Federal Health Policy Update for Friday, November 19

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, November 19.  Some of the language used below is taken directly from government documents.


On Friday the House passed a $1.7 trillion social spending bill, H.R. 5376 – Build Back Better Act, with no Republican votes and all but one Democratic vote.  The Congressional Budget Office score indicates that the health care policies in the bill are paid for by cuts in other health care programs.

The bill includes nearly $300 billion in health care provisions, including:

  • $57 billion to provide insurance to more than two million people in non-expansion states
  • $74 billion to temporarily extend subsidies for Affordable Care Act health plans
  • $146 billion for home health services
  • $36 billion to cover hearing services in Medicare
  • $26 billion to expand the public health workforce, address maternal mortality, and prepare for future pandemics

This new spending would be paid for in part by:

  • nearly $34 billion in savings from cuts in uncompensated care payments to hospitals in 12 states that have not expanded their Medicaid programs
  • nearly $300 billion in savings through policies to negotiate the cost of some expensive drugs, penalize drug companies that raise prices faster than inflation, redesign seniors’ Medicare benefits, and repeal the drug rebate rule

The bill that passed the House this morning is the result of a number of last-minute changes to smaller provisions from previous versions.  We are still going through that language and will update you on any changes you should be aware of.  The bill will certainly be changed by the Senate, where it will require the votes of all 50 Democratic senators to pass.

The White House

Provider Relief Fund

  • HHS’s Health Resources and Services Administration, which administers the Provider Relief Fund, has established a 60-day grace period for complying with the fund’s Reporting Period 1.  The grace period began on October 1, 2021, and will end on November 30, 2021 at 11:59 p.m. (eastern).  Learn more here, under “60-Day Grace Period – Reporting Period 1.”

Centers for Medicare & Medicaid Services


  • Effective April 1, 2022, CMS will introduce seven new ICD-10 codes for COVID-19 treatment and vaccines and the CDC will implement three new codes for reporting COVID-19 vaccination status.  To find these codes, go here and scroll down to the downloadable zip file “ICD-10 MS-DRGs V39.1 Effective April 1, 2022  (ZIP) – – Updated 11/16/2021.”
  • CMS has posted the first in a series of short podcasts for frontline nursing home staff.  “Nursing Home Series for Front Line Clinicians and Staff” addresses training and infection control practices in nursing homes to help combat the spread of COVID-19.  Find the podcast here.

Health Policy Update

  • CMS has published the latest edition of MLN Connects, its online newsletter of information about Medicare payment and other policies.  Articles in this edition address changes in nursing home visitation policies, opportunities for clinicians to review their 2020 quality payment program performance data before it is published on the Medicare Care Compare web site, the 2022 update of Medicare thresholds per beneficiary, and more.  Go here for the latest edition of MLN Connects.

Department of Health and Human Services

  • A new federal regulation requires health insurance issuers, employer-based health plans, and other group health plans to report on prescription drug and health coverage costs.  The requirement, issued as a final rule with comment period, was issued jointly by the departments of Health and Human Services, Labor, and Treasury and the federal Office of Personnel Management and was issued to implement the No Surprises Act and the transparency requirements of the Consolidated Appropriations Act of 2021.  The regulation requires health plans, health insurance issuers offering group or individual health insurance coverage, and health benefits plans offered to federal employees to submit selected data to the departments involved, which will work through the office of HHS’s Assistant Secretary for Planning and Evaluation to publish a report on prescription drug pricing trends and rebates and their impact on premiums and consumers’ out-of-pocket costs.  The data submission requirements include information on average monthly premiums and drug spending for patients compared to their employers and/or group health plans/health insurance issuers.  Learn more about the regulation from the following resources:
  • an HHS news release
  • an HHS fact sheet
  • the regulation itself
  • HHS Secretary Xavier Becerra spoke this week at the National Association of Medicaid Directors’ fall conference.  Read his remarks here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has authorized use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.  Learn more about this development, and the reasoning behind it, in this FDA news release.
  • The FDA has updated its enforcement policy for viral transport media during the COVID-19 public health emergency.  Among the audiences for this guidance is clinical laboratories.  Find the updated guidance here.

National Institutes of Health

Occupational Safety and Health Administration (OSHA)

  • In the wake of a federal court ruling that OSHA “take no steps to implement or enforce” its emergency temporary standard requiring employees of companies with 100 or more employees to be vaccinated, OSHA has suspended activities related to the implementation and enforcement of that requirement.  Learn more from this OSHA news release.

