This week in Washington: Senate agrees on infrastructure compromise, budget resolution with reconciliation instructions to be voted on.

Upcoming Hearings/Markups

Congress

House

  • 76 Members of Congress Request CMS Guidance for States to Extend Postpartum Medicaid Coverage
  • Rep. Trone’s Bill to Safely Dispose of Opioids Heads to President Biden’s Desk

Senate

  • Infrastructure Bill Compromise Includes Two Drug-Related Offsets
  • Sens. Cassidy and Schatz Introduce Public Health Emergency Response and Accountability Act
  • Senators Ask HHS to Support Policies that Would Allow Americans to Personally Import Certain Prescription Drugs from Canada
  • Senate to Hold Executive Session on Nominations and Bills

Administration

  • President Biden Announces Proposed Rule to Strengthen Supply Chains
  • CDC Issues New COVID-19 Mask Guidance
  • DOJ and OCR-HHS Issue Guidance on “Long COVID” Disability Rights
  • FDA Approves First Interchangeable Biosimilar Insulin Product

Notices

  • FDA Announces Biosimilar User Fee Rates for FY 2022
  • Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
  • Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2022

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
  • CMS Issued Proposed Rule for End-Stage Renal Disease Prospective Payment System
  • CMS Proposes 2022 Home Health Prospective Payment System Rate Update

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

Reports

  • GAO Report on Medicare Advantage Disenrollments in Last Year of Life
  • GAO Report on VA Education Benefit Programs for Veterans with Disabilities
  • GAO Report on COVID-19 Contractor Leave Reimbursement
  • GAO Report on VA Oversight of Infection Protection and Control in Community Living Centers
  • GAO Report on COVID-19 Contracting

Upcoming Hearings/Markups

August 2

Senate Appropriations Committee, Subcommittee on Military Construction, Veterans Affairs and Related Agencies Business Meeting: Markup of the “Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022”
5:30 p.m.
For more information, click here.

Senate Appropriations Committee, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies: Markup of the “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022”
5:45 p.m.
For more information, click here.

Congress

House

76 Members of Congress Request CMS Guidance for States to Extend Postpartum Medicaid Coverage

On July 26, a group of 14 Senate and 62 House members wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting that CMS take immediate steps to implement the State plan option authority authorized by the American Rescue Plan to provide 12 months’ postpartum Medicaid coverage. The letter encourages CMS to issue guidance in the form of a State Medicaid Director Letter with an accompanying toolkit for states to facilitate implementation of the State plan no later than April 1, 2022.

The letter can be found here.

Rep. Trone’s Bill to Safely Dispose of Opioids Heads to President Biden’s Desk

On July 28, Rep. David Trone (D-MD) announced that his bill, the Dispose Unused Medications and Prescription (DUMP) Opioids Act, passed the House floor and will now head to President Biden’s desk to be signed. The House bill was cosponsored by Rep. Mariannette Miller-Meeks (R-IA). The identical Senate version of the bill was introduced by Sens. John Kennedy (R-LA) and Jon Tester (D-MT) and passed the Senate earlier this year with unanimous consent. The DUMP Opioids Act would expand the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 to allow anyone to dispose of controlled substance medications at VA center drop boxes.

The bill text can be found here.

Senate

Infrastructure Bill Compromise Includes Two Drug-Related Offsets

On July 28, the Senate voted 67-32 to take up a $1 trillion bipartisan infrastructure bill after a compromise was reached. The bill still needs to be turned into legislative text and pass both the Senate and the House.

The infrastructure deal includes two offsets related to drugs: it would delay the Trump-era Part D Drug Rebate Rule and require drug companies to refund Medicare for leftover medicine when vials contain more than patients need. The rebate rule was intended to eliminate Part D rebates unless they are shared upfront at the point of sale, and its delay will offset $49 billion. The measure, which requires drug companies to pay back Medicare Part B for unused portions of drugs packaged in vials, would save $3 billion over a decade.

A summary of the deal can be found here.

Sens. Cassidy and Schatz Introduce Public Health Emergency Response and Accountability Act

On June 27, Sens. Bill Cassidy (R-LA) and Brian Schatz (D-HI) introduced the Public Health Emergency Response and Accountability Act. The bill would provide automatic funding for a new Public Health Emergency Fund based on a formula similar to the budget authority provided to FEMA, with the goal of facilitating a quick response to future public health emergencies.

