We list the healthcare-related items in “Phase 3” of the Coronavirus Response Package.

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Mar. 27, 2020

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Editor’s Note: For many of us, it’s been a tough few weeks…the uncertainty of what comes next, and when and how. But through it all, the sparks of humanity have been the light that shines the light ahead, whether it is a teacher leading an online yoga class, or people doing virtual happy hours, or the patterns for masks being shared in community forums. And mostly, we just remain grateful for those who are essential to our daily lives, whether they are first responders, or healthcare providers, or grocery store workers, or delivery people, or working in distribution centers making sure that medicines and supplies get to where they need to go. Thank you—you make it all possible.

 
FEATURED STORY
 

John Maynard Keynes Would be Beaming

 
 

On Wednesday, the Senate voted 96-0 in favor of the vehicle for the “Phase 3” Coronavirus Response Package, Middle Class Health Benefits Tax Repeal Act of 2019 (HR 748). The colossal $2.2 trillion effort, plus the Federal Reserve pumping more than $4 trillion into the economy and credit markets to stimulate the economy in response to the novel coronavirus epidemic is equal to roughly 28% of the country’s $21.44 trillion gross domestic product in 2019. It is, by far, the largest effort of its kind in US history.

Healthcare-related funding includes:

  • $16 billion to resupply the nation’s Strategic National Stockpile of masks, gowns, gloves, ventilators, and other medical supplies
  • $11 billion to fund the development of vaccines, therapeutics, diagnostics, and other medical needs
  • $275 million to expand services and capacity for rural hospitals, telehealth, poison control centers, and the Ryan White HIV/AIDS program
  • $200 million for the Federal Communications Commission to help healthcare providers (HCPs) offering telehealth
  • $250 million to boost the capacity of healthcare facilities
  • $4 million to the Office of the Inspector General for oversight activities

Most taxpayers will be provided with a 1-time rebate check of $1,200 for individual adults ($2,400 for joint filing), and $500 for each child in a household. The payments would be phased out at $75,000 in adjusted gross income based on 2018 tax returns.

The Senate bill also includes $500 billion for a corporate credit program administered by the Federal Reserve, establishing an oversight board with an inspector general for the $500 billion corporate liquidity program, $357 billion in forgivable bridge loans for small businesses that keep paying their employees, $150 billion for state and local governments, $130 billion for hospitals, and $45 billion toward disaster relief.

Earlier today, HR 748 passed the House and went to the President’s desk for his signature.

Lawmakers are already discussing Phase 4 for pandemic relief.

 

Determine Your Value Story With Greater Precision and Perspectives With Xcenda’s Value Identification Process 2.0

 
 

Gathering diverse perspectives to pinpoint and vet your product’s value messages is, well, invaluable. But assembling HEOR, brand, patient support, legal, and field personnel in 1 room for a workshop can be daunting, especially in this current safer-at-home or shelter-in-place environment.
 
With Xcenda’s Value Identification Process (VIP) 2.0, critical viewpoints of all your key stakeholders can now be captured through our interactive, real-time format that makes identifying and ranking your most salient go-to-market messages easier than ever before. Learn more >

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LEGISLATIVE UPDATE
 

Legislative Bytes

 
 
  • Rep. Raul Ruiz (D-CA) introduced HR 6311 that would require private health insurers to cover care related to COVID-19 without cost-sharing and to provide for special enrollment periods.
  • Rep. Joe Courtney (D-CT) introduced HR 6299 that would provide for the rapid coverage of preventive services and vaccines for COVID-19.

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THE VALUE CORNER
 

You Might Not be Able to Find a Slot for Grocery Delivery, but There’s Always Time for Value Assessment

 
 

Last Friday, the National Health Council hosted a presentation on the Institute for Clinical and Economic Review (ICER) 2020 Value Assessment Framework (VAF) update. ICER’s President, Steve Pearson, and Chief Operating Officer, Sarah Emond, provided an overview of the key VAF changes, including a description of ICER’s new Patient Engagement Program. As a reminder, ICER indefinitely postponed the public meetings for its sickle cell disease and cystic fibrosis reviews due to the COVID-19 pandemic, originally scheduled for March 26 and April 30, respectively. ICER also paused or extended the timelines for several ongoing reviews, including nonalcoholic steatohepatitis, ulcerative colitis, bladder cancer, digital apps for opioid use disorder, and hemophilia A. Updated timelines can be found on the ICER website.

