President Trump sits down with PhRMA and major manufacturers to discuss pricing and more. Learn more.

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Feb. 3, 2017

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FEATURED STORY
 

(Not Quite) Ready to Exhale: Trump Meets With Pharmaceutical Leaders

 
 

On Tuesday morning, President Donald Trump, Vice President Mike Pence, and Greg Walden (R-OR), the new Chairman of the House Energy and Commerce Committee, met with the heads of the Pharmaceutical Research and Manufacturers of America (PhRMA), Merck, Amgen, Eli Lilly, Novartis, and Johnson & Johnson to discuss how to lower drug prices. Streamlining regulatory approval, providing compassionate access to drugs, foreign price controls of US pharmaceuticals, and tax reform were discussed as potential avenues to reduce drug prices.

Following the meeting, PhRMA issued a statement that the meeting was a productive conversation about how the group can work together to improve American competitiveness around the world, create more jobs in the US, and enhance the US biopharmaceutical industry. Stephen Ubl, PhRMA’s President and CEO, asserted, “Our industry takes seriously the concerns raised about the affordability and accessibility of prescription medicines, and we have expressed our commitment to working with the administration to advance market-based reforms. The current system needs to evolve to enable the private sector to lead the move to a value-driven health care system.”

Following the gathering, the White House issued highlights from the meeting focusing on Trump’s commitment to making drugs affordable while promoting innovation, cutting regulations to promote drug manufacturing in the US, and streamlining the Food and Drug Administration (FDA)  process to get products on the market faster. Trump also announced he will be naming a “fantastic” person to lead the FDA fairly soon to spearhead this initiative.

To outsiders, it was hard to predict any Administration actions toward the biopharmaceutical sector, as it was difficult to square Trump’s measured language reported during the meeting with his bombastic statements during a news conference just 3 weeks ago in which he accused the industry of “getting away with murder.” There remains a whistling-past-the-graveyard feeling.

 
LEGISLATIVE UPDATE
 

And Then There Were None: Democrats Boycott Price Hearing

 
 

On Wednesday, the Senate Finance Committee suspended its rules to approve the nominations of Rep. Tom Price (R-GA) for Health and Human Services (HHS) Secretary and Steven Mnuchin for Treasury Secretary to the full Senate, after Democrats boycotted a hearing for the second day in a row. Republicans voted 14-0 to advance the nominations. (Yesterday, Republicans in the Senate Environment and Public Works Committee employed the same tactic to advance Scott Pruitt to head the Environmental Protection Agency. Democrats, again, did not show up.)

Price, Chairman of the House Budget Committee, has proposed his own alternative to the Affordable Care Act (ACA)—the Empowering Patients First Act (H.R. 2300)—which would replace the healthcare law with “patient-centered solutions.”

Democrats oppose Price not only for his desire to repeal the ACA but also because of revelations he traded shares in healthcare companies that would be affected by legislation he oversaw, plus he potentially withheld information on stock purchases from the Committee.

Ultimately, Democrats can do little to prevent final confirmation of any department or agency head, as the Republicans need only 51 votes for approval in the full Senate… and there are 52 Republican Senators.

 
REGULATORY UPDATES
 

Happy to be Bored: CY2018 Advance Notice and Draft Call Letter Released

 
 

Late Wednesday afternoon, the Centers for Medicare & Medicaid Services (CMS) released the 2018 Advance Notice and Draft Call Letter which outlines proposed changes to the 2018 Medicare Advantage (MA) and Part D programs. The release comes weeks before it has traditionally been published, enabling CMS to offer a longer comment window with feedback due by end of day on March 3; the final notice and call letter will be available on April 3, 2017.

MA payments are expected to have a 0.25% increase on average for 2018, which ultimately will translate to a revenue increase of about 2.75%, falling in line with market expectations. Another area of note is within the MA Employer Group Waiver Plans (EGWP). For 2018, CMS plans to continue establishing payment amounts rather than permitting bidding by these plans. But CMS is looking for comment on the best path forward to better understand if and how to continue to employ the bid-to-benchmark ratios used for 2017 payment (based on a blend of EGWP bids and individual market plan bids) or continue the transition by using only individual market plan bids to calculate the bid-to-benchmark ratios for 2018.

