This Week in Washington: President releases FY2024 Budget

Upcoming Hearings

Congress

House

• Prescription Information Modernization Act of 2023 Introduced
• EFFECTIVE Act Introduced

Senate

• Senators Send Letter Concerning Healthcare Pricing Transparency
• Access to Prescription Digital Therapeutics Act of 2023 Introduced
• Modernizing Opioid Treatment Access Act Introduced

Administration

• President’s Budget Extends Medicare Solvency
• HHS Releases Healthcare and Public Health Cybersecurity Guide
• CMS Issues Medicaid Third-Party Liability Guidance Letter
• FDA Notice Clarifies Post COVID-19 PHE Guidances
• FDA Issues Update Regarding Potential Toxic Exposure in Dialysis Systems
• FDA Grants Priority Review to Alzheimer’s Drug Leqembi
• CDC Announces Two Opioid Overdose Reduction Funding Opportunities
• CDC Releases Treatment Guide for Severe Mpox

Proposed Rules

• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation
• CMS Proposes Rule to Clarify Changes to DSH Payment Calculations
• ACF Proposes Rule to Revise Foster Family Home Definition
• CMS Proposes Rule to Increase Nursing Home Transparency
• SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement
• HHS Proposes Rule to Expand Access to ACA Birth Control Coverage
• HHS Proposes Rule to Clarify Beneficiary Religious Protections
• HHS Proposes Adopting Healthcare Attachments Standards

Final Rules

• FDA Issues Final Rule Regarding Mammography Quality Standards
• CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program
• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Report Analyzes Advanced Drug Manufacturing
• GAO Report Analyzes Advance Premium Tax Credit Payments and Program Integrity Efforts

Upcoming Hearings

March 15

Senate Committee on Veterans’ Affairs Hearing: “Examining the Future Path of VA’s Electronic Health Record Modernization Program”
3:30 p.m., Dirksen Senate Building 106

March 16

Senate Committee on Finance Hearing: “The President’s Fiscal Year 2024 Budget with Treasury Secretary Janet L. Yellen”
10:00 a.m., Dirksen Senate Building 215

Announced witnesses are:

• The Honorable Janet L. Yellen, Secretary of the U.S. Department of the Treasury

Congress

House

Prescription Information Modernization Act of 2023 Introduced

On March 9, Reps. Harshbarger (R-TN) and Sherrill (D-NJ) introduced the Prescription Information Modernization Act of 2023. The bipartisan bill would give healthcare professionals the option to choose whether to receive digital or printed versions of prescription information from manufacturers. Current policy restricts healthcare professionals from obtaining prescription information digitally. The bill will allow the Food and Drug Administration (FDA) to move forward with a proposed rule that will grant drug manufacturers permission to transmit prescription information electronically.

For more information, click here.

EFFECTIVE Act Introduced

On March 3, Reps. Trone (D-MD) and Meuser (R-PA) introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act. The bipartisan bill would grant the Food and Drug Administration (FDA) authority to deny new drug applications for opioids if they do not offer material safety advantages over approved opioids already on the market. Sens. Manchin (D-WV) and Braun (R-IN) introduced a companion bill in the Senate.

For more information, click here.

Senate

Senators Send Letter Concerning Healthcare Pricing Transparency

On March 6, Sens. Hassan (D-NH) and Braun (R-IN) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, expressing their concerns over the amount of transparency in healthcare pricing. The senators are concerned health insurance companies are evading CMS’ July 2022 Transparency in Coverage rule. That rule requires health insurance companies to publish their in- and out-of-network rates for healthcare plans. The letter urges CMS to update the rule and increase its enforcement of health plan pricing transparency and compliance.

For more information, click here.

Access to Prescription Digital Therapeutics Act of 2023 Introduced

On March 8, Sens. Shaheen (D-NH) and Capito (R-WV) introduced the Access to Prescription Digital Therapeutics Act of 2023. The bipartisan bill would expand Medicare coverage to include Prescription Digital Therapeutics (PDTs). PDTs are software-based disease treatments that can be used to treat a variety of illnesses, such as mental health and substance abuse disorders. Reps. Hern (R-OK) and Thompson (D-CA) introduced a companion bill in the House.

For more information, click here.

