Health Policy Weekly 04 28 22

April 29, 2022

Health Policy Weekly

Minding the gap. Ensuring patients can go with the flow

Apr 29, 2022

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Featured story

Minding the gap. Ensuring patients can go with the flow

Last Friday, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update the effective dates of coverage for Medicare enrollees, create 5 new special enrollment periods, and extend immunosuppressive drug coverage under Part B for beneficiaries with end-stage renal disease (ESRD) who have received a kidney transplant. This represents an implementation of provisions from the Consolidated Appropriations Act of 2021 (CAA).

Currently, Medicare coverage becomes effective at different dates depending on when an individual enrolls; the proposal would make coverage under Medicare effective 1 month after enrollment. This change, effective January 1, 2023, is intended to prevent gaps in coverage for Medicare enrollees.

In accordance with the CAA, the proposed rule extends immunosuppressive drug coverage under Part B for beneficiaries who have ESRD and who have received a kidney transplant. Currently, beneficiaries are only eligible for coverage up to 36 months after a kidney transplant. The extended coverage is only applicable for immunosuppressive drugs meant to support the kidney transplant.

Beneficiaries will lose their Part B benefit if they sign up for other coverage, including a group health plan, TRICARE, or Medicaid. Eligible beneficiaries can begin enrolling in the new benefit beginning October 2022, and coverage would begin January 1, 2023.

Finally, the proposed rule creates 5 special enrollment periods to help patients facing exceptional conditions, including:

Individuals impacted by an emergency or disaster: For those beneficiaries impacted by a federal, state, or local government-declared disaster or emergency
Health plan or employer error: For those impacted by an employer or health plan that materially misrepresented information about enrollment
Formerly incarcerated individuals: For incarcerated individuals after their release
Termination of Medicaid coverage: For those who need to enroll after the end of their Medicaid eligibility
Other exceptional conditions: Will be evaluated on a case-by-case basis

The proposed rule was published in the Federal Register on April 27 with a 60-day comment period.

Preparing manufacturers for a changing copay landscape

Corey Ford and Colleen Cummins meet with Rebecca Willumson, publisher of Fierce Pharma, to discuss affordability services. They provide insights on the importance of affordability for patients, specifically as it relates to copay solutions.

Read now

Legislative update

Trying to march into savings. Warren proposes prescription drug plan

On Monday, Sen. Elizabeth Warren (D-MA) sent a letter to Health and Human Services Secretary (HHS) Xavier Becerra sharing available legal authorities for the Biden Administration to help lower drug prices. The findings of the letter were organized by a group of experts from Yale Law School, Harvard Medical School, and Columbia Law School. The experts outlined 3 legal tools: 1) the “government patent power” codified at 28 U.S.C. § 1498; 2) the Bayh-Dole Act’s “royalty-free license”; and 3) “march-in rights.”

Section 1498 permits the federal government or a third party working on behalf of the government to use a patent without a license and to offer the patent holder “reasonable and entire compensation.” According to the experts, the patent-use approach may enable private entities to purchase low-cost generics and receive reimbursement from Medicare and Medicaid if the programs benefit from the savings.
The Bayh-Dole Act provides the government with a “royalty-free license” in a patent that arose from government-funded research. The license may be used to manufacture drugs for government use or to authorize production on the government’s behalf.
The Bayh-Dole Act also provides the government with the opportunity to issue “march-in” licenses to generic manufacturers to produce and distribute drugs at a reasonable price. The experts conclude that the excessive price of drugs may serve as the basis for the government to exercise its march-in rights.

Sen. Warren continues to advocate for policies to lower drug prices. In 2019, she introduced legislation to eliminate tax deductions for prescription drug advertising.

With drug pricing reform stalled in the Senate, the Biden Administration may review opportunities to act before midterm elections in November, but time—and momentum—are not on its side.

Legislative byte

Reps. Mikie Sherrill (D-NJ) and John Curtis (R-UT) introduced The Prescription Information Modernization Act to update distribution methods for prescribing information for pharmacists and physicians. Currently, the prescribing information sent to providers must be printed. The legislation would allow pharmaceutical manufacturers to send prescribing information to pharmacists digitally. The goal is to ensure reliable and timely information is shared with pharmacists, resulting in safe medication use by patients.

