Senate Republicans meet to review their policy options for healthcare reform. Learn more.

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June 9, 2017


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We Might Not Always Have Paris (Accord), but AHCA Still Kicking Around


Senate Majority Leader Mitch McConnell (R-KY) held a closed-door luncheon for Republican senators on Tuesday, seeking near-unanimous approval for the Senate’s version of policy options for healthcare.

Though no policy frameworks have yet been released, Politico has reported that Senate Republicans “expect their bill to be more generous than the House-passed measure in almost every way: a longer runway for ending the Medicaid expansion, more money for insurance market stabilization to lower premiums, and beefed up tax credits for Americans of lower income.”

The upper chamber hopes to have a vote on its version of healthcare reform before the July 4 recess. Republicans hold 52 seats and can only afford 2 defections. In the case of a 50-50 tie, Vice President Mike Pence could pass the deciding vote. The slog ahead continues.


The Whole Picture: Consideration of Personalized Medicine in Value Assessment Frameworks


BIO International Convention | June 19–22 | San Diego, CA

Join Xcenda’s Jennifer Snow, MPH, Director of Health Policy at Xcenda, as she moderates a panel titled, “The Whole Picture: Consideration of Personalized Medicine in Value Assessment Frameworks” on June 22 at 10:15 AM PT. This session will examine how value assessment frameworks have been developed historically, look at the current critiques of their processes and methodologies, and explore how they might have to change in the future to support personalized medicine. Learn more



Trucking Along: FDA User-Fee Bill Advances to Full House


The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance the FDA Reauthorization Act of 2017 to reauthorize the Food and Drug Administration’s user fee programs for prescription and generic drugs, biosimilars, and medical devices (PDUFA) to the full House.

During the mark-up, the committee adopted several amendments, including risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, and a pilot project for active surveillance of medical devices.

Perhaps more noteworthy were the 2 amendments on off-label communications (here and here) and 1 amendment addressing risk evaluation and mitigation strategies (REMS) abuse that were withdrawn, as well as an amendment that would have allowed drug importation from Canada that was voted down.

The committee adopted a “sense of Congress” amendment sponsored by Rep. Jan Schakowsky (D-IL) that encourages Congress and the Department of Health and Human Services (HHS) to commit to working on legislative and administrative actions that could lower the cost of prescription drugs and increase competition in the market.

The FDA Reauthorization Act of 2017 is considered “must-pass” legislation before the current authorization sunsets September 30; if it does not pass, massive layoffs at the FDA would result. The Senate’s work on user fee reauthorization legislation has slowed as the upper chamber has signaled it will prioritize Affordable Care Act (ACA) repeal legislation before it continues to advance the PDUFA legislation.


E&C Looking at 340B…Again


Last week, Republican members of the Energy and Commerce Committee sent a letter to the head of HHS’ Health Resources and Services Administration (HRSA) regarding its concern that HRSA’s oversight of the 340B program is not keeping up with the program’s growth.

The program that requires drug manufacturers to provide drugs to hospitals and other healthcare providers at reduced prices has been growing rapidly since eligibility requirements expanded with the implementation of the ACA. Drug sales for the program have doubled from 2010 to 2015, and as of 2011, almost a third of US hospitals participate in the program.

The committee members had several concerns about HRSA’s oversight of the program:

  • Prevalence of duplicate discounting (almost a quarter of HRSA-audited entities reported duplicate discounting from 2012 to 2016)
  • Reports of 340B drugs being resold or redirected to non-eligible patients (nearly 50% of HRSA-audited entities in fiscal year [FY] 2012, FY 2015, and FY 2016 had violations)
  • Lack of follow-up after identified offenses (after an FY 2014 HRSA audit, only 1 out of 81 audited covered entities deemed non-compliant were re-audited in the following year)
  • No legislative requirement for covered entities to report savings from the program nor requirements for how savings are used

The committee requested that HRSA provide all documents relating to audits conducted on covered entities during FY 2015 and FY 2016.

In response to the committee’s letter, 340B Health, a membership organization representing over 1,300 340B program participants, released a statement supporting the committee’s request. In the statement, 340B Health “welcome[d] balanced congressional oversight of all stakeholders—healthcare providers and drug manufacturers.” The statement also emphasized the value of the 340B program for low-income and rural populations, as well as reasonable explanations for duplicate discounting that does not result in providers receiving multiple discounts on the same drug.

340B continues to be a “subject of interest” amidst the growing push for transparency and moderation of drug pricing.


Payer Perceptions and Utilization of ICER Value Assessment Framework


Xcenda Original Research

The Institute for Clinical and Economic Review (ICER) was established as an independent, nonprofit organization that evaluates the value and affordability of drugs and other therapies. It takes a broad societal approach to evaluate comparative clinical effectiveness evidence to estimate value and affordability. While ICER has gained both praise and criticism, limited evidence has been gathered to evaluate stakeholder perceptions and utilization of the ICER framework.