Modernizing Opioid Treatment Access Act Introduced

On March 6, Sens. Markey (D-MA) and Paul (R-KY) introduced the Modernizing Opioid Treatment Access Act. The legislation would help patients access medication treatment for Opioid Use Disorder (OUD), by updating outdated rules, allowing board-certified physicians to prescribe methadone and granting U.S. pharmacies permission to dispense methadone. It would also require the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) to submit an annual report that provides the names of patients who were prescribed methadone, as well as those of the providers and state physicians who are registered to prescribe methadone. Reps. Norcross (D-NJ) and Bacon (R-NE) introduced a companion bill in the Senate.

Cosponsors of the Senate bill include Sens. Sanders (I-VT), Braun (R-IN), Booker (D-NJ) and Hassan (D-NH). Cosponsors of the House bill include Reps. Kuster (D-NH), Trone (D-MD), Fitzpatrick (R-PA), Tonko (D-NY), Pettersen (D-CO) and Kim (D-NJ).

For more information, click here.

Administration

President’s Budget Extends Medicare Solvency

On March 9, the president sent his budget to Capitol Hill. As almost always happens, the president’s budget is dead on arrival, but serves the important role of outlining the administration’s goals. In healthcare, the budget provides a plan for extending Medicare solvency by 25 years and invests in behavioral health and in improving home and community-based care services as well as nursing home quality.

The plan to increase Medicare solvency by 25 years includes the following:

• Raising the Medicare surtax on earned and unearned income above $400,000 from 3.8 percent to 5 percent
• Closing loopholes in existing Medicare taxes and dedicating the Medicare net investment income tax to the HI trust fund—this is getting at the way some business owners have managed to shield some of their income from tax by claiming it as neither earned income nor investment income
• Crediting savings from the prescription drug reforms passed last year to the HI trust fund—this amounts to $200 billion over 10 years
• Lower out-of-pocket costs for drugs subject to negotiation—the budget expands Medicare drug negotiations
• $2 cost-sharing for generic drugs for chronic conditions—capping Part D cost-sharing on certain generic drugs
• Lowering behavioral healthcare costs in Medicare—eliminating cost-sharing for three mental health or other behavioral health visits per year and requires parity between physical health and mental health coverage in Medicare. Also requires coverage and payment for new types of Medicare providers, such as peer support workers and certified addiction counselors and evidence-based digital applications and platforms that facilitate delivery of mental health services while removing limitations on beneficiary access to psychiatric hospitals

For more information, click here.

HHS Releases Healthcare and Public Health Cybersecurity Guide

On March 8, the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR) released a cybersecurity implementation guide titled “The Health Care and Public Health Sector Cybersecurity Framework Implementation Guide.” The guide, which was jointly developed by the HHS ASPR, the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group and other federal agencies, provides healthcare providers and organizations with a comprehensive understanding of how they can identify, address and prevent cybersecurity risks.

For more information, click here.

CMS Issues Medicaid Third-Party Liability Guidance Letter

On March 8, the Centers for Medicare and Medicaid Services (CMS) Center for Medicaid and Children’s Health Insurance Program (CHIP) Services (CMCS) issued a State Medicaid Director Letter (SMDL) to provide guidance to state Medicaid agencies on two new third-party liability (TPL) requirements. The first new TPL requirement, included in the Consolidated Appropriations Act of 2022, requires states to implement laws that bar liable third-party payers from refusing payment of items or services on the basis that the items or services did not obtain prior authorization under third-party payer rules. The second TPL requirement, which went into effect after the U.S. Supreme Court ruled on Gallardo v. Marstiller, requires the Social Security Act to permit states to create liens over injury settlement proceeds allocated for future medical expenses.

For more information, click here.

FDA Notice Clarifies Post COVID-19 PHE Guidances

On March 10, the Food and Drug Administration (FDA) published a notice clarifying which of the 72 FDA COVID-19-related guidance documents will expire and which will remain in effect following the upcoming COVID-19 public health emergency (PHE) termination on May 11, 2023. The FDA is planning to immediately wind down 44 guidances and will keep 24 guidances in place after the PHE expiration.

For more information, click here.

