CMS appears determined for a 2020 start to the proposed rebate rule.

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Apr. 5, 2019

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BREAKING NEWS

This morning, the Centers for Medicare & Medicaid Services (CMS) announced a demo that would—IF CMS finalizes the proposed rebate rule with a 2020 effective date—reduce uncertainty and risk for Part D plans as they prepare bids for the 2020 plan year. Under the demo, if the rebate rule goes forward, the Part D plan risk corridors would be narrowed from 5% to 0.5%. The revised risk corridor is symmetrical (narrowed on upside and downside). In sum, the demo allows plans to bid as if the new rebate rules will be in place in 2020. We’ll leave it to you to read through the tea leaves, but it sounds to us like we should be preparing for a new world order in 2020.

 
 
FEATURED STORY
 

Who’s Down With QPP: CMS Releases Year 1 Results

 
 

Late last month, CMS released comprehensive data on results from Year 1 of the Medicare Quality Payment Program (QPP). This program, implemented under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, significantly changed the way providers are paid for Medicare Part B services and advances the goal to move toward value-based care.

Under QPP, there are 2 pathways to receive payment:

  1. Merit-based Incentive Payment System (MIPS), a program that bases payment on 4 metric categories—Quality, Improvement Activities, Promoting Operability, and Cost
  2. Advanced Alternative Payment Models (Advanced APMs), a path that bases payment on required percentages of care provided to Part B payments or patients. (Examples of Advanced APMs are accountable care organizations [ACOs], patient-centered medical homes, and bundled payment models.)

Unless an exception was met, eligible providers were required to participate in 2017 in either the MIPS or an Advanced APM. However, CMS made some last-minute changes to the first year of reporting, offering participants to “Pick Your Pace” to encourage more participation in MIPS. Participants could choose to submit some data to avoid a penalty, report 1 or more measures for a 90-day period for a small bonus, or report on all categories for any 90 consecutive days to receive a modest bonus. (In the second year of MIPS, CMS changed the requirements to include a full year of reporting.) Providers who participated in MIPS or an Advanced APM will receive payments in 2019 for what they reported in 2017.

Highlights of the data findings include:

  • 95% of providers avoided the MIPS penalty (maximum of 4%); 22% will receive a small bonus, 71% will receive a modest bonus, and 2% will receive neither a penalty nor bonus.
  • Almost 100,000 providers will receive the associated 5% bonus under the Advanced APM track, with a majority of these providers enrolled in ACOs under the Medicare Shared Savings Program, followed by those in the Next Generation ACO model.
  • Even with the option to “Pick Your Pace,” across all MIPS performance categories, eligible providers who participated generally opted to report data for 90 days or longer.
  • The majority of eligible providers reported under MIPS as part of a group (54%, or 542,202/1,006,319).
  • 94% of eligible providers in rural practices participated in MIPS, which was about the same as the overall average.
  • Similarly, 81% of eligible providers in small practices participated in MIPS, a higher percentage than under the legacy CMS quality initiatives.

CMS believes the first year of the program to be more successful than anticipated. Given the requirements change from year to year, it will be interesting to see if the participation trends remain as high as the first year and whether or not providers are really meaningfully engaged in the transition from fee-for-service to value-based care.

 

HPW Rebuild

 
LEGISLATIVE UPDATE
 

Legislative Bytes

 
 
  • The House Energy and Commerce Committee passed 6 bills to the full House for a vote that would strengthen the Affordable Care Act (ACA) by either providing funding for various provisions of the ACA or rolling back efforts by the Trump Administration to weaken the ACA.
  • The House Ways and Means Committee is planning to mark up 4 drug-pricing bills next week, including proposed legislation to have additional price transparency for manufacturers and pharmacy benefit manager (PBM) rebates. And, because who doesn’t love a good name, the SAMPLES Act (HR 2064) would require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain healthcare providers.
  • Sen. Rick Scott (R-FL) announced the introduction of the Transparent Drug Pricing Act, which would promote transparency in drug pricing and reduce the cost of prescription drugs for American consumers.
  • Democrats have been looking at “Medicare-for-All” and “public plan” options. There is the Medicare-X Choice Act of 2019, which would allow individuals of any age to purchase plans that would include access to the Medicare program’s network of healthcare providers and the ACA’s range of benefits, and HR 2000 would establish a public health plan. We recommend this resource to make sense of it all: the Kaiser Family Foundation (KFF) released an interactive comparison tool of various Medicare-for-All and public plan proposals.
  • Insulin remains a focus (plus more under our Information Buffet):
    • The House Energy and Commerce Committee held a hearing on the impact of the rising costs of insulin.
    • Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) introduced a bill to bring down the cost of certain biologic drugs, such as insulin, by making it easier for manufacturers to get generic versions of those drugs approved by the Food and Drug Administration (FDA). See the press release for more information.

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THE VALUE CORNER
 

Looking for the Right ICER Analogy, and All We Got Was En Fuego

 
 

In looking for the right headline, we tried FER (like fire), which led to on fire, which led to dumpster fire, but that didn’t seem fair. Let’s just say, ICER has been busy.

On Wednesday, the Institute for Clinical and Economic Review (ICER) released the Final Evidence Report for its assessment of the spinal muscular atrophy (SMA) treatments SPINRAZA (nusinersen) and ZOLGENSMA (onasemnogene abeparvovec). The New England Comparative Effectiveness Public Advisory Council (CEPAC) unanimously voted that the clinical evidence was sufficient to show a net health benefit for SPINRAZA and ZOLGENSMA in type I SMA, and for SPINRAZA in the later-onset and pre-symptomatic populations. However, the committee agreed that the price for SPINRAZA is too high to align fairly with these benefits, and it encouraged lower pricing for ZOLGENSMA to support sustainable access to innovation.

