This Week in Washington: CMS Releases the Physician Fee Schedule Proposed Rule

Upcoming Hearings

Congress

House

• House Rules Committee to Discuss Two Healthcare Bills
• Reps. Fletcher, Strickland and Raskin Introduce Bill to Protect Americans Traveling for Abortion Services
• House Appropriations Committee Advances the FY 2023 Labor, HHS, Education and Related Agencies Funding Bill

Senate

• Senate Democrats Release Text of Drug Pricing Deal
• Sen. Wyden Releases Finance Committee Report on Big Pharma Tax Practices
• Sens. Toomey, Barrasso, Portman, Sasse and Daines Call for Insulin Proposal to Go to the Senate Finance Committee Prior to Floor Consideration
• Sens. Bennet and Cortez Masto Call on HHS to Update HIPAA to Protect the Privacy of Reproductive Health Services
• Sen. Shaheen Calls on Congressional Leadership to Make ACA’s Enhanced Premium Tax Credits Permanent

Administration

• President Biden Signs Executive Order to Protect Reproductive Healthcare and Abortion Services
• HHS Orders 2.5 Million More Monkeypox Vaccines
• HHS Announces $3 Million in Funding for Title X Family Planning Provider Training
• HHS Purchases 105 Million COVID-19 Vaccines for Fall Vaccination
• HHS Office of Civil Rights Issues Guidance on Patient Privacy for Sexual and Reproductive Healthcare
• CMS to Improve Oversight and Ensure Access to Care for Medicaid and CHIP Managed Care Programs
• CMS Approves 12-Month Extension of Postpartum Coverage in Washington
• CMS Publishes Open Payments Data for Program Year 2021
• CMS Updates the Health and Safety Standards for Long-Term Care Facilities
• CMS Approves Vermont’s Health Section 1115 Demonstration Extension
• CMS Announces Enhancing Oncology Model
• HRSA Awards $155 Million to Address Mental Health Workforce Needs
• FDA Updates EUA for Paxlovid
• FDA Stays Marketing Denial Order for Juul Products
• Secretaries Becerra, Walsh and Yellen Call on Group Health Plan Sponsors and Issuers to Ensure Access to Contraceptives

Proposed Rules

• 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 Home Health Prospective Payment Systems Rate Update Proposed Rule

Final Rules

• 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

• CBO Report on Questions About a Single-Payer Healthcare System
• CBO Publishes Projections for Federal Programs and Tax Provisions that Subsidize Health Insurance Coverage for People Under 65
• GAO Report on Priority Open Recommendations for the VA
• GAO Report on DOD Provision of Civilian Emergency Care
• GAO Report on State Directed Payments in Managed Care
• GAO Report on Improved Oversight for Medicare Advantage
• GAO Report on HHS Breach Reporting of Electronic Health Information
• HHS OIG Publishes Annual Health Care Fraud and Abuse Control Program Report

Upcoming Hearings

July 12

Senate Finance Committee Hearing: “Hearing to Consider the Nominations of Jay Curtis Shambaugh, of Maryland, to be an Under Secretary of the Treasury and Rebecca Lee Haffajee, of Massachusetts, to be an Assistant Secretary of Health and Human Services”
10:00 a.m.

Senate Judiciary Committee Hearing: “A Post-Roe America: The Legal Consequences of the Dobbs Decision”
10:00 a.m.

House Committee on Rules Meeting: H.R. 7900, H.R. 8296, H.R. 8297, and H.R. 6538
12:00 p.m.
For more information, see below.

July 13

Senate Health, Education, Labor and Pensions Committee Hearing: “Reproductive Care in a Post-Roe America: Barriers, Challenges, and Threats to Women's Health”
10:00 a.m.

July 14

House Committee on Veterans Affairs Subcommittee on Health Hearing: “Examining VA Community Care Access, Utilization, and Expenditures”
10:00 a.m.

Senate Committee on Veterans Affairs Hearing: “Review of the Fiscal Year 2023 Budget and 2024 Advance Appropriations Requests for the Department of Veterans Affairs”
3:00 p.m.

Congress

House

House Rules Committee to Discuss Two Healthcare Bills

On June 12, the House Rules Committee will meet to discuss the Women’s Health Protection Act of 2022 and the Ensuring Access to Abortion Act of 2022. In the meeting, the Rules Committee will decide matters related to the bills’ House floor discussion, including the length of the discussion, any amendments, and other relevant measures.

