adjustment; and a 2.3 percent decrease in the FY 2024 SNF PPS rates; and
• Make multiple changes to the SNF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates

On April 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Rehabilitation Facility (IRF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IRF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.0 percent payment increase for IRFs, based on the proposed market basket update of 3.2 percent minus the 0.2 percentage point productivity adjustment;
• Increase IRF outlier payments by 0.7 percent;
• Make it easier for hospitals to open IRF units by allowing them to immediately start billing under the IRS PPS at any time during the cost reporting period, so long as they notify the CMS Regional Office and Medicare Administrative Contractor in writing within 30 days; and
• Make changes to the IRF QRP measures.

Public comments will be accepted until June 2, 2023. For more information, click here.

CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make changes to hospice wage index rates, payment rates and aggregate cap amounts for fiscal year (FY) 2024. The proposed rule intends to inform patients and caregivers on hospice utilization trends, hospice center ownership information and Medicare hospice and non-hospice spending amounts. The proposed rule will:

• Codify the Hospice Quality Reporting Program (HQRP) data completion threshold policy;
• Provide an update on future Quality Measures (QM) development and health equity efforts;
• Provide an update on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment; and
• Require physicians who order or certify hospice services for Medicare beneficiaries to be enrolled in Medicare or validly opted-out.

Public comments will be accepted until May 30, 2023. For more information, click here.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls;
• Ensure that tobacco products meet established specifications;
• Crack down on tobacco products that do not meet specifications;
• Require manufacturers to take action in cases of product contamination;
• Require investigations of products that do not meet specifications; and
• Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers.

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

Final Rules

CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

On April 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize standards for issuers that offer qualified health plans (QHPs) through federally-facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs), and changes made to the payment parameters and provisions of the Department of Health and Human Services (HHS)-operated risk adjustment and risk adjustment data validation programs. The final rule will:

• Make it easier for individuals losing Medicaid or Children’s Health Insurance Program (CHIP) coverage to obtain health coverage by granting them a special enrollment period (SEP) 60 days before or 90 days after losing coverage;
• Grant healthcare plan assisters permission to provide enrollment assistance to individuals;
• Add Substance Use Disorder Treatment Centers and Mental Health Facilities to the essential community provider (ECP) list;
• Extend the requirement to contract with at least 35 percent of available ECPs in a service area to Federally Qualified Health Centers and Family Planning Providers;
• Refine health plan designs for standardized plan options; and
• Limit the number of non-standardized plan options offered by issuers of qualified health plans (QHPs) to four in each service area.

The rule will go into effect on June 18, 2023. For more information, click here.

CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations

On April 5, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize revisions made to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan program regulations, as well as the Programs of All-Inclusive Care for the Elderly (PACE) regulations, for calendar year (CY) 2024. The final rule will:

• Require that MA plans comply with national coverage determinations (NCDs), local coverage determinations (LCDs), and general coverage and benefit conditions included in Traditional Medicare regulations;
• Require that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary;
• Require coordinated care plans to provide a minimum 90-day transition period to enrollees who are undergoing treatment and switch to a new MA plan;
• Require all MA plans to establish a Utilization Management Committee and review policies to ensure consistency with Traditional Medicare guidelines;
• Require that approval of a prior authorization request be valid for as long as medically reasonable and necessary;
• Prohibit MA plan television ads from using words, imagery or names that may mislead or confuse beneficiaries;
• Expand access to behavioral healthcare by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties;
• Promote equitable care by adding a health equity index to the Star Ratings program and require MA and Part D plans to provide care to underserved populations; and
• Implement certain provisions of the Inflation Reduction Act (IRA), the Consolidated Appropriations Act (CAA) of 2021 and the Bipartisan Budget Act (BBA) of 2018.

