This week in Washington: Reconciliation markups begin.

Congress

Upcoming Hearings/Markups

House

• Need for Continuing Resolution to Fund the Government
• House Ways and Means Committee Acts on Budget Reconciliation
• House Energy and Commerce Committee to Mark Up Budget Reconciliation
• Congressional Black and Hispanic Caucus Members Urge Congressional Leadership to Close the Medicaid Gap
• Reps. Pallone and Maloney Request More Information on FDA’s Review and Approval of Aduhelm

Administration

• President Biden Releases New COVID-19 Plan with Wider Vaccine Mandates
• Biden Administration Announces $65 Billion Plan for Pandemic Preparedness
• HHS Publishes Drug Pricing Plan
• HHS Extends Liability Protections to Pharmacists to Administer FDA-authorized COVID-19 Therapies
• HHS OIG Report on CMS’s COVID-19 Nursing Home Data
• CMS Appoints First Dental Officer in the Office of the Administrator
• CMS Issues Guidance on Medicaid and CHIP Coverage of COVID-19 Testing
• CMS to Distribute Federal Funding to 13 States for 1332 Reinsurance Waivers
• FDA Announces the Launch of the Novel Excipient Review Pilot Program
• FDA Approves Schizophrenia Drug Administered Every Six Months
• FDA Revises Guidance on Generic Drug Development and Application
• FDA to Hold Advisory Committee Meeting to Discuss Pfizer’s COVID-19 Vaccine Booster Application
• FDA Vaccine Office Heads to Leave Agency
• FDA Issues Updated Guidance on Generic Drug Data Requirements

Proposed Rules

• CMS Issues Proposed Rule to Reassign Medicaid Provider Claims
• CMS Issues Calendar Year 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule
• CMS Issues CY 2022 Medicare Physician Fee Schedule Proposed Rule

Final Rules

• CMS Issues Final Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
• CMS Issues Final Rule on Inpatient Rehabilitation Facility Prospective Payment System
• CMS Issues Final Rule on Inpatient Psychiatric Facilities Prospective Payment System
• CMS Issues Final Rule on Hospice Wage Index and Payment Rate Update
• CMS Issues Final Rule for Long-Term Care Hospital Quality Reporting Program
• FDA Issues Final Rule to Make Technical Amendments to 2015 Biologics Regulation

Courts

• Supreme Court Refuses to Block Texas Senate Bill 8

Reports

• GAO Report on Medicare Home- and Community-Based Services
• GAO Report on Changes to Nurse Corps Loan Repayment Program

Upcoming Hearings/Markups

September 13

House Energy and Commerce Committee: Markup of the Build Back Better Act
11:00 a.m.

For more information, click here.

House Veterans’ Affairs Committee: Markup of proposals to comply with the reconciliation directive included in Section 2002 of the Concurrent Resolution on the Budget for FY 2022
2:00 p.m.

For more information, click here.

Congress

House

Need for Continuing Resolution to Fund the Government

On Sept.10, Majority Leader Steny Hoyer (D-MD) stated that he expected the House to act on a Continuing Resolution (CR) the week of Sept. 20. It is expected that the CR would run approximately through Dec. 10. This would provide more time for the House and Senate to finish appropriations bills to fund the government.

House Ways and Means Committee Acts on Budget Reconciliation

On Sept. 9 and 10, the House Ways and Means Committee held a markup of the committee’s portion of what will be the budget reconciliation package.

The Ways and Means Committee proposal includes expanding Medicare coverage to include dental, vision and hearing benefits and addressing staffing shortages in long-term care facilities by providing funds for recruitment and retention including wage subsidies, child care and tuition reimbursement. In addition, the proposal includes improving accuracy and reliability of data collected in long-term care facilities. The committee will continue marking up tax issues this week.

The chairman’s mark can be found here.

House Energy and Commerce Committee to Mark Up Budget Reconciliation

On Sept. 13, the House Energy and Commerce Committee will hold a markup of their section of the budget reconciliation package. Among the proposals under consideration are drug pricing reform, addressing the Medicaid gap and making funding for the CHIP program permanent.

The chairman’s mark can be found here.

Congressional Black and Hispanic Caucus Members Urge Congressional Leadership to Close the Medicaid Gap

On Sept. 5, four members of the Congressional Black Caucus (CBC) and the Congressional Hispanic Caucus leadership wrote to Majority Leader Chuck Schumer (D-NY) and Speaker Nancy Pelosi (D-CA) urging action to close the Medicaid coverage gap. The members wrote that improving Medicaid coverage will reduce racial health inequalities. Signatories to the letter included Rep. Robin Kelly (Health Braintrust chair of the CBC), Rep. Yvette Clarke (CBC member), Rep. Joyce Beatty (CBC chair) and Rep. Raul Ruiz (Hispanic Congressional Caucus chair).

