This week in Washington: HHS and CMS nominations move forward.

Upcoming Hearings/Markups

Congress

House

• Representatives Ask HHS Secretary Becerra to Extend Deadline to Spend COVID-19 Provider Relief Funds
• Bipartisan Bill to Protect 340B Eligibility for Hospitals Introduced
• Bipartisan Bill to Curb Youth Vaping Reintroduced
• 13 Healthcare Bills Passed the House This Week

Senate

• Brooks-LaSure’s Nomination for CMS Administrator Advances Out of Finance Committee
• Andrea Palm Confirmed as HHS Deputy Secretary

Administration

• HHS to Enforce the Affordable Care Act’s Anti-Discrimination Protections
• FDA Authorizes Pfizer’s COVID-19 Vaccine for Children Aged 12-15
• CDC Issues Additional Guidance for Fully Vaccinated Individuals
• CMS Guidance on American Rescue Plan Medicaid Match
• CMS Publishes Article on Takeaways from AI Challenge
• CMS Finds Vulnerable Americans are Forgoing Mental Health Care Due to the COVID-19 Pandemic

Proposed Rules

• CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals
• CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
• CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase
• CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System
• CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

Final Rule

• CMS Interoperability and Patient Access Rule Now in Effect

Reports

• GAO Report on Maternal Mortality and Morbidity

Upcoming Hearings/Markups

May 18

House Committee on Oversight and Reform Hearing: “Unsustainable Drug Prices (Part III): Testimony from AbbVie CEO Richard Gonzalez”
10:00 a.m.
For more information, click here.

May 19

Senate Committee on Homeland Security and Governmental Affairs Hearing: “COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps”
2:30 p.m.
For more information, click here.

House

Representatives Ask HHS Secretary Becerra to Extend Deadline to Spend COVID-19 Provider Relief Funds

In a May 11 letter, 77 representatives sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra stating their concern that existing program requirements limit providers from making full use of COVID-19 relief. They asked Becerra to extend the deadline to spend provider relief funds and expedite distribution of the remaining COVID-19 relief.

The letter can be found here.

Bipartisan Bill to Protect 340B Eligibility for Hospitals Introduced

On May 13, Reps. Doris Matsui (D-CA), Chris Stewart (R-UT), Cindy Axne (D-IA), David McKinley (R-WV), Abigail Spanberger (D-VA) and Dusty Johnson (R-SD) introduced a bill to protect hospitals from losing eligibility for the 340B drug pricing program during the COVID-19 public health emergency.

A press release from Matsui’s office can be found here.

Bipartisan Bill to Curb Youth Vaping Reintroduced

On May 13, Reps. David Trone (D-MD), Raja Krishnamoorthi (D-IL) and Chris Steward (R-UT) reintroduced the Accurate Reporting of Smoking Variants Act. The bill would require the National Coordinator for Health Information Technology to ensure that electronic health records (EHRs) allow doctors to record vaping and e-cigarette use, understand the long-term impacts of these products and develop strategies to curb vaping among young people.

The bill text can be found here.

13 Healthcare Bills Passed the House This Week

This past week, the House passed 13 healthcare bills. The bills are listed and linked below.

• H.R. 433, the Family Support Services for Addiction Act
• H.R. 1475, the Pursuing Equity in Mental Health Act
• H.R. 586, the Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act
• H.R. 721, the Mental Health Services for Students Act
• H.R. 1260, the Bipartisan Solution to Cyclical Violence Act
• H.R. 1205, Improving Mental Health Access from the Emergency Department Act
• H.R. 1324, the Effective Suicide Screening and Assessment in the Emergency Department Act
• H.R. 1480, the Helping Emergency Responders Overcome (HERO) Act
• H.R. 2862, the Campaign to Prevent Suicide Act
• H.R. 2981, the Suicide Prevention Lifeline Improvement Act
• H.R. 2955, the Suicide Prevention Act
• H.R. 768, the Block, Report, and Suspend Suspicious Shipments Act
• H.R. 2877, Behavioral Intervention Guidelines Act

A joint statement from Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Health Subcommittee Chair Anna Eshoo (D-CA) about the above bills can be found here.

