Weekly Health Care Policy Update – August 27, 2021

September 3, 2021

In this update: 

  • Covid-19 Response
    • FDA Approves Pfizer-BioNTech Vaccine
    • CMS Expands Medicare Payments for At-Home Vaccinations
    • CMS Clarifies Nursing Home Vaccine Mandate Implementation
  • Legislative
    • House Approves Budget Resolution
  • Regulatory
    • Regulators Delay Enforcement of Certain Price Transparency Rules for Health Plans and Providers
    • CMS Announces ACOs Earned $2.3 Billion in Shared Savings in 2020
    • CMS Releases Next Gen ACO Model Beneficiary and Provider RIF Files
    • HHS Announces $80 Million for Navigators in States with Federal Exchanges
    • HRSA Reiterates Provider Relief Fund Reporting Deadline of September 30th
    • CMS Encourages MA Plans to Relax Utilization Management Requirements
  • Other
    • CBO Releases Paper on Model for New Drug Development
    • Urban Institute Report Shows Steady Uninsured Rate During Pandemic
  • Congressional Hearings
  • New York State
    • DOH Releases New Medicaid 1115 Waiver Demonstration Proposal and Concept Paper
    • PHHPC Discusses and Approves Proposed Extension of COVID-19 Vaccine Mandate
    • DOH Updates Proposed Regulations for the Medicaid Transportation Program
    • DOH Resumes Certain MLTC Involuntary Disenrollments
    • DOH Updates Medicaid Coverage Policy and Billing Guidance for COVID-19 Vaccines to Include Booster Shots
    • Legislation Related to OPWDD Comprehensive Plan and Incident Report Requests Signed into Law

COVID-19 Response

This week, the Biden Administration announced new updates on the COVID-19 response: 

  • FDA Approves Pfizer-BioNTech Vaccine: On August 23rd, the Food and Drug Administration (FDA) announced full authorization for the Pfizer-BioNTech Covid-19 vaccine (“Comirnaty”) for  the prevention of Covid-19 in individuals 16 and older. The vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. The Pfizer-BioNTech vaccine has been available via EUA for individuals 16 and older since December 11, 2020.
  • CMS Expands Medicare Payments for At-Home Vaccinations: On August 24th, the Centers for Medicare and Medicaid Services (CMS) announced that health care providers can now receive additional payments for administering vaccines to multiple recipients in one home setting or communal setting of a home, including second and third doses. Providers may receive the increased payments up to five times when fewer than 10 Medicare beneficiaries get the vaccine on the same day in the same home or communal setting. Full information about Medicare Covid-19 vaccine reimbursement can be found here.
  • CMS Clarifies Nursing Home Vaccine Mandate Implementation: On August 25th, on a call with stakeholders, CMS leadership announced that they would not immediately remove nursing homes from the Medicaid and Medicare programs if they do not comply with the employee staff vaccination requirement announced last week. Instead, nursing homes will first be notified of their lack of compliance, followed by civil monetary penalties and then payment denial. Only after these steps would facilities be removed from the program. The requirement is planned to take effect in September.

Legislative Updates

House Approves Budget Resolution
On August 24th, the House of Representatives approved the Senate-passed budget resolution on a party-line vote (220-212). With this action, the budget has been deemed adopted, meaning that both houses have now begun to engage in the budget reconciliation process. Under the terms of the budget resolution, the reconciliation bill may contain up to $3.5 trillion in total spending, but at least half must be paid for with revenue increases or spending reductions. Senate Democrats have released a memo outlining the budget framework, available here.
 
Some health care policies mentioned in the reconciliation instructions include:

  • Extending the enhanced advanced premium tax credits (APTCs) included in the American Recovery Plan Act;
  • Expanding Medicare benefits to include dental, hearing, and vision, and lowering the eligibility age;
  • Addressing health care provider shortages;
  • Lowering prescription drug prices; and
  • Investing in health equity.

This list of policies is not final and not exclusive. Committees are to draft their legislation by September 15th, with floor consideration in both the House and Senate to follow.

Regulatory Updates

Regulators Delay Enforcement of Certain Price Transparency Rules for Health Plans and Providers
On August 20th, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued sub-regulatory guidance modifying and delaying the enforcement of several price transparency and surprise billing requirements for health plans and providers. The guidance released as a Frequently Asked Questions document, addresses the overlap between requirements in the Transparency in Coverage (TiC) final rule, released in October 2020, and the Consolidated Appropriations Act of 2021 (CAA), passed in December 2020. Specifically:

  • Machine-Readable Files: The TiC rule requires that health plans and issuers disclose three separate machine-readable files disclosing (1) in-network provider rates, (2) out-of-network allowed amounts and billed charges, and (3) prescription drug prices, for plan years beginning on or after January 1, 2022. Under this guidance: 
    • The Departments will defer enforcement of requirements (1) and (2) until July 1, 2022. For subsequent plan and policy years, plans/issuers should post these machine-readable files in the month in which the plan/policy year begins.
    • The Departments will indefinitely defer enforcement of requirement (3) pending future rulemaking that will address potentially duplicative requirements between TiC and the CAA.
  • Price Comparison Tool: The TiC final rule requires that, effective January 1, 2023, health plans and issuers provide an internet-based self-service price comparison tool (and in paper form upon request) for 500 items and services, and for all covered items and services by January 1, 2024. Separately, the CAA requires plans/issuers to offer a price comparison guide by phone and online beginning January 1, 2022. Under this guidance: 
    • The Departments will defer enforcement of the CAA requirements to January 1, 2023.
    • Because the CAA’s requirements are potentially duplicative of TiC requirements, the Departments intend to issue a future rule on whether compliance with the TiC final rule will satisfy the CAA requirements. The Departments expect that the new rule will contain at least one new requirement enacted in the CAA that this information also be made available by telephone.
  • ID Cards: The CAA included requirements that health plans and issuers include a set of plan information (deductibles, out-of-pocket maximum limits, and contact information) on all ID cards issued for plan years beginning on/after January 1, 2022. Under this guidance: 
    • The Departments will not issue a rule implementing these requirements before the effective date. However, the Departments will eventually propose such a rule. In the meantime, plans and issuers should use a “good faith, reasonable interpretation of the law.” The Departments do indicate that inclusion on the card of the applicable major medical deductible and out-of-pocket maximum would constitute compliance.
  • Good Faith Estimates and Advanced Explanations of Benefits: The CAA requires providers to offer, upon request, a “good faith estimate” of what they will charge for services furnished during the visit. Providers must send this estimate to the individual’s plan or issuer, if covered. It also requires that plans and issuers, when receiving such an estimate, provide the enrollee with an “Advanced Explanation of Benefits” based on this estimate. Under the CAA, these requirements are effective January 1, 2022. Under this guidance: 
    • The Departments intend to issue regulations implementing the “good faith estimate” requirement for uninsured individuals prior to the January 1, 2022 effective date.
    • The Departments will defer enforcement of the “good faith estimate” requirement for insured individuals and of the “Advanced Explanation of Benefits” requirement until after January 1, 2022. They will undertake future rulemaking with a prospective applicability date that will give providers reasonable time to come into compliance.
  • Pharmacy and Drug Cost Reporting: With regard to requirements that plans/issuers report on pharmacy benefits and drug costs: 
    • The Departments will defer enforcement of the first and second reporting deadline (December 27, 2021 and June 1, 2022) pending future rulemaking, but strongly encourage plans and issuers to ensure they are prepared to begin reporting the required information with respect to 2020 and 2021 by December 27, 2022. The Departments note that plans and issuers may need to modify contractual arrangements to enable price disclosure.

The Departments also address several other requirements, which they either believe do not require rulemaking or on which they expect to issue rules after the statutory deadlines have passed. These include: 

  • Prohibition on gag clauses on price and quality data;
  • Improving accuracy of provider directory; and
  • Continuity of care protections when provider networks change.

The full FAQ is available here.
 
CMS Announces ACOs Earned $2.3 Billion in Shared Savings in 2020
On August 25th, CMS announced that Accountable Care Organizations (ACOs) in the Medicare Shared Savings Program (MSSP) earned total shared savings performance payments of nearly $2.3 billion in Payment Year (PY) 2020. This performance amounted to approximately $1.9 billion in savings for the Medicare program, marking the fourth consecutive year of net savings to Medicare. Overall, 67 percent of ACOs participating in MSSP were able to earn shared savings from CMS in PY 2020, including 88 percent of those ACOs participating in the two-side model, and 55 percent of those ACOs participating in the one-sided model. Over 12.1 million Medicare fee-for-service beneficiaries are attributed to a Medicare ACO-participating provider. 
 
CMS Releases Next Gen ACO Model Beneficiary and Provider RIF Files
On August 24th, CMS announced the availability of new Research Identifiable Files (RIFs) containing from Next Generation ACO (NGACO) Model Performance Years 1 through 3. For each payment year, CMS has released the NGACO Beneficiary RIF, containing beneficiary enrollment data (beneficiary ID, ACO name, monthly assignment status information, and date of birth/death), and the NGACO Provider RIF, containing identifying information about participating providers (ACO identifier, performance year, organization name, TINs and CCNs, and provider type description).
 
More information on the NGACO Model can be found here.
 
HHS Announces $80 Million for Navigators in States with Federal Exchanges
On August 27th, HHS announced a total of $80 million in grant awards would be made to 60 Navigator organizations operating in 30 states that use the federal HealthCare.gov to operate their individual health insurance marketplace under the Affordable Care Act. The funding is expected to train more than 1,500 Navigators to help consumers in these states find affordable health coverage through HealthCare.gov. These awards particularly focus on underserved communities.
 
The HHS announcement is available here.
 
HRSA Reiterates Provider Relief Fund Reporting Deadline of September 30th
On August 26th, the Health Resources and Services Administration (HRSA) held two stakeholder calls on which it reaffirmed that providers who received at least $10,000 in Provider Relief Fund (PRF) grants before June 30, 2020 must report on their use of funds by September 30, 2021. Stakeholders have raised concerns that the PRF reporting requirements are complex and that deadlines are coinciding with further increases in Covid-19 cases. On the calls, HRSA staff released condensed versions of previous guidance, but did not address any new questions regarding PRF reporting and funds usage.
 
CMS Encourages MA Plans to Relax Utilization Management Requirements
On August 20th, CMS sent a letter to all Medicare Advantage (MA) Organizations and Medicare-Medicaid plans strongly encouraging them to implement or re-implement waivers on utilization management due to the national increase in Covid-19 infections. The letter says that plans should seek to “facilitate the movement of patients from general acute-cate hospitals to post-acute care and other clinically-appropriate settings” by not creating administrative burdens or delays, ensuring that hospitals can maximize bed capacity if needed. However, CMS is not changing any rules regarding MA payments. As such, such waivers must be “uniformly provided to similarly situated enrollees,” and coverage standards cannot be more stringent than those that apply for fee-for-service Medicare.
 
The letter can be found here.

Other Updates

CBO Releases Paper on Model for New Drug Development
On August 26th, the Congressional Budget Office (CBO) released a paper presenting its simulation model for analyzing legislative proposals that may substantially affect new drug development. The model produces estimates of how many new drugs would enter the market, given parameters such as changes in expected future profits and development costs. As an example, CBO says that a legislative change that reduced expected profits for top-earning drugs (top quintile of profits) by 15 to 25 percent would be projected to reduce the number of new drugs entering the market by 0.5 percent annually during the first decade of the policy, and by 8 percent annually by the third decade.
 
The paper is available here.
 
Urban Institute Report Shows Steady Uninsured Rate During Pandemic
On August 18th, the Urban Institute released a policy brief examining the proportion of uninsured non-elderly Americans during the Covid-19 pandemic. The brief finds that, between March 2019 and April 2021, despite rapid job losses in the early months of the pandemic, the national uninsured rate among adults between 18 and 64 did not significantly change, due to a corresponding increase in public health coverage. Approximately 5.5 million adults lost their employer-sponsored insurance (ESI) from March 2019 through April 2021, so that the share of adults covered by ESI decreased from 65.0 percent to 62.3 percent. However, approximately 7.9 million adults gained public coverage during the same period, with public coverage rising from 13.6 percent to 17.5 percent of adults. As a result, the national uninsured rate held steady at about 11 percent throughout.
 
The report is available here.

Congressional Hearings

Wednesday, September 1st:  

  • At 1pm, the House Committee on Small Business will hold a hearing on the loan forgiveness phase of the Small Business Administration’s (SBA) Paycheck Protection Program (PPP). More information is available here.

New York State Updates

DOH Releases New Medicaid 1115 Waiver Demonstration Proposal and Concept Paper
On August 25th, the New York State (NYS) Department of Health (DOH) submitted a concept paper for a new Medicaid 1115 Waiver Demonstration to the Centers for Medicare and Medicaid Services (CMS). Through this proposal, the State is requesting $17 billion to be reinvested over five years to support a transformational effort to address health equity by reforming systemic health care delivery issues that are linked to health disparities and have been exacerbated by the Covid-19 pandemic. Specifically, the waiver proposal seeks to achieve the following goals:

  • Build a more resilient, flexible, and integrated delivery system that reduces racial disparities, promotes health equity, and supports the delivery of social care;
  • Develop supportive housing and alternatives to institutions for the long-term care population;
  • Redesign and strengthen health and behavioral health system capabilities to provide optimal response to future pandemics and natural disasters; and
  • Create statewide digital health and telehealth infrastructure.

As previously announced by DOH, in this waiver, the State intends to develop entities called Health Equity Regional Organizations (HEROs) and social determinants of health networks (SDHNs) to inform and support targeted investments in social care and non-medical, community-based services. The waiver also would contain a new value-based payment (VBP) roadmap, with significant funding for VBP incentives.
 
SPG’s detailed summary of the concept paper is available here. The full paper is available here.
 
PHHPC Discusses and Approves Proposed Extension of Covid-19 Vaccine Mandate
On August 26th, the New York State Public Health and Health Planning Council (PHHPC) discussed and approved an emergency regulation that extends and supersedes the State’s Section 16 vaccine mandate to additional health care settings. The regulations are in effect immediately, but DOH will propose a version with revisions to be adopted in 90 days. The current vaccine mandate requires personnel at hospitals and nursing homes to receive their first Covid-19 vaccine dose by September 27th. This regulation extends the requirement to: 

  • All Article 28 licensed facilities, including ambulatory surgery centers (ASCs) and diagnostic and treatment centers (DTCs);
  • All Article 36 home care providers, including Licensed Home Care Services Agencies (LHCSAs), limited LHCSAs, Certified Home Health Agencies (CHHAs), AIDS home care programs, and long term care home health care programs;
  • Hospices; and
  • Adult care facilities.

Personnel at the newly covered provider types will be required to receive their first vaccine dose by October 7th. “Personnel” may include all persons employed or affiliated with a covered entity, including employees, members of the medical and nursing staff, contract staff, students, and volunteers, who could potentially expose others to Covid-19. For example, subcontracted housekeeping staff at a hospital would be covered, but emergency medical technicians (EMTs) would be covered if and only if the ambulance is operated by a covered entity. DOH will require reporting by facilities as to compliance.
 
The proposed regulations would have allowed exemptions for medical and religious reasons, but the final version adopted by the PHHPC removed the ability for facilities to offer religious exemptions. DOH stated that medical exemptions may potentially be denied by facilities if they are determined to be invalid, and that it may offer further instructions through a Dear Administrator Letter or other subregulatory guidance.
 
The proposed regulations are available here.
 
DOH Updates Proposed Regulations for the Medicaid Transportation Program
On August 25th, DOH published a revised rule in the State Register (available here) that implements the following Medicaid Redesign Team (MRT) II recommendations: 

  • Medicaid participation in an Emergency Triage, Treat, and Transport (ET3) model, which is a Medicare demonstration program that provides an alternative to hospital emergency department care for Medicaid beneficiaries otherwise transported to the hospital; and
  • Contracting with a transportation management broker to provide cost-effective nonemergency transportation to Medicaid beneficiaries.

The revised rule includes: 

  • Payment standards for emergency ambulance services provided by ET3 model participants;
  • Changes in the Medicaid transportation program, which will occur when nonemergency transportation services are provided and managed by one or more transportation management brokers;
  • Maintenance of certain aspects of the current prior authorization and payment standards necessary for the transition to one or more transportation management brokers;
  • Removal of out-of-date references to the old transportation program operated in conjunction with local social services districts; and
  • An amended definition of transportation services to include transportation network companies.

The full proposed regulations are available here. DOH will accept public comment through October 9th.
 
DOH Resumes Certain MLTC Involuntary Disenrollments
DOH suspended involuntary disenrollment from Managed Long-Term Care (MLTC) plans during the Covid-19 State Disaster Emergency. Updated guidance from DOH now allows the resumption of involuntary disenrollment for certain situations, including: 

  • Medicaid Advantage Plus (MAP) members who are not enrolled in the affiliated Medicare Dual Eligible Special Needs Plan (D-SNP); and
  • Members of any MLTC product who moved out of the product’s service area and legally changed their address.

More information is available here and the processing schedule is available here. Questions may be sent to mltcinfo@health.ny.gov.
 
DOH Updates Medicaid Coverage Policy and Billing Guidance for Covid-19 Vaccines to Include Booster Shots
On August 23rd, DOH updated the New York State Medicaid Coverage Policy and Billing Guidance for the Administration of Covid-19 vaccines (available here) to include CPT codes and fees for the third doses of the Pfizer-BioNTech and Moderna vaccines. The third doses may be billed at the same current fee ($40) for the first and second doses of the Pfizer-BioNTech and Moderna vaccines. DOH also updated the guidance to clarify that as of the expiration of the New York State Disaster Emergency on June 25, 2021, ambulance providers may only bill for Covid-19 vaccinations administered by paramedics.
 
Legislation Related to OPWDD Comprehensive Plan and Incident Report Requests Signed into Law
On August 20th, the following bills were signed into law by the Governor: 

  • S5945A/A7163 requires facilities operated, licensed, or certified by the Office for People with Developmental Disabilities (OPWDD), Office of Mental Health (OMH), or the Office of Alcoholism and Substance Abuse Services (OASAS) to provide a copy of a written incident report within 10 days of a request filed by a qualified individual. Facilities may offer to provide all reports electronically.
  • S6277/A7690 requires OPWDD to include in its comprehensive five-year plan the average Medicaid expenditures per service recipient and demographic information, including age, race, ethnicity, residence type, and primary language.