On the Medicare prescription drug benefit side, things were not much more exciting. The Benefit Parameters are making the usual minor adjustments, and some changes are suggested to Star Ratings, but, based on our initial read, the proposal seems mostly steady state. One area of interest involves CMS seeking voluntary information about tiering exceptions (volume, approved/denial and appeal rates, etc). The specialty tier is staying at $670.

Given the policy adrenaline over the past few weeks, the draft was a bit of a snooze, but that’s not always a bad thing.

 

340B Mega Guidance Withdrawn

 
 

On Monday, the Trump Administration withdrew the draft omnibus guidance (“Mega Guidance”) on the 340B program that was under review at the Office of Management and Budget (OMB) since September 2016.

The Health Resources and Services Administration (HRSA) released the proposed Mega Guidance in August 2015 and addressed a variety of topics, including the definition of a “patient,” contract pharmacy compliance requirements, hospital eligibility criteria, and eligibility of off-site outpatient locations.

Broadly speaking, the pharmaceutical industry supported the proposed Mega Guidance, while hospitals felt it would have narrowed the number of drugs that qualify for 340B pricing and threatened access to care for patients. “We are pleased that the Administration chose not to finalize the Health Resources and Services Administration’s guidance, which, if enacted would have jeopardized hospitals’ ability to serve vulnerable populations, including low-income and uninsured individuals and patients receiving cancer treatments,” said American Hospital Association (AHA) Executive Vice President Tom Nickels in a statement.

The withdrawal is a setback for HRSA, which has been trying for several years to clarify some of the more contentious provisions of the 340B program.

 

Oversight Committee Gets an Earful on Medicaid Expansion

 
 

On Tuesday, the House Energy and Commerce Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), held a hearing to examine the post-ACA expansion of the Medicaid program. The hearing served as a check-up to see if the Medicaid program is serving the most vulnerable Americans, which was its original intent.

According to Murphy, the federal matching rate is currently providing more funding for newly eligible Medicaid enrollees and is negatively affecting funding for those who have traditionally received Medicaid (ie, low-income children, the elderly, and Americans with disabilities). The argument was made that “new enrollment trends” were siphoning resources away from the most vulnerable enrollees toward “able-bodied,” childless adults due to waiting lists and other administrative tasks.

Questions also arose around Medicaid eligibility determination errors and CMS’ freeze on measuring eligibility determination from Medicaid, which were the focus of a Government Accountability Office (GAO) 2016 report. According to Carolyn Yocom, GAO’s Director of Health Care, data on error rates are over 3 years old without direct insight into eligibility determinations. According to testimony from Josh Archambault at The Foundation for Government Accountability, approximately 600,000 individuals are on waiting lists for Medicaid services. Archambault recommended Congress immediately freeze enrollment in expansion states and not allow new states to expand until states can refocus existing resources on the most vulnerable. Ann Maxwell, from the HHS Office of Inspector General, stated that the Medicaid program could also save money through fraud-prevention measures, including better screening providers, reducing improper payments to providers and beneficiaries, and improving claims data accuracy.

Committee members expressed concerns about the needs of the program to serve the most vulnerable populations. Testifiers stated that the lack of data is the chief problem for the Medicaid program and that future efforts will be made to improve data collection and reporting.

Diana DeGette (D-CO) protested the hearing was an excuse to cut Medicaid funding in anticipation of the Republicans’ preference for transforming Medicaid into a block-grant program. The hearing served as a precursor of what promises to be a partisan battle over the future direction of Medicaid.

 

A Little Spring Cleaning: Tidying up the ICER Value Assessment Framework

 
 

The Institute for Clinical and Economic Review (ICER) released proposed updates to its value assessment framework on Wednesday. In the past, industry stakeholders, including PhRMA, have criticized ICER’s methodology as having the potential to “confuse decision-makers” and could “create inherent bias against innovation.” The draft’s updates pull from more than 50 sets of comments from numerous interested parties comprising more than 300 pages of comments and suggestions during a national public comment period in late 2016. Additionally, the organization hosted a meeting with over 40 healthcare stakeholders to review the current framework.