Last Thursday, Health Affairs published a blog describing the importance of considering indirect benefits in value assessment. The authors highlighted that while VAFs typically focus on direct medical cost offsets (eg, mortality, emergency department visits, and hospitalizations), less tangible indirect benefits, such as caregiver burden, quality of life, or productivity, can also have a substantial impact. The authors identified 3 key opportunities to incorporate these measures in value assessment, including: 1) establishing clear standards for measuring the value of specific indirect benefits in clinical trials; 2) generating product-specific data on indirect benefits; and 3) making payment decisions that reflect these broader benefits. The authors concluded that incorporating indirect benefits into the value assessment process could change how health dollars are allocated in the future.

Last Tuesday, the Innovation and Value Initiative (IVI) published a press release describing its recently hosted multi-stakeholder summit that examined current gaps and emerging approaches in value assessment. Over 45 thought leaders were in attendance and included representation from patient organizations, health systems, health plans, clinicians, employer purchasers, and research and methods experts. The purpose of the summit was to share perspectives and priorities for improving methods of value assessment and to consider opportunities to address current gaps. Stakeholders identified several top priorities for improving value assessment methods, such as: 1) improving data inputs to better define patient value; 2) consistently engaging with and including patients; 3) improving methods for applying value assessment to decision making; 4) improving understanding of total cost of care; and 5) evaluating novel methods of value assessment.

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

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REGULATORY UPDATES
 

CHIPing Away Barriers to Access

 
 

In response to the COVID-19 crisis, the Trump Administration has issued a national emergency declaration, enabling the Centers for Medicare & Medicaid Services (CMS) to reduce federal regulations that could impede medical access for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries. The intention is to increase access to local healthcare services through state regulatory empowerment. Among 4 new tools are regulatory waivers and templates that ease federal rules on population-based services, enrollment criteria, and provider flexibilities (eg, prior authorization waiver).

The first 2 tools are Medicaid waivers. 1115 waivers allow states greater autonomy in creating population-based health services, including services that support enrollment in long-term care programs and home and community-based services. 1135 waivers allow states increased “flexibilities,” which include suspending prior authorization requirements, allowing out-of-state providers to bill services to Medicaid, allowing expedited enrollment of provider groups, and increasing time for beneficiary appeals. (See the related article below discussing states that have received 1135 waivers from the federal government.) These waivers support state efforts to provide healthcare to those most in need during the COVID-19 crisis.

In conjunction with waiver tools, CMS created 2 templates to help Medicaid and CHIP agencies respond to the emergency and expand eligibility and covered services for enrollees. The template for section Appendix K—pre-populated with relevant program changes—helps states seamlessly request flexibilities to approved 1915(c) waivers in response to the COVID-19 crisis. The second template addresses the Medicaid Disaster State Plan Amendment, which describes state rules regarding eligibility, benefits, and payments. The template allows state officials to make multiple changes to their state plan in 1 submission; some changes include coverage eligibility, telehealth coverage, and increasing provider reimbursement.

The COVID-19 crisis is constantly evolving, and in parallel so are the needs of states to address the growing health concerns affecting their most at-risk beneficiaries. The recent waiver and template tools will increase Medicaid and CHIP enrollee access to healthcare. In the coming months, CMS will likely continue to roll out tools to ensure states can meet the healthcare needs of their most vulnerable populations.

 

Blackjack: CMS Approves Medicaid 1135 Waivers

 
 

As noted in the story above, CMS has looked to advance state waivers to improve access to care during this pandemic. This week, CMS approved additional Medicaid 1135 waivers, which provide states the flexibility to waive certain requirements of the Medicare, Medicaid, and CHIP programs to help control the spread of COVID-19.

Examples of “temporary flexibilities” include removing prior authorization requirements, waiving some requirements for new or out-of-state providers, and suspending certain reporting and oversight activities. Additional examples can be found in the 1135 Medicaid & CHIP checklist. States can also request approval for actions not listed in the checklist. Waivers are retroactively effective March 1, 2020 and are valid until the end of the public health emergency.

Joining last week’s approvals of Medicaid 1135 waivers in Florida and Washington, the following 21 states now have approved Medicaid 1135 waivers: Alabama, Arizona, California, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Oklahoma, Oregon, Rhode Island, South Dakota, and Virginia.

