This Week in Washington: Sen. Manchin Expresses Support for a More Limited Budget Reconciliation Package That Includes Health Provisions

Upcoming Hearings

Congress

House

• House Energy and Commerce Committee Passes the Lymphedema Treatment Act
• Rep. Rosa DeLauro and Sen. Dick Durbin Introduce Bill to Create a New Food Safety Administration
• Reps. Eshoo and Pallone Call for USPSTF Process Reevaluation
• Energy and Commerce Committee Leadership Request Update on FDA’s Efforts to Improve Food Safety
• Rep. Huffman Introduces Bill to Increase HCSM Transparency

Senate

• Sen. Manchin Expresses Support for Limited Budget Reconciliation Package
• Sens. Warren, Booker and Padilla Call for Declaration of National and Public Health Emergency Due to Restrictions to Reproductive Care
• Sen. Burr Introduces New Bill to Reauthorize FDA User Fee Programs
• Sens. Feinstein, Murray and Warren Ask for Robust Funding for the Title X Family Planning Program

Administration

• HHS Publishes Guidance on Pharmacies’ Obligations to Provide Reproductive Health Services
• HHS Secures 3.2 Million Doses of Novavax’s COVID-19 Vaccine
• HHS OCR Announces Enforcement Actions Under HIPAA Right of Access Initiative
• CMS Approves Reinsurance Waiver Extensions in Alaska, Oregon and Minnesota
• CMS Issues Guidance Stating that Federal Law Requiring Emergency Medical Care to Include Abortion Services
• FDA Grants EUA for Novavax’s COVID-19 Vaccine

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

• 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

Courts

• Texas Attorney General Sues HHS Over Recent Emergency Abortion Guidance

Reports

• GAO Report on CDC’s Air Travel Contact Tracing
• CBO Cost Estimate of the INSULIN Act

Upcoming Hearings

July 19

House Committee on Homeland Security and Governmental Affairs Hearing: “Addressing Weapons of Mass Destruction and Health Security Threats to the Homeland”
10:00 a.m.

House Committee on Energy and Commerce Subcommittee on Oversight and Investigations Hearing: “Roe Reversal: The Impacts of Taking Away the Constitutional Right to an Abortion”
10:30 a.m.

July 20

House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Hearing:“Food Safety and the Food and Drug Administration”
10:10 a.m.

Senate Committee on Veterans’ Affairs Hearing: “Examining the Status of VA’s Electronic Health Record Modernization Program”
3:00 p.m.

Congress

House

House Energy and Commerce Committee Passes the Lymphedema Treatment Act

On July 13, the House Energy and Commerce Committee passed the Lymphedema Treatment Act by a voice vote. The bill would extend Medicare coverage to lymphedema compression treatment items.

Rep. Rosa DeLauro and Sen. Dick Durbin Introduce Bill to Create a New Food Safety Administration

On July 13, Rep. Rosa DeLauro (D-CT-03) and Sen. Dick Durbin (D-IL) introduced the Food Safety Administration Act, which would transfer the Food and Drug Administration’s food authorities to a new agency within the Department of Health and Human Services (HHS) called the Food Safety Administration.

Reps. Eshoo and Pallone Call for USPSTF Process Reevaluation

On July 13, Reps. Anna Eshoo (D-CA) and Frank Pallone (D-NJ) wrote to Secretary of Health and Human Services (HHS) Xavier Becerra calling for a reevaluation of the United States Preventive Services Taskforce (USPSTF) process to improve patient access to preventative services. The USPSTF is a volunteer panel of disease prevention experts that makes recommendations related to clinical preventative services. Private insurers are required to cover preventative services that receive a grade A or B from the USPSTF with no cost-sharing. In the letter, Reps. Eshoo and Pallone argue that time lapses between USPSTF recommendations and decreased funding have resulted in a disconnect between best clinical practices and the most recent USPSTF recommendations.

