CMS issued another round of regulatory waivers and rule changes to deliver expanded care to beneficiaries in the midst of COVID-19.

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May 1, 2020

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FEATURED STORY
 

Call Me Maybe: Additional Information on Flexibility in Medicare

 
 

Yesterday, the Centers for Medicare & Medicaid Services (CMS) issued another round of regulatory waivers and rule changes to deliver expanded care to beneficiaries and provide flexibility to the healthcare system as the country begins reopening. The changes include facilitating beneficiaries’ abilities to get tested for COVID-19 and continuing CMS’ efforts to further expand beneficiaries’ access to telehealth services.

Medicare will no longer require an order from the treating physician or other provider for beneficiaries to get COVID-19 tests and other laboratory tests required as part of a COVID-19 diagnosis. During the public health emergency, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law.

The changes allow pharmacists to work with a physician to provide assessment and specimen-collection services, and the physician can bill Medicare for the services. Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice and state law. These changes will allow beneficiaries to get tested at “parking lot” test sites operated by pharmacies.

Additionally, CMS will now pay hospitals and practitioners to assess beneficiaries and collect laboratory samples for COVID-19 testing and will make separate payment when that is the only service the patient receives.

Other regulatory changes include expanding telehealth, increasing hospital capacity, augmenting the healthcare workforce, and decreasing administrative burdens.

Providers and states can begin using the flexibilities immediately.

 

Webinar: Patient Assistance in the Wake of COVID-19

 
 

Friday, May 8 | 12:00 PM EDT

As the US economy continues to feel the ripple effects of the coronavirus pandemic and more Americans lose their jobs, will patients be able to afford their medications?

Join a panel of experts from Lash Group and Xcenda on Friday, May 8 at 12:00 PM ET who will offer insights on the impact to insurance coverage and patient assistance programs as the pandemic continues.

Register for webinar >

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LEGISLATIVE UPDATES
 

The Senate is scheduled to return to full session on Monday, May 4. The House was also scheduled to return on May 4, but Speaker Nancy Pelosi (D-CA) has delayed the return until at least May 11.

 

Cures Act 2…Scene 1

 
 

On Monday, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released a concept paper examining priorities to update the 21st Century Cures Act that passed in 2016. The concept paper—a precursor to draft legislation—is a set of strategies for improving biomedical innovation, testing, and medical supply readiness to mitigate current and future pandemics.

The priorities outlined in the concept paper include:

  • Modernizing and expanding domestic drug manufacturing, including using continuous manufacturing
  • Establishing a plan to develop, promote, and administer vaccines and therapeutics
  • Improving the commercial market for antibiotics
  • Reforming clinical trials
  • Enabling the Food and Drug Administration (FDA) to utilize patient-focused drug development by prioritizing digital health tools, real-world data, and real-world evidence
  • Providing financial assistance to help individuals with rare diseases receive treatment
  • Improving health literacy and access to health information for individuals
  • Expanding specialized training in medication adherence and injection for caregivers

The bill sponsors continue to seek stakeholder feedback and hope to include certain provisions in the next round of COVID-19 funding legislation. A draft bill is expected later in 2020.

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COVID-19 UPDATE
 

Feeling the Need for Speed: Plan for Testing and Rapid Response

 
 

Last week, the Trump administration released its Blueprint for Testing Plans and Rapid Response Programs. The blueprint relays the strategy, as well as roles and responsibilities of key stakeholders, for the implementation and adoption of COVID-19 testing, monitoring, and rapid response. This blueprint is 1 component the president is implementing to help state and local governments reopen their economies.

Testing Plans
The blueprint defines a partnership between federal, state, local, tribal governments; the private sector; and professional associations. To achieve the widespread testing, collection, and analysis that is needed, the administration has laid out key components to success in each category.

  • Increasing testing and laboratory supplies
  • Unlocking full laboratory capacity
  • Enhancing sample collection
  • Expanding the number of testing platforms

Monitoring Systems
States are responsible for establishing and utilizing existing monitoring tools, such as publicly available clinical monitoring systems. Monitoring disease spread will allow states to rapidly identify areas of potential outbreak and direct resources as appropriate. Through monitoring, states will also be able to proactively request federal assistance where needed.

The blueprint suggests, with little detail, that states establish sentinel monitoring systems at high-risk locations such as senior living communities and health clinics. To assist states’ monitoring efforts, the administration will provide technical assistance, but the blueprint does not elaborate on what “technical assistance” entails. Additionally, the federal government will provide states aid in identifying high-priority areas such as food-processing plants.