Senate

Brooks-LaSure’s Nomination for CMS Administrator Advances Out of Finance Committee

On May 12, the Senate voted 51 to 48 to advance the nomination of Chiquita Brooks-LaSure for administrator of the Centers for Medicare and Medicaid Services (CMS) after majority leader Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee. Republican Sens. Susan Collins (R-ME) and Jerry Moran (R-KS) joined Democrats in supporting the motion. Next, Sen. Schumer will need to file cloture to limit floor debate on the confirmation. If the Senate passes cloture, Brooks-LaSure’s nomination will go before the full Senate for a final vote. A simple majority is needed to confirm both the cloture and the nomination.

Andrea Palm Confirmed as HHS Deputy Secretary

On May 11, the Senate voted 61-37 to confirm Andrea Palm as deputy secretary of Health and Human Services (HHS). Palm previously served as Wisconsin’s top health official.

Administration

HHS to Enforce the Affordable Care Act’s Anti-Discrimination Protections

On May 10, the Department of Health and Human Services (HHS) announced that the Office of Civil Rights will interpret Section 1557 and Title IX’s prohibitions on discrimination based on sex as including discrimination on the basis of sexual orientation and gender identity. This update was made in light of the U.S. Supreme Court decision in Bostock v. Clayton County in June 2020.

FDA Authorizes Pfizer’s COVID-19 Vaccine for Children Aged 12-15

On May 10, the Food and Drug Administration (FDA) authorized Pfizer-BioNTech’s COVID-19 vaccine for use in children aged 12 to 15. This decision authorizes the Pfizer-BioNTech vaccine for all Americans aged 12 and older. The decision comes as the Biden administration attempts to get as many adolescents vaccinated as possible by July 4.

CDC Issues Additional Guidance for Fully Vaccinated Individuals

On May 13, the Centers for Disease Control and Prevention (CDC) announced that anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or social distancing. People traveling on public transportation are still required to wear masks.

The CDC stated that this decision was made with evidence that COVID-19 cases in the U.S. dropped by a third in the past two weeks, as well as other studies that demonstrated the effectiveness of the COVID-19 vaccine in preventing infection. The CDC notes that unvaccinated people should continue to wear masks, and if the virus changes course, recommendations could change.

CMS Guidance on American Rescue Plan Medicaid Match

On May 13, the Centers for Medicare and Medicaid Services released guidance on the increase in federal Medicaid matching funds for home- and community-based services detailed in the American Rescue Plan (ARP). The ARP allows states to spend this funding until March 31, 2024. The additional funds will allow for individuals with disabilities to better access health services in their homes and communities rather than in nursing homes or other institutions.

Section 9817 of the ARP provides states with a temporary 10 percentage point increase to the federal medical assistance percentage (FMAP) for certain Medicaid HCBS from April 1, 2021, through March 31, 2022, to improve HCBS under the Medicaid program.

The state Medicaid director letter can be found here.

CMS Publishes Article on Takeaways from AI Challenge

On May 13, the Centers for Medicare and Medicaid Services (CMS) published a blog article highlighting lessons learned from the CMS Artificial Intelligence Health Outcomes Challenge (“AI Challenge”). The blog article, co-authored by Center for Medicare and Medicaid Innovation Director Liz Fowler and Jim Gerber, who led the AI Challenge, reflects on key takeaways from hosting the AI Challenge, which include a strong, diverse participant interest; impressive participant submissions; and beneficial public-private partnerships.

For more, please see the blog post here.

CMS Finds Vulnerable Americans are Forgoing Mental Health Care Due to the COVID-19 Pandemic

On May 14, the Centers for Medicare and Medicaid Services (CMS) released data that showed that Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries have forgone millions of primary, preventive and mental health care visits due to the COVID-19 public health emergency (PHE). Although utilization rates for some treatments have returned to pre-pandemic levels, mental health services show the slowest rebound. This data comes at a time when evidence has shown that mental health conditions among Americans have worsened. This gap in service utilization for mental health services may have a considerable impact on long-term health outcomes.

In an effort to fill the gap, CMS recently launched the Connecting Kids to Coverage National Campaign, a national outreach and enrollment initiative funded by the Children’s Health Insurance Program Reauthorization Act (CHIPRA) and the Affordable Care Act (ACA). In addition, the American Rescue Plan provided $3 billion in block grant funding to address mental health and substance use prevention.

The data can be found here.

Proposed Rules

CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals

On April 27, the Centers for Medicare and Medicaid Service (CMS) issued a proposed rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.”

