It’s time for recess. The Senate adjourns after healthcare reform proposals fail. Learn more.

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Aug. 11, 2017

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FEATURED STORY
 

Where Do We Go From Here? Senate Adjourns With Questions Remaining

 
 

The Senate adjourned late last week for its August recess after proposals to repeal and partially replace the Affordable Care Act (ACA) failed. However, uncertainty remains regarding the future of the Cost-Sharing Reduction (CSR) program within the health insurance exchanges (HIXs) when lawmakers return after Labor Day.

Currently, CSR payments total approximately $8 billion in support to insurers, who have said failure of President Trump’s Administration to continue with them would force dramatic premium increases and cause some insurers to leave the individual market. The Trump Administration has been making the CSR payments on a month-by-month basis.

The Senate Health Education Labor and Pensions Committee plans to hold bipartisan hearings in early September on proposals to stabilize the individual insurance market. The committee hopes to produce a bill by mid-September, the same time insurers must commit to rates for plans offered in the 2018 insurance exchange.

Funding the CSR program remains a major sticking point between Congress and the Trump Administration.

 
GUEST BLOG POST FROM NATIONAL PHARMACEUTICAL COUNCIL (NPC)
 

Xcenda and NPC Partner on Original Research:

What Kinds of Information Do Payers and Providers Want for Decision Making?

 
 

We know that healthcare stakeholders rely on different types of data and evidence to inform their decision making. But what kinds of evidence do they really want and need?

A new white paper from Xcenda/AmerisourceBergen and the National Pharmaceutical Council (NPC) highlights survey findings from payers and providers on what types of evidence are most important to them when it comes to making population coverage decisions for formularies and care pathways. Recognizing the importance of these decisions on patients’ lives, it’s not surprising that payers and providers use multiple sources of information that offer a more complete picture about a treatment and its outcomes and impact on cost and quality, rather than just a snapshot.

According to payer respondents to the Xcenda/NPC survey, the majority found that at least 6 aspects of a medication are extremely or very important to understand when making policy or medical decisions. Only 3 of these are typically available in a Food and Drug Administration (FDA)-approved drug label: how well patients do clinically; comparative information from clinical trials; and potential side effects.

The other qualities—such as whether the medication helps reduce the utilization of other medical services, how effectively it can meet quality measures, or how it works in the “real world”—are typically not included in the FDA-approved product label. While this information may be consistent with the FDA-approved label, it could still be considered “off label,” making it subject to myriad regulations that govern whether it could be shared by biopharmaceutical companies with payers and providers.

And with the US healthcare system shifting payment and reimbursement models from volume- to value-based payment, both payers and providers surveyed expect new types of information to be impactful in guiding decisions in the next 3 to 5 years. They also expect that the potential benefits of having additional information will outweigh the potential risks.

Changes to existing laws and regulations could make it easier to access or exchange this information in the near future. In particular, FDA Administrator Dr. Scott Gottlieb has expressed an interest in clarifying some of the restrictions on the exchange of information, and his agency also is charged with putting communications provisions from the 21st Century Cures Act into effect, along with drafting comprehensive communications guidance documents.

Additionally, the House Energy and Commerce Subcommittee on Health held a hearing on July 12 to discuss the types of healthcare information that can be exchanged among biopharmaceutical companies and payer entities.

View the survey results and white paper on NPC’s website.

 

Biosimilar Coding—Could There Be Billions in Hidden Savings?

 
 

The finalized Medicare payment rule from the Centers for Medicare & Medicaid Services (CMS) for biosimilars creates a single, blended Medicare reimbursement rate for the biosimilars based on the average sales price (ASP) of all biosimilars to a reference product, plus 6% of the ASP for the reference biologic. Under the current policy, CMS estimates Medicare savings of $25 billion over 10 years.

Xcenda modeled alternative methodologies that could increase savings by 25%. Partnering with the Biosimilars Forum, Xcenda authored an original study, “Estimating the Budgetary Impact of Biosimilar Coding Policies Under Medicare Part B,” that demonstrates the need for changes in CMS reimbursement for biosimilars under Medicare Part B. Learn more

 

  

 
LEGISLATIVE UPDATE
 

No Matter How FDARA You Are, We’ll Find You

 
 

Late last week, the Senate passed the FDA Reauthorization Act of 2017 (FDARA) which includes a series of FDA user fee acts (UFAs). FDARA reauthorizes the prescription drug, generic drug, medical device, and biosimilar user fee programs through 2022. Without the Senate’s approval (94-1), the programs would have expired on September 30 and, considering they comprise about half of the FDA’s budget, are considered must-pass legislation. The CBO expects the FDA to collect approximately $9 billion in fees ($8 billion for drugs and $1 billion for devices) between 2018 and 2022, based on the fee levels and the inflation adjustments specified in the bill.

FDARA also included amendments on expanded access (including holding a public meeting on the subject within 270 days) and orphan drugs (need for clinical superiority).

Despite some initial noise about wanting to revisit the UFAs in his 2018 budget, President Trump is expected to sign the legislation.