The rule will go into effect on June 5, 2023. 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.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

GAO Releases Report Regarding NIH Drug Development Funding Recognition

On May 4, the Government Accountability Office (GAO) released a report that analyzes the extent to which the National Institutes of Health (NIH) is recognized for funding and supporting drug development and research efforts. The NIH is the largest public funder of biomedical research in the U.S. and awards billions of dollars to support basic research and clinical trial activities. Researchers who receive NIH funds typically disclose NIH support in the patents they submit for their drugs. However, the GAO found that out of 19,055 patents submitted between 2012 and 2021 by NIH-fund awardees, 2,700 had not fully or correctly disclosed NIH support as required. Awardees who do not correctly disclose NIH support cannot link their patents to NIH support. The GAO recommended that the NIH clarify to awardees that they should disclose support from the agency in their patent applications. The GAO conducted this study because they were asked to review how NIH-funded biomedical research and development efforts contribute to drug development.

For more information, click here.

GAO Releases Report Regarding VA Office of Rural Health Communication Practices

On May 4, the Government Accountability Office (GAO) released a report regarding the manner in which the Veterans Health Administration’s (VHA) Office of Rural Health informs researchers about available research funding opportunities. The Office of Rural Health frequently funds research projects that seek to address healthcare disparities among veterans living in rural areas. After reviewing Office of Rural Health documentation and interviewing Office of Rural Health officials and officials from four selected VHA healthcare delivery systems, the GAO determined that the Office of Rural Health had not done an adequate job of informing researchers about available funding opportunities, and determined that it advertises funding opportunities primarily via word-of-mouth and existing relationships. The GAO also determined that the Office of Rural Health lacks measurable performance goals. The GAO conducted this study because it was asked to review how the Office of Rural Health communicates its funding opportunities and how it assesses progress toward achieving its goals.

For more information, click here.

GAO Releases Report Regarding Federal Action on Antibiotic-Resistant Infections

On April 28, the Government Accountability Office (GAO) released a report regarding the rise of antibiotic-resistant infections in the U.S. The report looks specifically at what actions the federal government, specifically the Department of Health and Human Services (HHS), has taken to combat the emergence and spread of resistant bacteria since 2020. The GAO previously issued a report evaluating the state of antibiotic-resistant bacteria in the U.S. in March 2020, wherein it recommended that HHS implement specific steps to monitor, test, diagnose and identify these types of bacteria. In its latest report, GAO determined that HHS had adopted seven of the eight recommendations the GAO made in 2020. GAO acknowledged that the adoption of these recommendations is a step in the right direction but stated that further federal efforts are needed to combat the rise and spread of antibiotic resistant bacteria.

For more information, click here.

GAO Releases Report on IRS Oversight of Hospitals’ Tax-Exempt Status

On April 26, the Government Accountability Office (GAO) released a report regarding the Internal Revenue Service’s (IRS) oversight of hospitals that claim tax-exempt status. Over half of the hospitals in the United States are private, nonprofit organizations to which the IRS and the U.S. Department of Treasury have granted eligibility for tax exemption. Hospitals must satisfy three sets of requirements to claim tax-exempt status. They must provide community health benefits, adhere to Patient Protection and Affordable Care Act (PPACA) requirements and maintain specific organizational and operational frameworks. Despite clearly laid-out requirements, it has been difficult for the IRS to verify compliance.

In 2020, the GAO reviewed 2016 IRS data for 30 hospitals and determined that these specific hospitals had not reported spending any money on community health benefits. The GAO determined that the IRS had not done an adequate job of verifying hospital community health benefits and recommended that the agency instruct its employees on how to verify whether hospitals meet the community benefit standard. The GAO also recommended that Congress specify what services and activities count toward the hospital community health benefit requirement. As described in this report, the GAO has determined that Congress has yet to specify these requirements. The GAO has also determined that although the IRS made changes to the form that hospitals must use to describe their community benefit activities, the form itself remains unsatisfactory because it lacks transparency and fails to gather complete information. The GAO conducted this study as a follow-up to its 2020 report on oversight of hospitals’ tax-exempt status.

For more information, click here.

CBO Cost Estimates

CBO Releases Report Analyzing the Impact of Economic Conditions on the Federal Budget

On April 28, the Congressional Budget Office (CBO) released a report outlining how different economic conditions may impact its federal budget projections for the 2024-2033 period. In this report, the CBO acknowledged that its budget projects are subject to uncertainty for a number of reasons and decided to generate four economic scenarios for the 2024-2033 period, with varying revenue, outlay and deficit amounts.