Government Accountability Office (GAO)

  • The GAO has published a report with information on the transition to alternative payment models by providers in rural areas, health professional shortage areas (HPSAs), and medically underserved areas (MUAs).  Find a summary of the report here and the full report here.

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

Federal Health Policy Update for Monday, June 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, June 28.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services


  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services


  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention


Food and Drug Administration


Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – Register here

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Federal Health Policy Update for Wednesday, May 19

The following is the latest health policy news from the federal government as of 2:15 p.m. on Wednesday, May 19.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to all members of Congress urging them to contact Health and Human Services Secretary Xavier Becerra about directing more of its remaining CARES Act Provider Relief Fund money to private safety-net hospitals to help them serve their diverse, predominantly low-income communities during the COVID-19 emergency.  Go here to see NASH’s message to Congress.

The White House


Centers for Medicare & Medicaid Services

Health Policy News

Go here for links to these and other items.

Department of Health and Human Services


  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding for its mental health and substance use block grant programs.  The Community Mental Health Services Block Grant Program and Substance Abuse Prevention and Treatment Block Grant Program are distributing $1.5 billion each to states and territories to help communities addressing mental health and substance use needs during the COVID-19 pandemic.  Learn more from HHS’s news release announcing the funding.
  • HHS’s Office of the Inspector General has updated its work plan for COVID-19-related audits, evaluations, and inspections scheduled for May.
  • In conjunction with the California Justice Department and the U.S. Attorney’s Office for the Eastern District of California, HHS’s Office of the Inspector General has issued a news release advising the public that they should not be asked by providers to pay for COVID-19 vaccines and reminding providers that they may not attempt to charge or bill consumers for administering those vaccines.  See the news release here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published information about the challenges of providing hospice care amid the COVID-19 pandemic and about providing home care during the public health emergency.

Health Policy News

Senate Finance Committee Hearing

The Senate Finance Committee held a hearing today on COVID-19 flexibilities.

  • Go here to read the opening statement of the committee chair, Senator Ron Wyden (D-OR) and go here to read the opening statement of the committee’s ranking minority member, Senator Mike Crapo (R-ID).
  • Go here to see the testimony of individuals who appeared at the hearing.
  • The Medicare Payment Advisory Commission has submitted a written statement to the committee.  The MedPAC statement notes that “While many of these actions have been helpful in addressing the short-term issues presented by the pandemic, continuing those changes indefinitely would have drawbacks.  Therefore, policymakers should be cautious about extending them beyond the duration of the public health emergency (PHE) or other scheduled expiration date.”  The statement pays particular attention to telehealth and post-acute care.  Go here to see the MedPAC submission “Temporary modifications of Medicare policies in response to the coronavirus public health emergency.”
  • The Government Accountability Office has submitted a report to the Senate Finance Committee on the same subject.  The GAO notes that it undertook this work, titled “Medicare and Medicaid:  COVID-19 Program Flexibilities and Considerations for Their Continuation,” because of a CARES Act provision that calls for the agency to “… conduct monitoring and oversight of the federal government’s response to the COVID-19 pandemic.”  Find the GAO submission here.

Centers for Disease Control and Prevention


Food and Drug Administration


National Institutes of Health


National Academy of Medicine


Government Accountability Office

GAO Looks at Medicaid Managed Care Spending

The federal government should do more to help states ensure the accuracy and integrity of their payments to Medicaid managed care organizations and the payments those Medicaid managed care organizations make to health care providers.

This is the conclusion reached in a new study of Medicaid managed care performed by the U.S. Government Accountability Office at the request of the Permanent Subcommittee on Investigations of the Senate Committee on Homeland Security and Government Affairs.

The GAO study identified six payment risks among various transactions between state governments, Medicaid managed care organizations, and health care providers.  The two biggest risks, the GAO concluded, were:

  1. incorrect fee-for-service payments from MCOs, where the MCO paid providers for improper claims, such as claims for services not provided; and
  2. inaccurate state payments to MCOs resulting from using data that are not accurate or including costs that should be excluded in setting payment rates.

The GAO traces some of these problems to a delay in the Centers for Medicare & Medicaid Services’ planned Medicaid managed care guidance to states; limited implementation of new auditing practices CMS introduced in 2016; and CMS’s failure to account for overpayments to providers when it reviews state capitation rates for Medicaid managed care plans.

To address these shortcomings, the GAO report recommends that CMS:

  1. expedite issuing planned guidance on Medicaid managed care program integrity;
  2. address impediments to managed care audits; and
  3. ensure states account for overpayments in setting future MCO payments.