 

Tap Into Payer Market Insights This October in Dallas

 
 

MCN Forum | Monday, October 16 | Dallas

Join Xcenda’s Payer Insights team this October in Dallas, TX and get exclusive access to payer insights at Xcenda’s Managed Care Network (MCN) Forum. Gain real-time, truly interactive qualitative and quantitative insights from up to 30+ payers from across the managed care industry.

Start a conversation to learn more or to schedule your time with this insightful group.

 

 
 

 
 
REGULATORY UPDATES
 

Looking Beyond the Divide and Offering Bipartisan Solutions

 
 

In the wake of the failure to repeal and replace the ACA, a movement for bipartisan reform both from health policy groups and politicians is beginning to gain traction to stabilize the healthcare markets to help lower premiums.

One group offering bipartisan solutions is the Health Reform Roundtable (HRR), composed of health policy experts from both sides of the aisle who are working together on solutions that transcend political banter. This week, HRR has offered its 5-point proposal for healthcare reform to Congress:

1. Extend funding for the Children’s Health Insurance Program (CHIP) and community health centers through 2019.

2. Stabilize the federal and state exchanges/marketplaces via:

  • Continue CSR subsidies
  • Reassess the insurance-market stabilization mechanisms (3 Rs: reinsurance, risk adjustment, and risk corridors) with a focus on allowing and encouraging individual states to explore their own stabilization mechanisms tailored to their particular markets
  • Continue enrollment programs which inform Americans about their options and which help them sign up
  • Take action with respect to counties that have no participating insurance plan in 2018

3. Find ways to incentivize Americans to sign up for health insurance to increase exchange pools and lower cost.

4. Provide states more flexibility in financing coverage for low- and moderate-income populations through the ability to test innovation models and combine federal funding with private funding to promote continuity, efficiency, and more coverage.

5. Expand health savings accounts’ (HSAs) capabilities to include allowing HSA money to pay insurance premiums.

With the federal fiscal year ending soon (September 30), many of these recommendations are time sensitive. These proposals are just one policy group’s opinion, but it should be considered a positive sign to see bipartisan strategies to stabilize the marketplaces/exchanges and to reign in premium increases.

 
 

Survey Says… Healthcare Costs Hard to Manage

 
 

This week, the National Business Group on Health released its annual survey on large employers’ healthcare benefit expectations and projections. The Large Employers’ 2018 Health Care Strategy and Plan Design Survey found employers expect the total cost of providing medical and pharmacy benefits to rise 5% for the fifth consecutive year in 2018. Including premiums and out-of-pocket costs for employees and dependents, the total cost of healthcare is estimated to be $13,482 per employee this year and projected to rise to an average of $14,156 in 2018.

According to the survey, an increasing number of employers plan to pursue the following strategies to control healthcare costs:

  • Increase availability of telehealth services
  • Promote use of accountable care organizations
  • Open more onsite/near-site health centers
  • Contract with more Centers of Excellence that offer bundled payment arrangements
  • Incorporate more value-based benefit designs in which employees receive reduced cost-sharing or premium reductions when they take steps to manage chronic conditions or obtain higher-quality or more efficient care

For the second consecutive year, employers ranked specialty pharmacy (26%) as the top driver. To address these costs, 44% of employers will have site-of-care management tactics in place in 2018, a 47% increase over this year. Seven in 10 employers plan to use more aggressive utilization-management protocols.

Though the employer-based market is inherently more stable than the exchange market of individual and small-group plans, it is still experiencing some of the same challenges. Large employers are continuing to adopt a number of these novel, non-traditional mechanisms to control healthcare costs (eg, telehealth, onsite health centers, pursuing bundled payment arrangements) as alternative and/or supplemental tactics to transferring more costs to employees.

 

Show Them the Money: Incentivizing Antibiotic Development

 
 

At the beginning of the month, the Duke-Margolis Health Policy Center proposed an award to incentivize antibiotic development it hoped would promote value and appropriate use. Antimicrobial-resistant infections are a source of substantial economic and clinical burden to the healthcare system, and, in a broader context, they represent a significant public health issue.

The drive to encourage prudent use of antibiotics due to resistance concerns, coupled with the availability of low-cost generics to treat many infections, has caused antimicrobial development to slow.

To address concerns over slowed antimicrobial development augmented by the continued rise of antimicrobial-resistant infections, Duke-Margolis Health Policy Center proposed the Priority Antimicrobial Value and Entry (PAVE) Award, accompanied by a Viewpoint article in last week’s JAMA. The PAVE Award would involve providing a combination of both public and private funds to manufacturers, while ensuring that reimbursement from payers remains unchanged in this setting. The funds would be dispensed during the initial market entry of the drug, would decrease over time, and eventually would be replaced by revenues from value-based contracts between manufacturers and payers. The award is dual purposed—to assist in addressing the public health threat of antimicrobial-resistant infections, and to provide manufacturers with incentives for development of new agents.

Announced last week, the proposal indicates that it would take several years for full implementation and notes the potential for inclusion into several pieces of legislation currently in development. Consistent with the overarching theme of renewed interest in quality within the US healthcare system, the PAVE Award would help shift payment for antimicrobials away from volume and toward value-based reimbursement.

