This week in Washington:

Infrastructure, Executive Order on Anti-competitiveness, House Appropriations Committee Acts on Labor-HHS Appropriations Bill, Senate Budget Committee Democrats Agree on Budget Resolution.

Upcoming Hearings/Markups

Congress

House

• House Energy and Commerce Health Subcommittee Holds Markup of 19 Bills
• House Appropriations Committee Approves FY 2022 Funding Bill
• Rep. Doggett Introduces Bill to Provide Dental, Vision and Hearing Care in Medicare

Senate

• Senate Budget Committee Democrats Agree on $3.5 Billion Budget Resolution
• Democratic Senators Introduce Bill That Would Direct CMS to Create a Federal Medicaid-Style Program
• Sen. Schumer Releases Draft Legislation to Decriminalize Cannabis

Administration

• President Biden Executive Order Cracking Down on Anticompetitive Business Practices That Apply to the Health Care Sector
• HHS Says Provider Relief Reporting Deadline Will Not Be Extended
• Meena Seshamani Appointed as Deputy Administrator of CMS and Center for Medicare Director
• CMS Begins NCD Analysis for Alzheimer’s Disease Treatment
• CMS Announces Grant Funding Available for Mobile Crisis Intervention Services
• CMS Announces Ad Campaign to Incentivize ACA Enrollment
• CMS Issues NOFO for the SUPPORT for Patients and Communities Act Post-Planning Period
• FDA and CDC State That COVID-19 Booster Vaccines are not Currently Necessary
• Acting FDA Director Calls for Investigation into Aduhelm Approval
• Health Care Fraud and Abuse Control Program Annual Report

Proposed Rules

• CMS Issues CY 2022 Medicare Physician Fee Schedule Proposed Rule
• CMS Issued Proposed Rule for End-Stage Renal Disease Prospective Payment System
• CMS Proposes 2022 Home Health Prospective Payment System Rate Update
• CMS Issues Proposed Rule to Delay Medicaid Multiple Best Price Policy
• CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

Reports

• GAO Report on VA Disability Benefits Appeals Process
• GAO Report on the Health Care Costs of Firearm Injuries
• MedPAC Publishes its July 2021 Data Book

Upcoming Hearings/Markups

July 20

Senate Health, Education, Labor and Pensions Committee Hearing: “The Path Forward: A Federal Perspective on the COVID-19 Response”
10:00 a.m.
For more information, click here.

House Education and Labor Committee, Subcommittee on Health, Employment, Labor and Pensions; and on Higher Education and Workforce Investment Hearing: “Care for Our Communities: Investing in the Direct Care Workforce”
10:15 a.m.
For more information, click here.

July 21

Senate Health, Education and Labor Committee, Subcommittee on Primary Health and Retirement Security Hearing: “Addressing Disparities in Life Expectancy”
10:00 a.m.
For more information, click here.

Congress

House

House Energy and Commerce Health Subcommittee Holds Markup of 19 Bills

On July 15, the House Energy and Commerce Committee Subcommittee on Health held a markup of 19 bills. All of the bills were reported favorably to the full committee. The bills can be found below.

• H. R. 4369, the “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act”
• H. R. 654, the “Drug-Free Communities Pandemic Relief Act”
• H. R. 2051, the “Methamphetamine Response Act of 2021”
• H. R. 2379, the “State Opioid Response Grant Authorization Act of 2021”
• H. R. 2364, the “Synthetic Opioid Danger Awareness Act”
• H. R. 2355, the “Opioid Prescription Verification Act of 2021”
• H. R. 2503, the “Social Determinants Accelerator Act of 2021”
• H. R. 4026, the “Social Determinants of Health Data Analysis Act of 2021”
• H. R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”
• H. R. 550, the “Immunization Infrastructure Modernization Act”
• H. R. 1550, the “Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
• H. R. 951, the “Maternal Vaccination Act”
• H. R. 925, the “Data to Save Moms Act”
• H. R. 4387, the “Maternal Health Quality Improvement Act of 2021”
• H. R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
• H. R. 1978, the “Protecting Seniors Through Immunization Act”
• H. R. 2347, the “Strengthening the Vaccines for Children Program Act”
• H. R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021” or the “CARING for Social Determinants Act of 2021”
• H. R. 4406, the “Supporting Medicaid in the U.S. Territories Act”

