Health Care Watch: August 16, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 9 – August 15. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On August 10, Majority Leader Steny Hoyer (D-MD) announced that the House will return from recess on August 23 to consider the Senate-passed budget resolution and other legislation. On August 12, nine moderate Democrats called for the House to vote first on the Senate-passed infrastructure package and then consider the budget resolution.
Senate
On August 9, Senate Democrats released their fiscal year (FY) 2022 budget, with reconciliation instructions. Majority Leader Chuck Schumer (D-NY) asked committees to submit their reconciliation legislation by September 15. On August 10, the Senate voted 50-49 to begin debate and on August 11, the Senate passed the $3.5 trillion budget resolution in a 50-49 partisan vote just before 4 a.m., following a 15-hour “vote-a-rama” with 47 amendments. The package includes the following directive health care policies:
Adding a new dental, vision, and hearing Benefit to the Medicare program;
Extending the expanded Affordable Care Act (ACA) premium subsidies included in the American Rescue Plan (ARP);
Investing in home and community-based services to help seniors, persons with disabilities, and home care workers;
Investing in health equity, including maternal, behavioral, and racial justice health investments;
Investing in primary care and addressing health care provider shortages, including Community Health Centers, the National Health Service Corps, the Nurse Corps, and Teaching Health Center Graduate Medical Education;
Investing in pandemic preparedness;
Creating a new federal health program for Americans in the Medicaid Coverage Gap; and
Reducing prescription drug costs for patients.
A framework of the bill is available here. A topline summary of the package is available here.
On August 10, the Senate passed the $1.2 trillion infrastructure package in a 69-30 vote. The bill would delay the Medicare prescription drug rebate rule until 2026, extend the 2% Medicare sequestration cuts through FY 2031, and give Health & Human Services (HHS) the authority to require drug manufacturers to pay back the government for unused drugs that were packaged in single use vials beginning in 2023. A summary of the package is available here.
On August 10, Sens. Ron Wyden (D-OR), Bob Casey (D-PA), Richard Blumenthal (D-CT), Michael Bennet (D-CO), Sheldon Whitehouse (D-RI), and Sherrod Brown (D-OH) introduced the Nursing Home Improvement and Accountability Act of 2021, which would improve transparency and accountability, require staffing improvements, and establish a Skilled Nursing Facility (SNF) building modification and staff investment demonstration program. A section-by-section summary of the bill is available here.
On August 10, 46 Republican Senators sent letter stating their opposition to increasing the debt ceiling which is expected to be reached in late October or nearly November. They are argue that Democrats have exacerbated the debt issue due to the trillions of dollars of new and proposed spending.
NON-CORONAVIRUS REGULATORY UPDATE
On August 9, Treasury Secretary Janet Yellen urged Congress to address the debt ceiling in a bipartisan effort.
On August 10, the Centers for Medicare & Medicaid Services (CMS) announced that over 2.5 million Americans have signed up for new health insurance coverage through HealthCare.gov and State-based Marketplaces during the 2021 Marketplace Special Enrollment Period (SEP), through July 13, 2021. Data that the Agency released also showed that nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance Program (CHIP), as of March 2021. A fact sheet on the 2021 Marketplace SEP Report is available here.
On August 10, CMS Administrator Chiquita Brooks-LaSure sent letters to Ohio, Utah, and South Carolina withdrawing approval of the state’s Medicaid work requirement demonstration programs.
On August 10, CMS’ Division of Eligibility and Coverage Demonstrations sent a letter to Tennessee stating that the agency intends to open a new 30-day federal comment period to allow for public comment on Tennessee’s Medicaid waiver, which is the first Medicaid block grant program, that was approved on January 8, 2021.
On August 11, the Department of Veterans Affairs (VA) announced it will not cover Biogen’s Alzheimer's treatment, Aduhelm, due to safety concerns and a lack of evidence that the treatment provides "a robust and meaningful clinical benefit." The VA noted that it would make exceptions for "highly selected patients."
