Leaders in both the House and Senate agree to new legislation to address the national opioid epidemic.

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Sept. 28, 2018


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Legislative Win: Congress Agrees to Massive Opioid Legislation


On Wednesday, House of Representatives and Senate leaders agreed to sweeping new legislation to respond to the national opioid epidemic, including authorizing $8 billion in grant programs for states, expanding access to prevention and treatment, and cracking down on illicit drug shipments in the mail.

Staff for the House Energy and Commerce Committee provided a section-by-section analysis of the legislation. Provisions in the legislation include:

  • Accelerate the development and use of drug-management programs for at-risk beneficiaries within the Medicare program by mandating that all prescription drug plans use such a program by plan year 2022
  • Expand Medicare coverage to include opioid treatment programs (OTPs) for the purposes of delivering medication-assisted treatment (MAT)
  • Initiate a demonstration project to increase substance use provider capacity under the Medicaid program
  • Require state Medicaid programs to include safety edits for opioid refills, monitor concurrent prescribing of opioids and other drugs, and monitor antipsychotic prescribing for children
  • Review how Medicaid covers peer support services
  • Direct the Centers for Medicare & Medicaid Services (CMS) to issue guidance to states on options for providing Medicaid services via telehealth that address substance use disorders
  • Direct CMS to issue guidance on states’ options for treating and managing beneficiaries’ pain through non-opioid pain treatment and management options under Medicaid
  • Expand the use of Medicare telehealth services for the treatment of opioid use disorder and other substance use disorders

Notably, the legislation did not include the reversal of a $4 billion provision enacted by the February budget law that increased the share of manufacturers’ contributions to the Coverage Gap Discount Program from 50% to 70%. The pharmaceutical industry will continue to look for avenues to change this Medicare Part D provision; one path may be the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act which remains in Committee.

The House is scheduled to vote on the bill this week before adjourning for the midterm elections. The Senate is expected to vote early next month, sending the bill to the White House, where President Trump is expected to sign it into law.


Medicare Physician-Administered Drugs: Do Providers Choose Treatment Based on Payment Amount?


Do providers choose treatment based on payment amount?

That was the question at hand in Xcenda’s newest report regarding the Medicare Part B physician-administered drugs program. Conducted on behalf of the Part B Access for Seniors and Physicians (ASP) Coalition, data revealed no strong positive correlation between drug payment and utilization and suggest that physician prescribing is not driven by payment per drug administration.

Download the report now >



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Congressional Heimlich: Bills on Pharmacy Gag Clauses


On Tuesday, the House of Representatives passed, through voice vote, 2 measures blocking insurers from enforcing “gag clauses” that forbid pharmacies from telling customers about how they can pay less for drugs. Health Policy Weekly has been tracking the progress of the bills through both chambers over the past several months.

The Patient Right to Know Drug Prices Act (S 2554), applying to commercial insurers and pharmacy benefit managers (PBMs), and the Know the Lowest Price Act (S 2553), applying to Medicare Advantage and Medicare Part D plans, are intended to help patients find out whether a prescription would cost less if they were to pay for it out of pocket rather than through their health plan.

The bills, addressing an issue highlighted in President Trump’s American Patients First Blueprint, now head to Trump, who indicated he would sign them.

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A Trillion Here or There: Medicaid Spending


An analysis of 2016 Medicaid spending prepared by the CMS Office of the Actuary offers insight to the projected growth of enrollment and government spend for the next decade.

Comparing fiscal year (FY) 2015 and 2016 enrollment and spending, CMS calculated a 3.1% increase in Medicaid enrollments nationwide, to the tune of 72.2 million people, along with $581 billion in spending for Medicaid expenditures for services and administrative cost—an increase of 4.9% from the previous year. If this trend holds, CMS projects that federal Medicaid spending will increase 5.7% annually, topping $1 trillion annually by the year 2026.

At the federal level, these statistics are a cause for concern. The Medicaid expansion offered through the Affordable Care Act contributed significantly to the sharp growth of enrollments and left the bulk of financial responsibility to the federal government. According to the report, the growth of Medicaid spend is set to outpace the growth of the US economy (gross domestic product [GDP]) by 2026, triggering calls for reform. In a statement, CMS Administrator Seema Verma said the projected spending growth was “simply unsustainable” and the government should be looking for ways to slow that growth.

Some of the most robust efforts to quell Medicaid spending have focused on changes to the service offerings and funding for long-term care benefits for beneficiaries. These reductions have slowed, to some effect, the overall Medicaid spend by $104.1 billion. Although the average cost to the program for each enrollee continues to rise, these reductions have slowed projected spend by 0.1% through 2026, with credit for this reduction being given to the reduction of long-term care benefits.

As the Trump Administration examines ways to slow the momentum of the costs associated with Medicare and Medicaid without catastrophic consequences to a growing American population, Medicaid is an obvious target for reform.


Up, Up, and Away: Cancer Drug Prices Attached to a Not-So-Beautiful Balloon


A study published in the Journal of Oncology Practice found that total spending on anticancer drugs increased from $26.8 billion in 2011 to $42.1 billion in 2016, a 57.1% increase in the 5-year period. Spending increased an average of 9.6% annually from 2011 to 2016.

Antineoplastic expenditures represented 7% of total US drug expenditures in 2011 and increased to 9.4% in 2016. The authors attribute the growth in cancer drug expenditures to “technology advancements, increasing prices, changing patient demographics, and changes in duration of therapy.”

Adding to the cost increase was the Food and Drug Administration (FDA) approving 52 new cancer therapies during the study period, many of which were more expensive oral therapies.

The study will certainly add fuel to the fire for shifting toward a value-based approach, as payers otherwise have limited options to exert downward pressure on drug expenditures. However, the authors noted that an increased use of more expensive oral drugs may decrease overall healthcare costs, as the care setting can shift from high-cost outpatient facilities to lower-cost community oncology practices.