FDA Issues Update Regarding Potential Toxic Exposure in Dialysis Systems

On March 7, the Food and Drug Administration (FDA) issued an update on the potential risk of exposure to toxic compounds when using Fresenius Medical Care hemodialysis and peritoneal dialysis systems. The FDA had previously warned health care providers of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) in a letter issued on May 6, 2022. The FDA worked with Fresenius Medical Care and modified silicone tubing that was suspected of being the source of the toxins. No toxins were discovered in the modified machines. The FDA has clarified that it is working with other dialysis machine manufacturers and evaluating parts that are made of chlorinated peroxide cured silicone.

For more information, click here.

FDA Grants Priority Review to Alzheimer’s Drug Leqembi

On March 6, the Food and Drug Administration (FDA) granted priority review to Leqembi, an Alzheimer’s treatment drug manufactured by Eisai and Biogen. Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody drug, was shown to reduce the accumulation of amyloid beta in the brains of Alzheimer’s patients. The drug was granted accelerated approval on Jan. 18, 2023. A Prescription Drug User Fee Act (PDUFA) has been set for July 6.

For more information, click here.

CDC Announces Two Opioid Overdose Reduction Funding Opportunities

On March 8, the Centers for Disease Control and Prevention (CDC) announced that it was opening two new funding opportunities under its Overdose Data to Action (OD2A) program. The OD2A program focuses on tracking the U.S. opioid crisis, evaluating intervention strategies and reducing health disparities. The first funding opportunity, titled “Overdose Data to Action in States,” seeks to support state health departments in conducting overdose surveillance and implementing overdose prevention activities. The second funding opportunity, titled “Overdose Data to Action: Limiting Overdose through Collaborative Actions in Localities,” seeks to support local, city and county health departments in developing overdose-related surveillance infrastructure and prevention strategies. Applications will be accepted until May 8.

For more information, click here.

CDC Releases Treatment Guide for Severe Mpox

On March 6, the Centers for Disease Control and Prevention (CDC) released a guide detailing how patients with severe Mpox should be treated. The guide includes a list of available Mpox medications, and explains how they should be utilized. It also explains what complications may arise in moderately and severely immunocompromised Mpox patients.

For more information, click here.

Proposed Rules

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
• 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.

CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how it defines Medicaid-eligible patients who can be included in Medicare disproportionate share hospital (DSH) payment calculations. CMS is proposing to do this by limiting the types of Medicaid Section 1115 waiver days that can be used by hospitals when calculating their disproportionate patient percentage (DPP) Medicaid fraction. CMS is proposing to allow hospitals to only count Section 1115 waiver days for patients who received a health insurance plan directly from a Section 1115 demonstration, that covers inpatient hospital services or who received, with the help of Section 1115 demonstration premium assistance, a health insurance plan that covers 100 percent of the patient’s premium costs.

Public comments will be accepted until May 1, 2023. For more information, click here.

CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would clarify changes made to the Medicaid disproportionate share hospital (DSH) payment limit calculation by the Consolidated Appropriations Act of 2021. The proposed rule is intended to give states and hospitals a better understanding of how the limit is calculated. It also outlines technical and administrative changes CMS made recently to the DSH program.

Public comments will be accepted until April 25, 2023. For more information, click here.

ACF Proposes Rule to Revise Foster Family Home Definition

On Feb. 14, the Department of Health and Human Services (HHS) Administration for Children and Families (ACF) released a proposed rule that would revise the current definition of “foster family home” and allow Title IV-E agencies to adopt foster family home licensing and approval standards for foster family homes of individuals related to children by “kin” (blood, marriage or adoption). Title IV-E agencies would also be allowed to adopt licensing and approval standards for individuals related by emotionally significant relationships. The proposed rule would also allow Title IV-E agencies to claim federal financial participation (FFM) for the costs of foster care maintenance payments (FCMP) and would make changes to the requirement that Title IV-E agencies review FCMP amounts to ensure that children placed in “kin” foster homes receive the same FCMP as those in non-kin foster family homes.

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

CMS Proposes Rule to Increase Nursing Home Transparency

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of nursing home facility information. The proposed rule would require Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities to disclose the following information:

• Names, titles and period of service for every member of the nursing home facility’s governing body
• Names, titles and period of service for the nursing home facility’s officer, director, member, partner, trustee and managing employee
• Names, titles and period of service for any additional disclosable parties of the nursing home facility
• A description of the relationship the additional disclosable parties have with the nursing home facility and other disclosable parties

Public comments will be accepted until April 14, 2023. For more information, click here.

SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement

On Feb. 10, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking to solicit public comment on its proposal to remove certain provisions under the Controlled Substances Act (CSA). The removal of these provisions is a result of the Consolidated Appropriations Act (CAA) of 2023. The CAA amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain Schedule III-V drugs to treat opioid use disorder (OUD).

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

On Jan. 30, the Department of Health and Human Services (HHS) released a proposed rule that seeks to strengthen and expand health insurance birth control coverage for women. The proposed rule would prevent private health plans and insurers from excluding coverage of contraceptive services based on moral exemptions. It would also establish an independent birth control pathway for women covered under an objecting entity, which would allow them to access contraceptive services from a willing provider without any cost. Private health plans and insurers would still be allowed to deny birth control coverage based on religious exemptions and objecting private employers and universities would still have the right to choose whether to allow plan participants access to optional contraceptive services.

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

HHS Proposes Rule to Clarify Beneficiary Religious Protections

On Jan. 13, nine federal agencies, including the Department of Health and Human Services (HHS), released a proposed rule that seeks to clarify and restore religious liberty protections for individuals who receive federally funded social services. The proposed rule would require federal grantees who administer social service programs to notify individuals that they may not be discriminated against based on their religion. The rule would also advise federal agencies on how they can assist individuals with finding providers that are more reflective of their beliefs.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor and Veterans Affairs and the U.S. Agency for International Development are proposing the rule.

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Proposes Adopting Healthcare Attachments Standards

On Dec. 15, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that would implement standards for “health care attachments” transactions, to support healthcare claims and prior authorization transactions. The proposed rules would also implement a standard for electronic signatures and modify the standard for referral certification and authorization transactions.

Public comments will be accepted until March 21, 2023. For more information, click here.

Final Rules

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.

CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program

On Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released a final rule that alters the audit methodology for the Medicare Advantage Risk Adjustment Data Validation (RADV) program and implements new requirements on Medicare Advantage Organizations (MAOs). The final rule establishes that CMS will begin extrapolating RADV audit findings with payment year (PY) 2018 and will not extrapolate audit findings for PYs 2011 through 2017. It also codifies CMS’ intention of not applying a fee-for-service adjustment factor to RADV program audits. The final rule will also require Medicare Advantage Organizations (MAOs) to remit improper payments identified by CMS during RADV audits.

The rule will go into effect on April 3, 2023. For more information, click here.

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule will go into effect on April 17, 2023. 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 Report Analyzes Advanced Drug Manufacturing

On March 10, the Government Accountability Office (GAO) released a report analyzing the extent to which advanced drug manufacturing methods have been adopted and used to manufacture drugs. GAO conducted this study to comply with a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which asked it to examine the FDA’s efforts in supporting advanced manufacturing.

The Food and Drug Administration (FDA) highlighted advanced manufacturing as a means to combat drug and medical supply chain shortages during the COVID-19 pandemic. The FDA has attempted to promote the adoption of advanced manufacturing strategies through industry engagement, policy and guidance, and research. However, the GAO found that drug manufacturers have not been adopting advanced manufacturing strategies, largely due to the FDA’s lack of clarification regarding advanced manufacturing performance metrics and goals.

For more information, click here.

GAO Report Analyzes Advance Premium Tax Credit Payments and Program Integrity Efforts

On March 9, the Government Accountability Office (GAO) released a report that evaluated the integrity of health insurance advance premium tax credit payments. The GAO conducted this study because they were asked to review advance premium tax credit payment integrity efforts.

Advance premium tax credits are federal tax credits that individuals can use to pay for premiums of health insurance plans purchased on the federally facilitated marketplace. Individuals must meet certain eligibility requirements before receiving such tax credits.

The GAO looked at what methods the Centers for Medicare and Medicaid Services (CMS) and five states (California, Colorado, Nevada, New Jersey and Pennsylvania) have been using to prevent ineligible individuals from obtaining advance premium tax credits. GAO also looked at what methodologies CMS has developed to estimate improper payments. GAO found that there is little coordination between CMS and states when it comes to preventing ineligible individuals from obtaining tax credits, and no risk assessment has been conducted to help CMS and states identify whether additional risk-mitigation strategies are needed. GAO also found that the methodology used by CMS to estimate improper advance premium tax credit payments is limited because it only takes 33 states into consideration.

For more information, click here.