We examine the Coronavirus Treatment Acceleration Program (CTAP).

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Apr. 10, 2020

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FEATURED STORY
 

Hopping for a Cure. FDA Accelerates Approval of Possible Coronavirus Treatments

 
 

In response to COVID-19, the Food and Drug Administration (FDA) has created a special emergency program to expedite the development and approval of possible therapies, called the Coronavirus Treatment Acceleration Program (CTAP).

CTAP is coordinating efforts from regulators, drug makers, and academic communities, as well as private and public stakeholders, to expeditiously evaluate new drug and biologic therapies through triaging requests, collaborating with the various stakeholders to expedite quality assessments, and transferring manufacturing to alternative sites to avoid disruption in the supply chain.

Given the mounting urgency for a coordinated response against COVID-19, there are currently 10 therapeutic agents in active trials and another 15 therapeutic agents in planning stages. These numbers are expected to increase as a broader range of stakeholders are shifting resources to join the effort against the pandemic.

CTAP is a prime example of how collaboration can emerge quickly across the healthcare community when objectives are aligned toward a single outcome. The will is there; hopefully, the products will follow.

 

Impact of COVID-19 Pandemic on Patient Access Programs

 
 

As the COVID-19 pandemic continues, what could this mean for patients and the assistance programs that ensure access to medications?

Xcenda examined the ripple effect an economic downturn could have on families, on their employment and insured status, and ultimately on patient support programs.

Download our newest issue brief, Impact of COVID-19 Pandemic on Patient Access Programs, to get insights and to better understand how manufacturers can project future patient needs.

Download now >

HPW Rebuild

 
LEGISLATIVE UPDATES
 

Maybe the Bunny Will Come to the Rescue: Senate Coronavirus Relief Impasse

 
 

On Thursday morning, the Senate reached an impasse after Republicans and Democrats failed to unanimously pass a bill providing financial relief to small businesses. Senate Democrats blocked a Republican-proposed bid for increased small business aid, followed by Senate Republicans blocking a Democratic amendment to include emergency funding for hospitals and states.

Senate Republicans introduced the Paycheck Protection Program Increase Act of 2020 “to increase amounts authorized for commitments for the Paycheck Protection Program authorized under section 7(a) of the Small Business Act.” This interim spending plan proposed an additional $250 billion in aid through small business loans as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the $2 trillion relief plan enacted last month. Senate Majority Leader Mitch McConnell (R-KY) wanted to approve the measure quickly by a unanimous vote, with only a few senators at the Capitol. Sen. Ben Cardin (D-MD) objected to the request and stalled the legislation.

House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) support the additional $250 billion to small businesses but prefer guardrails on the spending. The Democratic-proposed interim emergency bill includes $100 billion for hospitals and community health centers, $150 billion for state and local governments, and a 15% increase in benefits under the food assistance program. Senate Democrats previously attempted to pass this measure by unanimous consent but were blocked by Republicans.

The Senate adjourned on Thursday following the failure to reach agreement on a funding measure. The House has a pro forma session today, and the Senate will reconvene on Monday and likely seek to move another bill by voice vote. Although it is unclear how each party will respond to the other’s proposal, we can anticipate that the amount and timing of the relief will continue to be the subject of debate in efforts to reach an agreement and deliver coronavirus relief.

 

Legislative Byte

 
 
  • Medicare Sequestration Suspended. In little talked-about section 4408 of the third coronavirus stimulus package, the CARES Act (S 3548) suspended the 2% Medicare sequestration from May 1, 2020 to December 31, 2020. Alas, no good deed goes unpunished, as Congress consequently extended the mandatory sequester for an additional year. Mandatory spending for all non-exempt programs, including Medicare and non-Medicare, will thus be reduced through 2030.

HPW Rebuild

 
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 & Medicare Services (CMS) Current Emergencies (Coronavirus)

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

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

 

COVID-19 Bulletin

 
 
  • The Department of Health and Human Services (HHS) announced it is purchasing the ID NOW COVID-19 rapid point-of-care test, developed by Abbott Diagnostics Scarborough, for state, territorial, and tribal public health labs.
  • HHS announced upcoming funding action to provide $186 million for COVID-19 response. To view the list of CDC funding actions to jurisdictions, click here.
  • CMS approved 5 more section 1135 waiver flexibility requests since last Friday (Maine, the US Virgin Islands, Nevada, Michigan, and the District of Columbia).
  • CMS issued a series of updated guidances focused on infection control to prevent the spread of the novel coronavirus in a variety of inpatient and outpatient care settings.
  • The American College of Physicians and other leading medical organizations urged CMS to pay for telephone services at a level on par with in-person visits.
  • A Health Affairs blog post identifies how policy makers can address challenges surrounding coverage, coding, and payment for COVID-19 therapies via immediate regulatory guidance from CMS and future legislative action from Congress.
  • CMS paid out nearly $34 billion last week to healthcare providers battling COVID-19 through the expanded Accelerated and Advance Payment Program. The program has approved over 17,000 requests in 1 week; to put that into perspective, this program has only approved slightly more than 100 requests over the last 5 years. These funds are essentially a loan; most providers and suppliers can receive 3 months of their Medicare reimbursements, while certain providers can receive up to 6 months. This program is separate from the CARES Act which does not require repayment. Manufacturers can help providers through education efforts on the Accelerated and Advance Payment Program as well as the CARES Act funding programs once those have been published.