We wanted to know more. Did payers use ICER reports? What were the strengths of its evaluations, and what were the limitations? Our survey findings illustrate the impact that the ICER framework has had on payer decision making.



Stanch the Bleeding: NY Looks to Preserve ACA Protections


In light of the continuing marketplace exits by some major insurers, as well as recent Republican proposals allowing states to weaken ACA standards, New York Gov. Andrew Cuomo (D) announced Monday new emergency regulations intended to shield New Yorkers from continuing uncertainty over the future of the ACA and to safeguard the ACA’s 10 “essential health benefits.”

Gov. Cuomo’s measures put pressure on insurers as follows:

  • Banning all insurers who withdraw from offering Qualified Health Plans in the exchange from contracting with the state and in any future participation in any program that interacts with the marketplace, including Medicaid, Child Health Plus, and the Essential Plan
  • Regardless of actions at the federal level, insurers may not discriminate based on pre-existing conditions, age, or gender
  • Regardless of actions at the federal level, contraceptive drugs/devices and medically necessary abortion services must be covered by commercial health insurance policies without copays, coinsurance, or deductibles

While these measures will include individual and small-group policies, large-group and self-insured employer plans are excluded.

Paul Macielak, President and CEO of the New York Health Plan Association, expressed doubt about the effectiveness of Cuomo’s emergency regulations:

“We believe most—if not all—these coverage requirements exist in current law or regulation, so we do not understand the ‘emergency’ here.

“There are issues about the legality and timing of the directive to ban plans that don’t participate on the exchange from the Medicaid, Child Health Plus, and Essential Plan markets, and the impact it might have on the overall marketplace in New York.”

Some observers have questioned the legality of excluding non-exchange-participating insurers from any other state health programs, saying it amounts to holding the state’s Medicaid beneficiaries “hostage.” New York is a bellwether state, and it has joined California as the most visible resistance to the Republican efforts to peel away the ACA.


Lordy, Anthem Pulls Out of Ohio Exchange


On Tuesday, Anthem announced it would not participate in the individual health insurance exchanges in Ohio for the 2018 plan year, potentially leaving 18 counties in the state without any plans on the marketplaces established by the ACA.

Changes in federal operations, rules, and guidance contributed to the decision. From the insurer’s statement:

“…[T]he individual market remains volatile, and the lack of certainty of funding for cost-sharing reduction subsidies, the restoration of taxes on fully insured coverage, and an increasing lack of overall predictability simply does not provide a sustainable path forward to provide affordable plan choices for consumers.”

In 2017, Anthem is the only insurer selling health insurance exchange plans in each of Ohio’s 88 counties. Exiting the state will leave about 10,500 Ohio residents in at least 18 counties without an insurance option on the exchange unless another carrier steps in, according to the state’s Department of Insurance.


ACOs Getting Better at Optimizing Medication Use


A recent study from the Journal of Managed Care & Specialty Pharmacy found that accountable care organizations (ACOs) have been developing effective strategies to optimize medication use since 2012.

The study evaluated 38 unique capabilities across 6 functional domains related to optimizing medication use. From the data collected, ACOs generally rated themselves as being in a better position to optimize the quality of the medication use than optimizing their costs.

The study found that the biggest struggles for ACOs were notifying care providers and pharmacies related to prescription use, as well as measuring the influence that optimized medication use has on costs and quality outcomes. On the positive side, the study found that, when compared to similar data previously collected in 2012, ACOs have made gains in adopting electronic prescription transmissions, educating patients, and achieving greater penetration of generics.

These factors have helped ACOs move toward optimizing medication use practices, especially along the quality dimension. However, the study suggested additional gains can be made with respect to optimization if ACOs focus on integrating more pharmacists into their leadership and care teams, removing technological barriers, and gathering feedback and buy-in from frontline physicians.

This study reflects the conclusions of the Centers for Medicare & Medicaid Services (CMS) when evaluating the quality and financial results of ACOs participating in the Medicare Shared Savings Program. CMS generally found that ACOs were able to improve the quality of healthcare, while cost savings tended to be relegated to just a few participants. Of course, improving the quality of healthcare while not increasing costs is still considered a net positive.


