Weekly Health Care Policy Update – November 19, 2021

November 26, 2021

In this update: 

  • Covid-19 Updates
    • FDA Authorizes Pfizer and Moderna Booster Shots for All Adults
    • Pfizer Asks FDA to Authorize Covid-19 Antiviral Treatment
    • CMS Changes Nursing Home Visitation Policy, Allows for Some Survey Flexibility
    • CMS Updates Vaccine Mandate FAQs
  • Legislative
    • House Passes Build Back Better Act; CBO Releases Full Cost Estimate
    • Reps. DeGette and Upton Introduce Cures 2.0 Legislation
  • Regulatory
    • HHS and Other Departments Issue Interim Final Rule on Prescription Drug and Health Care Spending
    • CMS Finalizes Delay of Changes to Medicaid Drug Rebate “Best Price” Definition
    • CMS Issues Revised Guidance for Hospital Co-location
    • CMS Announces Significantly Higher 2022 Medicare Part B Premiums
    • CMS Announces Continued Decline in Improper Payments 
    • QPP Doctors and Clinicians Preview Period Opens
  • Other
    • CMS Leaders Author Post on Future of Medicaid and CHIP; CMMI Holds Listening Session
    • CDC Finds Drug Overdoses Exceed 100,000 in 12 Months for the First Time
  • Congressional Hearings
  • New York State Updates
    • DOH Directs Entities to End Religious Exemptions for NYS Vaccine Mandate
    • OMH Issues Guidance on Application of Federal Vaccine Mandate
    • CMS Approves Appendix K Amendment to OPWDD 1915(c) HCBS Waiver
    • DOH Proposes Regulations to Address Nursing Home Expenditures, Staffing, and Application Process
    • OMH and OASAS Announce CORE Services Implementation Training Webinars

COVID-19 Updates

FDA Authorizes Pfizer and Moderna Booster Shots for All Adults
Today (November 19th), the Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for booster shots of the Pfizer and Moderna Covid-19 vaccines to all people ages 18 and older. Moderna’s booster is given at half the dose of the primary vaccination series (50 micrograms), while Pfizer’s is identical to the original.
 
The Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet later today to discuss further clinical recommendations. Several states, including New York, have already made boosters available to all adults upon request.
 
The FDA announcement is available here.
 
Pfizer Asks FDA to Authorize Covid-19 Antiviral Treatment
On November 16th, Pfizer submitted an application to the FDA to approve its Covid-19 oral antiviral for adults who have mild to moderate infections and are at risk of becoming seriously ill. The drug is a protease inhibitor, which blocks an enzyme that viruses require to multiply. In a population of unvaccinated individuals, Pfizer’s data showed that the treatments cut hospitalization and death by 89% among high-risk adults with early symptoms. The study did not include vaccinated individuals. On the same day, Pfizer signed an agreement to allow a group of generic drugmakers to produce a low-cost version of the drug in certain countries. Four Covid-19 antiviral or antibody therapies are currently approved by the FDA, but all require infusions by health professionals.
 
CMS Changes Nursing Home Visitation Policy, Allows for Some Survey Flexibility
On November 12th, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum revising its nursing home visitation policy to allow all residents to receive visitors at all times. CMS explained that the policy change is merited given the wide availability of Covid-19 vaccines, the requirement that nursing homes educate residents and staff on the risks and benefits of the vaccines, and the requirement that nursing homes report resident and staff vaccination data to the CDC. Visits should occur in a manner that does not impose on the rights of another resident, such as a clinical or safety restriction, and should continue to adhere to core principles of infection prevention (e.g., Covid-19 screening).
 
Also on November 12th, CMS issued a memorandum on changes to Covid-19 survey activities, in an effort to address the backlog of complaint and recertification surveys. This includes three major changes:

  1. CMS is rescinding the requirement to conduct Focused Infection Control surveys within three to five days of an outbreak of Covid-19;
  2. Recertification surveys will continue but recertification surveys that could not be completed during the Covid-19 public health emergency (PHE) do not need to be made up; and
  3. CMS is providing temporary guidance and minor flexibilities for State Survey Agencies to work through the current backlog of complaints and recertification surveys. 