HPW Rebuild

 
THE VALUE CORNER
 

Do QALYs Consider the Year Gained? Like, 2020 Has Been a Doozy So…

 
 

On Monday, pharmaphorum published an opinion article describing the challenges associated with some of the methodological approaches that the Institute for Clinical and Economic Review (ICER) uses to assess the value of new drugs and healthcare technologies. Specifically, the article highlights several shortcomings of ICER’s value assessments, including the inability to account for new information in a timely manner, the failure to account for differences in how stakeholders conceptualize value or the influence of patient preferences, and the lack of transparency in its models. The author argues that ICER could overcome many of these obstacles through an open-source approach where ICER would share the underlying code for its models with the public.

Last Wednesday, Value in Health published an article examining how various aspects of ICER’s value assessment methods affect the way members of its independent evidence appraisal committees vote on value. After analyzing data from 31 assessments published by ICER between December 2014 and April 2019, the findings demonstrated that the incremental cost-effectiveness results were a key driver of the councils’ value vote, but other factors, such as other benefits or disadvantages and contextual considerations, also played an important role.

Also last Wednesday, Value in Health published an article on how value frameworks should incorporate principles of precision medicine. The article describes how there is no uniform method for assessing the value of precision medicine, which can result in variable patient access to related treatments. In developing a value assessment framework for precision medicine, the authors suggest it will be important to consider multiple perspectives across the healthcare system to gain consensus on how stakeholders measure the value of precision medicine.

Last week, the Pioneer Institute released a report and an associated 1-page handout discussing how the quality-adjusted life-year (QALY) methodology discriminates against older adults. The report criticizes the QALY, which measures the value of a treatment according to its ability to extend life and improve quality of life, for favoring treatments meant for younger patients who have a longer life expectancy. Given recent proposals to create a “Medicare for All” healthcare system, the author argues that adoption of QALYs to make treatment decisions may prevent older patients from having access to high-quality, life-saving treatments. The article also notes that this bias against seniors comes at a critical and especially vulnerable time for older Americans, given the recent COVID-19 pandemic.

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

HPW Rebuild

 
REGULATORY UPDATES
 

Without a Peep: CMS Releases 2021 MA Rates and Part C/D Payment Policies

 
 

On Monday, CMS released the 2021 Rate Announcement, establishing Medicare Advantage (MA) and Part D payment rates for contract year (CY) 2021. MA organizations and Part D plan sponsors will see an average 1.66% payment rate increase for CY 2021—higher than the proposed 0.93%, but less than the 2020 increase of 2.53%. CMS expects the CY 2021 payment rate, once adjusted for the underlying coding trend, to increase risk scores, on average, by 3.56%.

The 2021 Rate Announcement also finalized the following policies related to MA:

  • Transitions MA payments to a new risk-adjustment model, taking the sum of 75% of the risk score based on the beneficiaries’ medical condition—known as the Hierarchical Condition Category (CMS-HCC) model—and 25% using 2017 risk adjustment model criteria
  • Incorporates more encounter data when calculating MA plans’ risk scores, taking the sum of 75% of a beneficiary’s risk score using encounter data and 25% of the risk score using fee-for-service data
  • Implements the statutory minimum MA coding pattern of 5.90%
  • Increases the rate of payment for MA beneficiaries with end-stage renal disease (ESRD) by 4.04%


CMS provided the following 2021 parameters for the defined standard Medicare Part D prescription drug benefit (2020 included for comparison):



Additionally, CMS continued to promote generic utilization by encouraging Part D plans to leverage favorable tier placement and effective formulary management tools. Finally, CMS emphasized modifications to Star Rating methodologies offered to MA and Part D plans to ease reporting requirements during the COVID-19 outbreak.

The Rate Announcement was accompanied by a fact sheet.

 

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:



 

No Shirt, No Shoes, No Problem. But Do You Have to Wear Pants for Doctor Appointments?

 
 

Considering today’s stay-at-home environment, some hospitals, physicians, and other healthcare professionals (HCPs) may be asking if they will be reimbursed for visits performed virtually. In recent days, coders and billers have been bombarded with information from the Trump Administration, CMS, the AMA, the CDC, and the International Classification of Diseases (ICD) Coordination and Maintenance Committee regarding new policies, guidelines, and codes created to report diagnosis and telehealth services related to the COVID-19 pandemic.

Much of the new guidance may also help HCPs obtain reimbursement for telehealth services for other conditions. For example, Medicare’s relaxed rules around covered telehealth services may allow certain HCPs to perform a “visit” with a patient at home using certain types of technology previously not allowed.

Xcenda’s consolidated coverage, coding, and payment research may help HCPs with their top reimbursement questions. Let Xcenda keep you informed on how HCPs can report virtual services performed via various forms of telecommunication. Start a conversation >

 
HEARD ON THE STREET

“[W]e have encouraged the Administration to look at various options to provide coverage for treatment of the uninsured for the coronavirus other than utilizing the emergency fund from the CARES Act.”

 – Rick Pollack, President and CEO, American Hospital Association (AHA), objecting to the use of the CARES Act emergency funding, initially allocated for hospitals, to treat the uninsured.

Source: “AHA Statement on the Use of the CARES Act,” April 3

 
POLICY BY NUMBERS
 

42% | 33%

 

According to a poll recently completed by Morning Consult on behalf of the Patient Access Network (PAN) Foundation, seniors with high OOP prescription drug costs say it has been difficult to pay for their prescription drugs and monthly premium in the first 2 months of 2020; 42% say it is difficult to pay for their prescriptions, and 33% say it is difficult to pay their monthly health insurance premium.

See the infographic and executive summary.

Source: “New Survey Shows Seniors Are Making Difficult Financial Choices at the Start of the Year to Afford Their Medications,” PAN Foundation, April 3

 
 

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 | Cliffrey Li | Reeya Patel | Scott Shields | Diane Smith | Robin Tan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Apr. 10, 2020

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