Rapid Response
Rapid response to positive cases of COVID-19 will be the responsibility of the states. The states should develop a protocol that quickly identifies, isolates, and contact traces positive cases, regardless of symptomatic or asymptomatic status. The rapid-response plan emphasizes contact tracing and triaging contact of high- to low-risk exposures.

Contact tracing can be prioritized as follows:

  • High-risk exposure contacts (eg, close contacts)
  • Healthcare worker contacts
  • Contacts who work with or are part of a vulnerable population
  • A high volume of low-risk contacts

The administration will provide technical assistance to states to enable contact-tracing efforts. The Centers for Disease Control and Prevention (CDC) will provide a nationwide support program conducting various public-health initiatives, epidemiology, laboratory analytics, and monitoring. The administration hopes CDC support will enable states to rapidly identify and contain possible sources of disease spread.

In tandem with the 3-pronged approach outlined in the Blueprint for Testing Plans and Rapid Response Programs, the administration is continuing to invest in the development of improved and innovative technology to more efficiently identify and respond to COVID-19 cases. The administration notes that continual updates to testing algorithms and protocols will be necessary as COVID-19 could co-circulate with influenza-like illnesses in Fall 2020. Despite evolving circumstances and the tools available to meet those circumstances, the pillars within the blueprint are unlikely to change. Through private, federal, and local partnerships, the blueprint should assist states in monitoring and controlling the spread of COVID-19.

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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

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

 

COVID-19 Bulletin

 
 

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VALUE CORNER
 

(Less Money) Would Make ICER Grow Fonder:
Cystic Fibrosis Treatment Should Be Discounted 75%

 
 

On Monday, the Institute for Clinical and Economic Review (ICER) announced the release of its Evidence Report evaluating elexacaftor/tezacaftor/ivacaftor (TRIFAFTA) for the treatment of cystic fibrosis. ICER had previously evaluated ivacaftor (KALYDECO), lumacaftor/ivacaftor (ORKAMBI), and tezacaftor/ivacaftor (SYMDEKO) in its May 2018 cystic fibrosis evaluation and also considered new evidence available for these therapies. The Evidence Report suggests that for the indicated populations where clinical data exist, the evidence provides high certainty that TRIFAFTA provides a substantial net health benefit over standard care and over SYMDEKO; however, TRIFAFTA would require a 73% to 78% discount from the treatment’s current list price to meet a cost-effectiveness ratio of $100k to $150k per quality-adjusted life-year (QALY). ICER also concluded that the new evidence for KALYDECO, ORKAMBI, and SYMDEKO confirmed its previous evidence ratings: the evidence provides high certainty that KALYDECO provides a substantial net health benefit, ORKAMBI provides a small net health benefit, and SYMDEKO provides at least a small net health benefit with the potential for a substantial benefit; however, substantial discounts (76%–81%) from the list prices are required to reach acceptable cost-effectiveness thresholds of $100k to $150k/QALY.

This week, the Journal of Managed Care and Specialty Pharmacy published an article titled, “Augmenting Cost-Effectiveness Analysis for Uncertainty: The Implications for Value Assessment—Rationale and Empirical Support” by Louis P. Garrison, PhD, and colleagues. The review article focused on describing several potentially significant uncertainty-related novel elements that could be included in augmented cost-effectiveness analyses such as insurance value, real option value, the value of knowing, and the value of hope. The article also discussed what has been or could be done to measure these elements and aggregate them to total value in a health technology assessment. The article concluded that there are only a few published studies related to elements of uncertainty when assessing value, highlighting the need to conduct further research in estimating the effects of these elements.  

Earlier this month, Value in Health published an article titled, “Peer Review and Transparency in Evidence-Source Selection in Value and Health Technology Assessment.” The article examined the use of peer-reviewed literature as sources of evidence by value and health technology assessment (V/HTA) bodies. The authors used publicly available documentation of V/HTA methods to identify trends in requirements for inclusion of peer-reviewed evidence sources. The review found many disparities among V/HTA organizations relating to requirements and guidance for evidence-source selection and a need to standardize approaches for evidence-source selection strategies.