On August 12, CMS Administrator Brooks-LaSure, CMS Center for Medicare & Medicaid Innovation (CMMI) Director Liz Fowler, Center for Medicare Director Meena Seshamani, and Center for Medicaid and CHIP Director Dan Tsai discussed their vision for the next 10 years of CMMI in a Health Affairs blog post. The CMS leaders highlighted the Agency’s focus on health equity, fewer Medicare payment models that do not overlap with existing models, re-evaluating how CMMI designs financial incentives in its models to ensure meaningful provider participation, offering providers tools to enable and empower changes in care delivery, and encouraging lasting transformation and a broader array of quality investments instead of just cost and quality improvements.
CMS will hold a virtual meeting on August 23 of the Advisory Panel on Hospital Outpatient Payment to advise the HHS Secretary and CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will hold a public meeting on September 22 to examine relevant health outcomes in studies for cerebrovascular disease treatment, with a particular focus on new technologies of interest to CMS.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will hold a meeting on September 29 and 30 to review and revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On August 12, President Biden released a plan to reduce drug prices, which calls on Congress to allow Medicare to negotiate drug prices, penalize companies that raise their prices faster than inflation, and establish an out-of-pocket cap for drugs for Medicare beneficiaries. A fact sheet on President Biden’s plan is available here.
On August 13, Biden Administration announced a series of new actions and available funding from the ARP in the coming weeks to address COVID-19 in rural areas and improve rural health, which include:
HHS providing $8.5 billion to compensate health care providers who serve rural Medicare, Medicaid, and CHIP patients for lost revenue and increased expenses associated with COVID-19;
Department of Agriculture providing $500 million to create the Emergency Rural Health Care Grant Program to expand rural hospitals and local communities’ access to COVID-19 vaccines and testing, medical supplies, telehealth, and food assistance, and support construction or renovation of rural health care facilities, and plan and implement models that help improve the long-term viability of rural health care providers;
HHS providing $52 million to train new rural health care providers, including community health workers and respiratory therapists, and expanding telehealth;
HHS supporting a demonstration project to enhance access to pulmonary rehabilitation services in Critical Access Hospitals that serve rural communities with high rates of chronic obstructive pulmonary disease;
HHS and the VA expanding training programs for rural providers, through the Rural Interprofessional Faculty Development Initiative; and
National Institutes of Health (NIH) holding a virtual public workshop to identify ways to improve rural health through telehealth-guided provider-to-provider communication.
President Biden also highlighted recent efforts to improve rural health through the reconciliation package and previous initiatives.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On August 9, Defense Secretary Lloyd Austin announced that he intends to seek approval from President Biden to make COVID-19 vaccines mandatory for all troops by September 15 or when Pfizer’s COVID-19 vaccine is fully authorized, whichever comes first.
On August 11, the CDC updated its recommendation for pregnant or breastfeeding people to get the COVID-19 vaccine, due to additional data suggesting that pregnant people face an increased risk of developing severe illness from COVID-19 and that there is no increased risk for miscarriage associated with the COVID-19 vaccine.
On August 12, HHS announced it will require its health care workforce, which includes staff at the Indian Health Service and NIH, to be vaccinated. Members of the Public Health Service Commissioned Corps are also required to be vaccinated.
On August 12, the Food & Drug Administration (FDA) updated its Emergency Use Authorization for the Pfizer and Moderna COVID-19 vaccines recommending that immunocompromised people get a third dose. Following this announcement, CMS noted that Medicare beneficiaries who qualify for an additional dose can receive it with no cost sharing.
On August 13, the CDC Advisory Committee on Immunization Practices voted unanimously to recommend that immunocompromised people should receive a third dose of Pfizer’s and Moderna’s COVID-19 vaccines. The meeting agenda is available here.
White House
On August 11, President Biden advocated for businesses to adopt COVID-19 vaccination requirements in a meeting with business, university and health care leaders.