If You Can’t Beat ’em, Join ’em: Gilead to Launch Hep C Generics


This week, Gilead CEO John Milligan announced the company is planning to launch generic versions of its hepatitis C (HCV) drugs, HARVONI and EPCLUSA, in January 2019. The plan is for a newly formed subsidiary, Asegua Therapeutics, to market the products.

The estimated list price is $24,000 for a full course of treatment, a quarter to a third of the price of the branded drugs. By doing so, HARVONI and EPCLUSA would be within the price range of AbbVie’s HCV treatment, MAVYRET, which has a $26,000 list price. Moreover, health insurers will have the choice to cover the branded or authorized generic products.

When HCV drugs first came to market, they sparked much debate; while these novel medications offered a cure for HCV, the high costs garnered significant attention. Milligan stated he hopes the decision will lead to increased access and greater affordability, and he anticipates certain Medicare patients may save up to $2,500 in out-of-pocket costs.

Express Scripts has come out in support of this decision, stating it was “a step in the right direction” to help ensure affordable access for patients and payers.

This move may represent one potential avenue that manufacturers are exploring to combat the issue of rising drug prices, as the lower list prices of the authorized generics should translate to lower cost-sharing for patients.


340B + Cancer = Site of Care Shift + Medicare Spending Increases


A recent analysis published in Health Services Research of Medicare claims data of beneficiaries with cancer from 2010 through 2013 showed expected, but startling, results of the federal 340B program. The study is the first showing estimated impacts of 340B hospitals on both the site of care for provider-administered cancer drugs and Medicare spending for cancer care.

Researchers found the probability of a patient receiving provider-administered drugs in a hospital outpatient department, instead of an office, was 7.8% higher. Additionally, per-patient spending on other cancer care was $1,162 more in 340B markets than in markets without 340B hospitals. They recommend that, as the program continues to expand, further assessment of the impact on service utilization and spending should be explored.

Congress has spent much of this term conducting hearings on reforming the 340B program, due to its rapid expansion in recent years. No bills were voted on, but this is likely not an issue Republicans will put to rest, should they retain the House in November.


Less Can Be More: Clinical Trials With a Smaller Price Tag


On Monday, JAMA Internal Medicine published a systematic evaluation of the costs of 138 clinical trials supporting FDA approval of 59 new agents from 2015 to 2016. The authors found more than a 100-fold difference in the cost of these trials—the lowest with a mean of $5 million, the highest with a mean of $346.8 million, and a central cluster with estimated costs of $12.2 million to $33.1 million.

Trial costs were lowest for new agents approved based on uncontrolled trials (ie, trials without any protections against bias, such as a comparison group, randomization, or blinding). Costs grew when larger patient enrollments were required to detect a difference from placebo or an active drug comparator. Costs were greatest for those new agents that needed to have a clinical benefit that was noninferior to another drug already available.
The authors suggest the scientific evidence needed to establish a new agent with substantial clinical benefits can be generated at a lower cost. The timeliness of these findings is undoubtedly welcomed by policy advocates and lawmakers seeking to address trial cost and design aspects.

The FDA recently issued requests for public comments over draft guidance to promote development of clinical outcomes assessments (COAs) and endpoints, on first-in-human (FIH), multiple-expansion cohort clinical trials to fast-tracking experimental cancer drugs, and the use of placebos in trials.

With a focus on removing barriers faced by patients in clinical trials, recent recommendations from the American Society of Clinical Oncology (ASCO) and pending legislation from states such as Massachusetts, outline steps to address financial burdens and legal concerns.


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:

  • The head of the Government Accountability Office announced the appointment of a vice chair and 7 new members to the Governing Board of the Patient-Centered Outcomes Research Institute (PCORI).
  • WellCare Health Plans entered into an asset purchase agreement to acquire Aetna’s entire standalone Medicare Part D prescription drug plan business, which is expected to close by the end of the year. CVS Health indicated the divestiture is a significant step toward completing the Department of Justice’s review of the CVS-Aetna merger.
  • The Institute for Clinical and Economic Review (ICER) issued a draft evidence report on the effectiveness and value of DUPIXENT (dupilumab), XOLAIR (omalizumab), NUCALA (mepolizumab), CINQAIR (reslizumab), and FASENRA (benralizumab) to treat asthma associated with type 2 inflammation and/or allergic asthma. (See press release.)
  • George Mason University’s Mercatus Center released the first installment of a 5-part series on the fallacies and gaps in America’s healthcare debate.
  • Our editors are crying over spilt beer (and thinking about ideas for that extra space in the office kitchen): the FDA issued a warning to Pharmaceutical Laboratories and Consultants, Inc. for several manufacturing quality violations, including using its space to craft small-batch beer. As reported by STAT, in one instance, the facility had stored a beer fermenter and created a workspace for a brewery employee preparing kegs, all within 10 feet of an area where microbiological material is kept.


“Frankly, I want them in a cage match fighting this out.”

– Office of Management and Budget Health Director Joe Grogan, commenting on how the Trump Administration plans to give Medicare Part D sponsors more power to negotiate with drug manufacturers

Source: “OMB healthcare official: Seeking simple solutions on healthcare policy is a ‘fallacy’,” FierceHealthcare, September 20





Bucking the trend of every other state, Maryland announced an average 13.2% premium rate decrease for individual health insurance plans with an effective date of January 1, 2019.

Source: “Governor Larry Hogan Announces Health Insurance Premium Rate Decreases,” September 21


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.

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


Darren Jensen | Isabell Kang | Jenna Kappel | Scott Shields | Stephen Wilson


Laurie Kozbelt | Ellen Olson


Sept. 28, 2018


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