The CMS memorandum on visitation can be found here. The CMS memorandum on survey activities can be found here.
 
CMS Updates Vaccine Mandate FAQs
On November 18th, CMS updated its frequently asked questions (FAQs) on the November 4th rule establishing a Covid-19 vaccination mandate for workers in Medicare and Medicaid-participating facilities. Updated guidance includes: 

  • Although assisted living facilities (ALFs) are not covered under the mandate, any staff who are shared with covered facilities (e.g., nursing homes) must be vaccinated.
  • Emergency medical services (EMS) workers are not covered under the mandate, unless through contracts with covered facilities (e.g., hospitals).
  • Private or group practices of therapists are not covered under the mandate. However, CMS-certified outpatient therapy providers are covered, which includes any provider who has a CMS Certification Number (CCN) that it uses to bill Medicare. Providers who use a Provider Transaction Access Number (PTAN) are private practices that are not covered.

The updated FAQs are available here.

Legislative Update

House Passes Build Back Better Act; CBO Releases Full Cost Estimate
Today, the House of Representatives passed the Build Back Better Act by a 220-213 vote along party lines, except for one Democrat voting against. The legislation will now move to the Senate, where significant changes are expected over the next several weeks.
 
On November 18th, the Congressional Budget Office (CBO) released its score of the bill, which estimated that it would increase the deficit by a net of approximately $160 billion over 10 years. Previous estimates from the White House had indicated that the bill would in fact reduce the deficit, but the CBO estimate includes a significantly lower estimate for the effects of enhanced tax enforcement.
 
The full CBO score is available here.
 
Reps. DeGette and Upton Introduce Cures 2.0
On November 16th, House Energy and Commerce Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) introduced bipartisan Cures 2.0 legislation. The bill expands on the 21st Century Cures Act of 2016 and incorporates several pieces of previously-introduced legislation. Key elements of the bill include provisions to: 

  • Transform Medicare coverage of innovative new treatments and technologies to make those them available to patients sooner;
  • Increase access to telehealth services under Medicare, Medicaid, and CHIP;
  • Provide training and educational programs for at-home caregivers;
  • Require more diversity in clinical trials;
  • Provide patients more information about conditions and treatment options;
  • Authorize $6.5 billion to create the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health;
  • Conduct a study on long Covid; and
  • Develop a nationwide testing and vaccine distribution strategy for future pandemics.

The bill can be found here. A section-by-section summary can be found here.

Regulatory Updates

HHS and Other Departments Issue Interim Final Rule on Prescription Drug and Health Care Spending
On November 17th, the Department of Health and Human Services (HHS), the Department of Labor, the Department of the Treasury, and the Office of Personnel Management released an interim final rule, “Prescription Drug and Health Care Spending,” which implements new prescription drug price transparency requirements for health plans and issuers in the group and individual markets, as passed in the 2020 year-end omnibus spending bill (the Consolidated Appropriations Act of 2021). Specifically, submissions are required to include information on:

  • The 50 most frequently dispensed and 50 costliest drugs by total annual spending;
  • The 50 drugs with the greatest increase in plan or coverage expenditures from the previous year;
  • Prescription drug rebates paid by drug manufacturers to plans, issuers, third-party administrators, and pharmacy benefit managers; and
  • The impact of such rebates on premiums and out-of-pocket costs.

The Departments will issue biennial public reports on prescription drug pricing trends and the impact of prescription drug costs on premiums and out of pocket costs starting in 2023.
By statute, plans and issuers must begin submitting the required information by December 27, 2021, though the Departments will exercise discretion to provide temporary deferral of enforcement with regard to this date. Comments are due at 5pm on January 24, 2022.
 
A CMS fact sheet on the rule can be found here.
 
CMS Finalizes Delay of Changes to Medicaid Drug Rebate “Best Price” Definition
On November 17th, CMS issued a final rule delaying changes to the Medicaid Drug Rebate Program’s definition of “best price” for six months, from January 1, 2022 to July 1, 2022. The final rule also delays the window of time during which U.S. territories may join the Medicaid Drug Rebate Program, now beginning January 1, 2023 and ending April 1, 2024.
 