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:

  • Senate Health, Education, Labor, and Pensions (HELP) Committee announces June 13 hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay”
  • House Ways and Means Committee held a hearing on promoting integrated and coordinated care for Medicare beneficiaries in Medicare Advantage plans
  • CMS is seeking public input on reducing the regulatory burdens of the ACA
  • The National Academy for State Health Policy announced a June 19 webinar, “Tackling Prescription Drug Prices: A Closer Look at State Policy Successes”
  • The World Health Organization updated its Essential Medicines List with new advice on use of antibiotics, adding medicines for hepatitis C, HIV, tuberculosis, and cancer
  • New York Department of Financial Services provided 2018 rate requests for the individual market (weighted average 16.6% requested increase) and the small-group market (11.5%)
  • Blue Cross and Blue Shield of Nebraska announced its decision to exit the ACA-compliant individual market in 2018
  • As part of MaineCare’s Value-Based Purchasing strategy, the Accountable Communities program saved the state $5.41 million

“I’m limited in what I can say.”


– HHS Secretary Tom Price, citing a pending lawsuit regarding subsidy payments for consumers in the exchanges during testimony on Capitol Hill about the HHS budget for 2018. Some lawmakers are concerned that withdrawing subsidy payments would collapse the insurance exchanges.




As of 2017, 1 in 3 people with Medicare (33%, or 19 million beneficiaries) is enrolled in a Medicare Advantage plan.

Source: “Medicare Advantage 2017 Spotlight: Enrollment Market Update,” Kaiser Family Foundation, June 6


HDA 2017 Business and Leadership Conference

June 11–14 l Phoenix, AZ
HDA’s Business and Leadership Conference (BLC) is the healthcare distribution industry’s signature annual conference. The conference brings together high-level executives and influencers across the healthcare supply chain to hold strategic business discussions on the industry’s most pressing issues. AmerisourceBergen’s John Wernicki, Senior Director of Strategic Accounts, will join a panel titled, “Ask the Distributors: How Personalization Works” on June 12 from 11:45 AM–3:30 PM to provide tips on how to help the independent pharmacy channel grow its front end and drive a more profitable business mix. Learn more


2017 BIO International Convention

June 19–22 l San Diego, CA
Join experts from World Courier and Xcenda at the 2017 BIO International Convention in San Diego. This annual conference, hosted by the Biotechnology Innovation Organization (BIO), is the largest global event for the biotechnology industry and attracts the biggest names in biotech. Visit the World Courier booth at #5408. In addition, Jennifer Snow, MPH, Director of Health Policy at Xcenda, will moderate a panel titled, “The Whole Picture: Consideration of Personalized Medicine in Value Assessment Frameworks” on June 22 at 10:15 AM PT. Learn more


ThoughtSpot 2017

July 19–22 l Las Vegas, NV
ThoughtSpot, the annual conference and trade show by Good Neighbor Pharmacy, is a 4-day event for independent community pharmacies where you’ll receive practical and clinical education to help you diversify your revenue streams and optimize your core business, plus exclusive deals and discounts on product purchases. The insights and expertise you’ll experience at ThoughtSpot will help you build a better business, find growth opportunities, and maintain your status as a preferred healthcare destination in your community. Learn more


2017 Pharmaceutical End-to-End Supply Chain Management Summit
4th Annual Specialty Network Design and Channel Optimization Summit

July 24–25 l Philadelphia, PA | Part of Pharma4
Matt Sample, Senior Director, Secure Supply Chain at AmerisourceBergen, will present, “Utilize Serialization and Traceability Data to Ensure End-to-End Supply Chain Visibility.” He will discuss standardized product packaging and serialization, show how to integrate data standards within the commercial supply chain for enhanced visibility, and review the methods to secure the data and ensure interoperability throughout the end-to-end supply chain. Donna Gilbert, Vice President, Specialty and Branded Strategic Accounts, Global Sourcing and Manufacturer Relations, AmerisourceBergen, will also contribute insights on the Stakeholder Roundtable titled, “Collaborate to Achieve Streamlined Approaches to HUB Design and Channel Optimization.” Learn more


4th Annual Patient Support Services and HUB Design Summit
2017 Patient Services Compliance Summit

July 24–25 l Philadelphia, PA | Part of Pharma4 
Join Derek Cothran, Vice President, Strategic Account Management at Lash Group, as he presents a session titled, “Achieve Brand Goals With the Optional Approach to Patient Support Services and Product Distribution.” Donna Gilbert, Vice President, Specialty and Branded Strategic Accounts, Global Sourcing and Manufacturer Relations, AmerisourceBergen, will also contribute insights on the Keynote Stakeholder Roundtable titled, “Internal Big Picture: Explore Strategies Used to Ensure Patient Centricity Through HUB Design, Channel Optimization, Compliance, and Distribution.” Learn more


The Bioprocessing Summit

August 21–25 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


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
Health Policy

Scott Shields
Associate Director,
Health Policy



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


Aaron Dancy | Jennifer Le | Scott Shields | Stephen Wilson 


Laurie Kozbelt | Ellen Olson


June 9, 2017


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