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This week in Washington: CBO Scores Reconciliation Package While House Waits.
Congress
The House and Senate were not in session.
House
Administration
- HHS Announces $143.5 Million in Grants for Local Efforts to Overcome Barriers to COVID-19 Vaccination
- HHS to Invest $650 Million in Rapid COVID-19 Testing
- HHS OIG Updates Its Health Care Fraud Self-Disclosure Protocol Timeline
- Robert Califf Nominated as FDA Commissioner
- CMS Announces Largest Medicare Part B Premium Increase in 15 Years
- CMS Announces 60-Day Comment Period for Georgia’s Section 1332 Waiver
- CMS Increases Basic Health Program Funding to New York and Minnesota
Proposed Rules
- FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
- HHS Issues Proposed Rule to Withdraw the SUNSET Rule
- FDA Issues Draft Industry Guidance on Real-World Data Standards
- FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
- HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules
- FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
- FDA Issues Guidance Updating Unique Device Identification Policy
Final Rules
- CMS Issues Final Rule Rescinding Medicare Coverage of Innovative Technology and “Reasonable and Necessary” Final Rule
- CMS Issues Final Rule for End-Stage Renal Disease Prospective Payment System
- CMS Issues CY 2022 Medicare Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems Final Rule
- CMS Issues CY 2022 Medicare Physician Fee Schedule Final Rule
- CMS Issues 2022 Home Health Prospective Payment System Rate Final Rule
Courts
Reports
Upcoming Hearings/Markups
November 17
House Veterans’ Affairs Committee, Subcommittee on Disability Assistance and Memorial Affairs and Subcommittee on Health Hearing: “Supporting Survivors: Assessing VA’s Military Sexual Trauma Programs”
10:00 a.m.
For more information, click here.
House Appropriations Committee, Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Hearing: “U.S. Role in Global COVID-19 Vaccine Equity”
10:30 a.m.
For more information, click here.
Senate Veterans’ Affairs Committee Hearing: “Hearing to Consider Pending Legislation”
3:00 p.m.
For more information, click here.
November 18
Senate Special Committee on Aging Hearing: “Inclusive Disaster Management: Improving Preparedness, Response, and Recovery”
9:30 a.m.
For more information, click here.
House Veterans’ Affairs Committee, Subcommittee on Oversight and Investigations and Subcommittee on Technology Modernization Hearing: “Modernizing VA’s Medical Supply Chain: Progress Made?”
10:00 a.m.
For more information, click here.
Congress
House
Reconciliation Update
In a Nov. 9 post, Congressional Budget Committee (CBO) Director Phillip Swagel said the CBO is in the process of preparing a cost estimate for the $1.75 trillion social spending reconciliation package. Swagel stated that the CBO will release estimates for some of the bill’s titles within the week, while other titles will take longer. Moderate House Democrats previously stated they would not vote for the reconciliation package until seeing the CBO scores.
House Speaker Nancy Pelosi (D-CA) has committed to holding votes on the $1.75 trillion social spending reconciliation package before Thanksgiving.
150 Members of Congress Request the Surprise Billing Final Rule be Amended
On Nov. 5, a group of 150 members of Congress, led by Reps. Brad Wenstrup (R-OH) and Tom Suozzi (D-NY), wrote to the Secretaries of the Health and Human Services, Treasury and Labor Departments. In the letter, the members requested that the recent Interim Final Rule for Surprise Billing be amended to align with the No Surprises Act, which was passed by Congress in 2020. Specifically, the letter states that the independent dispute resolution (IDR) process in the final rule does not align with the process laid out in the No Surprises Act and represents an unbalanced approach.
The letter can be found here.
Administration
HHS Announces $143.5 Million in Grants for Local Efforts to Overcome Barriers to COVID-19 Vaccination
On Nov. 10, the Health and Human Services (HHS) Department announced $143.5 million in American Rescue Plan funding would be allocated to local outreach efforts to build vaccine confidence and address barriers to vaccination. The funding will be distributed through the Health Resources and Services Administration (HRSA).
HHS to Invest $650 Million in Rapid COVID-19 Testing
On Nov. 10, the Department of Health and Human Services (HHS) announced that $650 million of American Rescue Plan funding would be used to strengthen manufacturing capability and increase public access to rapid COVID-19 tests.
HHS OIG Updates Its Health Care Fraud Self-Disclosure Protocol Timeline
On Nov. 8, the Health and Human Services (HHS) Department’s Office of the Inspector General (OIG) updated its Health Care Fraud Self-Disclosure Protocol (SDP). The SDP is an avenue for companies to voluntarily disclose fraudulent conduct and receive more lenient treatment for potential misconduct. The update includes a timeline change, with the OIG now required to release findings of internal investigations within 90 days of the initial report submission.
