This Week in Washington: The Senate waits to see if budget reconciliation agreement has enough votes to pass.

Upcoming Hearings

Congress

House

• House Passes Three Healthcare Bills
• More Than 100 Members Call for Additional Funding to Aid Health Clinics’ Monkeypox Response

Senate

• Sen. Leahy Releases Appropriations Package
• Sens. Manchin and Schumer Reach Agreement on Budget Reconciliation
• Five Senate Democrats Introduce Bill to Allow U.S. Foreign Assistance for Abortion Care Abroad
• Sen. Hassan Calls for No Surprises Act to be Extended to Additional Facilities
• Sen. Peters Calls on HHS and DHS to Clarify Guidance on the Importation of and Travel with Abortion Medication
• Sens. Schumer, Wyden and Booker Introduce Bill to Remove Cannabis from the Federal List of Controlled Substances
• Sen. Klobuchar Calls on FTC to Investigate Amazon’s Proposed Acquisition of One Medical

Administration

• HHS Secures 66 Million Doses of Moderna’s COVID-19 Booster Vaccine
• HHS Allocates Additional Monkeypox Vaccines
• HHS, Department of Labor and Treasury Issue Guidance on Birth Control Coverage
• HHS Releases Fact Sheet on Monkeypox Response
• CMS Announces the Launch of the Nursing Home Five-Star Quality Rating System
• CMS Approves Extension of Postpartum Coverage in Connecticut, Massachusetts and Kansas
• CMS Releases Maternity Care Action Plan
• CMS Releases HCBS Quality Measure Set
• CMS Announces $49 Million in Grants Awarded Through the Connecting Kids to Coverage National Campaign
• FDA to Hold Public Workshop on Biosimilar Development Programs

Proposed Rules

• HHS Announces Proposed Rule to Implement Section 1557 of the ACA
• FDA Releases Proposed Rule to Standardize the National Drug Code Format
• CMS Releases CY 2023 Physician Fee Schedule Proposed Rule
• CMS Publishes Proposed Rule on Rural Hospitals
• CMS Publishes End-Stage Renal Disease Prospective Payment System Proposed Rule
• CMS Releases FY 2023 Home Health Prospective Payment Systems Rate Proposed Rule

Final Rules

• CMS Publishes Final Rule to Update FY 2023 Hospice Payment Rate
• CMS Publishes FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Final Rule
• CMS Issues FY 2023 Inpatient Rehabilitation Facility Prospective Payment System Final Rule
• CMS Publishes Final Rule Updating CLIA Proficiency Testing Regulations for Analytes
• HHS Issues Final Rule Withdrawing SUNSET Rule
• CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
• Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

Reports

• FDA Releases Progress Report on the Generic Drug Cluster
• GAO Report on Sexual Harassment Policies at the VA
• GAO Report on the Defense Health Agency’s Oversight of Pediatric Lead Exposure
• GAO Report on Federal Efforts to Promote Healthy Eating
• CBO Report Provides Additional Information on the INSULIN Act
• CBO Report on the Impact of Making the Enhanced Premium Tax Credits Permanent
• Congressional Budget Office Cost Estimates of Healthcare Bills

Upcoming Hearings

August 3

Senate Finance Committee Hearing: “A System in Need of Repair: Addressing Organizational Failures of the U.S.’s Organ Procurement and Transplantation Network”
2:30 p.m.

Congress

House

House Passes Three Healthcare Bills

On July 27, the House of Representatives voted to pass three healthcare bills. Information on the bills and their content can be found below.

More Than 100 Members Call for Additional Funding to Aid Health Clinics’ Monkeypox Response

On July 25, Reps. Jerrold Nadler (D-NY) and David Cicilline (D-RI) led a group of more than 100 members of Congress in a letter to President Biden, Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky. In the letter, the members commended recent actions to improve monkeypox vaccine distribution and expand testing capacity, and requested that additional funding be provided to support health clinics.