On Tuesday, ICER announced the appointment of Pamela Bradt, MD, MPH, as the organization’s new Chief Scientific Officer. In her new role, Dr. Bradt will be responsible for leading the organization’s research enterprise and will help evolve ICER’s methods of value assessment and expand its application.

Last week, ICER also announced plans to conduct an update to its 2017 assessment on therapies for rheumatoid arthritis (RA). In the 2017 assessment, ICER evaluated 11 targeted immune modulators for the treatment of moderately-to-severely active RA. The report concluded that the evidence was inadequate to distinguish overall benefits between newer agents and that the prices were too high in relation to the clinical value provided to patients.

ICER’s new RA assessment will include new data on upadacitinib, which is currently under review by the FDA. Other interventions of interest include adalimumab, CIMZIA (certolizumab pegol), ENBREL (etanercept), SIMPONI (golimumab), REMICADE (infliximab), RITUXAN (rituximab), ORENCIA (abatacept), KEVZARA (sarilumab), ACTEMRA (tocilizumab), OLUMIANT (baricitinib), and XELJANZ (tofacitinib). Additionally, ICER said it is considering investigating several biosimilars as part of the update.

The open input period for this RA assessment began last week, and ICER will be accepting feedback from interested stakeholders until 5:00 PM ET on April 8. Input can be emailed to publiccomments@icer-review.org. The Draft Scoping Document will be available on April 11.

In other value assessment framework-related news, the Innovation and Value Initiative (IVI) closed the public comment period for its non-small cell lung cancer Value Model earlier this week. Keep an eye out for the release of the revised model later this summer or fall.

As always, if you need assistance with all things ICER or value-related, please contact kristen.migliaccio@xcenda.com.

 

The Evolving Healthcare Landscape and the Impact on Patient Access and Affordability

 
 

Xcenda experts joined over 450 leaders from the patient assistance and product access field at CBIs 2019 Patient Assistance and Access Programs conference in Baltimore to prepare for what’s ahead in the industry.  

Xcenda’s Jennifer Snow, MPH, Vice President of Reimbursement and Policy Insights, presented the “State of the Industry” session titled, “The Evolving Healthcare Landscape and the Impact on Patient Access and Affordability.” Ms. Snow provided insights on the access and affordability challenges facing patients today and how patient support programs are being impacted by trends in the marketplace.

Download the presentation >

 

 

 

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REGULATORY UPDATES
 

“If Saving Money Is Wrong, I Don’t Want To Be Right”*: States and Copay Assistance

 
 

Some states are now siding against payer practices that make it difficult for beneficiaries to benefit from drug copay coupons. Last week, governors in Virginia (Republican) and West Virginia (Democrat) approved bills that will allow health plans and PBMs to use tactics designed to exclude manufacturer-sponsored copay assistance from counting toward beneficiaries’ cost-sharing responsibilities, SB 1596 and HB 2770, respectively.

An IQVIA report noted that, in 2011, drug copay coupons were redeemed for 12% of branded and 29% of specialty drugs; however, by 2017, coupons accounted for 18% of branded and 42% of specialty drugs. Payers have responded by implementing copay accumulator adjustment programs, as recently detailed in an Xcenda issue brief. Xcenda’s survey of payer decision makers showed a significant year-over-year increase of payers employing some form of a copay accumulator to counteract drug copay coupons.

But state reaction has been mixed. Early responses from some states sought to discourage the practice of manufacturer-sponsored drug discounts via copay coupons. In 2017, California enacted AB 265 to prohibit manufacturers from offering any discounts or drug coupons when a beneficiary’s health plan offers a lower-cost generic. In 2018, a similar bill was introduced and remains under consideration in New Jersey.

Critics contend that the availability of manufacturer-sponsored copay assistance undermines formulary management, driving beneficiaries toward higher-cost branded drugs, resulting in higher premiums and overall plan cost. But bills comparable to those enacted in the Virginias are under consideration in 9 states.

Proponents emphasize that the primary concern should be enabling financially burdened patients’ access to the therapy recommended by their physician. Without financial assistance from manufacturers, patient adherence issues have been shown to drive up overall plan costs.

*Quote from William Shatner.

 

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:



 
HEARD ON THE STREET
 

“I think it’s important for scientists to speak up, because one of the reasons that we have this whole anti-vaccine movement is because of the silence from the scientific community.”

– Dr. Peter Hotez, Houston doctor standing up for use of vaccines, April 4

 

 
POLICY BY NUMBERS
 

−3.3%

 

CMS announced that approximately 11.4 million consumers selected or were automatically re-enrolled in an exchange plan during the 2019 Open Enrollment period in the 50 states, plus DC. The enrollment total is a decrease from 11.8 million consumers, or 3.3%, during the 2018 Open Enrollment period.

Source: “Health Insurance Exchanges 2019 Open Enrollment Report,” March 25

 
UPCOMING MEETINGS & CONFERENCES
 

2019 Asembia Specialty Pharmacy Summit

April 29–May 2 | Las Vegas, NV
Join Platinum sponsor AmerisourceBergen at this year’s Asembia Specialty Pharmacy Summit at the Wynn & Encore Las Vegas. Each year, the Summit welcomes thousands of senior executives, key decision makers, and other industry professionals to the nation’s largest annual gathering for specialty pharmacy. Visit the AmerisourceBergen associates at booth #311. 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
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Amy Grogg, PharmD
Senior Vice President | Commercialization Solutions | AmerisourceBergen Corporation

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:

Irene Sheynis | Scott Shields | Linnea Tennant | Steve Wilson

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Apr. 5, 2019

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