Robert Califf Nominated as FDA Commissioner
On Nov. 12, President Biden nominated Robert Califf to lead the Food and Drug Administration (FDA). Califf previously served as FDA Commissioner from 2016-2017. Califf’s nomination requires Senate approval.
CMS Announces Largest Medicare Part B Premium Increase in 15 Years
On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) released next year’s Medicare Part A and Part B premiums, deductibles and coinsurance amounts. While Part B premiums increased by $21.60 from 2021, the annual deductible for Part B beneficiaries is $233, a $30 increase from this year’s deductible. CMS says low-income seniors and adults with disabilities may qualify for financial assistance from the Medicare Savings Programs.
The Medicare Part B premium increase is the largest in 15 years. Half of the increase is due to the need to build up the Part B Medicare trust fund to account for the potential cost of the recently FDA-approved Alzheimer’s drug, Aduhelm, in case CMS decides to cover the drug. The other half of the increase is due to the growth of Part B and the need to make up for the Congressional move to decrease premiums for 2021. That congressional decision caused a $3-a-month per beneficiary increase to extend into 2025.
The administration acknowledged that the jump in premiums from $148.50 in 2021 to $170.10 in 2022 is steep, but CMS senior officials point to the 5.9% adjustment in 2022 Social Security benefits will more than cover the increase for most Medicare beneficiaries. This is the largest cost-of-living adjustment in 30 years.
The National Association of Medicaid Directors warned last month if Medicare denies Aduhelm coverage, Medicaid will have to pay the entire cost of the drug, costing states’ Medicaid programs $1.9 billion
CMS Announces 60-Day Comment Period for Georgia’s Section 1332 Waiver
On Nov. 9, the Centers for Medicare and Medicaid Services (CMS) announced a 60-day comment period to gather input on Georgia’s Section 1332 waiver. The comment period comes after CMS and the Treasury Department asked Georgia state officials for updated actuarial and economic analyses that are needed to be compliant to assess the waiver. Public comments are due on Jan. 9, 2022.
CMS Increases Basic Health Program Funding to New York and Minnesota
On Nov. 10, the Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure announced that the states of New York and Minnesota will receive additional funds for their Basic Health Programs (BHP), due to the American Rescue Plan’s revised payment factors. The BHP was established under the Affordable Care Act to cover individuals earning between 138-200% of the federal poverty level. With the updated payment rates, New York will receive an additional $750 million, and Minnesota will receive an additional $100 million.
The proposed rule can be found here.
Proposed Rules
FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.
Public comments will be accepted until Feb. 2, 2022. The draft guidance can be found here.
HHS Issues Proposed Rule to Withdraw the SUNSET Rule
On Oct. 29, the Department of Health and Human Services (HHS) issued a proposed rule that would withdraw the January 2021 final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The SUNSET final rule required HHS regulations with a significant economic impact to be reviewed every 10 years, with regulations automatically expiring if they were not reviewed. This would have impacted more than 17,000 HHS regulations and required a review process considerably faster than HHS ever conducted.
The rule would have gone into effect in March 2021, but HHS issued a delay following a lawsuit.
Comments will be accepted until Dec. 28, 2021. The proposed rule can be found here.
FDA Issues Draft Industry Guidance on Real-World Data Standards
On Oct. 22, the Food and Drug Administration (FDA) announced industry draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The guidance includes recommendations to help sponsors comply with the Federal Food, Drug and Cosmetic Act when submitting study data from real-world data sources.
Public comments will be accepted until Dec. 21, 2021. The draft guidance can be found here.
FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
On Oct. 20, the Food and Drug Administration (FDA) issued a proposed rule titled “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The proposed rule would establish a new category of over-the-counter (OTC) hearing aids that could be sold to consumers directly without a medical exam or audiologic hearing. The proposed rule comes after President Biden’s July Executive Order aimed at promoting competition in the economy directed the FDA to increase access to OTC hearing aids.
Public comments will be accepted until Jan. 18, 2022.
The proposed rule can be found here.
HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules
On Oct. 20, the Department of Health and Human Services (HHS) issued a proposed rule to repeal two final rules: the Dec. 7, 2020, rule titled “Department of Health and Human Services Good Guidance Practices” and the Jan. 14, 2021, rule titled “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions.” HHS stated that the 2020 Good Guidance rule conflicts with the Food and Drug Administration’s (FDA) good guidance regulations and complicates the Centers for Medicare and Medicaid Services’ (CMS) issuing of Medicaid and Children’s Health Insurance Program (CHIP) guidance.