Senate

Sen. Leahy Releases Appropriations Package

On July 28, Sen. Pat Leahy (D-CT) released 12 appropriations bills. The legislation would provide $10.5 billion for the Centers for Disease Control and Prevention and $1.4 billion for the Mental Health Block Grant. Sens. Leahy, Patty Murray (D-WA) and Chris Coons (D-DE) also introduced a $21 billion emergency supplemental funding bill to address the ongoing COVID-19 pandemic. Additional information on the Labor, Health and Human Services, Education, and Related Agencies section of the Appropriations package can be found below.

Sens. Manchin and Schumer Reach Agreement on Budget Reconciliation

On July 27, Senate Majority Leader Chuck Schumer (D-NY) announced that he had reached an agreement with Sen. Joe Manchin (D-WV) on the Fiscal Year (FY) 2022 Budget Reconciliation Package. As part of the agreement, the Inflation Reduction Act of 2022 will be added to the FY 2022 Budget Reconciliation bill. The agreement revives the reconciliation package, which was previously thought to be dead as it did not have enough votes. Votes will be held on the new reconciliation package next week. Information on the Inflation Reduction Act of 2022 can be found below.

Five Senate Democrats Introduce Bill to Allow U.S. Foreign Assistance for Abortion Care Abroad

On July 27, Sens. Cory Booker (D-NJ), Tammy Duckworth (D-IL), Mazie Hirono (D-HI), Tina Smith (D-MN) and Richard Blumenthal (D-CT) introduced the Abortion is Health Care Everywhere Act. The bill would ensure that U.S. foreign assistance could be used to provide comprehensive healthcare, including abortion services, by repealing the 1973 Helms Amendment to Foreign Assistance Act.

Sen. Hassan Calls for No Surprises Act to be Extended to Additional Facilities

On July 25, Sen. Maggie Hassan (D-NH) wrote a letter to the Health and Human Services Secretary Xavier Becerra, Labor Secretary Marty Walsh and Treasury Secretary Janet Yellen calling for additional surprise medical billing protections. Sen. Hassan called for the protections in the No Surprises Act to be extended to all relevant facilities, including birthing centers, clinics, hospice facilities, nursing homes, urgent care centers and addiction treatment centers.

Sen. Peters Calls on HHS and DHS to Clarify Guidance on the Importation of and Travel with Abortion Medication

On July 21, Sen. Gary Peters (D-MI) wrote to the Secretary of Health and Human Services (HHS) Xavier Becerra and Secretary of Homeland Security (DHS) Alejandro Mayorkas, calling on them to more proactively protect reproductive healthcare. In his letter, Sen. Peters asked for HHS and DHS to clarify guidance on the importation of abortion medication and travel with abortion medication.

Sens. Schumer, Wyden and Booker Introduce Bill to Remove Cannabis from the Federal List of Controlled Substances

On July 21, Sens. Chuck Schumer (D-NY), Ron Wyden (D-OR) and Cory Booker (D-NJ) introduced the Cannabis Administration and Opportunity Act (CAOA), which would remove cannabis from the federal list of controlled substances. The bill would also establish a Center for Cannabis Products at the Food and Drug Administration (FDA) to regulate the cannabis industry. A summary of the bill can be found here.

Sen. Klobuchar Calls on FTC to Investigate Amazon’s Proposed Acquisition of One Medical

On July 21, Sen. Amy Klobuchar (D-MN) wrote to Federal Trade Commission (FTC) Chair Lina Khan calling for an investigation into Amazon’s proposed acquisition of One Medical. Sen. Klobuchar expressed concern that the acquisition would harm competition and could have negative implications for personal health data.

Administration

HHS Secures 66 Million Doses of Moderna’s COVID-19 Booster Vaccine

On July 29, the Department of Health and Human Services (HHS) announced that it would be purchasing 66 million doses of Moderna COVID-19 booster vaccine in preparation for use in the fall and winter.

HHS Allocates Additional Monkeypox Vaccines

On July 28, the Department of Health and Human Services (HHS) announced it would allocate an additional 786,000 doses of the JYNNEOS monkeypox vaccine to states and jurisdictions, bringing the total amount of vaccines to 1.1 million doses.