Reps. Fletcher, Strickland and Raskin Introduce Bill to Protect Americans Traveling for Abortion Services

On July 7, Reps. Lizzie Fletcher (D-TX), Marilyn Strickland (D-WA) and Jamie Raskin (D-MD) introduced the Ensuring Access to Abortion Act of 2022. The bill would prohibit anyone operating under state law from punishing Americans who travel for reproductive healthcare.

House Appropriations Committee Advances the FY 2023 Labor, HHS, Education and Related Agencies Funding Bill

On June 30, the House Appropriations Committee voted to advance the Fiscal Year (FY) 2023 Labor, Health and Human Services (HHS), Education and Related Agencies funding bill. The bill provides $242.1 billion in funding, an increase of $28.5 billion over the 2022 amount. A bill summary can be found here.

Senate

Senate Democrats Release Text of Drug Pricing Deal

On July 6, Senate Democrats released the legislative text of a drug pricing deal. The legislation would allow Medicare to negotiate the prices of 10 drugs starting in 2026, with the number increasing to 15 in 2027 and increasing by an additional 20 in 2029 and every year after. The drugs subject to negotiation will be chosen by the Department of Health and Human Services (HHS) based on their total Medicare Parts B and D spending. In addition, the legislation would also repeal the Part D rebate rule sought to eliminate the safe harbor for Part D drug rebates. The bill would also cap Medicare Part B and D rebates for single-source drugs and biologics’ manufacturers whose prices are increasing above the rate of inflation. Lastly, the bill would cap prescription drug plans’ cost-sharing payments in Medicare Advantage and Part D plans.

Sen. Wyden Releases Finance Committee Report on Big Pharma Tax Practices

On July 7, Sen. Ron Wyden (D-OR) released an interim report titled “Big Pharma Tax Avoidance,” which is part of the Senate Finance Committee’s investigation into the pharmaceutical industry’s tax practices. The report states that pharmaceutical company AbbVie uses tax loopholes and tax havens to avoid paying U.S. taxes on prescription drug sales. In addition, the report states that the 2017 Tax Cuts and Jobs Act halved AbbVie’s effective tax rate. A press release on the report and its findings can be found here.

Sens. Toomey, Barrasso, Portman, Sasse and Daines Call for Insulin Proposal to Go to the Senate Finance Committee Prior to Floor Consideration

On July 6, Sens. Pat Toomey (R-PA), John Barrasso (R-WY), Rob Portman (R-OH), Ben Sasse (R-NE) and Steve Daines (R-MT) wrote to Senate Finance Committee Chair Ron Wyden (D-OR) and Sen. Mike Crapo, Ranking Member (R-ID), to stress the importance that the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act undergo proper committee procedure. The INSULIN Act was introduced by Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME). Specifically, the senators called for the bill to go to the Senate Finance Committee for a markup before being brought to the Senate floor.

Sens. Bennet and Cortez Masto Call on HHS to Update HIPAA to Protect the Privacy of Reproductive Health Services

On July 1, Sens. Michael Bennet (D-CO) and Catherine Cortez Masto (D-NV) wrote to the Secretary of the Health and Human Services Department (HHS), Xavier Becerra, calling on HHS to update the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to protect the privacy of reproductive healthcare services following the Supreme Court’s decision to overturn Roe v. Wade.

Sen. Shaheen Calls on Congressional Leadership to Make ACA’s Enhanced Premium Tax Credits Permanent

On June 30, Sen. Jeanne Shaheen (D-NH) led a group of 13 senators in a letter to Senate Majority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA). In the letter, the senators requested that a measure making the Affordable Care Act’s (ACA) enhanced premium tax credit permanent be included in the upcoming reconciliation legislation. The tax credits are set to expire at the end of this year.

Administration

President Biden Signs Executive Order to Protect Reproductive Healthcare and Abortion Services

On July 8, President Biden signed an executive order to protect access to reproductive healthcare and abortion services. The executive order directs the Department of Health and Human Services (HHS) to protect and expand access to medication abortion, ensure that all patients have the rights to emergency medical care, protect access to contraception, carry out outreach efforts and convene volunteer lawyers. In addition, the executive order takes steps to protect patient privacy and health data. A White House fact sheet on the executive order can be found here.

HHS Orders 2.5 Million More Monkeypox Vaccines

On July 1, the Department of Health and Human Services (HHS) ordered 2.5 million more doses of Bavarian Nordic’s JYNNEOS, a vaccine to prevent smallpox and monkeypox that has been licensed by the Food and Drug Administration (FDA). The vaccines will start to be delivered to the Strategic National Stockpile later this year.