The bill text can be found here.

Senators Ask HHS to Support Policies that Would Allow Americans to Personally Import Certain Prescription Drugs from Canada

On July 27, Sens. Amy Klobuchar (D-MN), Chuck Grassley (R-IA), Angus King (I-ME) and Susan Collins (R-ME) sent a letter to the Department of Health and Human Services (HHS) requesting that the agency support policies to allow Americans to personally import certain prescription drugs from Canada. The letter states that the Biden administration’s recent Executive Order on Promoting Competition in the American Economy recognized that importing safe drugs from Canada could lower U.S. prescription drug prices. Sens. Klobuchar, Grassley, King and Collins recently introduced the Safe and Affordable Drugs from Canada Act, which would allow for the importation of certain prescription drugs from approved Canadian pharmacies.

The letter can be found here.

Senate to Hold Executive Session on Nominations and Bills

On Aug. 3, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold an executive session to consider several nominations and bills. The executive session agenda items can be found below:

  • Nomination of David Weil to be the administrator of the Wage and Hour Division of the Department of Labor
  • Nomination of Catherine Lhamon to be assistant secretary for Civil Rights at the Department of Education
  • Nomination of Javier Ramirez to be the director of the Federal Mediation and Conciliation Service
  • S. 1486, The Pregnant Workers Fairness Act
  • S. 1543, The Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act
  • S. 2425, The Suicide Prevention Lifeline Improvement Act
  • S. 2401, The 21st Century Assistive Technology Act
  • Any additional business for consideration

The meeting will not be broadcast to the public. For more information, click here.

Administration

President Biden Announces Proposed Rule to Strengthen Supply Chains

On July 28, President Biden announced the Buy American Proposed Rule, which aims to strengthen critical domestic supply chains, including for drugs and medical supplies. The proposed rule would make it so that 60 percent of a product’s component parts need to be manufactured in the U.S. to be bought by the federal government, an increase from the current 55 percent required. The proposed rule would raise the threshold to 65 percent by 2024 and 75 percent by 2029. The proposed rule would also apply enhanced price preference to some critical products, which would provide a source of stable demand. In addition, the proposed rule would establish a reporting requirement for critical products. The proposed rule will be published with a 60-day comment period.

The White House fact sheet on the proposed rule and background can be found here.

CDC Issues New COVID-19 Mask Guidance

On July 27, the Centers for Disease Control and Prevention (CDC) released a revised mask recommendation, stating that fully vaccinated people should wear masks in public indoor settings in areas with high COVID-19 transmission rates. The recommendation comes as new data shows that in some cases, vaccinated people infected with the Delta variant can spread the virus. The Delta variant is currently the predominant variant circulating in the U.S. The updated guidance comes two months after CDC released guidance saying fully vaccinated people can participate in indoor and outdoor activities without masking or social distancing.

The updated guidance can be found here.

DOJ and OCR-HHS Issue Guidance on “Long COVID” Disability Rights

On July 26, the Office for Civil Rights of the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) issued a guidance stating that “long COVID” can be considered a disability under federal civil rights laws. Some people who had COVID-19 continue to experience symptoms that can last for weeks or months after first developing the virus, a condition known as “long COVID.” The guidance states that long COVID can be a disability under the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act and Section 1557 of the Affordable Care Act, federal laws that protect people with disabilities from discrimination. The guidance also provides additional information and best practices.

The guidance can be found here.

FDA Approves First Interchangeable Biosimilar Insulin Product

On July 28, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product. Semglee (insulin glargine-yfgn), a product of Mylan Pharmaceuticals, is shown to improve glycemic control in adults and children with Type 1 diabetes and adults with Type 2 diabetes. Semglee is biosimilar to and interchangeable with its reference product Lantus (insulin glargine).

The FDA press release with additional information can be found here.

Notices

FDA Announces Biosimilar User Fee Rates for FY 2022

On July 28, the Food and Drug Administration (FDA) announced the rates for biosimilar user fees for fiscal year (FY) 2022. The FDA is authorized by the Federal Food, Drug and Cosmetic Act as amended by the Biosimilar User Fee Amendments of 2017 to establish the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee and the biosimilar biological product application and program fees for the year.

