Senate tax bill in the hunt for votes; other initiatives on back burner. Read more.

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Dec. 1, 2017

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FEATURED STORY
 

Congress Might Outwork Santa’s Elves in December

 
 

Returning from the Thanksgiving break, the Senate Budget Committee voted Wednesday to approve, on a party line (12-11), the Republican Senate version of the Tax Cuts and Jobs Act of 2017. Just before press time, Senate Leader Mitch McConnell (R-KY) announced the Senate had the votes to pass its tax overhaul bill; a vote is expected later today. The bill includes a repeal of the individual insurance mandate.

If the Senate passes the bill, the next step will be for a conference committee to iron out differences with the House version. President Trump has said he would like a tax bill on his desk by the end of the year.

With attention focused on the tax bill, a number of other legislative initiatives have been placed on the back burner, including: reauthorizing the Children’s Health Insurance Program (CHIP); fate of the disproportionate-share hospital payments mandated by the Affordable Care Act (ACA), which has been delayed by Congress until this year; and a Medicare extenders package.

In addition, funding for the government is set to expire on December 8. The assumption is that a short-term continuing resolution will be passed to avoid a government shutdown, allowing additional time to take action on these issues.

 

Amanda Forys Moderates a Center for Biosimilars Panel on Interchangeability and Rheumatology Prescribing Practices

 
 

What variables would a clinician consider when prescribing interchangeable biosimilar products once they become available? Xcenda’s Amanda Forys discusses the clinical perspective with Dr. Angus Worthing of Arthritis & Rheumatism Associates P.C.

Watch video

 

 

 
LEGISLATIVE UPDATES
 

Sorry Not Sorry, Pharma: Confirmation Hearing for Azar

 
 

On Wednesday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing for Alex Azar, President Trump’s nominee to head the Department of Health and Human Services (HHS). If confirmed, Azar, the former HHS general counsel and deputy secretary, would replace former Secretary Rep. Tom Price (R-GA).

At this point, his nomination appears almost certain. No Democrats are likely to support him, but the Republicans can afford 2 defections, and Sen. Rand Paul (R-KY) was the only one to mention opposition (over Azar’s lack of support for drug importation).

As expected, the hearing was dominated by drug prices, given Azar’s years as an Eli Lilly executive and the ongoing national debate over the issue. When asked about high drug prices, Azar responded that he favors encouraging competition between brand and generic drugs and supports wider use of drug rebates.

The hearing was the first of 2 the Senate will conduct before Azar’s confirmation vote. Wednesday’s session was a “courtesy” hearing because the HELP Committee does not vote on the confirmation. That power rests with the Senate Finance Committee, which has not yet scheduled its hearing.

Expect Azar to have similar treatment before the Senate Finance Committee, with Democrats continuing to press him on efforts to restrain drug prices.

 

Legislative Byte

 
 

The lawsuit filed by the American Hospital Association and others to prevent the Centers for Medicare & Medicaid Services (CMS) from implementing the rule reducing Medicare payments to hospitals participating in the 340B Drug Pricing Program is scheduled to be heard on December 21 in US District Court.

 
REGULATORY UPDATES
 

Holy Grail for Cancer Treatment? Approval and Draft Coverage for NGS IVD Test

 
 

Late Thursday, CMS and the Food and Drug Administration (FDA) announced the approval of FoundationOne CDx (F1CDx) and a proposed national coverage determination (NCD) for the diagnostic test and other similar next-generation sequencing (NGS)-based in vivo diagnostic (IVD) tests. F1CDx is a diagnostic test that can detect genetic mutation in 324 genes and 2 genomic signatures in any solid tumor type.

The approval and announcements are significant for many reasons:

  • It is the first approval of an NGS test, typically a laboratory-developed test, through the supplemental premarket approval pathway that is easier and faster than traditional approval pathways.
  • Clinically, it is a movement away from the standard companion diagnostic paradigm of one-test-for-one-mutation; this advance now allows providers to better manage and treat a multitude of tumor types with a number of targeted treatments and to avoid duplicate biopsies.
  • The approval and proposed NCD leveraged the voluntary FDA-CMS Parallel Review Program for certain devices with new technology to not only obtain approval but also clarify coverage and reimbursement at the national level for Medicare beneficiaries.

The impact of access to F1CDx through the proposed NCD for Medicare beneficiaries with advanced cancer (ie, recurrent, metastatic, or advanced stage IV cancer), who have not been previously tested using the same NGS technology and continue to seek further cancer therapy will be the subject of comments submitted over the subsequent 90-day comment period for multiple stakeholders. Provider groups and patient advocacy groups should evaluate if the NCD as written restricts or expands access to NGS IVD tests compared to the current coverage paradigm. Manufacturers of companion diagnostics and precision oncology therapies should evaluate the impact of the NCD on existing companion diagnostics in use and the potential impact of access to their treatments for clinically appropriate patients using the newly approved diagnostic.