Other
On August 9, the Mayo Clinic published a study that has yet to be peer reviewed that found that the risk of Delta variant breakthrough infections was 60% lower for those who received the Moderna COVID-19 vaccine, compared to those who received the Pfizer COVID-19 vaccine.
On August 9, a preliminary Israeli study found that most people who received a third Pfizer COVID-19 dose had similar or fewer side effects than they did after the second dose.
Governors across the country are continuing to reinstate mask mandates and implementing vaccine mandates. On August 10, D.C. Mayor Muriel E. Bowser (D) issued a vaccine mandate for all city employees and contractors or submit to weekly COVID-19 testing. Maine, Pennsylvania, and Washington also implemented vaccine requirements for employees in health care settings or submit to weekly testing. Delaware, Kentucky, New Jersey, and Virginia implemented a mask mandate in K-12 schools for students and staff, regardless of vaccination status. California implemented a vaccine mandate for all teachers and school employees.
On August 11, the World Health Organization (WHO) announced that it intends to study artesunate, imatinib, and infliximab for the treatment of hospitalized COVID-19 patients. WHO Director-General Tedros Adhanom Ghebreyesus also predicted that the world will pass 300 million COVID-19 cases by early next year.
On August 12, the WHO reiterated its commitment to investigate the origins of COVID-19 and urged all governments to depoliticize the investigation and cooperate to accelerate the origins studies.
On August 12, Florida Gov. Ron DeSantis (R) announced that the state will begin setting up mobile units to offer Regeneron’s monoclonal antibody treatment, casirivimab and imdevimabto, for early treatment of COVID-19 to keep people out of the hospital.
As of August 13, more than 167 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 197 million have received both doses) and more than 414 million doses have been distributed, according to the CDC COVID Data Tracker.
As of August 13, the U.S. had more than 36.5 million confirmed COVID-19 cases resulting in 620,981 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; Received 5/12/21
Reporting Requirements Related to Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions; Proposed Rule; 7/7/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; Received 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
REPORTS
HHS Office of Inspector General (OIG)
On August 9, OIG released a report entitled Medicare Continues To Make Overpayments for Chronic Care Management (CCM) Services, Costing the Program and Its Beneficiaries Millions of Dollars. The report found that not all payments made by CMS to providers for noncomplex and complex CCM services rendered during calendar years (CYs) 2017 and 2018 complied with Federal requirements, resulting in $1.9 million in overpayments associated with 50,192 claims. OIG identified that these errors occurred because CMS did not have claim system edits to prevent and detect overpayments. OIG recommended that CMS direct Medicare contractors to recover and refund the mispayments; notify appropriate providers so that they can exercise reasonable diligence to identify, report, and return any overpayments; implement claim system edits to prevent and detect overpayments for noncomplex and complex CCM services; and implement claim system edits at CMS level. CMS agreed with all of the recommendations and described corrective actions for the recovery of the overpayments identified and the refund of amounts overcharged to beneficiaries. A summary of the report is available here.
On August 10, OIG released three reports related to Companion Data Services, LLC, (CDS) including: (1) Almost All of the Medicare Pension Costs That CDS Claimed Through Its Incurred Cost Proposals Were Allowable (available here); (2) CDS Claimed Some Unallowable Medicare Excess Plan Costs Through Its Incurred Cost Proposals (available here); and (3) CDS Claimed Some Unallowable Medicare Postretirement Benefit Costs Through Its Incurred Cost Proposals (available here). OIG found that CDS claimed: (1) $8,989 in unallowable Medicare pension costs due to the use of incorrect indirect cost rates when claiming pension costs for Medicare reimbursement; (2) claimed $8,581 in unallowable Medicare Excess Plan costs that CDS claimed on its Incurred Cost Proposals (ICPs) for CYs 2015 and 2016; and (3) $73,594 in unallowable Medicare postretirement benefit (PRB) costs for CYs 2012 through 2016. OIG recommended that CDS work with CMS to resolve these discrepancies.