In December 2020, under the Trump Administration, CMS finalized changes to the Medicaid best price definition to help facilitate value-based payment (VBP) arrangements between prescription drug manufacturers and state Medicaid programs. As a result, drug manufacturers would be able to offer prices that are tied to patient outcomes without affecting the overall “best price” framework, in effect allowing them to report multiple “best prices” if offered under VBP arrangements. CMS extended the deadline in acknowledgement of the demands placed on many manufacturers due to COVID-19 and to ensure time to make complex system changes required to report multiple “best prices.”
 
The final rule is available here.
 
CMS Issues Revised Guidance for Hospital Co-location
On November 12th, CMS issued revised guidance for hospitals that are co-located with other hospitals or health care facilities. Co-location occurs when two Medicare-certified hospitals, or a hospital and other health care entity, are “located on the same campus or in the same building and share space, staff, or services.”
 
In the guidance, CMS notes that hospitals and other entities are compliant so long as each can independently comply with Medicare and Medicaid Conditions of Participation (CoPs), a flexibility they have not been granted before. Surveyors will determine whether a hospital is complying with CoPs regardless of co-location status. The revised guidance is less stringent than May 2019 draft guidance, which instructed hospitals to have “defined and distinct spaces” under their independent control.
 
The revised guidance can be found here.  
 
CMS Announces Significantly Higher 2022 Medicare Part B Premiums
On November 12th, CMS released the 2022 Medicare Parts A and B premiums, deductibles, and coinsurance amounts, as well as the 2022 Part D income-related monthly adjustments amounts. The standard monthly Part B premium will increase from $148.50 in 2021 to $170.10 in 2022, based on spending trends driven by Covid-19, limitations on 2021 Part B premium increases the pandemic, and uncertainty regarding potential future spending on Aduhelm, an Alzheimer’s drug that is currently the subject of a Medicare National Coverage Determination analysis. The Part B annual deductible will increase from $203 to $233.
 
Most beneficiaries will also see a 5.9% cost-of-living adjustment to their Social Security benefits, the largest in 30 years. CMS expects this increase to “more than cover the increase in the Medicare Part B monthly premium.”
 
The CMS announcement can be found here.
 
CMS Announces Continued Decline in Improper Payments
On November 15th, CMS announced it has reduced Medicare Fee-For-Service (FFS) improper payments by an estimated $20.72 billion over the past seven years. The estimated improper payment rate for 2021 is 6.2%, an historic low. For the past five years, the improper payment rate has been below the 10% threshold established by the Payment Integrity Information Act of 2019. CMS notes that not all improper payments represent fraud and abuse, and that most involve situations where a state or provider missed an administrative step.
 
A fact sheet on improper payment may be found here and a press release may be found here.
 
QPP Doctors and Clinicians Preview Period Opens
 On November 15th, the Doctors and Clinicians Preview Period officially opened, allowing providers to preview 2020 Quality Payment Program (QPP) performance information before it appears on the Medicare Care Compare website and in the Provider Data Catalog.
 
Data can be accessed here, through the QPP website. A “2020 Doctors and Clinicians Performance Information: Guide to the Preview period” may be found here.

Other Updates

CMS Leaders Issue Post on Future of Medicaid and CHIP; CMMI Holds Listening Session
On November 16th, CMS Administrator Chiquita Brooks-LaSure and Director of the Center for Medicaid and CHIP Services (CMCS) Daniel Tsai authored a blog post in Health Affairsoutlining the future of Medicaid and the Children’s Health Insurance Program. The blog outlines three strategic priorities:

  1.  Coverage and Access:
  • Protect access to coverage after the Covid-19 continuous coverage requirement ends.
  • Close the coverage gap.
  • Increase and strengthen eligibility and enrollment, including by improving data collection and related systems.
  • Protect and expand access to care.
  • Broaden access to home and community-based services (HCBS).
  1. Equity:
  • Measure disparities in health care access, quality, experience, and outcomes.
  • Make evidence-based investments in equity-focused interventions.
  • Close or reduce those gaps in health equity, including by making funding and new federal investments linked to progress on reducing health disparities.
  1.  Innovation and Whole-Person Care:
  • Transition the vast majority of Medicaid beneficiaries into accountable care relationships by 2030.
  • Establish policy principles and criteria for new section 1115 (experimental, pilot, or demonstration projects), including: 
    • Enhanced coverage, access, and quality;
    • A stronger safety net;
    • Value-based care delivery and payment innovation; and
    • Increased access to HCBS, substance use disorder services, and mental health services.
  • Bring behavioral health care up to parity with physical health.