 

Industry Payments Not Found to Influence Prescribing

 
 

A multivariate median regression study of 2 Medicare databases published recently found the number of prescriptions was similar between providers who did and did not accept industry payments from Johnson & Johnson and Astellas Pharmaceuticals for abiraterone and enzalutamide, respectively. Both products are prescribed for metastatic castration-resistant prostate cancer, a crowded therapeutic area with a host of treatment options.

This new study has a slightly more neutral correlation compared to another study published earlier this year, which found a weak association between prescribing behavior and industry payment to physicians.

Both studies explored drugs to treat prostate cancer and leveraged the Open Payments/General Payments Medicare database, as well as the respective Medicare Provider Utilization and Payment Data. Of note, the new study examines oral Medicare Part D products, while the earlier study examined physician-administered Medicare Part B products.

With Open Payments data being accessible, there will likely be more analysis of claims data compared to industry payments. Now, however, there appears to be no consensus on the impact of industry payments, even within the same disease state.

 

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:

  • Blue Cross and Blue Shield of North Carolina’s Board of Trustees has elected Patrick Conway, MD, MSc, as its new President and CEO, effective October 1. Dr. Conway currently serves as CMS Deputy Administrator for Innovation and Quality and as Director of the Center for Medicare and Medicaid Innovation (CMMI)
  • Nevada Division of Insurance announces Anthem’s withdrawal from Silver State Exchange for plan year 2018; Anthem posts statement
  • Health Affairs’ blog post discusses 3 ways President Trump could lower drug prices (though none are new)
  • The Institute for Clinical and Economic Review (ICER) posts draft scoping document on Chimeric Antigen Receptor T-Cell therapy for B-Cell cancers
 
HEARD ON THE STREET
 

“Our new @POTUS has of course not been in this line of work before, and I think had excessive expectations.”

 

– Senate Majority Leader Mitch McConnell (R-KY), speaking in Kentucky about the Senate’s failure to pass any repeal or revision of the ACA, August 9

 

“More excuses. @SenateMajLdr must have needed another 4 years—in addition to the 7 years—to repeal and replace Obamacare....”

 

– Dan Scavino, White House Director of Social Media and Assistant to the President, responding to McConnell, August 9

 
POLICY BY NUMBERS
 

73%

 

The Medical Group Management Association (MGMA) surveyed 750 medical practices, with 73% of them reporting the Merit-Based Incentive Payment System (MIPS) does not support their clinical quality priorities, and rating MIPS as either “very” or “extremely” complex.

Source: “MGMA Regulatory Burden Survey,” August 2017

 
UPCOMING MEETINGS & CONFERENCES
 

The Bioprocessing Summit

August 2125 l Boston, MA
World Courier, part of AmerisourceBergen, is proud to be a sponsor of The Bioprocessing Summit 2017. In its ninth year, the conference focuses on upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. Visit World Courier at booth #308. Learn more

 

The Diagnostic Conference | DxCon17

September 1415 l San Francisco, CA
The Diagnostic Conference, produced by Premier Source, part of AmerisourceBergen, is the premier venue for thought leaders and executives in personalized medicine seeking to successfully launch and grow new diagnostics. Participants will bring perspectives from leading diagnostic companies, pharmaceutical manufacturers, payers, and other stakeholders. DxCon17 will explore the rise of companion diagnostics and how pharma and diagnostics companies can collaborate to increase opportunities in a growing market. Learn more

 

Cell & Gene Meeting on the Mesa

October 46 l LaJolla, CA
The Cell & Gene Meeting on the Mesa is a 3-day conference bringing together senior executives and top decision makers in the industry with the scientific community to advance cutting-edge research into cures. World Courier, part of AmerisourceBergen, is proud to be a Gold Sponsor of this unique event. The meeting features a nationally recognized Scientific Symposium, attended by leading researchers and clinical experts from around the globe, in conjunction with the industry’s premier annual Partnering Forum, the first event of its kind dedicated solely to facilitating connections in this sector. Learn more

 

AMCP Nexus 2017

October 1619 l Dallas, TX
Join Xcenda at this year’s AMCP Nexus 2017 conference in Dallas, TX. AMCP Nexus 2017 will explore perhaps the most transformative change taking place in healthcare: how we pay for healthcare and the emergence of value as the defining factor and goal. Xcenda’s team of experts can help you navigate the value landscape and maximize access for your product. Visit Xcenda’s booth in The Exchange at #503, or contact us to schedule a meeting at the conference. Learn more

 
 
 

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
Director,
Health Policy
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Peyton Howell, MHA
President | Global Sourcing & Manufacturer Relations | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | AmerisourceBergen Specialty Group

Tommy Bramley, PhD, RPh
President | Xcenda

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

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

Ana Stojanovska
Vice President | Reimbursement & Policy Insights | Xcenda

CONTRIBUTING AUTHORS:

Aaron Dancy | Andrew Gaiser | Scott Shields Jennifer Snow | Diane Wilson 

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Aug. 11, 2017

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