Energy and Commerce Committee Leadership Request Update on FDA’s Efforts to Improve Food Safety

On July 12, Reps. Cathy McMorris Rodgers (R-WA), Frank Pallone (D-NJ), Brett Guthrie (R-KY), Anna Eshoo (D-CA), Morgan Griffith (R-VA) and Diana DeGette (D-CO) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf requesting an update on the agency’s plans to improve food safety. The members cited concerns with the FDA’s recent handling of the infant formula shortage.

Rep. Huffman Introduces Bill to Increase HCSM Transparency

On July 11, Rep. Jared Huffman (D-CA) introduced the Health Share Transparency Act, which would provide consumers with information directly before they enroll in Health Care Sharing Ministry (HCSM) coverage, in an effort to prevent deceptive practices. Health Care Sharing Ministries are organizations in which healthcare costs are shared among members, who are typically of the same religious group. HCSM members generally contribute monthly payments to cover the expenses of other members. The bill also includes measures to hold accountable HCSMs that fail to make timely disclosures. In a press release, Rep. Huffman argued that HCSMs sometimes take advantage of citizens seeking care, and use their religious basis to avoid regulation.

Senate

Sen. Manchin Expresses Support for Limited Budget Reconciliation Package

On July 14, Sen. Joe Manchin (D-WV) said he would only support a budget reconciliation package with provisions that permit two years of Affordable Care Act (ACA) tax credits and Medicare drug price negotiations. Sen. Manchin’s position means that Democrats will have to decide whether to support a less ambitious reconciliation package that leaves out measures to address the Medicare trust fund tax loophole and the Medicaid gap. Manchin has said he will not support other provisions related to climate change and tax changes. The tight margins in the Senate mean that Sen. Manchin’s vote is needed to pass the reconciliation package.

Sens. Warren, Booker and Padilla Call for Declaration of National and Public Health Emergency Due to Restrictions to Reproductive Care

On July 14, Sens. Elizabeth Warren (D-MA), Cory Booker (D-NJ) and Alex Padilla (D-CA) led a group of 18 Senate Democrats in a letter to President Biden and Health and Human Services (HHS) Secretary Xavier Becerra calling for the declaration of a national and public health emergency due to Americans’ lack of access to reproductive care. In the letter, the senators state that declaring a national and public health emergency would ensure that abortion and reproductive care are available and affordable.

Sen. Burr Introduces New Bill to Reauthorize FDA User Fee Programs

On July 14, Sen. Richard Burr (R-NC) introduced the Food and Drug Administration Simple Reauthorization Act. The bill would reauthorize the Food and Drug Administration’s (FDA) prescription, generic, biosimilar and medical device user fee agreements. Sen. Burr’s bill is a narrower version of the Food and Drug Administration Safety and Landmark Advancements Act, which passed the Senate Health, Education, Labor and Pensions Committee in June. Sen. Burr’s version does not contain measures granting the FDA authority to regulate cosmetics, dietary supplements, laboratory-developed tests and other measures that he believes could stifle innovation. Sen. Patty Murray (D-WA), Chair of the Health, Education, Labor and Pensions Committee which has jurisdiction over the FDA stated she was still interested in the broader bill the committee produced. Reps. Frank Pallone (D-NJ) and Cathy McMorris Rodgers (R-WA) stated that Sen. Burr’s bill will only delay the user fee reauthorization process. If the user fee reauthorization is not passed by September, a number of FDA programs will be disrupted and staff will have to be let go.

Sens. Feinstein, Murray and Warren Ask for Robust Funding for the Title X Family Planning Program

On July 13, Sens. Dianne Feinstein (D-CA), Patty Murray (D-WA) and Elizabeth Warren (D-MA) led a group of 15 senators in a letter to congressional leadership calling for robust funding for the Title X Family Planning Program. The senators argued that the Title X Family Planning Program, which provides birth control and family planning services, needs more funding now that 19 states have moved to impose bans or severe restrictions on abortion. A companion letter in the House was led by Reps. Judy Chu, Dina Titus (D-NV), Chrissy Houlahan (D-PA), Diana DeGette (D-CO) and Barbara Lee (D-CA) and was signed by 128 members.