Xcenda insights

Changing the paradigm: Understanding cell and gene therapy

A world of innovation is at our doorstep with cell and gene therapy, but challenges on how to navigate the payment and reimbursement of these high-cost, yet potentially curative therapies are (almost) insurmountable.

In December, CMS offered some potential steps through a final rule that included provisions to help overcome existing barriers surrounding Medicaid Best Price for outcomes-based contracts, including long-term contracts lasting several years. Here at AmerisourceBergen, we’ve been trying to think through (and maybe even reimagine) how to make it work given the CMS rule and the need to ensure the path to appropriate access remains clear.

Download our new issue brief that explains this final rule and its impact on cell and gene therapies.

Download the issue brief

COVID-19 update

COVID-19 bulletin

The Food and Drug Administration (FDA) expanded the approval of the COVID-19 treatment VEKLURY (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds).
Pfizer and BioNTech submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in children 5–11 years of age.
A Centers for Disease Control and Prevention study estimated that 58% of Americans have been infected with SARS-CoV-2.

Value Corner

Valuing same but different

On Thursday, the Innovation and Value Initiative (IVI) announced the launch of a 2-year Health Equity Initiative (HEI). The HEI aims to promote health equity by identifying relevant gaps and developing best practices in value assessment methodology. Rick Chapman, Chief Science Officer of IVI, underscored the critical need for the initiative: “IVI has found that without a consistent and intentional focus on equity, we are blind to key differences among patients. Also, current assessments run the risk of reinforcing or even exacerbating inequities that already exist in the US healthcare system.” A multidisciplinary advisory board will guide the work of the HEI, bringing deep expertise in disparities and health equity, value assessment methodologies, and patient preference research.

Last summer, Xcenda released research that supported the need to consider health equity during the value assessment framework (VAF) process. Our work found that current VAFs in the US do not yet adequately incorporate health disparities in the value assessment process. With the exception of IVI, other US-based VAFs also do not explicitly incorporate health or healthcare disparities in their respective frameworks, though some VAF organizations have recently implemented other initiatives centered around addressing disparities in cancer care.

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

Digital interview: Addressing medication affordability amid evolving copay rules

The traditional pharmacy copay model, which was more commoditized by focusing on the value of each transaction and managing patient eligibility, is quickly shifting toward a patient-focused format. What was a comfortable and familiar landscape to manufacturers has been challenged by accumulator and maximizer programs, and manufacturers are challenged to pivot to patient value-based plans, risk-sharing models, and other forward-looking strategies. Corey Ford and Colleen Cummins provide manufacturer considerations on the changing copay landscape.

Watch interview

Regulatory Update

If wishes were horses, this OIG would get biosimilars to ride

A recent report issued by the Office of the Inspector General (OIG) argued that the Medicare prescription drug benefit (Part D) could have saved millions of dollars in 2019 if biosimilars were used at a 60% utilization rate. According to the OIG, the report is part of a broader strategy to tackle drug prices and evaluate the use of biosimilars.

In 2019, 8 biosimilars were available and approved as alternatives to 4 reference products in Part D. Part D and beneficiary spending on these biosimilars and their reference products was about $466 million.

The OIG estimates that if biosimilars had been used more often than reference products, Part D and beneficiary spending could have been significantly reduced in 2019. Accordingly, Part D spending on biologics with biosimilar alternatives could have been reduced by $84 million, or 18%, if all biosimilar alternatives had been used as frequently as the most frequently used biosimilar alternatives (60%). Moreover, beneficiaries’ out-of-pocket costs for these drugs could have been reduced by $1.8 million, or 12%.

The increased use of biosimilars could result in significant cost savings for Part D and its beneficiaries, especially after the expected introduction of biosimilars for blockbuster drugs HUMIRA (adalimumab) in 2023 and ENBREL (etanercept) in 2029.

To enable Part D and beneficiaries to capitalize on potential savings, the OIG recommends that CMS encourage plans to increase access to and use of biosimilars in Part D. The OIG also encourages CMS to monitor the coverage for biosimilars on formularies so that it can identify ongoing trends of concern.