HHS, Department of Labor and Treasury Issue Guidance on Birth Control Coverage

On July 28, the Departments of Health and Human Services (HHS), Labor and Treasury issued guidance to clarify protections for birth control coverage included in the Affordable Care Act (ACA). The guidance stresses that the ACA requires most private health plans to provide birth control and family planning counseling at no cost.

HHS Releases Fact Sheet on Monkeypox Response

On July 21, the Department of Health and Human Services (HHS) released a fact sheet on the agency’s response to the monkeypox outbreak. The fact sheet includes efforts taken to increase the distribution of vaccines, tests and treatments as well as raising awareness.

CMS Announces the Launch of the Nursing Home Five-Star Quality Rating System

On July 27, the Centers for Medicare and Medicaid Services (CMS) announced the launch of its enhanced Nursing Home Five-Star Quality Rating System. The rating system incorporates nursing home data on weekend staffing rates and staff turnover, which has been published since January. The Nursing Home Five-Star Quality Rating System will incorporate additional data on total nurse staffing hours per resident, RN turnover, administrator turnover and total nurse staff turnover. The rating system presents the data in a more consumer-friendly format and will be updated quarterly. A fact sheet on the updates can be found here.

CMS Approves Extension of Postpartum Coverage in Connecticut, Massachusetts and Kansas

On July 26, the Centers for Medicare and Medicaid Services (CMS) approved a Medicaid and Children’s Health Insurance Program (CHIP) coverage extension for 12 months postpartum in the states of Connecticut, Massachusetts and Kansas. This will extend Medicaid and CHIP coverage to an additional 19,000 people.

CMS Releases Maternity Care Action Plan

On July 26, the Centers for Medicare and Medicaid Services (CMS) released its Maternity Care Action Plan. The action plan identifies five key gaps in maternity care: coverage and access to care, data, quality of care, workforce and social supports. The action plan explains the steps CMS is taking to address these gaps.

CMS Releases HCBS Quality Measure Set

On July 21, the Centers for Medicare and Medicaid Services (CMS) released a home- and community-based services (HCBS) quality measure set for the first time. The measure set will provide insight into the quality of HCBS programs and facilitate efforts to track health outcomes. Use of the quality measure is voluntary.

CMS Announces $49 Million in Grants Awarded Through the Connecting Kids to Coverage National Campaign

On July 19, the Centers for Medicare and Medicaid Services (CMS) announced that $49 million had been awarded through the new Connecting Kids to Coverage Campaign to organizations working to reduce uninsured rates among children and families. Information on the grantees can be found here.

FDA to Hold Public Workshop on Biosimilar Development Programs

On July 19, the Food and Drug Administration (FDA) announced that it would be holding a virtual public workshop titled “Increasing the Efficiency of Biosimilar Development Programs” on Sept. 19 from 9 a.m. to 4 p.m. Registration information and additional details can be found here.

Proposed Rules

HHS Announces Proposed Rule to Implement Section 1557 of the ACA

On July 25, the Department of Health and Human Services (HHS) released a proposed rule to implement Section 1557 of the Affordable Care Act (ACA) that bans discrimination based on race, color, national origin, sex, age and disability in certain health programs and activities. The proposed rule expands civil rights protections for patients in certain federally funded programs by clarifying the scope and application of Section 1557. An HHS press release on the proposed rule can be found here.

FDA Releases Proposed Rule to Standardize the National Drug Code Format

On July 25, the Food and Drug Administration (FDA) issued a proposed rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The proposed rule would amend the National Drug Code (NDC) to require one standardized format for all NDCs.

Public comments will be accepted until Nov. 22, 2022.