The letter can be found here.

Reps. Pallone and Maloney Request More Information on FDA’s Review and Approval of Aduhelm

On Sept. 1, Chair of the Energy and Commerce Committee Frank Pallone (D-NJ) and Chair of the Oversight and Reform Committee Carolyn Maloney (D-NY) sent a letter to Acting Food and Drug Administration (FDA) Commissioner Dr. Janet Woodcock. In the letter, Reps. Pallone and Maloney requested additional information on the review and approval of Biogen’s Alzheimer drug Aduhelm. Reps. Pallone and Maloney state that although the FDA’s Center for Drug Evaluation and Research (CDER) provided a briefing and related materials to committee staff in July, questions about the approval process remain.

The letter can be found here.

Administration

President Biden Releases New COVID-19 Plan with Wider Vaccine Mandates

On Sept. 9, the White House released a new COVID-19 response plan titled “Path out of the Pandemic.” The plan includes vaccination requirements for health care workers at facilities that receive Medicare and Medicaid funding, federal employees and large employers. In addition, the plan increases access to diagnostic tests and treatment.

The full plan can be found here.

Biden Administration Announces $65 Billion Plan for Pandemic Preparedness

On Sept. 3, the Biden administration released a $65 billion plan to prepare the U.S. for future pandemics. The plan includes measures to expand vaccine supply, therapeutics and diagnostic tests. In addition, the plan would streamline the Food and Drug Administration’s regulatory processes, improve warning and monitoring capabilities and increase the supply of personal protective equipment.

The plan would cost $65 billion over 7-10 years, with the largest amount, $24 billion, dedicated to vaccine development and distribution. The administration is asking for $15 billion to be provided through the budget reconciliation bill currently under negotiations in Congress.

The complete plan document can be found here.

The White House fact sheet on the plan can be found here.

HHS Publishes Drug Pricing Plan

On Sept. 9, the Secretary of the Department of Health and Human Services (HHS) Xavier Becerra released a plan to reduce prescription drug costs. The plan was required by a presidential executive order signed in July that gave HHS 45 days to create a plan to combat high prescription drug prices and price gouging. The plan calls for congressional and administrative actions to allow for Medicare negotiations, Part D caps and banning pay-for-delay agreements, among other things. HHS did not take a position on march-in rights.

The details of the plan can be found here.

HHS Extends Liability Protections to Pharmacists to Administer FDA-authorized COVID-19 Therapies

On Sept. 9, HHS announced that licensed pharmacists, qualified pharmacy technicians and pharmacy interns can now administer FDA-authorized COVID-19 therapies, including monoclonal antibodies, while being protected from liability under the Public Readiness and Emergency Preparedness Act.

HHS issued the PREP Act expansion as part of the Biden administration’s broader six-point plan to combat the pandemic. Biden’s plan aims to expand the number of providers who can administer COVID-19 monoclonal antibodies.

Under Biden’s plan, so-called federal monoclonal antibody strike teams also will deploy clinical personnel through HHS, the Federal Emergency Management Agency and the Defense Department to help hospitals and health systems increase the delivery of antibodies. The Biden administration plans to increase the average weekly pace of shipments of free monoclonal antibody treatment to states by 50 percent in September. Therefore, HHS sees a need to increase the pool of providers able to order and administer COVID-19 therapeutics.

HHS OIG Report on CMS’s COVID-19 Nursing Home Data

On Sept. 3, the Health and Human Services (HHS) Department’s Office of the Inspector General (OIG) released a report on the Center for Medicare and Medicaid Services’ (CMS) COVID-19 data for nursing homes. The OIG carried out an audit of the data and CMS staff to determine if the COVID-19 data for nursing homes was complete.

The OIG determined that CMS’s COVID-19 data included the required data from most nursing homes, but about 5 percent of nursing homes did not have complete or accurate data. The report notes that CMS’s quality assurance checks were not always effective in ensuring data was accurate. The report recommends that CMS provide technical assistance to nursing homes that fail quality assurance checks. In addition, the OIG also recommended that CMS make additional efforts to ensure that CMS and state COVID-19 data elements are comparable.

Nursing homes were required to report COVID-19 data starting on May 8, 2020. The Centers for Disease Control and Prevention (CDC) then aggregates the data and sends it to the CMS website to be published.

The complete report can be found here.