House Appropriations Committee Approves FY 2022 Funding Bill

On July 15, the House Appropriations Committee approved the fiscal year (FY) 2022 Labor, Health and Human Services, Education, and Related funding bill with a vote of 32-25. The bill would provide HHS with $119.8 billion, which is $22.9 billion above the 2021 amount but $129 million lower than President Biden’s May budget request. The bill would give the National Institutes of Health (NIH) $3 billion to create the Advanced Research Projects Agency for Health (ARPA-H), less than the $6.5 billion requested by President Biden. Two amendments were adopted by a voice vote.

The bill text, before the adoption of the amendments, can be found here.

Rep. Doggett Introduces Bill to Provide Dental, Vision and Hearing Care in Medicare

On July 6, Rep. Lloyd Doggett (D-TX) introduced the Medicare Dental, Vision and Hearing Benefit Act, which would add dental, vision and hearing benefits to Medicare. The bill would treat dental, vision and hearing care the same as existing health care under Medicare, with no cost-sharing or preventative care, with no more than 20 percent copay for all other services. The bill has the support of 75 members of Congress.

The press release for the bill can be found here.

Senate

Senate Budget Committee Democrats Agree on $3.5 Billion Budget Resolution

On July 12, the Senate Budget Committee Democrats agreed on a budget resolution that would add dental, hearing and vision benefits to Medicare. The resolution would cost $3.5 billion and would be paid for with tax changes. Senate Majority Leader Chuck Schumer (D-NY) stated the budget resolution includes priorities President Biden detailed in the American Jobs Plan and the American Families Plan.

Democratic Senators Introduce Bill That Would Direct CMS to Create a Federal Medicaid-Style Program

On July 12, Sens. Raphael Warnock (D-GA), Jon Ossoff (D-GA) and Tammy Baldwin (D-WI) introduced the Medicaid Saves Lives Act. The bill would direct the Centers for Medicare and Medicaid Services (CMS) to create a federal Medicaid-style program. The program, which would be administered by CMS, would be available to people in non-Medicaid expansion states that earn up to 138 percent of the federal poverty level.

The bill text can be found here.

A fact sheet on the bill can be found here.

Sen. Schumer Releases Draft Legislation to Decriminalize Cannabis

On July 14, Senate Majority Leader Chuck Schumer (D-NY), along with Sens. Ron Wyden (D-OR) and Corey Booker (D-NJ), released a draft of the Cannabis Administration and Opportunity Act. The bill would remove cannabis from the federal list of controlled substances, provide for the expungement of certain cannabis offenses and devote resources to communities that were harmed during the War on Drugs.

The draft bill text can be found here.

A summary of the draft bill can be found here.

Administration

President Biden Executive Order Cracking Down on Anticompetitive Business Practices That Apply to the Health Care Sector

On July 9, President Biden signed an executive order aimed to counter anticompetitive business practices that apply to the health care sector. The executive order:

• Directs the Food and Drug Administration (FDA) to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003;
• Directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which provide low-cost options for patients;
• Directs HHS to issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging;
• Encourages the FTC to ban “pay for delay” and similar agreements by rule;
• Directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter;
• Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers;

• Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing; and
• Directs HHS to standardize plan options in the National Health Insurance Marketplace so people can comparison shop more easily.

For more information, find the fact sheet here.

The executive order can be found here.

HHS Says Provider Relief Reporting Deadline Will Not Be Extended

On July 8, the Department of Health and Human Services (HHS) stated that provider relief recipients will not receive an extension beyond Sept. 30 to report their relief fund usage. In addition, provider relief recipients must prove that they used the money to respond to the COVID-19 pandemic, and any funds unspent by June 30 will need to be returned to HHS by Oct. 30. The provider relief portal went live on July 1.

Meena Seshamani Appointed as Deputy Administrator of CMS and Center for Medicare Director

On July 6, the Biden administration announced that Meena Seshamani will be the deputy administrator of the Centers for Medicaid and Medicare Services (CMS) and the Center for Medicare director. Seshamani was formerly the director of the Health Reform Office at the Department of Health and Human Services (HHS).

