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We examine Congress’ continuing-resolution legislation, which includes major healthcare provisions and offsets.

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Feb. 9, 2018

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FEATURED STORY
 

Bats in the Belfry of the Capitol May Explain Latest Budget Extension

 
 

Early Friday morning, Congress passed and the President signed into law continuing-resolution (CR) legislation to fund the government until March 23 but lays out the foundation for legislation to fund the government for 2 years and raise spending by $300 billion over that time.

The deal will boost military spending by $160 billion and non-defense spending by $128 billion and will add more than $80 billion in disaster relief. The debt ceiling will be raised until March 2019.

To help pay for the programs, the budget deal includes a number of offsets, several that are healthcare related. (A section-by-section summary of the healthcare provisions was provided.) The Affordable Care Act’s (ACA’s) Prevention and Public Health Fund, a frequent target of Republicans, would be cut again, and higher-income beneficiaries would see their Part B and Part D premiums increase. Additionally, the update to the Physician Fee Schedule for 2019 will be reduced from 0.50% to 0.25%.

Pharmaceutical manufacturers would have their share of costs for patients in the Medicare Part D coverage gap, or “donut hole,” increased from 50% to 70% in 2019—effectively closing the donut hole a year early. Health plans would then be responsible for 5% and patients 25%. Manufacturers’ contributions to the coverage gap will continue to count toward beneficiary out-of-pocket spending calculations. The decision to increase manufacturer contributions surprised the industry, which did not anticipate Republicans would introduce a measure that shifts nearly all of the insurance industry’s coverage gap financial responsibility to drug makers.

The bill also includes biosimilar manufacturers in the Part D Coverage Gap Discount Program; the ACA had excluded them from having to contribute to donut hole costs. Biosimilar advocates had argued that requiring patients to pay more in the coverage gap when on biosimilars would dampen their uptake.

The agreement would also fund a host of more limited health programs—some of which are known as “extenders” because they often ride along with other larger health or spending bills:

  • Repeal of Medicare payment cap for therapy services; limitation to ensure appropriate therapy
  • Medicare ambulance services
  • Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals
  • Extension of the Medicare-dependent hospital (MDH) program
  • Extension of funding for quality measure endorsement, input, and selection; reporting requirements
  • Extension of funding outreach and assistance for low-income programs; state health insurance assistance program reporting requirements
  • Extension of home health rural add-on

The bill would repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not been triggered by Medicare spending increases.

The deal would provide an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress last month.

Disproportionate share hospital (DSH) payments were scheduled to be reduced starting in fiscal year (FY) 2018. Now, the reductions will not begin until 2020.

This CR keeps the federal government funded until March 23, so Congress has 6 weeks to agree on an omnibus bill that will fund the government for the remainder of this FY, which ends September 30.

In the meantime, the Trump Administration has been busy. On Monday, President Trump will release his budget document for FY 2019. Today, the Administration released its plan to lower prescription drug costs for Medicare beneficiaries, Reforming Biopharmaceutical Pricing at Home and Abroad. We will tackle that in next week’s issue.

 

Xcenda Issue Brief: 2018 Healthcare Outlook—Leaning Into the Chaos

 
 

What’s next in the healthcare environment for 2018?

While 2017 started with the sense of radical possibility, it quickly dissolved into steady-state chaos. This year, we’re keen on watching several key trends as we learn to embrace and anticipate what’s next in the healthcare environment and make the most of it.

Download our latest issue brief to learn more about what healthcare trends we’re keeping an eye on. Learn more

 

 

 
LEGISLATIVE UPDATES
 

Sometimes the Devil Is in the Details: Understanding Right to Try

 
 

The push to pass the Right to Try Act of 2017 (S. 204) increased momentum after President Trump expressed support for the measure during his first State of the Union Address. The act would allow patients with life-threatening illnesses who do not have any other treatment options and cannot participate in a clinical trial to bypass the full Food and Drug Administration (FDA) approval process and request the use of investigational drugs that have passed phase 1 clinical trials.