On August 11, OIG released three reports related to Palmetto Government Benefits Administrator including: (1) Palmetto Government Benefits Administrator, LLC, Did Not Claim Some Allowable Medicare Pension Costs Through Its Incurred Cost Proposals (available here); and (2) Palmetto Government Benefits Administrator, LLC, Claimed Some Unallowable Medicare Supplemental Executive Retirement Plan III Costs Through Its Incurred Cost Proposals (available here); and (3) Palmetto Government Benefits Administrator, LLC, Claimed Some Unallowable Excess Plan Costs Through Its Incurred Cost Proposals (available here). OIG found that: (1) Palmetto did not claim $998,912 allowable Medicare pension costs on its ICPs for CYs 2012 through 2016 because it used incorrect indirect cost rates when claiming pension costs for Medicare reimbursement; (2) Palmetto received $25,162 in unallowable Medicare Supplemental Executive Retirement Plan (SERP) III costs on its ICPs for CYs 2015 through 2016; and (3) Palmetto claimed $406,791 in unallowable Medicare Excess Plan costs on its ICPs for CYs 2015 and 2016. OIG recommended that Palmetto work with CMS to resolve these discrepancies.
On August 12, OIG released a report entitled CDS Supplemental Executive Retirement Plan III Costs Claimed Through Incurred Cost Proposals Were Allowable and Reasonable. The report found that the SERP III costs that CDS claimed for Medicare reimbursement on its ICPs for CYs 2015 and 2016 were allowable and reasonable, and thus were correctly claimed. The report made no recommendations. A summary of the report is available here.
On August 12, OIG released a report entitled Concerns Persist about Opioid Overdoses and Medicare Beneficiaries' Access to Treatment and Overdose-Reversal Drugs. OIG found that in 2020, more than 43,000 Medicare Part D beneficiaries suffered an opioid overdose from prescription opioids, illicit opioids, or both. Nearly 1 in 4 Part D beneficiaries received opioids during 2020 and the number of beneficiaries who received Medication-Assisted Treatment (MAT) drugs through Part D increased, but at a slower rate in 2020 than in prior years. OIG noted that the slower growth rates in the numbers of beneficiaries receiving MAT drugs and naloxone add to ongoing concerns about access to MAT drugs and naloxone. OIG reiterated a previous recommendation for CMS to educate Part D beneficiaries and providers about access to MAT drugs and naloxone. OIG also advocated for CMS to closely monitor the number of beneficiaries receiving MAT drugs and naloxone and take action, if needed. A summary of the report is available here.
On August 12, OIG updated its database on Addressing the Opioid Epidemic.
Government Accountability Office (GAO)
On August 9, GAO released a report entitled Medicare: Additional Reporting on Key Staffing Information and Stronger Payment Incentives Needed for SNFs. GAO found that almost all SNFs frequently met a federal requirement for a registered nurse on site for 8 hours per day but fewer SNFs frequently met two other staffing measures that specify different numbers of nursing hours per resident per day. GAO estimated that in 2018, Medicare spent over $5 billion on potentially preventable critical incidents, which were mostly the 377,000 hospital readmissions that occurred within 30 days of the SNF admission. GAO predicted that without stronger payment incentives, Medicare is unlikely to reduce the billions in spending on potentially preventable critical incidents or the patient harm that can occur from them. GAO recommended that Congress consider directing the HHS Secretary to implement appropriate payment reductions for SNFs that generate Medicare spending on potentially preventable critical incidents and that CMS report more staffing information on Care Compare. A summary of the report is available here.
On August 10, GAO released a report entitled Private Health Coverage: Results of Covert Testing for Selected Sales Representatives Listed on Healthcare.gov. The report found that all sales representatives from Healthcare.gov contacted by GAO appropriately referred GAO's fictitious applicants with pre-existing conditions to an ACA-compliant plan. A majority of representatives contacted also explained that an ACA-exempt plan would not cover the applicant's pre-existing condition. GAO found that none of the representatives GAO contacted engaged in potentially deceptive marketing practices that misrepresented or omitted information about the products they were selling. A summary of the report is available here.