The proposed updates include:

  • Instead of wholesale acquisition costs in all analyses, ICER will use estimates of prices net of rebates in the US market
  • ICER will include an “affordability and access alert” in the final reports if utilization will exceed the budget impact threshold
  • ICER will provide analyses in reports to allow stakeholders to determine potential budget impact instead of attempting to estimate “unmanaged uptake”
  • The vote on the provisional health system value will no longer have short-term affordability formally integrated

ICER President Steve Pearson will present the proposed updates in a webinar on February 13. ICER invites public comments for 60 days (deadline April 3), and the finalized framework should be released by April 15. Once finalized, the updated value assessment framework will provide direction for ICER’s reports from 2017 to 2019.

 

Minnesota Reduces Some Health Insurance Premiums by 25%

 
 

On January 26, Minnesota Governor Mark Dayton (D) signed a bill (SF 1) providing urgently needed health insurance premium relief for more than 125,000 Minnesotans facing skyrocketing premium increases in the individual market for calendar year 2017.

The SF 1 bill establishes a premium subsidy program payable to health carriers effectively reducing a beneficiary’s health insurance monthly gross premium by 25%, which would reduce rate increases from 55% to 16% on average. The state estimates it will spend approximately $310 million throughout 2017 to give the discounts to Minnesotans who purchase health insurance on the individual market and make too much money to qualify for federal subsidies. The premium subsidy program sunsets on June 30, 2018.

It is surprising more states have not offered similar discounts to their residents facing premium increases, but that may also reflect the precariousness of states’ finances. Given the impact the exchanges have had on those purchasing health insurance on the individual market, expect state governors to petition the Trump Administration for a role in any federal healthcare reforms.

 

Get the Latest From HTA Quarterly:
Multiple Myeloma: A Rapidly Advancing Therapeutic Landscape

 
 

With a 5-year prevalence of 230,000 patients worldwide, multiple myeloma (MM) represents 15% of all hematologic cancer malignancies. Deaths related to MM are estimated at 11,090 in the US in 2014 and 10,390 in Europe in 2012.

In the last decade, advancements in genomics have increased the understanding of disease biology, cellular mechanisms, and pathogenesis, which has led to tremendous improvements in the diagnosis and treatment of MM. We examine the approved therapies in both the US and Europe. Learn more

 
 

 

 
HEARD ON THE STREET
 

“ICER released its proposed new value framework approach with the usual display [of] self-congratulation and condescension.”

Source: “ICER's New Value Framework Still Discriminates Against the Sick,” DrugWonks, February 1

 
 
POLICY BY NUMBERS
 

$47 Billion Annually

 

Amount the AHA estimates that hospitals spent each year between 2010 and 2014 on information technology

Source: “The Cost of Caring,” AHA, February 2017

 
UPCOMING MEETINGS & CONFERENCES
 

MGMA 2017 Financial Management and Payer Contracting Conference

February 19–21 l Las Vegas
The MGMA Financial Management and Payer Contracting Conference brings together medical practice management professionals for the financial education that is essential to leading their organizations. Whether you’re new to practice management or you’ve been in the field for several years, building your financial acumen is essential to enhancing your practice’s operations and improving its performance. Meet Xcenda consultants at booth #403. Learn more

 

CBI 18th Annual Patient Assistance & Access Programs

March 16–17 l Baltimore, MD
Join AmerisourceBergen companies, Lash Group and Xcenda, at the premier conference for patient assistance and access programs. Tracy Foster, President of Lash Group, presents the keynote address titled, “Navigating Out of the Grey of Patient Support Services.” Learn more

 

AMCP 2017 Annual Meeting & Expo

March 27–30 l Denver, CO
Join leaders from AmerisourceBergen, US Bioservices, and Xcenda for the 29th Annual AMCP Meeting & Expo at booth #513. Learn more about the integrated solutions and insights that will drive success across healthcare delivery. Learn more

 

Asembia Specialty Pharmacy Summit 2017

April 30–May 3 l Las Vegas, NV
Join Xcenda at the largest US conference for specialty pharmacy. Matt Sarnes, PharmD, Senior Vice President of Commercial Consulting at Xcenda, will present, “The Future of FDAMA 114—How Will It Impact Access to Specialty Therapies?” 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

Loreen Brown, LMSW
Senior Vice President | Product, Strategy & Commercialization Excellence | Lash 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:

Amanda Forys | Milda Kaitz | Marla Kugel | Tony Pekarek | Scott Shields | Jennifer Snow | Diane Wilson

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Feb. 3, 2017

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