The legislation would not require pharmaceutical companies to give the drug to patients. There is a similar FDA “compassionate use” program, but it requires a regulatory submission (ie, a new or protocol amendment to an investigational new drug application) and approval from the FDA. The “right-to-try” legislation would lessen the FDA’s oversight.

Thirty-eight states have already passed a version of the right-to-try legislation, and the federal version of the right-to-try legislation passed in the Senate by unanimous consent last August. Earlier this week, Representatives Andy Biggs (R-AZ) and Brian Fitzpatrick (R-PA) wrote a letter to House of Representatives leaders Paul Ryan (R-WI) and Kevin McCarthy (R-CA) urging them to bring the Right to Try Act of 2017 to a vote. The letter was signed by about 40 lawmakers.

Accelerating right to try, while sounding innocuous, may not be. Medical experts wrote a letter to the House Committee on Energy and Commerce describing the potential dangers of passing the right-to-try law. Signed by over 300 supporters, including ethicists and physicians, the letter warns that passing the measure could potentially give patients and families false hope without the proper FDA oversight and could “do more harm than good.” Historically one of the arguments made by pharmaceutical companies is that right to try can siphon already limited supplies from clinical trials.

There currently are pathways for patients to access these drugs, but rhetoric may win over FDA oversight.

 

Legislative Bytes

 
 

 
CODING CONCEPTS CORNER
 

HCPCS Coding Just Got Reassuringly Consistent for Biosimilars

 
 

Effective April 1, 2018, biosimilars previously grouped in the same Healthcare Procedure Coding System (HCPCS) code used by all biosimilars of the same reference product will be reported with their own unique billing code. The Centers for Medicare & Medicaid Services (CMS) has released the Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes—April 2018 Update which provides the new HCPCS coding guidance for biosimilars and also makes inactive the modifiers previously used to identify the individual biosimilar manufacturers.



Finally, effective January 1, 2018, newly approved biosimilar biological products with a common reference product have their own unique billing code.

Although this guidance is intended specifically for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries, CMS has also released the HCPCS Quarterly Update for April 2018 with the same guidance that will apply to outpatient hospitals and all Health Insurance Portability and Accountability Act (HIPAA)-covered entities.

For an analysis of how coding may affect reimbursement for interested products, reach out to your Xcenda contacts or to certified professional coder Milda Kaitz at milda.kaitz@xcenda.com.

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REGULATORY UPDATES
 

Hoosiers Working It

 
 

Last Friday, CMS approved Indiana’s Section 1115 waiver, the state’s alternative to traditional Medicaid expansion, known as the Healthy Indiana Plan (HIP), which is now enhanced with a work or other type of community-engagement requirement for some Medicaid beneficiaries. HIP will continue in its new configuration through December 31, 2020. The approval authorizes Indiana HIP to use matching federal funds to make plan changes that may help to move beneficiaries from welfare to work while improving beneficiary health outcomes.

Beginning 2019, Indiana will phase in a 20-hour-per-week community engagement requirement as a condition of continued Medicaid coverage and eligibility for able-bodied, working-age individuals. Certain groups are exempt from the requirement, including the disabled, elderly beneficiaries, children, and pregnant women. Non-exempt Medicaid beneficiaries must comply with community engagement activities for 8 months annually, which may include employment, education, job skills training, caregiving, or volunteer work.

Indiana is the second state, after Kentucky, to receive federal approval to continue its successful alternative to traditional Medicaid expansion.

 

Latest Recommendations for Biosimilars

 
 

A recent study published in Annals of the Rheumatic Diseases provided consensus-based overarching principles and recommendations for the use of biosimilars to treat rheumatological diseases. With delays to market entrants and uncertainty about interchangeability, stakeholders have struggled with how to manage these new market entrants.

The recommendation development process used for the study included a systematic literature review and Delphi panel process with expert opinion. Notable recommendations include:

  • Biosimilar availability must significantly lower the cost and increase access to therapy
  • Confirming efficacy and safety of a biosimilar in a single indication is sufficient for extrapolation to other diseases for which the bio-originator has been approved
  • No switch to or from a biosimilar should be initiated without the prior awareness of the patient and provider

While proponents have cited the potential benefits associated with biosimilars including reduced cost and expanded access, barriers to increased utilization persist such as patient and provider hesitation.

