After a blow to the BCRA, Senate Republicans look at repealing vs replacing the ACA. Learn more.

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July 21, 2017

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FEATURED STORY
 

Hunting for a Rabbit to Pull Out of a Hat: GOP Struggles With Repeal and Replace and/or Repeal

 
 

Senate Republicans had a rough week, which started out with 4 Senators announcing opposition to even beginning debate on their latest version of the Better Care Reconciliation Act (BCRA).

After all-but-certain defeat, several Senators proposed voting on a repeal-only measure of the Affordable Care Act (ACA), the Obamacare Repeal Reconciliation Act of 2017, which is now tentatively scheduled for Tuesday. Despite it being an updated version of the bill nearly all GOP senators voted for in 2015, most experts predict there will not be enough votes for it to pass. Senator John McCain’s (R-AZ) diagnosis of brain cancer puts additional pressure on Republicans, as they can only afford 2 defections for anything to pass.

Additionally, efforts were not buoyed by the Congressional Budget Office’s estimate that the Obamacare Repeal Reconciliation Act of 2017 would leave 32 million more people uninsured and double premiums over a decade.

All of which leaves the question: What next? The health insurance marketplaces (exchanges) are working in some states better than in others, but moving forward, the uncertainty that the Republicans are maintaining is going to result in fewer insurance options for next year and higher premiums. Insurance companies are businesses; without knowing what guarantees they have for payment, they will protect themselves.

 

Cell and Gene Therapies: Commercializing Life-Saving Treatments

 
 

Cell and gene therapies face unique regulatory challenges that can cripple a program before its therapeutic benefits have even been realized. It takes a commitment to innovation, seamless coordination, and the support of an experienced partner to overcome every barrier on the journey from clinical to commercial success.

Download our latest white paper to gain strategy-shaping insights on this life-saving and industry-changing landscape. 

 

 
LEGISLATIVE UPDATES
 

Shining a Light on 340B

 
 

On Tuesday, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing examining the Health Resources and Services Administration’s (HRSA’s) oversight of the 340B drug pricing program. The Government Accountability Office (GAO) testified on HRSA’s efforts to improve 340B program oversight by discussing the agency’s progress since 2011, when the GAO found weaknesses in HRSA’s oversight of the program.

The GAO discussed how HRSA (1) now audits entities to ensure they comply with program rules and (2) clarified its guidance on equitable distribution of drugs to 340B entities. However, the GAO noted that HRSA still needed to clarify eligibility on the definition of an eligible patient and hospital eligibility criteria for program participation.

The hearing highlighted the divergent opinions of the 340B program held by Republicans and Democrats. Republicans highlighted the program’s lack of transparency and accountability regarding hospitals’ use of the revenue generated from the program, while Democrats stressed the importance of the program to hospitals and other safety-net providers, as well as the need to focus on drug pricing.

During the hearing, Democrats excoriated the discounted payment methodology the Centers for  Medicare & Medicaid Services (CMS) proposed in last week’s Outpatient Prospective Payment System (OPPS) proposed rule, commenting that they do not address drug costs. The stage is set for Democrats to use the proposed OPPS cuts as their version of the proposed Part B Drug Payment Model; ie, put immense pressure on the Administration and to rally public opinion behind their cause (in this case, high drug prices). Republicans will counter that the forced discounts distort the market and will actually increase drug prices.

Meanwhile, a white paper by the Berkeley Research Group challenged the oft-cited statistic that 340B sales represent approximately 2% of US drug sales. Instead, the authors claim their more accurate calculation finds that the 340B program accounted for 8% of total branded outpatient drug sales in 2016. Additionally, they note the program has expanded at an average of 21% annually since 2010. Which all but guarantees that 340B will be a topic of discussion for future Health Policy Weekly issues.

 

Connecticut Joins Other States to Stop PBM “Clawbacks”

 
 

On Monday, Connecticut Governor Dan Malloy (D) signed into law a bill to limit the power pharmacy benefit managers (PBMs) have over a pharmacist’s ability to help patients get the best price for their prescriptions.

The practice, known as a “clawback,” occurs when a pharmacy-PBM contract precludes the pharmacist from being able to inform a patient if the cash price for the drug is lower than his or her copay for the drug. This provision allows the PBM to pocket the difference. The new law would override these contracts, allow pharmacists to inform the patient if the cash price is lower than their copay for the drug, and also put a cap on the copay for a prescription drug at no more than the cash price of the generic drug.

The law goes into effect on January 1, 2018. There are several other states that have instituted similar laws, including Louisiana, Georgia, North Dakota, and Maine.