HHS Announces $3 Million in Funding for Title X Family Planning Provider Training

On June 30, the Department of Health and Human Services (HHS) Office of Population Affairs announced that $3 million in grants would be allocated towards training and technical assistance for Title X family planning providers.

HHS Purchases 105 Million COVID-19 Vaccines for Fall Vaccination

On June 29, the Department of Health and Human Services (HHS) and the Department of Defense announced the purchase of 105 million doses of the Pfizer COVID-19 vaccine for a fall vaccination campaign.

HHS Office of Civil Rights Issues Guidance on Patient Privacy for Sexual and Reproductive Healthcare

On June 29, the Department of Health and Human Services (HHS) Office for Civil Rights issued new guidance on patient privacy following the Supreme Court decision to overturn Roe v. Wade. The guidance clarifies the federal protections for individuals’ protected health information related to sexual and reproductive healthcare and also addresses the degree to which private medical information is protected on cell phones and tablets.

CMS to Improve Oversight and Ensure Access to Care for Medicaid and CHIP Managed Care Programs

On July 6, the Centers for Medicare and Medicaid Services (CMS) announced additional resources to improve oversight and access to care for Medicaid and Children’s Health Insurance Program (CHIP) managed care programs. The resources, summarized in a Center for Medicaid and CHIP Services Informational Bulletin (CIB), include templates and tactics to improve state reporting of managed care programs.

CMS Approves 12-Month Extension of Postpartum Coverage in Washington

On June 30, the Centers for Medicare and Medicaid Services (CMS) announced that it had approved Washington state’s extension to expand Medicaid and Children’s Health Insurance Program (CHIP) coverage for 12 months after pregnancy. This will expand coverage for an addition 12,000 people. Washington now joins a list of 15 states and D.C. that have gained access to 12 months of postpartum coverage.

CMS Publishes Open Payments Data for Program Year 2021

On June 30, the Centers for Medicare and Medicaid Services (CMS) released the Program Year 2021 Open Payments data. Open Payments is a national disclosure program that works to advance a transparent healthcare system. The data publication includes 12.1 million records and shows the financial relationships between certain manufacturers, group purchasing organizations (GPOs) and relevant providers.

CMS Updates the Health and Safety Standards for Long-Term Care Facilities

On June 29, the Centers for Medicare and Medicaid Services (CMS) issued guidance on minimum health and safety standards that long-term care facilities must meet in order to participate in Medicare and Medicaid. The guidance is part of the Biden Administration’s efforts to improve nursing home safety nationally. The update clarifies CMS’s expectations for investigations and makes changes to the guidance on mental health and substance use disorder services in long-term care facilities.

CMS Approves Vermont’s Health Section 1115 Demonstration Extension

On June 28, the Centers for Medicare and Medicaid Services (CMS) approved an extension of Vermont’s Medicaid section 1115 demonstration titled “Global Commitment to Health.” The extension approval means that Vermont can continue to fund efforts to reduce the number of uninsured individuals, improve access to quality care and advance home and community-based services until Dec. 31, 2027.

CMS Announces Enhancing Oncology Model

On June 27, the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center announced its new Enhancing Oncology Model. The model is voluntary and will test payment and service delivery models with the objective of improving quality of care and reducing Medicare, Medicaid and Children’s Health Insurance Program (CHIP) expenditures. The model performance period is from July 2023 to June 2028. Applications, which can be found here, close on Sept. 30, 2022.

HRSA Awards $155 Million to Address Mental Health Workforce Needs

On July 1, the Health Resources Services Administration (HRSA) awarded $155 million to 72 teaching health centers with primary care medical and dental programs with high need specialties such as psychiatry. This is part of a greater effort to ensure that the healthcare workforce is adequately trained to address mental and behavioral health issues.

FDA Updates EUA for Paxlovid

On July 6, the Food and Drug Administration (FDA) updated the emergency use authorization (EUA) for Paxlovid, which is used to treat mild-to-moderate COVID-19 in adults and children 12 years old and above who are at high risk for progression to severe COVID-19. The EUA now allows for state-licensed pharmacists to prescribe Paxlovid to eligible patients, with some limitations to ensure proper patient assessments are made.

FDA Stays Marketing Denial Order for Juul Products

On June 5, the Food and Drug Administration (FDA) announced that it had stayed a marketing denial order to review the scientific issues related to Juul’s product application. This decision comes after the FDA denied Juul’s marketing authorization for its products on June 23, which required the company to remove its products from the market. Juul appealed this decision, saying that the FDA denied the application for arbitrary reasons. While the stay of the marketing denial order does not rescind the initial denial order, it means that Juul products can remain on the market during the FDA review.

