Washington Healthcare Update - August 2021 #2

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This week in Washington: House in recess, Senate continues to debate bipartisan infrastructure bill, Senate to pass a budget resolution with reconciliation instructions before they leave for recess.

Congress

House

  • Bicameral Legislation to Update Food Labeling Introduced

Senate

  • Senate Appropriations Committee Passes Funding Bill on to the Senate Floor
  • Bill to Expand Substance Use Treatment in Jails and Prisons Passes Senate
  • Senators Encourage Leadership to Include Provisions from the Medicaid Saves Lives Act in Reconciliation Package
  • Sens. Wyden and Crapo Request Input on Mental Healthcare

Administration

  • HHS OIG to Review the FDA’s Accelerated Approval Pathway
  • HHS Announces $90 Million Investment in Rural Communities
  • FDA Launches Crowdsourcing Challenge for Pediatric Drug Development
  • CMS Releases Report on State-Level Reinsurance Programs
  • CMMI 2020 Report to Congress Published

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

Reports

  • GAO Report on HHS Collection of Hospital Capacity Data

Congress

House

Bicameral Legislation to Update Food Labeling Introduced

On Aug. 4, Reps. Frank Pallone (D-NJ) and Rosa DeLauro (D-CT) and Sens. Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI) and Ed Markey (D-MA) reintroduced the Food Labeling Modernization Act in both the House and Senate. The bills would update front-of-package food labeling requirements, update ingredient lists on packaged foods and apply consumer-friendly labeling requirements. The bill was previously introduced in 2018 but was not taken up by the Energy and Commerce Committee.

The bill text can be found here.

Senate

Senate Appropriations Committee Passes Funding Bill on to the Senate Floor

On Aug. 4, the Senate Appropriations Committee voted 25-5 to send the fiscal year (FY) 2022 funding bill to the Senate floor. The bill would give the Food and Drug Administration (FDA) $3.41 billion in discretionary funding, an increase of $200 million from FY 2021 levels.

Bill to Expand Substance Use Treatment in Jails and Prisons Passes Senate

On Aug. 3, the Senate passed the bipartisan Residential Substance Use Disorder Treatment Act of 2021. The bill was introduced by Sens. Sheldon Whitehouse (D-RI) and John Cornyn (R-TX) and would expand access to substance use treatment in jails and prisons. The bill was cosponsored by Sens. Thom Tillis (R-NC), Amy Klobuchar (D-MN), Dianne Feinstein (D-CA), Bill Cassidy, M.D. (R-LA), Maggie Hassan (D-NH), James Lankford (R-OK) and Tim Scott (R-SC).

The bill text can be found here.

Senators Encourage Leadership to Include Provisions from the Medicaid Saves Lives Act in Reconciliation Package

On Aug. 3, a group of 30 senators led by Sens. Tammy Baldwin (D-WI), Raphael Warnock (D-GA) and Jon Ossoff (D-GA) wrote to congressional leadership to emphasize the need to include the federally funded program detailed in the Medicaid Saves Lives Act (H.R. 4595 and S. 2315) in the upcoming reconciliation package. The Medicare Saves Lives Act was introduced earlier in July and would create a Medicaid-like program to provide health care to the more than 4 million Americans currently denied health insurance through Medicaid due to where they live.

The letter can be found here.

Sens. Wyden and Crapo Request Input on Mental Healthcare

On Aug. 5, chairman of the Senate Finance Committee Ron Wyden (D-OR) and Finance Committee ranking member Mike Crapo (R-ID) wrote a letter to their fellow committee members requesting input on matters related to mental healthcare. In the letter, Sens. Wyden and Crapo welcome input on how to improve the behavioral health workforce, support care integration, achieve parity and improve telehealth, and ask that proposals be submitted prior to Aug. 31. The letter states that a separate request for public- and private-sector input will be announced later this month.

The letter can be found here.

Administration

HHS OIG to Review the FDA’s Accelerated Approval Pathway

On Aug. 4, the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) announced that it would review the Food and Drug Administration’s (FDA) Accelerated Approval pathway. The Accelerated Approval pathway was the process by which Biogen’s Alzheimer’s drug Aduhelm was approved. The OIG report will investigate several drugs brought to market under the Accelerated Approval pathway and if the agency engaged in an inappropriate relationship with pharmaceutical companies during the review and approval process. The review will produce several reports that will be released in 2023.

HHS Announces $90 Million Investment in Rural Communities

On Aug. 5, the Department of Health and Human Services (HHS) announced it would provide nearly $90 million to rural communities to help combat opioid use and other substance use disorders, as well as improving access to maternal and obstetrics care. The funding will be distributed through the Health Resources and Services Administration (HRSA).

The press release with additional information can be found here.

FDA Launches Crowdsourcing Challenge for Pediatric Drug Development

On Aug. 2, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Division of Pediatric and Maternal Health (DPMH) launched a crowdsourcing challenge called “Send Your Pediatric Research Questions to FDA.” The challenge provides an opportunity for stakeholders to submit ideas for research directly to FDA staff that can accelerate or inform pediatric drug development. Submissions must be received by Aug. 20.

The crowdsourcing site can be found here.

CMS Releases Report on State-Level Reinsurance Programs

On Aug. 5, the Centers for Medicare and Medicaid Services (CMS) released a report on state-level reinsurance programs approved under the Affordable Care Act’s 1332 waiver authority, which found that the programs lowered premiums, increased plan participation and increased enrollment of the nonsubsidized population.

CMMI 2020 Report to Congress Published

On Aug. 4, the Center for Medicare and Medicaid Innovation (CMMI) published the CMMI 2020 Report to Congress. CMMI is required to report its activities to Congress every other year. The 2020 report covers activities from Oct. 1, 2018, to Sept. 30, 2020.

The report 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.

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.

Reports

GAO Report on HHS Collection of Hospital Capacity Data

On Aug. 5, the Government Accountability Office (GAO) published a report titled “COVID-19: HHS’s Collection of Hospital Capacity Data.” The report states that in April 2020, the Department of Health and Human Services (HHS) created a data system to collect information on hospital access to beds and supplies. This data was then used to distribute resources. The report observes that HHS changed its data requirements during the pandemic, which made it harder for hospitals to report their data.

The full report can be found here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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