The notice provides fee rates for FY 2022 for the initial and annual BPD fee ($57,184), for the reactivation fee ($114,368), for an application requiring clinical data ($1,746,745), for an application not requiring clinical data ($873,373) and for the program fee ($304,162). The fees apply from Oct. 1, 2021, to Sept. 30, 2022.

The notice can be found here.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022

On July 28, the Food and Drug Administration (FDA) issued a notice titled “Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year (FY) 2022.” The notice announced the FY 2022 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). The fees are effective on Oct. 1, 2021 and will remain in effect through Sept. 30, 2022.

The notice can be found here.

Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2022

On July 28, the Food and Drug Administration (FDA) issued a notice titled “Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2022.”

In the notice, the FDA announces the (FY) 2022 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). The FDA also announced the fee rate for certification bodies that are applying to be directly accredited by FDA. The fee is effective Oct. 1, 2021.

The notice 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.

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.

Courts

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

Reports

GAO Report on Medicare Advantage Disenrollments in Last Year of Life

On July 28, the Government Accountability Office (GAO) published a report titled “Medicare Advantage: Beneficiary Disenrollments to Fee-For-Service in Last Year of Life Increase Medicare Spending.” The report states that in the last year of life, Medicare Advantage beneficiaries disproportionately disenrolled to enroll in fee-for-service. This indicates possible issues with care and resulted in increased Medicare spending by hundreds of millions of dollars. The GAO recommends that end-of-life Medicare Advantage disenrollments be monitored to identify and address quality of care concerns.

The complete report can be found here.

GAO Report on VA Education Benefit Programs for Veterans with Disabilities

On July 28, the Government Accountability Office (GAO) published a report titled “Veterans with Disabilities: VA Could Better Inform Veterans with Disabilities about Their Education Benefit Options.” The report states that the Department of Veterans Affairs (VA) offers education benefits to veterans through the Post-9/11 GI Bill. In addition, the Veteran Readiness and Employment program can provide education benefits for veterans with disabilities seeking to re-enter the workforce. The report notes that many veterans with disabilities are not aware of the Veteran Readiness and Employment program and its benefits and recommended that the VA better inform veterans about the program and how it differs from the GI Bill.

The complete report can be found here.

GAO Report on COVID-19 Contractor Leave Reimbursement

On July 28, the Government Accountability Office (GAO) published a report titled “COVID-19 Contracting: Contractor Paid Leave Reimbursements Could Provide Lessons Learned for Future Emergency Responses.” The report states that the CARES Act allows agencies to reimburse contractors for paid leave provided to employees who cannot access worksites during the pandemic and whose jobs cannot be performed remotely. NASA and the department Defense, Energy and Homeland Security reported bills of $883 million for contractor paid leave costs, and each agency’s policy and reimbursement tracking was different. The GAO recommends that the Office of Management and Budget (OMB) collect and share lessons learned about reimbursing contractors.

The full report can be found here.

GAO Report on VA Oversight of Infection Protection and Control in Community Living Centers

On July 28, the Government Accountability Office (GAO) published a report titled “COVID-19: VA Should Assess Its Oversight of Infection Prevention and Control in Community Living Centers.” The report states that the Department of Veterans Affairs (VA) issued guidance on limiting entry, testing and training to its community living centers during the pandemic. The report notes that despite this guidance, the VA had little oversight over practices in the nursing home facilities, and facilities self-assessed their practices. The GAO recommends that the VA review its oversight of infection prevention and control to better prepare facilities for future outbreaks.

The full report can be found here.

GAO Report on COVID-19 Contracting

On July 29, the Government Accountability Office (GAO) published a report titled “COVID-19 Contracting: Opportunities to Improve Practices to Assess Prospective Vendors and Capture Lessons Learned.” The report stated that federal agencies obligated billions of dollars in contracts for medical supplies and other pandemic-related goods and services, with 88 percent of vendors having prior federal experience. The report observes that the share of vendors new to federal contracting was five times greater than in a typical year and recommended that agencies include contracting challenges as they share lessons learned from the COVID-19 pandemic.

The full report can be found here.

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