Information buffet (AKA, other stuff that caught our attention)

CMS posted the second quarter 2022 Healthcare Common Procedure Coding System (HCPCS) file summaries of code decisions for drugs and biologicals for implementation (or not) on/after July 1, 2022 dates of service.
President Joe Biden has been talking about wanting Democrats to cap monthly out-of-pocket spending on insulin at $35, impose penalties on manufacturers that increase drug prices faster than inflation, cap beneficiaries’ annual retail drug costs at $2,000, and direct Medicare to negotiate drug prices.
The FDA’s Office of Prescription Drug Promotion proposed a survey-based study to understand how physicians and patients might differ in how they calculate the tradeoffs of drugs to treat various conditions when presented with pharmaceutical promotional materials.
The Center for Medicare and Medicaid Innovation (CMMI) posted the fourth annual Part D Enhanced Medication Therapy Management Model Report.
Biogen withdrew the application for ADUHELM (aducanumab), its drug to treat Alzheimer’s, from the European Medicines Agency’s consideration. The company made the decision after it became clear from interactions with the agency’s scientific committee that the drug would not receive a positive opinion based on the data provided.

Heard on the street

“Healthcare is not just about mending bones or dispensing pills. It’s about giving people peace of mind that comes with having coverage when you need it.”

– HHS Secretary Xavier Becerra, commenting on the CMS proposed rule to update Medicare enrollment and eligibility rules that would expand coverage for people with Medicare and advance health equity. (See Featured story.)

Source: “CMS Proposes Updates to Reduce Barriers to Coverage, Simplify Medicare Enrollment, and Expand Access,” HHS, April 22

Policy by numbers

$769 billion | $1.5 trillion

A Kaiser Family Foundation (KFF) analysis found that net Medicare outlays are projected to increase from $769 billion in 2020 to nearly $1.5 trillion in 2031 due to growth in the Medicare population and increases in healthcare costs.

Source: “The Facts About Medicare Spending,” KFF, April 2022

Upcoming meetings and conferences

Asembia 2022

May 2-5, 2022 Las Vegas, NV
Join AmerisourceBergen at Asembia 2022 in Las Vegas, NV. As you think through your commercialization strategy, we offer the opportunity to meet one-on-one with a commercialization strategist to explore all of the services AmerisourceBergen has to offer. We know that every therapy is unique. During this discussion, our strategists will share how AmerisourceBergen customizes solutions to simplify the process and develop a unique and comprehensive commercialization strategy.

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Career opportunities

Associate Director, Market Access Agency of Record (Remote- US)

Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. Under the general direction of the AoR account lead and on behalf of clients, this active, hands-on role maintains and grows strong client relationships with assigned brands, leads product payer strategy development, drives innovative managed markets initiatives, and leads internal teams to ensure the quality of deliverables and interactions with assigned clients.

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Assistant Director, Evidence Synthesis and Modeling (remote)

At AmerisourceBergen, you will find an innovative and collaborative culture that is patient-focused and dedicated to making a difference. Under general direction of Xcenda senior leadership within the Evidence Synthesis and Modeling service line, this position will be responsible for developing high-quality economic models, from model concept stage to final report and training, to meet the needs of Xcenda’s clients.

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Assistant Director, Clinical Data Management (remote)

The Assistant Director, Clinical Data Management is responsible for independently leading the clinical data management aspects of prospective clinical studies. The Assistant Director, Clinical Data Management has thorough knowledge of FDA regulations and industry standards, possesses strong technical skills, and can work collaboratively with team members to assure that data management functions are performed in compliance with regulations and according to study protocol.

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

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Featured contributors

Editor-in-chief

Jennifer Snow

Vice President, Reimbursement and Policy Insights, Xcenda

Managing editor

Scott Shields

Associate Director, Health Policy,
Xcenda

Contributing editor

Daniel Fellenbaum

Assistant Director, Reimbursement and Policy Insights,
Xcenda

Advisory board:

Willis Chandler
SVP and President | Biopharma Services and Commercial Solutions | AmerisourceBergen

Tommy Bramley, PhD, RPh
SVP, Global Consulting | AmerisourceBergen

Rita Norton
SVP, Government Affairs and Public Policy | AmerisourceBergen

Ana Stojanovska
Vice President | Commercial Consulting | AmerisourceBergen

Contributing authors:

Tracy Acheampong | Leigh Gallo | Puru Gaur | Scott Shields | Kimberly Westrich

Production:

Laurie Kozbelt | Frank Jorfi