Administration

HHS Publishes Guidance on Pharmacies’ Obligations to Provide Reproductive Health Services

On July 13, the Department of Health and Human Services (HHS) issued guidance reminding retail pharmacies of their obligations to ensure comprehensive reproductive healthcare services under federal civil rights laws. The guidance stresses that pharmacies are recipients of federal financial assistance, including Medicare and Medicaid payments, and are thus prohibited from engaging in any discrimination based on race, color, national origin, sex, age, disability and current, past, potential or intended pregnancy in their programs and activities. The guidance is part of wider efforts to ensure patient access to reproductive healthcare.

HHS Secures 3.2 Million Doses of Novavax’s COVID-19 Vaccine

On July 11, the Department of Health and Human Services (HHS) and the Department of Defense (DOD) announced that it had secured 3.2 million doses of Novavax’s COVID-19 vaccine, which will be distributed without cost to states, jurisdictions, federal pharmacy partners and federal qualified health centers upon receiving emergency use authorization from the Food and Drug Administration (FDA) and a recommendation from the Centers for Disease Control and Prevention (CDC).

HHS OCR Announces Enforcement Actions Under HIPAA Right of Access Initiative

On July 15, the Health and Human Services (HHS) Department’s Office of Civil Rights (OCR) announced that 11 investigations carried out under its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative had been resolved. This brings the total number of enforcement actions under the program to 38.

CMS Approves Reinsurance Waiver Extensions in Alaska, Oregon and Minnesota

On July 13, the Centers for Medicare and Medicaid Services (CMS) approved requests from Alaska, Oregon and Minnesota to extend their reinsurance program under the Affordable Care Act’s (ACA) Section 1332 waivers for an additional five years.

CMS Issues Guidance Stating that Federal Law Requiring Emergency Medical Care to Include Abortion Services

On July 11, the Centers for Medicare and Medicaid Services (CMS) issued guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA). The guidance clarifies that providers are protected by the EMTALA when offering abortion services to save an individual’s life or health in an emergency situation. The letter warns that hospitals and providers that do not comply with the EMTALA could be kicked out of Medicare. The Department of Health and Human Services (HHS) Secretary also wrote a letter on the subject to providers, stressing that the EMTALA preempts state law restricting abortion access in emergency situations.

FDA Grants EUA for Novavax’s COVID-19 Vaccine

On July 13, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) of Novavax’s COVID-19 vaccine for individuals 18 years old and above.

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,
• 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:

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 “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 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 go into effect 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.

Courts

Texas Attorney General Sues HHS Over Recent Emergency Abortion Guidance

On July 14, the Texas Attorney General filed a lawsuit to challenge the Department of Health and Human Services’ (HHS) July 11 guidance that says that the Emergency Medical Treatment and Labor Act (EMTLA) preempts state abortion bans in emergency care situations. In the lawsuit, the Texas Attorney General argues that HHS did not follow the proper rulemaking procedure and the guidance violates states’ rights.

Reports

GAO Report on CDC’s Air Travel Contact Tracing

On July 11, the Government Accountability Office (GAO) published a report titled “Contact Tracing for Air Travel: CDC’s Data System Needs Substantial Improvement.” The report states that the manner in which the Centers for Disease Control and Prevention (CDC) collects and manages passengers’ information complicates efforts to facilitate contact tracing. The report includes recommendations to improve the CDC’s air passenger data system.

CBO Cost Estimate of the INSULIN Act

On July 14, the Congressional Budget Office (CBO) published a cost report of the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act. The bill would cap out-of-pocket costs for insulin products and would require coverage of certified insulin products. The CBO estimates that the cost the private sector would face in complying with the bill’s measures would exceed the annual private sector threshold of $184 million that was established in the Unfunded Mandates Reform Act.