More details about each states’ waivers can be found here. Please note our count of 1135 waivers provided to 23 states is accurate as of noon yesterday.

The complete list of CMS regulatory actions to address the COVID-19 crisis can be accessed here.

 

Planning Ahead: Part D Modernization Model for 2021

 
 

Last Monday, CMS released a Request for Applications for Contract Year (CY) 2021 for the Part D Payment Modernization model. As part of the model, CMS will provide participants with a range of programmatic tools to better manage drug spending and promote better enrollee understanding of their Part D benefit, out-of-pocket costs, and clinically equivalent therapeutic options.

These include:

  • Part D Rewards and Incentives Programs
  • Medication Therapy Management+ (MTM+) (new for 2021)
  • New Flexibilities to Lower Costs for Beneficiaries: Limited Initial Days’ Supply and Cost-Sharing Smoothing (new for 2021)
  • Reduction or Elimination of Cost-Sharing on Generic Drugs and Biosimilars for Low-Income Subsidy Beneficiaries
  • Plan Timeliness for Standard Initial Coverage Determinations

Last year, CMS announced that the Center for Medicare and Medicaid Innovation (CMMI) would begin the Part D Payment Modernization model in 2020. (Even organizations participating in CY 2020 must apply for participation in the model for the 2021 plan year. All 2 of them.) The model tests the impact of a revised Part D program that encourages participating plans to better manage spending on drugs with high list prices.

Under this voluntary Part D Payment Modernization model, participating plans will assume greater risk for spending in the catastrophic phase of Part D; the Administration hopes this will incentivize plans, patients, and providers to choose drugs with lower list prices. CMS will calculate a spending target for what governmental spending would have been without plans taking on this additional risk. This is a 2-sided risk model—participating Part D plans will share in savings if they stay below the target but will be accountable for losses if they exceed the threshold.

However, Part D plan sponsors are concerned that making changes to catastrophic coverage in Part D will not impact drug costs; instead, they believe it will change insurance cost-sharing by increasing premiums.

While the model is authorized for 5 years, plans are only applying to participate in CY 2021. If CMS continues the demo, a new application would be required for future years. Additional information about the model is available at the CMS website and in the fact sheet.

 

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 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 American Medical Association (AMA), the Centers for Disease Control and Prevention (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.

 

Another Reason to Stare at Our Phones: Our Health Data

 
 

On March 6, the Department of Health and Human Services released 2 final rules to expand consumer access to their personal health information. The department hopes the rules will facilitate the free flow of healthcare data, advance interoperability, and improve care coordination. The final rules, issued by CMS and the Office of the National Coordinator for Health IT (ONC), reflect the Trump Administration’s MyHealthEData Initiative to give every American control of their full medical record and take it with them from doctor to doctor.

CMS Patient Access and Interoperability Final Rule
The CMS rule requires health plans in Medicare Advantage, Medicaid, CHIP, and the federally facilitated exchanges to share clinical, coverage, encounter, and cost-sharing information electronically with patients. Consumers will gain access to their electronic health information for free, using a smartphone app of their choice. Provider directories will also be made available through application program interfaces (APIs). Hospitals will be required to electronically share admission and discharge information with treating HCPs.

ONC 21st Century Cures Act Final Rule
Separately, the ONC rule advances policies to end information blocking—the practice of interfering with the exchange of electronic health information. The broad rule impacts any entity that creates or exchanges electronic health information including providers, electronic health record (EHR) vendors, and health information networks as required by the 21st Century Cures Act. ONC has defined 8 exceptions to information blocking.

Following the release of the final rules, ONC National Coordinator for Health Information Technology Don Rucker remarked, “Delivering interoperability actually gives patients the ability to manage their healthcare the same way they manage their finances, travel, and every other component of their lives.”

Various stakeholders, including America’s Health Insurance Plans (AHIP) and the American Hospital Association, oppose the final rules. They believe permitting unregulated third-party apps to access patients’ protected health information creates privacy concerns because the data would no longer be protected under the Health Insurance Portability and Accountability Act (HIPAA). Alternatively, technology companies such as Apple, Google, and Microsoft support policies to increase consumers’ control over their health data.