 

OIG: CMS Should Exclude Non-Covered Versions of Self-Administered Drugs From Part B ASP Calculations

 
 

This week, the HHS Office of Inspector General (OIG) released an issue brief, “Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries,” suggesting that the Medicare Part B program paid an extra $366 million between 2014 and 2016 for ORENCIA® (abatacept) and CIMZIA® (certolizumab) by including prices for non-covered, self-administered versions of these drugs in the calculation of the average sales price (ASP).

The ASP calculation includes volume-weighted sales of a drug’s National Drug Codes (NDCs); CMS included non-covered NDCs because the self-administered versions were approved by the FDA under the same Biologics License Application (BLA) as the physician-administered version, and their interpretation of the law includes them.

The OIG estimates that, between 2014 and 2016, Medicare payments were 30%–35% higher for ORENCIA, and 1%–25% higher for CIMZIA, than they should have been if the non-covered NDCs had been excluded from the ASP calculation. This exclusion would have saved Medicare $302 million and $64 million, respectively.

Additionally, the analysis highlights the patient-cost implications in 2016: over 23,000 beneficiaries received at least 1 Part B administration of ORENCIA and owed an average of $665 in coinsurance per treatment (generally once a month). If the ASP had been calculated without the non-covered NDCs, each copayment would have been reduced by $171 ($494). Approximately 12,000 patients received CIMZIA at least once (usually given twice a month), and copayments would have been reduced from $525 to $457 ($68 less).

The OIG believes this policy is inconsistent with the agency’s overarching goals of establishing appropriate payment rates for drugs, and recommends that a legislative change be implemented to allow CMS flexibility to determine when non-covered drugs should be included in ASP calculation amounts. CMS, however, disagrees, stating that this modification could limit prescribing flexibility of providers and negatively affect patient access to these products.

Additionally, this could ultimately influence the cost of these drugs. The OIG’s response suggests that, if CMS had this flexibility, they could add a modifier code to claims where a physician is using the self-administered product in the office setting and, in turn, allow for higher payment in those instances rather than overall.

 

Slow and Steady: VBID Model Expansion

 
 

Beginning in 2019, an additional 15 states will participate in the Medicare Advantage Value-Based Insurance Design (VBID) model, according to the CMS Center for Medicare and Medicaid Innovation (CMMI). Last week, the Innovation Center announced it would be opening the door for participation to the additional states as well as implementing a slew of other changes to the model for calendar year (CY) 2019.

The VBID model, which began in 2017, was developed to test if enhanced benefit packages for Medicare Advantage (MA) enrollees can cut costs by improving enrollee health. Traditionally, MA plans are required to offer uniform benefits to enrollees of the same plan; however, under the VBID model, plans may offer additional benefits to subsets of their MA members with certain chronic conditions selected by CMS.

In addition to bringing the grand total to 25 test states for CY 2019, CMMI will also allow Chronic Condition Special Needs Plans (C-SNPs) to participate and provide increased flexibility for MA organizations to identify and include beneficiaries in model interventions.

Eligible test states were selected for inclusion in the model if they were generally representative of the national MA market. The model will run for 5 years and conclude on December 31, 2021.

The VBID model will be a crucial test to determine if encouraging enrollees to use high-value clinical services will reduce costs. Though commercial payers have been testing VBID, Medicare’s breadth allows it to test value-based healthcare on a much larger population.

 

Medicare Parts A and B Premiums and Deductibles Largely the Same in 2018

 
 

Recently, CMS announced the 2018 premium and deductible amounts for the Medicare Part A and Part B programs.

Monthly premiums for Medicare Part A will increase by $9 in 2018 to $422. However, about 99% of Medicare beneficiaries do not have a Part A premium because they have at least 40 quarters of Medicare-covered employment. The Part A deductible that beneficiaries pay when admitted to the hospital will be $1,340 in 2018, an increase of $24. The deductible covers beneficiaries’ share of costs for the first 60 days they are in the hospital.

The standard monthly premium for Medicare Part B enrollees will be $134 for 2018, the same amount as in 2017. Some beneficiaries who were held harmless against Part B premium increases in prior years will have a Part B premium increase in 2018, due to the 2% increase in Social Security benefits. Additionally, the annual deductible for all Medicare Part B beneficiaries will be $183 in 2018, the same as in 2017.

See below for a comparison of Medicare Parts A and B premium amounts in 2017 and 2018.

Although Medicare Part B premium and deductible amounts will not increase in 2018, the increase in Social Security benefits may mean some beneficiaries will pay more for their premiums. This additional cost may create downstream effects in regard to how beneficiaries utilize services in 2018. Will it cause them to consume fewer healthcare items and services? We shall see.

 

Late to the Game. Not Tardy for the Party: PCORI Keeps Rolling

 
 

Just before Thanksgiving, the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved $57 million to fund 14 new comparative clinical effectiveness research (CER) studies. The funds “will support studies of a range of conditions and problems that impose high burdens on patients, caregivers, and the healthcare system.”