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

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REGULATORY UPDATES
 

Supreme Court Rules No Backsies Just Cause You Don’t Want to Pay

 
 

On Monday, the Supreme Court, in an 8-1 decision, upheld the federal government’s obligation to reimburse eligible health insurers for financial losses accumulated during the first few years of the Affordable Care Act (ACA). The decision focused on the “risk corridors” program, a temporary incentive to encourage plan entry and competitive markets. Section 1342 of the ACA, modeled after the version included in Medicare Part D, set a formula for sharing risk between the Department of Health and Human Services (HHS) and qualified health plans.

For each of the applicable years of the risk corridors program (2014, 2015, and 2016), HHS owed qualified plans a total of over $12 billion, but HHS never paid. In the ruling, the court determined that the federal government was required to abide by its preexisting commitment to pay insurers for participating in the ACA’s exchanges and the commitment was not contingent on appropriations by Congress.
 
While this decision does not affect the ACA moving forward, the Supreme Court has agreed to hear a separate case on the constitutionality of the ACA’s individual mandate in October. In 2012, the Supreme Court rejected a challenge to the individual mandate. Since that time, Congress passed a tax reform package that set the individual mandate tax penalty at zero. A group of states argues that since the individual mandate is no longer a tax, it is unconstitutional, and as a key part of the ACA, the rest of the law must also be struck down. The Court is expected to issue their ruling in early 2021.

 

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 (really) quick hit list of other news we thought you should know:

  • CMS extended the implementation timeline for the admission, discharge, and transfer notification Conditions of Participation (CoPs) provisions of the sweeping Interoperability and Patient Access final rule by 6 months.
  • The National Academy of Medicine released a discussion paper on opioid treatment addressing strategies to handle key barriers within the treatment system.
  • The Community Oncology Alliance’s (COA’s) 2020 Practice Impact Report showed that over the last 12 years, 1,748 community oncology clinics and/or practices have closed, been acquired by hospitals, undergone corporate mergers, or reported that they are struggling financially. Since the last report issued in 2018, there has been a 20.8% increase in practices merging with, or being acquired by, another community oncology practice and/or acquired by a corporate entity. COA attributes this major jump to practices seeking protection from hospital merger pressures.


 

New White Paper: Xcenda Examines Possible Outcomes for Current and Proposed Future Interventions and Strategies for COVID-19 in the US

 
 

As policymakers assess and respond to the COVID-19 pandemic, how will the current and proposed future interventions and strategies possibly affect outcomes in the US?

That’s a question Xcenda set out to investigate in its latest white paper, The Potential Impact of Pharmaceutical and Non-Pharmaceutical Interventions to Mitigate the COVID-19 Crisis in the United States: A Model-Based Analysis.

Using an infectious disease model, we analyze the potential impact of both non-pharmaceutical and pharmaceutical interventions in mitigating the COVID-19 health crisis.

Download now >

 
HEARD ON THE STREET

“The Food and Drug Administration is moving at lightning speed to review data on Gilead Sciences’ experimental COVID-19 treatment remdesivir, after encouraging results emerged from a key US trial. We’re working with the company to emphasize the necessity of speed while at the same time to understand the data.”

 – FDA Commissioner Stephen Hahn, after Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, shared early trial results Wednesday that showed remdesivir had a significant effect in treating the virus. Patients who received the drug recovered from their illness in 11 days, on average, while those who got a placebo recovered in 15 days.

Source: “FDA Moving at ‘Lightning Speed’ on Gilead Drug, Commissioner Says,” Bloomberg, April 30

 
POLICY BY NUMBERS
 

47%

 

The US Bureau of Economic Analysis announced a stunning 4.8% decline in real economic activity for the first quarter of 2020. Of that decline, health services accounted for 47%—a staggering, hitherto-unseen contribution.

Source: “Gross Domestic Product, 1st Quarter 2020 (Advance Estimate),” Bureau of Economic Analysis, April 29

 
UPCOMING MEETINGS & CONFERENCES
 

Webinar: Patient Assistance in the Wake of COVID-19

Friday, May 8, 2020 | 21:00 PM EDT

As the US economy continues to feel the ripple effect of the coronavirus pandemic and more Americans lose their jobs, will patients be able to afford their medications? Join a panel of experts from Lash Group and Xcenda on Friday, May 8 at 12:00 PM ET who will offer insights on the impact to insurance coverage and patient assistance programs as the pandemic continues. Register today

 
 
 

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:

Daniel Fellenbaum | Anuja Kanaskar | Scott Shields | Ryan Sullivan

PRODUCTION:

Kylie Matthews | Ellen Olson

 

May 1, 2020

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