 

A Little Friendly Competition: Boosting the Generics Market

 
 

Earlier this month, the Food and Drug Administration (FDA) finalized the competitive generic therapies (CGTs) guidance for industry to encourage the entry of generic drugs on the market and increase competition. The FDA outlined the process and criteria that generic drug applicants should follow when requesting designation of a drug as a CGT. According to the FDA, CGT designation is intended to provide incentives for the development of generic versions of drug products that currently face “little or no competition.”

In a statement, FDA Commissioner Stephen Hahn commented, “By providing incentives for the development of generic versions of drugs that currently face little or no competition, we are better able to foster the development of more safe and effective generic drugs, which we expect will result in increased access to necessary treatments and potentially lower the cost of these medications.”

Since the establishment of the CGT designation in 2017, the FDA has received more than 350 requests for designation and has granted approvals to 31 products. The final guidance provides information on actions the FDA can take to expedite development and review of Abbreviated New Drug Applications (ANDAs) for drugs designated as CGTs. Furthermore, it explains how the FDA implements the 180-day exclusivity period for the first-approved generics under this designation.

This move stems from the FDA’s Drug Competition Action Plan, launched in 2017, which aimed to advance new policies aimed at bringing more competition to the drug market. With the addition of a final guidance on CGTs, there will be a further push to remove the barriers that exist with generic drug development and market entry, so that consumers are allowed to access medications at a more affordable price. Overall, the increased competition will allow patients to have more choices for their healthcare and increase access to treatments.

 

We Attend so You Don’t Have to: ICD-10-PCS Meeting

 
 

On Tuesday, Xcenda attended the CMS International Classification of Diseases Coordination & Maintenance Committee meeting for the Procedure Coding System (ICD-10-PCS). In light of COVID-19, it was the first meeting with 100% virtual attendance.

Twenty-one topics were presented for consideration of new and unique ICD-10-PCS or procedure codes used in the hospital inpatient setting of care. Presenters discussed their respective topics/technologies and offered coding options for consideration. Participating as a panelist in this meeting, Xcenda noted the continued trend toward limiting the number of ICD-10-PCS codes and creating less-specific codes and descriptions.

CMS seemed in favor of creating ICD-10-PCS codes with descriptions that could be used by similar procedures, and not just the one being proposed. CMS clearly wants to limit the number of ICD-10-PCS codes created simply for the purposes of identifying a new technology approved or undergoing the approval process for new technology add-on payment (NTAP). CMS indicated that once NTAP expires (up to 3 years), a unique ICD-10-PCS code that is so specific to a product (eg, that includes the product name) may no longer be necessary. CMS is working on a new process by which NTAP procedures can be identified on claims without the use of new or unique ICD-10-PCS codes. One suggestion mentioned was to require the use of National Drug Codes (NDCs) in combination with a not-so-specific ICD-10-PCS code.

Xcenda hopes these few underlying takeaways are of interest and that you’ll consider Xcenda as your partner through your next ICD-10-PCS application process. Contact Milda Kaitz to learn more.

 

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:



 

Video: Removing Barriers for Biosimilars

 
 

In 2019, physicians cited their own confidence as the #1 barrier to biosimilar adoption. What education and resources can manufacturers provide to build physician confidence as more biosimilars launch in the US?

In this video, Xcenda’s Melissa Mulchahey, Vice President of Field Services Business Development and Strategy, shares what the Xcenda Field Reimbursement Team has learned from the many physician office visits they make on a daily basis. Learn more >

 
HEARD ON THE STREET


 – David Sabatini, scientist and professor of biology at the Massachusetts Institute of Technology, March 23, via Twitter

 
POLICY BY NUMBERS
 

719,133 | $4.8 Billion | $7,853

 

Cancer drugs approved during 2000–2014 are estimated to have reduced the number of potential years of life lost before age 75 in 2014 by 719,133. Cancer drugs approved during 1989–2005 are estimated to have reduced hospital cost in 2013 by $4.8 billion. Our baseline estimate of the cost per life-year gained in 2014 from cancer drugs approved during 2000–2014 is $7,853.

Source: “How Cost-Effective Are New Cancer Drugs in the US?,” Expert Review of Pharmacoeconomics & Outcomes Research, January 6

 
 

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:

Milda Kaitz | Jennifer Le | Scott Shields | Ryan Sullivan | Linnea Tennant

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Mar. 27, 2020

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