CMS Appoints First Dental Officer in the Office of the Administrator

On Aug. 30, the Centers for Medicare and Medicaid Services (CMS) announced that Dr. Natalia Chalmers was appointed as the first-ever chief dental officer in the Office of the Administrator. Although CMS has employed other chief dental officers, Dr. Chalmers’ appointment marks the first time the role is located within the Office of the Administrator. This decision comes as the agency faces pressure to expand Medicare dental benefits.

The CMS press release can be found here.

CMS Issues Guidance on Medicaid and CHIP Coverage of COVID-19 Testing

On Aug. 30, the Centers for Medicare and Medicaid Services (CMS) issued a guidance on Medicaid and Children’s Health Insurance Program (CHIP) coverage and reimbursement of COVID-19 testing. The American Rescue Plan Act of 2021 required state Medicaid and CHIP programs to cover all Food and Drug Administration (FDA)-authorized COVID-19 tests without cost-sharing obligations. In addition, the notice clarifies that states can cover habilitation services provided to children enrolled in Section 1915(c) or 1915(i) waiver or program. However, states can only cover these services if the habilitation services are not available through local government agencies, and this is only allowed during the COVID-19 public health emergency.

The guidance can be found here.

CMS to Distribute Federal Funding to 13 States for 1332 Reinsurance Waivers

On Sept. 7, the Centers for Medicare and Medicaid Services (CMS) announced it would distribute an additional $452 million in federal funding to support 13 states’ efforts to improve access to health insurance coverage through already-approved Section 1332 reinsurance waivers. These funds, known as “pass-through funding,” are determined by the Departments of the Treasury and Health and Human Services annually, and are available to states with approved Section 1332 waivers. The American Rescue Plan granted additional flexibility, allowing residents in states implementing reinsurance waivers access to affordable health insurance coverage.

FDA Announces the Launch of the Novel Excipient Review Pilot Program

On Sept. 7, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the launch of the voluntary Novel Excipient Review Pilot Program. The pilot program will give excipient manufacturers the chance to obtain FDA review on certain novel expedients prior to their use in drug formulations. The pilot program will be available for excipients that have not been previously used in FDA-approved products and do not have an established use in food. Excipients that meet these requirements can then enter a two-step approval process. The deadline for proposals is Dec. 7, 2021.

For more information on the pilot program and how to apply, click here.

FDA Approves Schizophrenia Drug Administered Every Six Months

On Sept. 7, the Food and Drug Administration (FDA) approved Invega Hafyera (paliperidone palmitate), an extended-release injectable suspension used to treat schizophrenia in some adults. Invega Hafyera is the first schizophrenia medication to be injected once every six months. Other long-acting injectable antipsychotics are administered from every few weeks to every three months.

FDA Revises Guidance on Generic Drug Development and Application

On Sept. 8, the Food and Drug Administration (FDA) revised industry guidance on the development of abbreviated new drug applications (ANDAs) during the COVID-19 pandemic. The guidance was originally published in April 2021. The revision includes clarification on when the FDA will accept requests to receive ANDAs with less than the recommended stability data as well as additional information on what should be done when a test product batch expires.

The revised guidance can be found here.

FDA to Hold Advisory Committee Meeting to Discuss Pfizer’s COVID-19 Vaccine Booster Application

On Sept. 1, the Food and Drug Administration (FDA) announced the Vaccines and Related Biological Products Advisory Committee will meet on Sept. 17 from 8:30 a.m. to 3:45 p.m. to discuss additional doses of COVID-19 vaccines. The advisory committee will specifically discuss the Pfizer-BioNTech application for administration of a third dose of its vaccine for individuals 16 years old and above.

FDA Vaccine Office Heads to Leave Agency

In an Aug. 31 memo, the Food and Drug Administration’s (FDA) biologics center director Peter Marks announced the departure of two senior members of the FDA’s Office of Vaccines Research and Review. Marion Gruber currently serves as the director of the vaccine office and will retire on Oct. 31. Phil Krause, deputy director of the vaccine office, will leave the agency in November. The FDA’s Office of Vaccines Research and Review was central to the FDA’s COVID-19 vaccine review and approval process.

FDA Issues Updated Guidance on Generic Drug Data Requirements

On Sept. 8, the Food and Drug Administration (FDA) published a revised question-and-answer guidance that stated that some generic drug manufacturers seeking FDA approval can skip submitting some stability data if the generic drugs are in shortage, have the potential to be vulnerable to shortage or could assist in combatting the COVID-19 pandemic.

The guidance can be found here.