On August 12, GAO released a report entitled Medicare Durable Medical Equipment: Effect of New Bid Surety Bond Requirement on Small Supplier Participation in the Competitive Bidding Program (CBP). The report found that following Medicare implementing a CBP and suppliers being required to get a $50,000 surety bond for each area they bid in, small durable medical equipment suppliers were still able to participate in the program. GAO found that small suppliers successfully obtained contracts in CBP round 202, accounting for 58% of the suppliers awarded contracts. Trade organizations noted that the new bid surety bond requirement did not create a barrier for small suppliers but other factors may affect small suppliers' future participation, including concerns related to small suppliers' ability to provide items at rates that are competitive with larger suppliers. A summary of the report is available here.
Congressional Budget Office (CBO)
On August 9, CBO released a report entitled Monthly Budget Review: July 2021. The report estimated that the federal budget deficit was $2.5 trillion in the first 10 months of FY 2021, which is $269 billion less than the deficit during the same period last year
On August 9, CBO announced the 2021 CBO’s Panel of Health Advisers. The panel includes: Katherine Baicker, Amitabh Chandra, Michael Chernew, Leemore Dafny, Melissa Favreault, Craig Garthwaite, Darrell Gaskin, Gautam Gowrisankaran, Kate Ho, David Lansky, Thomas Lee, Catherine Livingston, Patricia MacTaggart, David Meltzer, Teresa Miller, Peter Neumann, Jonathan Perlin, Daniel Polsky, Lewis Sandy, Kosali Simon, and Cori Uccello.
On August 12, CBO released a blog post entitled Sequestration Update for August 2021. The post noted that as of January 2021, an additional $2.1 billion has been appropriated, bringing the total discretionary budget to $1,592 billion. However, additional funding was designated as an emergency requirement and therefore caused the caps to be adjusted upward rather than breached. CBO noted that no sequestration will be required.
On August 13, CBO released a report on S. 610, Dr. Lorna Breen Health Care Provider Protection Act, which would establish programs to improve mental and behavioral health among health care professionals and require HHS to report on activities included in the bill. CBO estimated that establishing an education and awareness initiative to encourage health care workers to use services addressing mental health and substance use disorder would cost $29 million over the 2021‑2026 period. CBO estimates that grants to health care entities to establish or enhance efforts to improve mental health and resiliency among health care professionals would cost $103 million over the 2021-2026 period. CBO estimates that requiring the HHS Secretary to identify and disseminate information on evidence-based practices for improving mental health and resiliency among health care workers and to report back to Congress would cost less than $500,000 over the 2021-2026 period. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
None of note.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On August 9, the Urban Institute released a study that found that most adults who feel treated or judged unfairly because of their race or ethnicity by health care providers felt that the treatment disrupted their receipt of care, including resulting in delayed care, looking for a new health care provider, and not getting needed care.
On August 10, Cole County Circuit Judge Jon Beetem ruled that Missouri Governor Mike Parson’s (R) Administration must give Medicaid coverage to newly eligible adults and ordered that newly eligible adults won’t face any additional restrictions to get health care coverage through the program. In 2020 Missouri voters passed a constitutional 2020 ballot measure to expand the state’s Medicaid program but after the state legislature did not approve funding for the program, Governor Parson refused to implement the program.
On August 10, U.S. Chamber of Commerce filed a lawsuit against HHS and other agencies regarding the HHS Transparency in Coverage rule requiring group health plans and insurance issuers to publicly disclose cost-sharing estimates, negotiated rates, prescription drugs, and other price information that was implemented during the former Trump Administration. On August 12, the Pharmaceutical Care Management Association filed a lawsuit against HHS regarding the same rule.
On August 12, the Kaiser Family Foundation published a report that found that substance use issues are worsening, with over 93,000 drug overdose deaths reported in 2020, which is a 30% increase from 2019. White people continue to account for the largest share of deaths due to drug overdose, but people of color are accounting for a growing share of drug overdose deaths over time. The report also highlighted that COVID-19 impacted access and utilization of substance use services.