The proposed rule would update Medicare fee-for-service payment rates and policies for inpatient hospitals and long-term care hospitals for fiscal year (FY) 2022. CMS is publishing this proposed rule to meet the legal requirements to update Medicare payment policies for IPPS hospitals and LTCHs on an annual basis. A fact sheet that discusses major provisions of the proposed rule can be downloaded from the Federal Register here.

The public comment period closes on June 28.

The rule can be found here.

CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year (FY) 2022.” In the rule, CMS proposes increasing skilled nursing facilities’ (SNF) pay a net 1.3 percent, or $444 million, in FY 2022 and adding two new quality reporting measures in FY 2021: vaccination rates among health care workers and health care–acquired infections.

The proposed rule also asks for public comments on potential ways to readjust the Patient Driven Payment Model (PDPM), a patient payment classification system created in 2019 to be budget-neutral but that data shows caused an unintended $1.7 billion increase in payments in fiscal year 2020. It is possible that the data was affected by the COVID-19 pandemic.

CMS proposes to add a new claims-based measure, health care–associated infections (HAI), to the quality reporting, which would use Medicare fee-for-service claims data to estimate the rate of health care–associated infections acquired during nursing home care that result in hospitalization. The goal is to assess which nursing homes have higher rates of infections acquired during care. The proposed rule also suggests several changes to the SNF Quality Reporting Program and seeks feedback on plans to define digital quality measures for the program. The proposed rule would also alter the SNF Value-Based Purchasing Program, which offers incentive payments to nursing homes based on the quality of care.

Public comments on the proposed rule will be accepted until June 7.

The rule can be found here.

CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The proposed rule would increase payments in FY 2022 by 2.3 percent, or $530 million. Providers that do not meet the quality reporting requirements will receive a 2 percentage point reduction to their annual market basket update. The proposed rule also would increase the aggregate payment cap from $30,683.93 in 2021 to $31,389.66 for fiscal year 2022, a 2.3 percent increase.

The proposed rule would also revise the labor shares based on the compensation cost weights for each level of care, with labor share at 74.6 percent for continuous home care, 64.7 percent for routine home care, 60.1 percent for inpatient respite care and 62.8 percent for general inpatient care. In addition, the proposed rule would make the pseudo-patient waiver for hospice aide competency testing permanent and let pseudo-patients be used for hospice aide competency training. It would also have hospices conduct a competency evaluation related to whatever deficiencies and related skills a hospice aide supervisor noted. Also, the rule would allow CMS to modify the Hospice Quality Reporting Program by adding measures meant to promote health equity measures.

Comments are accepted until June 7.

The proposed rule can be found here.

CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

On April 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates for facilities under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP) for fiscal year (FY) 2022. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for IRFs on an annual basis.

For FY 2022, CMS proposes to update the IRF PPS payment rates by 2.2 percent based on the proposed IRF market basket update of 2.4 percent, less a 0.2 percentage point multi-factor productivity (MFP) adjustment. IRFs that do not meet reporting requirements are subject to a 2 percentage point (2.0 percent) reduction in their annual increase factor. With the objective of advancing racial equity, CMS plans to utilize several social determinants of health measures and is seeking feedback. In addition, the rule proposes using COVID-19 vaccination coverage measures and updating transfer of health (TOH) information to determine quality of care.

Comments are accepted until June 7.

The proposed rule 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.

Final Rule

CMS Interoperability and Patient Access Rule Now in Effect

May 1 marked the effective date for a Centers for Medicare and Medicaid Services (CMS) rule first published in May 2020, titled “Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers.”

The rule included revisions to the hospital Conditions of Participation (CoPs) that would require hospitals that utilize electronic medical records systems or electronic administrative system to send electronic patient event notifications of a patient’s admission, discharge and/or transfer to applicable post-acute care service providers and suppliers that a patient considers primarily responsible for their care.

CMS guidance on the rule can be found here.

The rule can be found here.

Courts

Find a comprehensive look at “The Courts and Healthcare Policy” here.

Reports

GAO Report on Maternal Mortality and Morbidity

On May 10, the Government Accountability Office (GAO) released a report titled “Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas.” The report found there is a greater risk of maternal deaths during pregnancy or soon after among rural residents. The GAO recommends the disaggregation of data on maternal health outcomes collected by the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to allocate resources where most needed. GAO also recommends that the Department of Health and Human Services’ (HHS) workgroups establish a formal coordinated approach for monitoring maternal health efforts.

The complete report can be found here.