Proposed Rules

CMS Issues Proposed Rule to Reassign Medicaid Provider Claims

On July 30, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The proposed rule would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner’s behalf.

Comments will be accepted until Sept. 28.

The proposed rule can be found here.

CMS Issues Calendar Year 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule

On July 19, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Calendar Year (CY) 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule.” CMS is required by the Jan. 2021 Hospital Price Transparency Final Rule to update Medicare payment policies for OPPS hospitals and ASCs on an annual basis. In the proposed rule, CMS proposes several changes aimed at increasing compliance and reducing hospital burden. These changes include setting a minimum civil monetary penalty (CMP) of $300 a day that would apply to smaller hospitals and apply a $10/bed/day charge for hospitals with a bed count over 30, not to exceed a daily amount of $5,500. The minimum total penalty amount for a full year of noncompliance would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.

CMS is seeking input on how to make data on health disparities based on social risk factors more comprehensive. The proposed rule includes a request for information (RFI) to seek public input on establishing rural emergency hospitals (REHs). CMS is also proposing changes to the Radiation Oncology (RO) Model and halting the elimination of the inpatient-only list. The final rule will be published in early November.

Comments will be accepted until Sept. 17.

The fact sheet on the proposed rule can be found here.

The proposed rule can be found here.

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.

Final Rules

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

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final 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 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements.” The final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the final rule includes a forecast error adjustment for FY 2022, updates the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), rebases and revises the SNF market basket, implements a recently enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates and includes a discussion of a PDPM parity adjustment. The regulations are effective Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule on Inpatient Rehabilitation Facility Prospective Payment System

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection with Such Wheelchairs.” The final rule provides updates to and finalized proposals for the fiscal year (FY) 2022 Inpatient Rehabilitation Facilities Quality Reporting Program (IRF QRP). This rule includes one new finalized measure, the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) Measure, as well as an update to the specifications for the Transfer of Health (TOH) Information to the Patient-Post-Acute Care Quality Measure. The rule will go into effect on Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule on Inpatient Psychiatric Facilities Prospective Payment System

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022).” The rule updates the prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital.

The final rule can be found here.

CMS Issues Final Rule on Hospice Wage Index and Payment Rate Update

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a rule titled “FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The final rule updates the hospice wage index, payment rates and aggregate cap amount for fiscal year 2022. In addition, this rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations text changes to the election statement addendum that was implemented on Oct. 1, 2020. The regulations are effective on Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule for Long-Term Care Hospital Quality Reporting Program

On Aug. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.” The rule will update and finalize proposals for the FY 2022 Long Term Care Hospital Quality Reporting Program and includes the new COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure, among other things. The rule will go into effect Oct. 1, 2021.

The final rule can be found here.

FDA Issues Final Rule to Make Technical Amendments to 2015 Biologics Regulation

On Sept. 7, the Food and Drug Administration (FDA) published a final rule to make technical amendments to a 2015 final rule titled “Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions.” The FDA stated that the agency was amending the biologics regulation to improve clarity and fix an incorrect regulatory citation.

The final rule with the technical amendment can be found here.

Courts

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

Supreme Court Refuses to Block Texas Senate Bill 8

On Sept. 1, the Supreme Court refused to block a Texas law, Senate Bill 8, that bans abortion after roughly six weeks of pregnancy. With this decision, the law went into effect.

Reports

GAO Report on Medicare Home- and Community-Based Services

On Sept. 8, the Government Accountability Office (GAO) published a report titled “Medicare Home- and Community-Based Services: Evaluating COVID-19 Response Could Help CMS Prepare for Future Emergencies.” The report stated that the Centers for Medicare and Medicaid Services (CMS) allowed states to make temporary changes to Medicaid home- and community-based services during the COVID-19 pandemic, such as providing home-delivered meals or granting hazard pay. The report noted that CMS provided little guidance to states on how to monitor these changes, and recommended that CMS evaluate lessons learned and develop plans to monitor this topic for future public health emergencies.

The full report can be found here.

GAO Report on Changes to Nurse Corps Loan Repayment Program

On Sept. 8, the Government Accountability Office (GAO) published a report titled “Nurse Corps Loan Repayment Program: Too Early to Determine Effects of Allowing Recipients to Serve at For-Profit Facilities.” The report noted that certain nurses who agree to work in facilities with critical nurse shortages receive loan repayments from the Nurse Corps Loan Repayment Program, which is managed by the Health Resources and Services Administration (HRSA). In 2020, a prior requirement to work at nonprofits was dropped. The report stated it is too early to determine the effects of eliminating the restriction.

The full report can be found here.