CMS Releases CY 2023 Physician Fee Schedule Proposed Rule

On July 7, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare and Medicaid Programs: Calendar Year (CY) 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, Medicare Shared Savings Program Requirements, etc.” The proposed rule would make changes to the physician fee schedule (PFS) and Medicare Part B payment policies to better reflect the value of services. The proposed rule also would:

• Allow licensed professional counselors, counselors and therapists to provide behavioral health services under general supervision,
• Consider clinical psychologists and clinical social workers as part of a patient’s primary care team for payment purposes,
• Incorporate advance shared savings payments to certain new Medicare Shared Savings Program Accountable Care Organizations (ACOs),
• Improve access to colon cancer screening,
• Allow CMS to pay for dental services that are integral to covered medical services,
• Update the Medicare Economic Index (MEI) cost share weights,
• Solicit public feedback on ways to improve global surgical package valuation,
• Adopt changes to the Evaluation and Management (E/M) visit coding and documentation,
• Extend some services temporarily available via telehealth through CY 2023,
• Add new Healthcare Common Procedure Coding System (HCPCS) codes and valuation for chronic pain management,
• Provide Medicare coverage for opioid use disorder services provided by opioid treatment programs,
• Allow beneficiaries to access audiology services without a physician referral,
• Clarify Medicare fee-for-service payment policies for dental services,
• Change the coding, billing and payment rules for skin substitutes,
• Refine the payment amount for preventive vaccine administration under the Medicare Part B vaccine benefit and
• Update regulations on Medicare Ground Ambulance data collection.

Additional resources on the proposed rule can be found below:

Public comments will be accepted until Sept. 6, 2022.

CMS Publishes Proposed Rule on Rural Hospitals

On July 7, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare and Medicaid Programs; Conditions of Participation (CoPs) for Rural Emergency Hospitals (REH) and Critical Access Hospital CoP Updates.” The proposed rule establishes the CoPs that REHs need to meet in order to participate in Medicare and Medicaid, with the objective of ensuring that REHs provide a high quality of care. In addition, the proposed rule would also change the Critical Access Hospital requirements for participation in Medicare and Medicaid.

Public comments will be accepted until Aug. 29, 2022.

CMS Publishes End-Stage Renal Disease Prospective Payment System Proposed Rule

On June 28, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, etc.” The proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System and the payment rate for renal dialysis service provided by an ESRD facility for people with acute kidney injury for calendar year 2023. In addition, the rule includes requests for information on potential payment adjustments for new renal dialysis drugs and products and health equity issues.

Public comments will be accepted until Aug. 22, 2022.

CMS Releases FY 2023 Home Health Prospective Payment Systems Rate Proposed Rule

On June 17, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Calendar Year 2023 Home Health Prospective Payment System Rate Update.” The proposed rule would update Medicare payment policies and rates for home health agencies (HHAs). A CMS fact sheet says the rule would update home health payment and home infusion therapy rates for Fiscal Year 2023. In addition, the rule would end the suspension of non-Medicare and non-Medicaid data for HHA patients and expand the baseline years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model.

Public comments will be accepted until Aug. 16, 2022.

Final Rules

CMS Publishes Final Rule to Update FY 2023 Hospice Payment Rate

On July 27, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The final rule makes updates to Medicare hospice payments and the aggregate cap amount for Fiscal Year (FY) 2023. The FY 2023 hospice payment update will be increased to 3.8% and a permanent budget-neutral 5% cap will be established on any decrease to an area’s wage index. The final rule also discusses the Hospice Outcomes and Patient Evaluation tool and provides an update on FY 2023 Quality Measures, the Consumer Assessment of Healthcare Providers and Systems, and Hospice Survey Mode Experiment. A press release on the final rule with additional information can be found here.

The final rule will go into effect on Oct. 1, 2022.

CMS Publishes FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Final Rule

On July 27, the Centers for Medicare and Medicaid Services published a final rule titled “Medicare Program: FY 2023 Inpatient Psychiatric Facilities Prospective Payment System; Rate Update and Quality Reporting; Request for Information.” The final rule will update Medicare payment rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for Fiscal Year (FY) 2023 and sets a permanent 5% cap. The rule does not make any changes to the IPF Quality Reporting Program. A press release with additional information can be found here.

The final rule will go into effect on Oct. 1, 2022.

CMS Issues FY 2023 Inpatient Rehabilitation Facility Prospective Payment System Final Rule

On July 27, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program.” The final rule updates payment policies under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program. The final rule includes a permanent cap on year-to-year wage index decreases and will expand the IRF quality data reporting requirements. A fact sheet about the final rule can be found here.