Public comments will be accepted until Nov. 19, 2021.
The proposed rule can be found here.
FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
On Oct. 12, the Food and Drug Administration issued a draft guidance document titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products,” which was prepared with the support of the International Council for Harmonisation (ICH). The draft guidance provides clarification on the development and operation of continuous manufacturing and builds on prior guidelines Q7-Q10.
Comments will be accepted until Dec. 13, 2021.
The guidance can be found here.
FDA Issues Guidance Updating Unique Device Identification Policy
On Oct. 14, the Food and Drug Administration (FDA) issued a draft guidance titled “Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.” The guidance revises the 2020 Unique Device Identification Guidance. The updated guidance explains there are certain class I devices for which the FDA will not enforce the Global Unique Device Identification Database (GUDID) submission requirements, and also states how a class I device labeler can determine if the device is in the scope of compliance policy.
Comments will be accepted until Dec. 13, 2021.
The guidance can be found here.
Final Rules
CMS Issues Final Rule Rescinding Medicare Coverage of Innovative Technology and “Reasonable and Necessary” Final Rule
On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule to rescind the Trump administration’s “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (MCIT/R&N) Final Rule. The final rule was published on Jan. 14, 2021, and would have gone into effect on Dec. 15, 2021. The rule would have granted up to four years of expedited Medicare coverage for certain designated “breakthrough” devices that receive market authorization. CMS states that the rule did consider the differences in devices and the potential safety impact on Medicare patients.
The final rule can be found here. A CMS press release on the final rule can be found here.
CMS Issues Final Rule for End-Stage Renal Disease Prospective Payment System
On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) published a final 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 final rule updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services starting Jan. 1, 2022. The rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services and the ESRD Treatment Choices (ETC) Model.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues CY 2022 Medicare Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule titled “Calendar Year (CY) Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model.” CMS is required by the January 2021 Hospital Price Transparency Final Rule to update Medicare payment policies for Outpatient Prospective Payment System (OPPS) hospitals and ASCs on an annual basis. The changes in the final rule aim to strengthen enforcement of hospital price transparency requirements and will stop the phased elimination of the Inpatient Only (IPO) list for surgical procedures. CMS will increase the penalty for hospitals that do not comply with the Hospital Price Transparency Rule starting on Jan. 1, 2022. The final rule also halts the elimination of the IPO list. In addition, the rule updates the OPPS payment rates for hospitals that meet quality reporting requirements by 2.0 percent. The final rule also details the Radiation Oncology Model, which is set to begin on Jan. 1, 2022, and last for five years.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues CY 2022 Medicare Physician Fee Schedule Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Calendar Year (CY) 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-payment Medical Review Requirements.” The rule includes policy changes for Medicare payments under the Physician Fee Schedule (PFS) and would continue the coverage of Medicare telehealth services and finalize changes to the Medicare Diabetes Prevention Program (MDPP) expanded model, among other things. The CY 2022 PFS conversion factor is $33.59, a decrease from the CY 2021 factor of $34.89.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
CMS Issues 2022 Home Health Prospective Payment System Rate Final Rule
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Calendar Year (CY) 2022 Home Health Prospective Payment System Rate Final Rule.” The rule will expand the Home Health Value-Based Purchasing (HHVBP) Model. In addition, the rule updates 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 makes permanent changes to the home health Conditions of Participation (CoP) implemented during the COVID-19 public health emergency.
The final rule will go into effect on Jan. 1, 2022.
The final rule can be found here. The CMS fact sheet on the final rule can be found here.
Courts
Ten States Sue Over CMS COVID-19 Vaccination Mandate Rule
On Nov. 10, ten states filed a lawsuit against the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) regarding the recent CMS COVID-19 vaccine mandate. The CMS rule requires COVID-19 vaccinations for all clinical and non-clinical staff of facilities that receive federal funding from Medicare or Medicaid. The states argue that the decision to require vaccines should be left up to states and the rule will contribute to workforce shortages. The states suing include Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire.
Reports
GAO Report on SSA Screening and Training of Disability Medical Consultants
On Nov. 9, the Government Accountability Office (GAO) released a report titled “Social Security Administration (SSA): Actions Needed by SSA to Ensure Disability Medical Consultants are Properly Screened and Trained.” The report says that SSA requires state agencies to ensure that consultants meet employment and training standards, and while most surveyed states meet these requirements, some did not. The GAO recommends that SSA take steps to ensure that states properly screen and train consultants.
The full report can be found here.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Alexandra Gale, Research Associate
Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.
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