These priorities align with the CMS’s overall six pillars as well as the CMS Innovation Center’s (CMMI) strategic refresh white paper published last month, which set similar goals. On November 18th, CMMI held a listening session to hear from stakeholders regarding the paper. Stakeholders expressed concerns on various topics, including additional ways to incent smaller practices to participate, the ability of federally qualified health centers (FQHCs) and other providers in underserved areas to participate in CMMI models, the need for greater and more real-time data availability, and issues related to current model design. Further listening sessions will be scheduled in the next few months.
 
The blog post can be found here. CMMI published an “At-a-Glance” summary of its strategy white paper here.

CDC Finds Drug Overdoses Exceed 100,000 in 12 Months for the First Time
On November 17th, the CDC announced that there were an estimated 100,036 drug overdose deaths in the United States during the 12-month period ending in April 2021, according to provisional data from the Center for Health Statistics. This is the first time overdose deaths have exceeded 100,000 in a year, an increase of 28.5% deaths over the same period during the preceding year. Overdose deaths increased across several drugs or drug classes, including opioids, synthetic opioids (primarily fentanyl), psychostimulants (such as methamphetamine), cocaine, and natural/semi-synthetic opioids (such as prescription pain medication).
 
A press release may be found here and an interactive data dashboard may be found here.

Congressional Hearings

No major health care-related hearings are scheduled next week.

New York State Updates

DOH Directs Entities to End Religious Exemptions for NYS Vaccine Mandate
On November 15th, the New York State Department of Health (DOH) released a notice (available here) to covered entities regarding the State’s Covid-19 vaccination mandate for health care workers, due to the recent ruling from the Court of Appeals for the Second Circuit which allowed the mandate to proceed without allowing for religious exemptions. As a result of this ruling, covered health care personnel who were previously granted religious exemptions must document either a first Covid-19 vaccination dose or a valid medical exemption beginning on November 22nd.
 
Facilities should have a process in place to consider reasonable accommodation requests from covered personnel based on sincerely held religious beliefs consistent with federal, state, and local laws; however, unvaccinated individuals may not continue in positions in which they could potentially expose other personnel, patients, or residents with Covid-19. Covered entities could consider other reasonable accommodations to eliminate the risk of such exposure.
 
An updated FAQ document regarding the vaccine mandate emergency regulation is available here (see FAQ #20). Questions may be submitted to hospinfo@health.ny.gov, covidnursinghomeinfo@health.ny.gov, covidadultcareinfo@health.ny.gov, or covidhomecareinfo@health.ny.gov as applicable.
 
OMH Issues Guidance on Application of Federal Vaccine Mandate
Today, the Office of Mental Health (OMH) issued guidance regarding the intersection of the federal and New York State Covid-19 vaccination mandates. OMH notes that the CMS rule applies to Medicare-certified facilities, which include: 

  • OMH-operated or licensed hospitals and Comprehensive Psychiatric Emergency Programs (CPEP); and
  • Medicare-certified residential treatment facilities (RTFs) for youth.

However, the CMS rule does not apply to other OMH-licensed facilities, including freestanding clinics, rehab, and residential programs not operated by a hospital. OMH stated that it does not believe any CMS-certified community mental health centers operate in New York.
 
The guidance is available here.
 