CMS agrees with these recommendations.

Learn more about the study – why it was undertaken, how it was conducted, what it found, and what it recommended – by going here to see the GAO report Medicaid Managed Care:  Improvements Needed to Better Oversee Payment Risks.

GAO Urges Medicare Action on Opioids

The Centers for Medicare & Medicaid Services is not doing enough to oversee the prescribing of opioids to Medicare beneficiaries.

Or so concludes the U.S. Government Accountability Office.

According to the GAO, CMS provides guidance to Medicare drug plans “…but does not analyze data specifically on opioids.”  Also, according to the GAO,

…CMS does not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and does not require plan sponsors to report actions they take when they identify such providers.  As a result, CMS is lacking information that it could use to assess how opioid prescribing patterns are changing over time, and whether its efforts to reduce harm are effective.

To address these and other problems, the GAO report recommends that CMS

  • gather information on the full number of at-risk beneficiaries receiving high doses of opioids
  • identify providers who prescribe high amounts of opioids
  • require plan sponsors to report to CMS on actions related to providers who inappropriately prescribe opioids

Learn more in report Prescription Opioids:  Medicare Needs to Expand Oversight Efforts to Reduce the Risk of Harm, which can be found here, on the GAO web site.

GAO Reports on 340B Program

The U.S. Government Accountability Office (GAO) recently completed a review of the federal 340B Drug Pricing Program.

gaoThe program, which requires pharmaceutical companies to provide drug discounts to qualified hospitals that serve especially large proportions of low-income patients, has come under fire recently because approximately 40 percent of U.S. hospitals now participate in the program and there have been questions about how hospitals use the program and its drug discounts.

The GAO found that Medicare Part B spending on drugs was much higher at participating 340B hospitals than it was at non-participating hospitals, suggesting that participating hospitals prescribe more drugs and more expensive drugs. It found that

The Centers for Medicare & Medicaid Services (CMS), which administers the Medicare program, uses a statutorily defined formula to pay hospitals for drugs at set rates regardless of hospitals’ costs for acquiring the drugs. Therefore, there is a financial incentive at hospitals participating in the 340B program to prescribe more drugs or more expensive drugs to Medicare beneficiaries.

In the review, GAO recommended that

Congress should consider eliminating the incentive to prescribe more drugs or more expensive drugs than necessary to treat Medicare Part B beneficiaries at 340B hospitals.

Go here to find the GAO report Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals.

A number of groups have criticized GAO’s findings. Learn about their perspective in articles in Healthcare Finance News and Becker’s Hospital Review.

5% of Medicaid Recipients Account for 50% of Costs

Just five percent of all Medicaid recipients are responsible for nearly half of the program’s expenditures.

gaoOr so says a new report by the U.S. Government Accountability Office (GAO).

Conversely, the 50 percent of Medicaid’s least costly recipients account for only eight percent of the program’s costs.

Disabled Medicaid recipients, while fewer than 10 percent of the overall total, represent nearly two-thirds of the highest-cost group.

These figures reflect spending from 2009 through 2011.

The greatest Medicaid expenditures were invested in seven types of care: for patients with asthma, diabetes, HIV/AIDS, mental health conditions, substance abuse, and delivery or childbirth along with those residing in long-term-care facilities.

To learn more about the GAO’s findings, see a summary of the report Medicaid: A Small Share of Enrollees Consistently Accounted for a Large Share of Expenditures and find a link to the complete report here on the GAO web site.

GAO Questions State Medicaid Financing

States are now financing more than a quarter of their share of Medicaid expenditures with money from sources other than state general funds, according to a new study by the Government Accountability Office (GAO).

According to the GAO, 26 percent of state share of Medicaid funding comes from taxes on health care providers, transfers from local governments and local government providers, and other sources.  Such funding, the GAO noted, shifts additional Medicaid costs to the federal government.

gaoExacerbating this problem, the GAO reports, is that the Centers for Medicare & Medicaid Services (CMS), which oversees Medicaid, does not assure that it receives complete and accurate data on funding sources from the states, leaving CMS without a complete understanding of how states are financing their Medicaid expenditures.  In the report, the GAO recommends a stronger CMS effort to gather such data – a recommendation that CMS did not accept.

Learn more about the GAO study “States Increased Reliance on Funds From Health Care Providers and Local Governments Warrants Improved CMS Data Collection” by finding the complete report and a summary here, on the GAO web site.