The group of experts and patients achieved a high level of agreement about the evaluation of biosimilars and their use to treat rheumatological diseases. The recommendations should help to raise awareness about biosimilars and the key issues that healthcare providers must consider when using biosimilars to treat their patients.

 

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:

 

What Information Do Payers and Providers Want From Manufacturers to Make Coverage and Treatment Decisions?

 
 

Optimizing Evidence Exchange for Improved Outcomes

Payers and providers rely on various types of information from manufacturers to make coverage and treatment decisions. But what do they find most valuable? View our new infographic of our joint study with the National Pharmaceutical Council that highlights the data and evidence that matter most. View infographic

 

 

 
HEARD ON THE STREET
 

“It’s good news that at least some Republicans are facing reality and accepting that families don’t want any part of Trumpcare—but that won’t help people whose premiums are going up or who will lose coverage as a result of the last year of Republican healthcare sabotage. If Republicans are really serious about turning the page, they’ll start working with Democrats to undo the damage they’ve done and focus on what families do want—lower healthcare costs and better coverage.

 

– Sen. Patty Murray (D-WA)

Source: “Trump Silent on ACA in Remarks at GOP Retreat as Lawmakers Signal End of Repeal Effort,” Inside Health Policy, February 1

 
POLICY BY NUMBERS
 

12.2 Million vs 11.8 Million

 

The National Academy for State Health Policy (NASHP) released new plan selection data for the state insurance exchanges this week. The national total of consumers who selected a plan for 2018 comes to 11.8 million, about 3.7% less than the 12.2 million consumers who selected a plan in 2017. States that operate a state-based marketplace or state-based marketplaces that use the federal platform show an aggregate increase of 0.2% over last year; states that use the federally facilitated marketplace show an aggregate decrease of 5.3%.

Source: “Individual Marketplace Enrollment Remains Stable in the Face of National Uncertainty,” NASHP, February 7

 
UPCOMING MEETINGS & CONFERENCES
 

CBI 10th HUB and SPP Model Optimization Conference

February 27–28 l Philadelphia, PA
Join AmerisourceBergen sister company Lash Group at CBI’s 10th Annual HUB and SPP Model Optimization Conference in Philadelphia. Mark Sypkerman, Senior Vice President of Premier Source at Lash Group, will present a session titled, “Implement New Technology Innovations to Improve Speed, Scale, and Patient and Provider Experience for Electronic Benefit Verification and Prior Authorization.” Learn more

 

CBI 19th Patient Assistance and Access Programs Conference

March 6–7 l Baltimore, MD
Join leaders from Xcenda and Lash Group at the 19th PAP Conference in Baltimore. Ana Stojanovska, Vice President, Reimbursement & Policy Insights, and Teri’ Burnell, PharmD, Senior Vice President, Field Support at Xcenda, will host the Opening Luminary Address on “The Changing Landscape of Healthcare Coverage and Access.” Tommy Bramley, PhD, President of Lash Group, will present the Keynote Address on “Pioneering to New Grounds in Patient Access—Rewriting the Playbook for Patient Programs.” Learn more

 

AMCP Managed Care & Specialty Pharmacy Annual Meeting

April 23–26 l Boston, MA
Join AmerisourceBergen companies, US Bioservices and Xcenda, at AMCP’s Annual Meeting at the Boston Convention and Exhibition Center April 23–26. Meet with our specialty pharmacy and commercialization experts at the largest gathering of managed care professionals who work, lead, and innovate in the ever-changing world of pharmaceutical management. Visit AmerisourceBergen at booths 316 and 321. Learn more

 

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Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 

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FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Senior Director,
Health Policy
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Peyton Howell, MHA
Executive Vice President & President, Health Systems & Specialty Care Solutions | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | 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 | Reimbursement & Policy Insights | Xcenda

CONTRIBUTING AUTHORS:

Andrew Gaiser | Milda KaitzJennifer Le | Scott Shields

PRODUCTION:

Laurie Kozbelt | Ellen Olson | Tia O’Brien

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Feb. 9, 2018

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