Critics of PBMs claim they artificially inflate drug prices, in part, by putting clawback clauses in their contracts, which they claim is a form of price gouging. Clawbacks are just one of several practices by PBMs that have come under criticism recently, as discussions of high drug prices and costs delve into each waystation of the drug journey from manufacturer to patient.

 

Get the Latest From HTA Quarterly

 
 

Navigating Coverage and Reimbursement for Immunotherapy in Oncology: Perspectives on Challenges and Opportunities in the HTA Evaluation Process

Despite being hailed as the future of oncology, given the high cost of therapy and payer skepticism toward new oncologic agents, obtaining coverage and reimbursement for immunotherapy (IO) can be difficult. We take a look at the challenges of obtaining approval from global HTA authorities and local market payers, and we present some potential solutions to address evaluator concerns.

 

  

 
REGULATORY UPDATES
 

Between a Rock and a Hard Place, Granite State Pursues Waiver

 
 

New Hampshire’s Department of Insurance announced Wednesday it would be pursuing a State Innovation Waiver under section 1322 of the ACA to stabilize the state’s individual health insurance market.

The state proposes to stabilize the individual market and reduce “dramatic” health insurance rate increases by creating a state-operated reinsurance program to raise $45 million. The program would be funded by a fee applied to all health insurance companies operating in the state, along with federal funds. To receive the funding, New Hampshire hopes to receive financial support from the federal government by using the section 1332 waiver to receive pass-through funding based on the reinsurance savings.

The program would begin in 2018. State officials estimate the program would reduce premiums by roughly 7% for about 98,000 people in its individual market.

Given the shaky ground of the individual insurance market due to skyrocketing premiums, insurers exiting the market, and the Administration’s lukewarm (at best) language about supporting the exchange markets, other states are likely to follow New Hampshire’s path.

 
 

Not Minding the Gap: OOP Costs for Part D

 
 

The Journal of Clinical Oncology recently published a study that examined the trends in targeted oral anticancer medication (TOAM) prices and Medicare prescription drug benefit (Part D) patient out-of-pocket (OOP) costs and growing concerns that Medicare Part D enrollees may experience substantial financial burden. TOAM therapy, one of the most popularly developed cancer treatments in the past 20 years, improves patient survival rates for various cancer disease states; however, its high costs and price increases translate to potentially unaffordable increases in patients’ prescription drug costs.

Researchers used the SEER-Medicare database and discovered that from 2007 and 2012, TOAM prices increased by nearly 12% per year. As a result, TOAM drug costs reached $7,719 per patient per month in 2012.

At the same time, the authors studied the effect of the Medicare Part D Coverage Gap Discount Program (CGDP) on OOP costs for patients who received TOAM therapy. The authors found that the CGDP resulted in a 20% OOP savings for Medicare Part D patients. However, for patients undergoing TOAM therapy, increasing prices would cause any savings from the CGDP to evaporate.

The study also shows the immediate financial benefits of the CGDP to beneficiaries—but that increasing drug costs could shrink any resulting OOP savings. Additionally, the authors observe that, had the CGDP not gone into effect, increasing OOP costs may have caused some beneficiaries to stop treatment, potentially increasing morbidity and mortality.

 

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 Department of Health and Human Services (HHS) OIG announces it will update its Work Plan monthly to “enhance transparency around OIG’s continuous work planning efforts”
  • CMS posted an update to its Health Insurance Exchanges Issuer County Map
  • The US Preventive Services Task Force seeks comments on a draft recommendation statement and draft evidence review on screening for ovarian cancer
  • The Institute for Clinical and Economic Review (ICER) releases its final evidence report on anabolic therapies for osteoporosis in postmenopausal women
  • The National Academy for State Health Policy updates it chart comparing the ACA, BCRA, and American Health Care Act
 
HEARD ON THE STREET
 

“I think we're probably in that position where we'll just let Obamacare fail. We're not going to own it. I'm not going to own it. I can tell you that the Republicans are not going to own it. We'll let Obamacare fail and then the Democrats are going to come to us and are going to say how do we fix it, how do we fix it, or how do we come up with a new plan?”

 

– President Donald Trump, while discussing the Senate’s failure to pass a healthcare bill to reporters

Source: “Trump: ‘Let Obamacare Fail,’ I'm Not Going to Own It,” RealClearPolitics, July 18

 
POLICY BY NUMBERS
 

74%

 

Percentage of medicines in clinical development with the potential to be first-in-class treatments

Source: “New Report Shows 74 Percent of Medicines in Development Have Potential to Be First-in-Class Treatments,” PhRMA, July 18

 
UPCOMING MEETINGS & CONFERENCES
 

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.

 
 
 
 
 
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

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:

Zachary Bridges | Scott Shields | Stacie Smith |Stephen Wilson 

PRODUCTION:

Kylie Matthews | Ellen Olson

 

July 21, 2017

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