President Trump signs 2 acts that allow more drug price transparency at the pharmacy counter.

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Oct. 12, 2018


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Editor’s Note: We are taking advantage of a comparatively quiet week to discuss the removal of pharmacy “gag clauses” and to showcase some of Xcenda’s research that we have released over the past few months (and a rest; witty headlines don’t write themselves). Back to regularly scheduled programming next week.


Giving Pharmacists a Say: Removing the Gag


On Wednesday, President Donald Trump hosted leaders from pharmacy associations, including the National Community Pharmacists Association and the National Association of Chain Drug Stores, several independent pharmacists, Health and Human Services Secretary Alex Azar, and the Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma at a signing ceremony for the Patient Right to Know Prices Act (S. 2554) and the Know the Lowest Price Act (S. 2553). The legislation bans plan or pharmacy benefit manager (PBM) “gag clauses” that restrict pharmacists from telling patients when the cash price of a medicine is less than what they would pay under their insurance plan.

Combined, the legislation prohibits such restrictions for group plans offered by employers, plans offered on the individual market, and Medicare Advantage and Medicare Part D plans. As well, the Patient Right to Know Prices Act includes language requiring biosimilar and brand-name biological companies to submit patent settlement agreements to the Federal Trade Commission and Justice Department in an effort to prevent “pay-for-delay” deals. This provision addresses one of the Administration’s priorities to prevent patent settlements from delaying competition by keeping less expensive medicines from entering the market.

At Wednesday’s signing ceremony, President Trump promised more regulatory action to increase drug price transparency and lower drug prices for consumers, stating enactment of the gag-clause prohibition is only the “tip of the iceberg.”

In related news, we await several proposed rules aimed at advancing the Administration’s policies to lower drug prices. The pending proposals will likely address:

  • Drug price transparency in Medicare and Medicaid
  • Medicare Advantage and Part D prescription drug reforms
  • Anti-Kickback Statute rebate safe harbors

Finding the Patient Voice in ICER’s Value Assessments


Earlier this week, Xcenda released research co-authored with the Partnership to Improve Patient Care (PIPC) that examined the extent to which the Institute for Clinical and Economic Review (ICER) incorporates stakeholder input in its final assessments. Value assessment frameworks such as ICER have been criticized by patient advocacy groups for not taking into account patient perspectives when evaluating therapies. This research aimed to quantify the extent to which ICER meaningfully engages patient advocacy groups and other stakeholders through its public comment process. Xcenda developed a new methodology that systematically analyzed the degree to which stakeholder comments were acknowledged and incorporated into final ICER assessments.

Findings from the analysis indicated that ICER has formally acknowledged over 95% of comments received from stakeholders in writing since refining its process in 2017 for public comments. Despite this, ICER only incorporated 27% of all stakeholders’ comments into its final assessments. Feedback was more likely to be incorporated into final assessments when a recommended solution was provided by stakeholders and for comments specific to methodological issues, as compared to general feedback.

Input from patient advocacy groups, in particular, was half as likely to be incorporated into ICER’s final assessments compared to other stakeholders. Patient advocacy groups tended to provide comments that were less solution-oriented and less targeted relative to industry stakeholders and were most likely to comment on the adequacy of existing evidence, incorporation of the patient perspective, and ICER’s transparency.

Patient advocacy groups have expressed concern that the increased uptake of ICER’s framework by PBMs, such as CVS Health, state Medicaid formularies, and the Department of Veterans Affairs, poses barriers and risks limiting beneficiaries’ access to important treatments.

Xcenda’s research in collaboration with PIPC reinforced the importance of developing patient-centered value assessment frameworks and identified areas of high concern for patient advocacy groups relating to ICER’s evaluations. Further, this research highlighted the need to make evaluations and related documents, such as economic models and analysis plans, more accessible and understandable to patients and patient advocates. The results illustrated the need to refine and improve 2-way communication between patient advocacy groups and ICER throughout all stages of ICER’s evaluation process.

Click the report above to learn more.


I’m Lovin’ It: Utilization Not Tied to Reimbursement Rates in Part B


Last month, Xcenda released the results of research that tested the hypothesis that prescribers of Part B drugs disproportionately prescribe therapies with higher reimbursement rates to financially benefit from larger add-on payments. The Medicare Part B reimbursement methodology for covered drugs, average sales price (ASP) plus 6%, has been criticized for incentivizing physicians to prescribe medications based on maximizing profit potential, since the 6% “add-on” payment increases as the Medicare payment amount for the drug increases. The physician community counters this argument by asserting that medicines are not often interchangeable, and their prescribing is guided by best available evidence on the safety and effectiveness of medicines and patient needs.