Secretaries Becerra, Walsh and Yellen Call on Group Health Plan Sponsors and Issuers to Ensure Access to Contraceptives

On June 27, Secretary of Health and Human Services (HHS) Xavier Becerra, Secretary of Labor Marty Walsh and Secretary of the Treasury Janet Yellen wrote to group health plans and health insurance issuers to remind issuers and plans that they are required to provide contraceptive services at no cost under the Affordable Care Act. In the letter, the secretaries note that recent reports have shown that some issuers and plans are not appropriately providing free birth control and contraceptive counseling for individuals and covered dependents.

Proposed Rules

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,
• 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:

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 Home Health Prospective Payment Systems Rate Update Proposed Rule

On June 17, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Calendar Year 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; etc.” 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

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 go 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

CBO Report on Questions About a Single-Payer Healthcare System

On July 7, the Congressional Budget Office (CBO) published a report titled “Answers to Questions for the Record Following a Hearing on a Single-Payer Health Care System That is Based on Medicare’s Fee-for-Service Program.” The report answers questions posed by Sen. Chris Van Hollen (D-MD) in a May 12 Senate Budget Committee hearing where CBO Director Phillip Swagel presented the agency’s analysis of single-payer healthcare systems.

CBO Publishes Projections for Federal Programs and Tax Provisions that Subsidize Health Insurance Coverage for People Under 65

On June 30, the Congressional Budget Office (CBO) published a report titled “Federal Subsidies for Health Insurance Coverage for People Under 65: 2022 to 2032.” The report describes baseline projections made by CBO and the Joint Committee on Taxation for federal government programs and tax provisions that subsidize health insurance for Americans under age 65.

GAO Report on Priority Open Recommendations for the VA

On July 7, the Government Accountability Office (GAO) released a report titled “Priority Open Recommendations: Department of Veterans Affairs.” The report includes 22 priority open recommendations for the Department of Veterans Affairs (VA) and addresses veterans’ access to healthcare, VA health system efficiency and the Veterans Community Care Program.

GAO Report on DOD Provision of Civilian Emergency Care

On July 7, the Government Accountability Office (GAO) released a report titled “Defense Health Care: Actions Needed to Improve Billing and Collection of Debt for Civilian Emergency Care.” The report notes that while the Department of Defense (DOD) sometimes provides care to civilian emergency patients at DOD medical treatment facilities, DOD has not monitored whether or not providing this care provides the relevant mix and volume of cases needed for these facilities to maintain readiness. In addition, DOD has limited oversight of billing and debt collection for civilian emergency care patients. The GAO recommends that the DOD better monitor how providing civilian emergency care contributes to readiness and collect more complete information.

GAO Report on State Directed Payments in Managed Care

On June 28, the Government Accountability Office (GAO) published a report titled “Medicaid: State Directed Payments in Managed Care.” The report says that the Centers for Medicare and Medicaid Services (CMS) has recently taken action to enhance oversight of state directed payments in managed care. However, despite these efforts, information gaps remain. GAO recommends that CMS collect more complete and provider-specific information about Medicaid providers, which would improve its ability to identify impermissible financing and payments that need review.

GAO Report on Improved Oversight for Medicare Advantage

On June 28, the Government Accountability Office (GAO) published a report titled “Medicare Advantage (MA): Continued Monitoring and Implementing GAO Recommendations Could Improve Oversight.” The report found that MA beneficiaries with certain organization contracts were more likely to disenroll during the last year of life. The GAO estimates that these disenrollments cost Medicare nearly half a billion dollars annually, and recommends that the Centers for Medicare and Medicaid Services (CMS) monitor disenrollments from MA in the last year of life and validate the encounter data that is used to risk-adjust MA organization payments.

GAO Report on HHS Breach Reporting of Electronic Health Information

On June 27, the Government Accountability Office (GAO) released a report titled “Electronic Health Information: HHS Needs to Improve Communications for Breach Reporting.” The report notes that the Department of Health and Human Services (HHS) has experienced an increase in reported breaches of health information from 2015 to 2021. These breaches have involved the exposure or loss of identifiable health information. The GAO recommended that HHS create a feedback mechanism to improve its breach reporting process.

HHS OIG Publishes Annual Health Care Fraud and Abuse Control Program Report

On July 5, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2021. The report states that the federal government received more than $5 billion from healthcare fraud judgments and settlements in 2021.