In its first scenario, the CBO analyzed what would happen if productivity growth was 0.1 percentage point lower than current projections. For its second scenario, the CBO analyzed what would happen if the labor force rate grew 0.1 percentage point slower than current projections. For its third scenario, the CBO analyzed what would happen if interest rates rose 0.1 percentage point higher than current projections. For its fourth scenario, the CBO analyzed what would happen if all wage and price indexes rose 0.1 percentage point higher than current projections. After evaluating the results, the CBO determined that in each of its four generated scenarios, the cumulative federal budget deficit would be larger than the currently projected CBO baseline by amounts ranging from $110 to $307 billion.

For more information, click here.

CBO Releases Report on Medicare and Medicaid Improvement Funds

On April 27, the Congressional Budget Office (CBO) released a report regarding the Medicare and Medicaid improvement funds. The report provides general information on the Medicare and Medicaid programs and describes how Medicare and Medicaid improvement funds have been spent and altered over time. The report also explains how CBO accounts for both funds in their baseline and cost estimates.

For more information, click here.

CBO Releases Report on 1984-2021 Outlays Projections

On April 26, the Congressional Budget Office (CBO) released a report on the measures it uses to assess the quality of federal outlay projections it predicted between 1984 and 2021. The CBO regularly publishes baseline projections of federal outlays. However, baseline projections only provide a projection for the current year, and typically a projection 5 years or 10 years in the future. In this report, the CBO looked at data from 6 and 11 years in the future, and compared it to the estimates it made originally. The CBO determined that it typically overestimates total and net interest outlays, but that it is very close in its predictions of mandatory, discretionary and other outlays.

For more information, click here.

CBO Releases Cost Estimates for H.R. 2811 Amendment

On April 26, the Congressional Budget Office (CBO) released a cost estimate for an amendment to H.R. 2811, the Limit, Save, Grow Act of 2023, adopted by the House Committee on Rules on April 26. Amendment 22 would:

• Permanently rescind unobligated balances from five sections in Public Law 117-169;
• Strike sections 225, 227 and 228 from the bill;
• Establish circumstances in which sections 229 and 244 of the bill would not apply to taxpayers; and
• Change the effective date for expanded work requirements for Temporary Assistance for Needy Families (TANF) from fiscal year (FY) 2026 to 2025, and for Supplemental Nutrition Assistance Program (SNAP) individuals from FY 2025 to 2024.

For more information, click here.

CBO Releases Cost Estimate of Medicaid Work Requirements in H.R. 2811

On April 26, the Congressional Budget Office (CBO) released a cost estimate for the Medicaid work requirements outlined in H.R. 2811, the Limit, Save, Grow Act of 2023. CBO estimated that the work requirements would:

• Decrease federal spending by $109 billion over the 2023-2033 period;
• Result in approximately 1.5 million people losing health insurance coverage. CBO predicts that 60 percent of these individuals would still be eligible for Medicaid state-only funding;
• Have a negligible effect on employment status or hours worked by people who would be subject to the Medicaid work requirements; and
• Increase state costs by approximately $65 billion over the 2023-2033 period.

For more information, click here.

CBO Releases Cost Estimate on H.R. 2811, the Limit, Save, Grow Act of 2023

On April 25, the Congressional Budget Office (CBO) released a cost estimate for the budgetary effects of H.R. 2811, the Limit, Save, Grow Act of 2023. The CBO projects that the bill would reduce budget deficits by $4.8 trillion over the 2023-2033 period, relative to CBO’s baseline. CBO projects that the bill would have the following budgetary impacts:

• Reduce discretionary outlays by $3.2 trillion;
• Decrease net mandatory spending by $0.7 trillion;
• Increase net revenues by $0.4 trillion; and
• Reduce public debt interest by $0.5 trillion.

CBO acknowledged that these estimates could vary depending on if appropriations subject to discretionary funding caps in the next 10 years are not equal to specified limits.

For more information, click here.