On behalf of the Part B Access for Seniors and Physicians Coalition, Xcenda analyzed claims data for Medicare Part B fee-for-service beneficiaries receiving physician-administered drugs for rheumatoid arthritis (RA), breast cancer (BC), and non-small cell lung cancer (NSCLC) in the office setting.

Xcenda found no meaningful correlation between drug payment and utilization. The payment rates of RA, BC, and NSCLC drugs only contributed 5%, 1%, and 1% of the variation in utilization, respectively. In other words, the lack of a strong, positive correlation between drug payment and utilization suggests that physician prescribing is not driven by payment per drug administration.

These findings are particularly important now, as the Trump Administration is considering actions that would materially affect the Part B architecture of drug payment, such as reintroducing a Competitive Acquisition Program and shifting some or all Part B drugs to the Part D program. Policy makers should evaluate the payment and utilization relationship as they consider reforms; such changes may not secure savings but place patients and providers in turmoil and lead to treatment delays and adverse health consequences.

Click the report above to learn more.


Fifteen Years of Part D: Gaining Perspective on the Medicare Prescription Drug Benefit


Xcenda is proud to contribute to a new report recently released by Medicare Access for Patients Rx (MAPRx) on Medicare Part D. Findings reveal the program is as popular and robust as ever but faces challenges that could result in increased costs and limited access for millions of beneficiaries. The study—Fifteen Years of Part D: Gaining Perspective on the Medicare Prescription Drug Benefit—was commissioned by MAPRx to commemorate the 15th anniversary of Part D.

Key highlights of the report include:

  • Without congressional action, Medicare Part D beneficiaries will experience an increase of $1,250 in out-of-pocket spending to reach the catastrophic coverage phase in 2020. This dramatic cost increase, known as the “out-of-pocket cliff,” combined with other proposed policy changes, could devastate beneficiary access to needed medications. The report affirms that an “out-of-pocket cap would offer significant relief.”
  • One factor driving high out-of-pocket costs is the actual drug price that beneficiaries must pay at the point-of-sale, particularly in instances where a beneficiary faces a deductible or a coinsurance. In Part D, the price at the point-of-sale is based on the list price and does not account for any rebates or discounts that might reduce the overall price. Applying rebates “at the point-of-sale” would ensure that beneficiaries and the government could benefit from these lower costs.
  • The proliferation of specialty tiers, subject to significant coinsurance and excluded from cost-sharing exceptions, forces beneficiaries to pay a significant percentage of the medication’s cost. For drugs covered on the specialty tiers, coinsurance amounts can range anywhere from 25% to 33%, leaving beneficiaries paying thousands of dollars in out-of-pocket costs for drugs and biologics used to treat cancer, multiple sclerosis (MS), RA, and other conditions.

Our experts provided significant support to this report and are honored to be part of the collaboration with MAPRx.

Click the report above to learn more.


Diving Into the What-Ifs of ICER: Implications of Applying Cost-Effectiveness Thresholds in Medicare


Continued concerns about rising healthcare costs have prompted renewed proposals for use of a single value threshold (eg, cost-effectiveness threshold or similar approaches) as the basis for setting coverage or payment policy.

To further inform debate about the role and implications of value standards in healthcare policy, Xcenda examined the potential impact if ICER’s value assessment framework was applied across 4 conditions in the Medicare Part B program. Xcenda selected ICER’s framework because it appears to be designed for use at the policy level, was referenced in Medicare Payment Advisory Commission (MedPAC) deliberations, and was cited by CMS in its controversial 2016 Part B Drug Payment Model proposal.

Our study looked at the over 200,000 Medicare Part B fee-for-service beneficiaries with RA, MS, NSCLC, and/or multiple myeloma who used a physician-administered product evaluated by ICER. If the Medicare program was to adopt an ICER-based formulary, 59% to 93%, or nearly 140,000 of these patients, could lose access to their physician’s treatment of choice and could be forced to switch to a therapy deemed cost-effective.

Our results underscore the importance of ensuring that value assessments are used in ways that do not prevent patients and doctors from making informed choices about care options and the need for alternatives that are more physician- and patient-centered. Ideally, current or alternative tools could be tailored and supported to encourage informed, individualized decisions at the physician and patient level.

Click the report above to learn more.


AMCP 2018 Nexus

October 22–25 | Orlando, FL
Xcenda is proud to support AMCP at this year’s AMCP Nexus conference in Orlando. We're also proud to contribute research and present findings at this year's AMCP Foundation Research Symposium on Monday, October 22 from 12:30–5:30 PM ET. Don't miss meeitng Xcenda’s team of experts and consultants at booth #407. Students are also welcome to join our team at the Residency and Fellowship Showcase on Wednesday, October 24, 5:00–8:00 PM ET. 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.


Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,

Scott Shields
Associate Director,
Health Policy



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


Stacie Heller


Laurie Kozbelt | Ellen Olson


Oct. 12, 2018


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