That total includes $32 million to fund 3 large-scale pragmatic clinical studies, including evaluating approaches to keep individuals with dementia in their homes and reducing caregiver stress and depression, comparing therapies for prostate cancer, and comparing strategies for increasing the use of the human papillomavirus (HPV) vaccine among Latino populations.

The board also approved $25 million for 11 additional studies, including $4.9 million for a University of Washington project that addresses how best to deliver collaborative, patient-centered care for trauma survivors. This project is near and dear to our hearts; our very own Health Policy Weekly managing editor will be the patient representative on the data safety monitoring board.

PCORI was criticized for its late start to underwrite studies; however, with these latest awards, the institute has invested $2 billion to fund more than 400 patient-centered CER studies.

 

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 National Academies of Sciences, Engineering, and Medicines released their long-anticipated report, Making Medicines Affordable: A National Imperative, which recommends a number of actions aimed at improving the affordability of prescription drugs without discouraging continued innovation in drug development.
  • CMS posted the Measures Under Consideration (MUC) List for 2018 pre-rulemaking and has sent it to the National Quality Forum in preparation for multi-stakeholder input. CMS winnowed the original list of 184 measures to 32.
  • The National Academy for State Health Policy posted infographics to educate state leaders who are considering importing prescription drugs from Canada.
  • The National Bureau of Economic Research published a working paper on the moral hazards of health insurance.
  • The Institute for Clinical and Economic Review published an evidence report on the effectiveness and value of vesicular monoamine transporter 2 inhibitors for tardive dyskinesia, finding that the estimated lifetime cost-effectiveness of these agents far exceeds commonly cited cost-effectiveness thresholds.
  • The Journal of Oncology Practice published a study finding the American Society of Clinical Oncology (ASCO) Value Framework has essential limitations for its application in clinical practice for the treatment of chronic lymphocytic leukemia (CLL).
 
OPEN ENROLLMENT BY THE NUMBERS

 
Comparison of 2017 and 2018 Weekly Open Enrollment Snapshots for Healthcare.gov

 

 

  Cumulative Enrollment After 4 Weeks

  2017 Enrollment 2018 Enrollment Percent Difference,
2017 to 2018
Cumulative (to date)
 2,137,717 2,781,260  +30.1%
 
 
 
HEARD ON THE STREET
 

“Two examples of ‘findings’ recently used by Acting Secretary [of HHS Eric] Hargan that were taken directly from the lead ‘Key Highlights/Summaries’ from the ASPE [Office of the Assistant Secretary for Planning and Evaluation] reports highlight why the framing and presentation of the data [regarding individual marketplace costs, enrollment, and trends] are misleading. While the points are technically accurate, they are misleading because they narrowly interpret the data and fail to reflect the realities of the vast majority of consumers about whom, in theory, the data is supposed to represent. The result are ‘findings’ that are misleading and create unfair representations of the consumer experience in the individual market.”

 

–  Peter Lee, Covered California Executive Director, criticizing recent reports released by ASPE and accusing the department’s research arm of inaccurately portraying the state of the ACA exchanges

Source: “Concerns with Recent ASPE Reports Regarding Individual Marketplace Costs, Enrollment, and Trends,” November 21

 
POLICY BY NUMBERS
 

6.7 Million

 

In 2015, about 6.7 million tax filers, or 4.5%, paid the individual mandate penalty for not purchasing qualifying health insurance in 2015, down from 8.1 million in 2014. Reasons cited for preferring to pay the penalty included high levels of political opposition to the ACA, inability to afford health insurance, do not want or need health insurance, and citizenship or residency issues.

Source: “Millions Pay the Obamacare Penalty Instead of Buying Insurance. Who Are They?The New York Times, November 28

 
UPCOMING MEETINGS & CONFERENCES
 

ASHP Midyear 2017

December 3–7 l Orlando, FL
Join AmerisourceBergen at the largest gathering of pharmacy professionals in the world. Attended by more than 25,000 pharmacy professionals from all over the globe, the Midyear Clinical Meeting provides valuable opportunities for professional development, networking, enhancing practice skills, and staying current with the latest products and innovations. AmerisourceBergen is proud to support the 2017 ASHP Midyear Clinical Meeting. Visit AmerisourceBergen at booth #1941 and PhaMEDium Services at booth #1121. Learn more

 

AMCP Partnership Forum: Managing Care in the Wave of Precision Medicine

December 7–8 l Arlington, VA
Xcenda’s Kristin Migliaccio-Walle, Director of GHEOR, will be participating at the upcoming AMCP Partnership Forum to discuss key considerations for the managed care market on precision medicine. This panel will discuss the evidentiary needs for precision medicine from the perspective of a managed care organization. The panel will also discuss how various stakeholder perspectives should be taken into account when defining the evidentiary standards for formulary placement, coverage reimbursement, analysis of real-world evidence for precision medicines, and clinical decision making.

 
 
 

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
Senior 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 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:

Amanda Forys | Andrew Gaiser | Maureen Holmes | Scott Shields | Diane Smith

PRODUCTION:

Laurie Kozbelt | Tia O’Brien | Ellen Olson

 

Dec. 1, 2017

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