CMS Approves Appendix K Amendment to OPWDD 1915(c) HCBS Waiver
On November 16th, CMS approved a request by New York to amend the Appendix K to the Office for People with Developmental Disabilities (OPWDD) comprehensive 1915(c) HCBS waiver. The amendment enacts $1.5 billion in incentives for Direct Support Professionals (DSPs) and Family Care (FC) providers in the OPWDD workforce, which comes from New York State’s plan to enhance HCBS using funds from the enhanced Federal Medical Assistance Percentage (FMAP) for HCBS under Section 9817 of the American Rescue Plan Act.
 
Funds will be provided as lump-sum payments through eMedNY to qualifying HCBS provider agencies based on the number of DSPs and FC providers who qualify. The incentives are structured as follows.
 
Covid-19 Workforce Performance Incentive
This will be a retroactive, one-time performance payment for Direct Support Professionals (DSPs) and Family Care (FC) providers implemented through a supplemental payment mechanism. Payments will be directed to staff who worked full- or part-time between March 17, 2020 and September 1, 2021 for at least 90 days, and who are still employed by the agency or who continue to deliver services. The bonus amount will be $1,000 for full-time employees, which will be prorated for part-time employees.
 
Workforce Longevity and Retention Bonus
This will include two bonus payments, the Longevity Bonus and Retention Bonus, to qualified workers employed by an eligible, OPWDD-certified HCBS provider in a DSP or FC capacity. Each bonus will be the same amount, as follows: 

  • Not-for-profit agencies will receive 20% of their DSP payroll expenditures, adjusted for salary-sensitive fringe benefit costs, as reported on their 2019 cost reports.
  • DSPs hired under self-direction will be paid 20% of their approved wage.
  • FC providers will be paid 20% of the current difficulty of care payment rate.

Eligibility for the bonuses will be as follows: 

  • The Longevity Bonus will be available to DSP and FC staff who worked from April 1, 2020 to March 31, 2021, and who are still on payroll after September 1, 2021.
  • The Retention Bonus will be prospectively available to DSP and FC staff who work from April 1, 2021 to March 31, 2022, and who are still on payroll as of March 31, 2022. The bonus will be paid at the end of the retention period.

Vaccination Incentive Payments
This is a payment available to qualified workers employed by an eligible, OPWDD-certified HCBS provider in a DSP or FC capacity, who are fully vaccinated by December 1, 2021. Self-directed DSPs are also eligible. The amount of the payment is $500 for full-time employees, $250 for part-time employees who work over 20 hours per week, and $125 for employees working less than 20 hours per week.
 
Additionally, the Appendix K will enhance payment for Intensive Behavioral Support (IBS) services. Effective July 1, 2021, IBS payments will be increased by approximately 31.3%, which will be used to increase clinician wages and expand the availability of services.
 
Governor Hochul announced the funding in a press release available here. The CMS approval letter is available here. The full text of the Appendix K amendment is available here. The provisions will be effective from March 7, 2020 until six months after the end of the federal Covid-19 public health emergency.
 
DOH Proposes Regulations to Address Nursing Home Expenditures, Staffing, and Application Process
On November 17th, DOH issued several proposed rules in the State Register (available here) that would implement the following regulations for nursing homes: 

  • Require nursing homes to spend a minimum of 70 percent of revenue on direct resident care and 40 percent of revenue on resident-facing staffing;
  • Strengthen the establishment application review process for all Article 28 facilities; and
  • Implement standard minimum nursing home staffing levels.

Public comment on these regulations may be submitted through January 16, 2022.
 
OMH and OASAS Announce CORE Services Implementation Training Webinars
On November 13th, OMH and the Office of Addiction Services and Supports (OASAS) announced the following training webinars for currently designated adult behavioral health home and community-based services (BH HCBS) providers that will be participating in the transition to Community Oriented Recovery and Empowerment (CORE) services: 

  • CORE Peer Support – November 29th from 2pm-3pm (registration here)
  • CORE Community Psychiatric Support and Treatment (CPST) – November 30thfrom 1pm-2pm (registration here)
  • CORE Psychosocial Rehabilitation (PSR) – December 1st from 9:30am-11am (registration here)
  • CORE Family Support and Training (FST) – December 7th from 2:30pm-3:30pm (registration here)
  • Person-Centered Planning & Documentation – December 8th from 9am-10am (registration here)