The final rule will go into effect for Oct. 1, 2022.

CMS Publishes Final Rule Updating CLIA Proficiency Testing Regulations for Analytes

On July 11, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.” The final rule makes changes to the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The updates will address current analytes and new technologies. In addition, the final rule will make changes to the PT referral regulations to make sure they are aligned with the CLIA statute. The final rule will go into effect on Aug. 10, 2022, but amendments to Sec. Sec. 493.2 and 493.801 through 493.959 (amendatory instructions 2 and 5 through 21) will be effective on July 11, 2024.

HHS Issues Final Rule Withdrawing SUNSET Rule

On May 27, the Department of Health and Human Services (HHS) published a final rule to withdraw the “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)” Final Rule of 2021. The SUNSET rule was originally set to go into effect on March 22, 2021, but was delayed until Sept. 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to review every rule to determine if it was still applicable after 10 years, and any rules not reviewed within that time frame would be automatically eliminated. In its withdrawal of the SUNSET rule, HHS stated that the rule faced significant opposition from stakeholders and would not expedite rulemaking.

The rule is effective immediately.

CMS Releases Notice of Benefit and Parameters for 2023 Final Rule

On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods. The regulations went into effect on July 1, 2022.

A CMS fact sheet on the final rule can be found here.

Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.

The White House Fact Sheet on the final rule can be found here.

Reports

FDA Releases Progress Report on the Generic Drug Cluster

On July 28, the Food and Drug Administration (FDA) released a progress report on the Global Generic Drug Affairs’ Generic Drug Cluster. The Generic Drug Cluster was created to advance generic drug development internationally. Since its creation, the forum has held a number of events and meetings to facilitate collaboration on regulatory topics.

GAO Report on Sexual Harassment Policies at the VA

On July 28, the Government Accountability Office (GAO) published a report titled “Sexual Harassment: Opportunities Remain for VA to Improve Program Structure, Policies, and Data Collection.” The report notes that the Department of Veterans’ Affairs (VA) implemented two of the seven GAO recommendations from the June 2020 report, and significant issues remain. The GAO states that without additional action, the VA will continue to have high rates of sexual harassment reported by employees.

GAO Report on the Defense Health Agency’s Oversight of Pediatric Lead Exposure

On July 26, the Government Accountability Office (GAO) released a report titled “Defense Health Agency: Oversight Needed to Better Ensure That Children Are Screened, Tested, and Treated for Lead Exposure.” The report notes that while the Defense Health Agency (DHA) has pediatric lead screening, testing and treatment guidelines for military medical facilities, the DHA does not ensure that the guidelines are being adhered to. The GAO recommends that the DHA develop an oversight plan and implement it at its facilities.

GAO Report on Federal Efforts to Promote Healthy Eating

On July 19, the Government Accountability Office (GAO) published a report titled “Healthy Eating: Government-wide solutions for promoting healthy diets, food safety, and food security.” The report summarizes work federal agencies have done on diet, food safety and food security. The GAO recommends that federal agencies better coordinate these efforts, as there have been duplicative efforts and other problems.

CBO Report Provides Additional Information on the INSULIN Act

On July 22, the Congressional Budget Office (CBO) released a report titled “Additional Information about the INSULIN Act.” The report contains information on how the INSULIN Act would impact insulin prices and the federal budget in response to a request from Sens. Susan Collins (R-ME) and Jeanne Shaheen (D-NH).

CBO Report on the Impact of Making the Enhanced Premium Tax Credits Permanent

On July 21, the Congressional Budget Office (CBO) released a report titled “Health Insurance Policies.” In the report, CBO explains how making the American Rescue Plan’s enhanced premium tax credits permanent could impact the affordability of employment-based coverage. The report was written in response to a request from Sens. Richard Burr (R-NC), Mike Crapo (R-ID) and Lindsey Graham (R-SC).

Congressional Budget Office Cost Estimates of Healthcare Bills

The Congressional Budget Office (CBO) published cost estimates of the following bills: