President Trump challenges WHO to make improvements or lose US funding.

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June 5, 2020

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FEATURED STORY

WHO Cares. We All Should, Too

This week, President Trump (again) announced his intentions to withdraw US funding from the World Health Organization (WHO). Over the past few months, WHO has been thrust into the spotlight as the face of the response to the novel coronavirus pandemic. It has also come under scrutiny for its late reproach of China for withholding key information about the coronavirus and its spread. 

Most people have a fuzzy vision of what WHO does. It was established in 1948 as a specialized agency of the United Nations responsible for international public health. WHO has played a leading role in several global public health achievements, including the eradication of smallpox, the near eradication of polio, and the development of an Ebola vaccine. 

The US is the single biggest funder of WHO, with its $893 million accounting for over 15% of the organization’s total funding in the 2018–2019 cycle. The US funding, however, is in jeopardy. On May 18, President Trump informed WHO that, if it “does not commit to major substantive improvements within the next 30 days,” he will permanently freeze US funding and “reconsider membership in the organization.”

This is likely political theater; the US must give WHO a 1-year notice of withdrawal, placing a US departure more like mid-2021—at which time there may be a new President (and potentially a vaccine and a repair in the relationship).

 

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Recorded on Tuesday, June 2, 2020
Brought to you by FormularyDecisions and AMCP

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LEGISLATIVE UPDATE

Legislative Bytes


  • The Senate Health, Education, Labor, and Pensions (HELP) Committee announced a June 17 hearing on telehealth lessons from the COVID-19 pandemic.
  • Rep. Robin Kelly (D-IL) introduced HR 7078 to study the effects of changes to telehealth under the Medicare and Medicaid programs during the COVID-19 emergency.
COVID-19 UPDATES

A Little Less Conversation. More Action: COVID-19 FAQs on FFS Medicare


On Tuesday, the Centers for Medicare & Medicaid Services (CMS) published a comprehensive Medicare Fee-for-Service (FFS) billing guide, answering COVID-19 frequently asked questions. The billing guide categorized questions into 32 key topics, including physician services, drugs and vaccines under Part B, and National Coverage Determinations (NDCs) during the public health emergency. Key components include changes to supervision rules that began March 1, 2020, and that will remain in effect for the duration of the COVID-19 public health emergency. Although the revisions have significantly relaxed rules, the guidance continually “reminds physicians, practitioners, and suppliers that services and equipment furnished to patients must be reasonable and necessary. Accordingly, the medical record should be sufficient to support payment for the services billed” in the key segments outlined below.

Physician Services

  • Patient services provided via interactive telecommunications technology will be reimbursed through the Physician Fee Schedule. Supervision requirements have also been changed from direct to general supervision, meaning that the physician must supervise the procedure but can be virtually present.
  • Under the emergency declaration, Medicare will pay for in-home and telehealth services provided by physicians and non-physician practitioners. 

Drugs and Vaccines Under Part B 

  • Medicare will pay for COVID-19 vaccinations under Part B, as provided for in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
  • New treatment drugs that are covered under Medicare Part B can be paid by the Medicare Administrative Contractors (MACs) once they receive a code and are on the pricing files.
  • A hospital’s use of medicines and supplies received from the Strategic National Stockpile to treat patients with known or suspected COVID-19 will be paid under Medicare’s Inpatient Prospective Payment System (IPPS) or Outpatient Prospective Payment System (OPPS).
  • MACs will locally determine if Part B will cover an extended supply of drugs during the pandemic. 

NCDs During the Public Health Emergency

  • Physicians can furnish services, including medically necessary injected or infused drugs, in the patient’s home. Physicians can also furnish services in the patient’s home as an incident to their professional services with their auxiliary personnel under direct supervision using interactive audio-video technology. Such services would not be considered a home health service under the Medicare home health benefit or a service under the home infusion therapy services benefit.
  • CMS will continue to update non-enforcement policy to include anticoagulation management and infusion pump services. Additionally, no coverage exception will be made for hyperbaric oxygen for COVID-19 patients specifically with pulmonary fibrosis or other related conditions.

The outlined revisions represent significant policy changes, allowing increased access to care, safe treatment, and needed medical supplies. Nevertheless, the guideline clearly intimates that policy will continue to adapt and evolve based on the severity of the pandemic and need of Medicare beneficiaries. We can expect the CMS guidelines to remain flexible during the public health emergency; the duration of the policy changes will largely depend on future COVID-19 prevalence. 

Hoping to Learn Lessons: CMMI Adjusts in Response to Pandemic


On Wednesday, CMS Administrator Seema Verma announced adjustments to the Center for Medicare and Medicaid Innovation (CMMI) models due to the COVID-19 public health emergency. The announcement describes the principles CMS used to determine which changes were appropriate.

The adjustments include changing implementation dates for new models and delaying certain model reporting requirements. CMMI is also adjusting some model payment methodologies, including mitigating risk during the emergency, and/or modifying cost targets and benchmarks to adjust for the response to COVID-19.

CMS released a chart with the flexibilities relating to financial methodology changes, quality reporting changes, and model timeline changes for certain CMMI models. Flexibilities are being provided for the following models:

  • Bundled Payments for Care Improvement Advanced
  • Comprehensive End-Stage Renal Disease (ESRD) Care Model
  • Comprehensive Care for Joint Replacement Model
  • Direct Contracting (Global and Professional)
  • Emergency Triage, Treat, and Transport
  • Home Health Value-Based Purchasing Model
  • Independence at Home
  • Integrated Care for Kids Model
  • Kidney Care Choices
  • Maternal Opioid Misuse Model
  • Medicare Care Choices Model
  • Medicare Diabetes Prevention Program Expanded Model
  • Medicare Accountable Care Organization (ACO) Track 1+ Model
  • Next Generation ACO
  • Oncology Care Model
  • Primary Care First—Serious Illness Component

Administrator Verma stated that CMMI will be working directly with model participants on the changes and the processes for implementing them. The agency will also continue to review the model data during the COVID-19 pandemic to identify short-term and long-term lessons learned.

These implementation, reporting, and payment adjustments were necessary, given the tremendous disruption caused by both the pandemic and the response to it. Fingers crossed that the models can weather the past 3 months and the uncertainty ahead so that meaningful conclusions can still be drawn from them.

COVID-19 RESOURCES AND BULLETIN

COVID-19 Resources


Coronavirus Task Force Resources and Updates

Centers for Disease Control and Prevention (CDC) Information for Healthcare Professionals

Centers for Medicare & Medicaid Services (CMS) Current Emergencies (Coronavirus)

Food and Drug Administration (FDA) COVID-19 Information

Medicaid and Children’s Health Insurance Program (CHIP) Resources

American Medical Association (AMA) Physician’s Guide to COVID-19

Health Affairs COVID-19 Resource Center

National Foundation for Cancer Research (NFCR) Coronavirus Resource Center for Cancer Patients and Caregivers

COVID-19 Bulletin


  • A Department of Health and Human Services advisory opinion states that pharmacies may order and administer COVID-19 tests in all states.
  • The National Academy for State Health Policy published state approaches to contact tracing during the COVID-19 pandemic.
VALUE CORNER

Valuing Life: Allowing Patient Voices a Larger Role


On Monday, Health Affairs published an article titled, “Traditional Cost-Effectiveness Formulas and Precision Medicines,” which highlighted that a one-size-fits-all approach for evaluating cost-effectiveness may not be suitable for all types of therapies, especially innovative therapies for rare, genetic, and chronic diseases. 

The author suggested that, when interpreting data from health economic models, it is important to: 1) discount biases against therapies with long-term benefits; 2) consider that the quality-adjusted life-year (QALY) may not fully capture value in rare diseases; 3) examine the extent to which life-saving medicines are devalued by routine healthcare costs; 4) take into account that generic drugs may impact price assumptions; and 5) re-evaluate if a traditional $100,000–$150,000 per QALY cost-effectiveness threshold is outdated when evaluating innovative therapies. 

Last month, the American Journal of Managed Care spoke with Lou Garrison, PhD, and Leah Howard, JD, who presented at the “Addressing Gaps in Value Assessments” panel during the virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020 meeting. This panel discussed the Innovation and Value Initiative (IVI) Methods Summit, which focused on priorities for improving methods in value assessments. Dr. Garrison mentioned the need to focus on patient-centered outcomes in value assessment methodologies, incentivize people to move toward high-value care, and create a better infrastructure to collect and share data on value-based agreements. Ms. Howard discussed the importance of increasing the use of real-world data in value assessments to achieve better patient outcomes and the importance of value assessments in light of the COVID-19 pandemic. 

Also last month, the Partnership to Improve Patient Care (PIPC) submitted a letter signed by 64 patient organizations to the Institute for Clinical and Economic Review (ICER) in support of the appointment of Yvette Venable as ICER’s first-ever Vice President of Patient Engagement. The letter summarized past recommendations by PIPC to ICER, such as: 1) partnering with patients with disabilities to develop innovative measures of value that do not have the discriminatory implications of the QALY; 2) working with patients to ensure that real-world evidence is available and incorporated in ICER’s assessments; 3) engaging with patients to identify condition-specific preferences of health-related quality of life tools; 4) including disease specialists as voting members for all ICER reviews; and 5) extending comment periods for patient stakeholders. The letter also highlighted initiatives from the Patient-Centered Outcomes Research Institute (PCORI) to increase patient-centeredness in research and urged ICER to advocate internally for patient representation on ICER’s advisory and governing boards, as well as voting committees, and to meaningfully incorporate patient input into ICER’s base models. 

In case you missed it, the May 2020 issue of ISPOR’s Value in Health is now available online. The issue includes numerous abstracts related to value assessments, with research describing the evolution of value assessment frameworks (VAFs) in the US, the challenges of using VAFs in rare diseases, payer access and utilization of ICER reports, and more.

If you need assistance with all things ICER or value-related, please contact Linnea Tennant.

REGULATORY UPDATES

Information Buffet (AKA, Other Stuff That Caught Our Attention)


We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:

  • The Food and Drug Administration (FDA) issued guidance on Institutional Review Board review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
  • PCORI announced a funding opportunity for phased large awards for comparative effectiveness research will open June 9.
  • A new infographic in the May 2020 print and online issues of JCO Oncology Practice outlined paths to implementing the American Society of Clinical Oncology (ASCO) Patient-Centered Oncology Payment model.
  • The Commonwealth Fund released research on how to improve coordination between Medicare and Medicaid.
HEARD ON THE STREET

“Senate Finance Committee Chairman Chuck Grassley said that he intends to push for a vote this year on a bill that would limit drug-price increases, even as pharmaceutical companies race to find treatments and vaccines for COVID-19….

“‘There’s no better time to address this issue,’ said Grassley…. Grassley pointed to the need to prepare for future pandemics and keep ‘bad actors’ in the drug industry ‘from hiking prices astronomically’ in future health crises.
 
“If the bill doesn’t pass, Grassley worries drugmakers will charge ‘whatever they want to’ for COVID-19 products.
 
“‘It will be the Wild West,’ he said.”

Source: “ICYMI: Long-Delayed Drug-Price Bill Not Dead Yet, Grassley Says,” Bloomberg, June 2

POLICY BY NUMBERS

$15.7 Trillion (With a T)

The Congressional Budget Office (CBO) estimates COVID-19 will cut the US gross domestic product by a staggering $15.7 trillion by 2030.

Source: “Comparison of CBO’s May 2020 Interim Projections of Gross Domestic Product and Its January 2020 Baseline Projections,” CBO, June 1

 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
FEATURED CONTRIBUTORS

EDITOR-IN-CHIEF:
Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Anuja Kanaskar | Scott Shields | Ryan Sullivan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

June 5, 2020

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