CMS Begins NCD Analysis for Alzheimer’s Disease Treatment

On July 12, the Centers for Medicare and Medicaid Services (CMS) opened a National Coverage Determination (NCD) analysis that will allow the agency to review and decide if Medicare will establish a national coverage policy for monoclonal antibodies targeting amyloid in the treatment of Alzheimer’s disease. The NCD analysis will apply to national coverage considerations for recently FDA-approved aducanumab and future monoclonal antibodies that target amyloid. The announcement marked the beginning of a 30-day public comment period. In addition, CMS will hold two public listening sessions to gather public input.

After the analysis is complete, CMS will post a proposed NCD, which will be open to another 30-day public comment period. After reviewing these comments, CMS will announce its final decision for a national policy.

Public comments can be viewed and submitted here.

To register for the July 22 listening session, click here. To register for the July 27 listening session, click here.

CMS Announces Grant Funding Available for Mobile Crisis Intervention Services

On July 12, the Centers for Medicare and Medicaid Services (CMS) announced that funds from the American Rescue Plan will be used to fund programs that send crisis intervention teams to people experiencing mental health and substance use challenges that require emergency care. The $15 million funding opportunity is available to state Medicaid agencies. States and territories that wish to apply should submit a letter of intent by July 23 and submit their final applications by Aug. 13.

CMS Announces Ad Campaign to Incentivize ACA Enrollment

On July 15, the Centers for Medicare and Medicaid Services (CMS) announced a new advertising campaign called “Summer Sprint to Coverage” that will encourage Americans, specifically traditionally underserved and minority populations, to enroll in Affordable Care Act coverage. The advertising campaign will run for the last 30 days of the special enrollment period that is set to end Aug. 15. Approximately 2 million have registered for plans via healthcare.gov or state-based exchanges since the Feb. 15 special enrollment period began.

CMS Issues NOFO for the SUPPORT for Patients and Communities Act Post-Planning Period

On July 9, the Centers for Medicare and Medicaid Services (CMS) released a notice of funding opportunity (NOFO) soliciting applications for the Substance Use Disorder (SUD) Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act post-planning period demonstration project. The project aims to increase the treatment capacity of providers participating in the state’s Medicaid program to provide SUD treatment and recovery services. The demonstration project is only open to the 15 states receiving planning grants.

A technical supplement with more details about how the agency will implement the SUPPORT Act payment provision can be found here.

The NOFO can be found here.

FDA and CDC State That COVID-19 Booster Vaccines are not Currently Necessary

On July 8, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released a statement that stated that fully vaccinated Americans do not need a COVID-19 booster vaccination at this time.

The statement comes after Pfizer and BioNTech stated that data shows that COVID-19 immunity begins to decrease six months to a year after vaccination, demonstrating the need for a third dose.

The official statement can be found here.

Acting FDA Director Calls for Investigation into Aduhelm Approval

In a June 9 letter, acting director of the Food and Drug Administration (FDA) Janet Woodcock called on the Department of Health and Human Services (HHS) to conduct an independent investigation into FDA’s approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab). The letter states that an independent assessment will help determine if any interactions occurred between the manufacturer and FDA review staff that are inconsistent with agency procedures.

Woodcock shared the letter on Twitter, and it can be found linked here.

Health Care Fraud and Abuse Control Program Annual Report

The Health Care Fraud and Abuse Control (HCFAC) program FY 2020 annual report released in July found that the program returned $3.1 billion to the federal government or private citizens in 2020, a slightly smaller amount than the previous year. HCFAC was created to identify fraud and abuse in public and private health care plans and is administered by the Department of Health and Human Services (HHS) and the Department of Justice (DOJ). The report notes that there has been a $4.30 return for every $1.00 spent on the HCFAC program from 2018-2020.

The full report can be found here.

Proposed Rules

CMS Issues CY 2022 Medicare Physician Fee Schedule Proposed Rule

On July 13, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule.” The proposed rule includes policy changes for Medicare payments under the Physician Fee Schedule (PFS) and would continue the coverage of Medicare telehealth services through the end of 2023, among other changes.

The proposed CY 2021 PFS conversion factor is $33.58, a decrease from the CY 2021 factor of $34.89. The proposed rule would also waive the provider enrollment Medicare application fee for organizations that apply as a Medicare Diabetes Prevention Program (MDPP) supplier on or after Jan. 1, 2022. In the proposed rule, CMS requests feedback on how to best update pay rates for the administration of preventive vaccines covered under Part B and whether to assign certain Section 505(b)(2) drug products to existing multiple source codes.

Comments will be accepted until Sept. 13, 2021.

The proposed rule can be found here.

The fact sheet for the rule can be found here.

For additional information on the proposed rule, click here.

CMS Issued Proposed Rule for End-Stage Renal Disease Prospective Payment System

On July 1, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.” The proposed rule would update payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services starting Jan. 1, 2022. The rule also would update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services and the ESRD Treatment Choices (ETC) Model.

Comments will be accepted until Aug. 31, 2021.

The proposed rule can be found here.

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

CMS Proposes 2022 Home Health Prospective Payment System Rate Update

On June 28, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Calendar Year (CY) 2022 Home Health Prospective Payment System Rate Update.” The rule would expand the Home Health Value-Based Purchasing (HHVBP) Model. In addition, the rule would update the Medicare Home Health Prospective Payment System (HH PPS) and the home infusion therapy services payment rates for CY 2022. In addition, the proposed rule would also make permanent changes to the home health Conditions of Participation (CoP) implemented during the COVID-19 public health emergency.

Comments will be accepted until Aug. 27.

The proposed rule can be found here.

The CMS Fact Sheet on the rule can be found here.

CMS Issues Proposed Rule to Delay Medicaid Multiple Best Price Policy

On May 26, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would delay the Medicaid Multiple Best Price Policy implementation for six months. The Medicaid Multiple Best Price Policy would require manufacturers to report multiple best prices for a drug under Medicaid if the drug manufacturer is participating in a value-based purchasing arrangement.

The original rule, which was finalized on Dec. 31, 2020, would have implemented the requirements on Jan. 21, 2022, but the Biden administration’s proposed rule would delay the implementation until July 1, 2022.

The most recent proposed rule, titled “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States,” can be found here.

CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

On May 11, the Centers for Medicare and Medicaid Services released an interim final rule titled “COVID-19 Vaccine Requirements for Long-Term Care Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities Residents, Clients, and Staff.”

The rule requires long-term care (LTC) facilities and intermediate care facilities treating individuals with intellectual disabilities to submit weekly reports on the COVID-19 vaccination status of residents and staff. In addition, the interim final rule requires LTC and intermediate care facilities to educate residents and staff about the vaccine and offer shots when supplies are available.

There is a 60-day comment period.

The rule can be found here.

Reports

GAO Report on VA Disability Benefits Appeals Process

On July 12, the Government Accountability Office (GAO) released a report titled “VA Disability Benefits: Actions Needed to Better Manage Appeals Workload Risks, Performance, and Information Technology.” The report states that a 2017 law required the Department of Veterans Affairs (VA) to implement a new appeals process for veterans who appealed their disability claim decisions. Although the VA offers more appeal options, the report notes that the VA could improve by better monitoring its decisions and plan for new information technology.

The full report can be found here.

GAO Report on the Health Care Costs of Firearm Injuries

On July 14, the Government Accountability Office (GAO) released a report titled “Firearm Injuries: Health Care Service Needs and Costs.” The report states that 40,000 people died from a gun injury in the U.S. in 2019, but there is no complete information on the health care costs of gun injuries. Using existing data on the initial hospital costs of firearm injuries, the GAO found that hospital costs were slightly over $1 billion annually, with 30,000 inpatient stays and 50,000 emergency department visits.

The full report can be found here.

MedPAC Publishes its July 2021 Data Book

On July 16, the Medicare Payment Advisory Commission (MedPAC) released its July 2021 Data Book: Health Care Spending and the Medicare Program. The data book provides information on national health care and Medicare spending, examines provider settings, and covers the Medicare Advantage program and prescription drug coverage for Medicare beneficiaries.

The data book can be found here.