Democratic-led states asked the US Supreme Court to take up the case challenging the ACA’s legality.

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Jan. 17, 2020

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FEATURED STORY
 

Can’t Triple Stamp a Double Stamp but Can Keep Challenging ACA

 
 

Earlier this month, 20 Democratic-led states filed a motion asking the Supreme Court to weigh in on the ongoing case against the Affordable Care Act (ACA) and expedite the ruling that could decide the fate of the entire legislation.

In December 2018, a Texas District Court judge decided that the ACA’s individual mandate was unconstitutional and that the individual mandate is inseverable from the rest of the ACA; therefore, the judge ruled the rest of the legislation cannot stand. Last month, the Court of Appeals for the Fifth Circuit held that the individual mandate is unconstitutional but remanded the issue of its severability to the Texas District Court.

Rather than have the Texas District Court decide the severability of the individual mandate, the coalition of Democratic-led states and members of the House of Representatives submitted a legal brief requesting the Supreme Court’s intervention in this case as soon as possible, stating the ongoing challenge against the ACA creates “uncertainty about the future of the entire Affordable Care Act, and that uncertainty threatens adverse consequences for our Nation’s healthcare system, including for patients, doctors, insurers, and state and local governments.” Although the Supreme Court does not usually respond to cases before lower-court rulings are complete, the motion requests a decision in this term, which ends in June. The Supreme Court, in turn, asked the Republican-led states to respond by last Friday to the Democratic coalition’s request for the high court to intervene quickly.

The Department of Justice and a separate group of Republican state attorneys general both asked the Court not to take on the case this year. The Trump Administration’s response indicated there is no reason to fast-track its consideration of the case. The Administration’s rationale was that the justices taking on such an issue before the lower courts issue a judgment would be practically difficult. Additionally, it said, the Supreme Court usually does not analyze large factual records before a lower court has done so.

With 5 votes required on the Supreme Court to hear a case on an expedited basis, the 4 liberal justices will have to gain the support of at least 1 conservative justice. The stakes for this ruling and the consequences of the timing of the decision are high, as the Supreme Court could decide the fate of the ACA during a vital election year where healthcare continues to be a campaign focus for all presidential candidates.

 
 

Embracing Format v4.1 for Early, Effective Exchange of Information With Payers

 
 

AMCP Webinar | Tuesday, January 28, 2020 | 2:00 PM ET

With the recent release of AMCP Format v4.1, what does it mean for the preapproval information exchange between payers and manufacturers?

Join Xcenda’s Evelyn Sarnes, PharmD, MPH, Vice President of Medical Communications, and other key stakeholders for a live webinar on January 28. Moderated by Elizabeth Sampsel, PharmD, MBA, BCPS, Senior Director of Payer, Provider, and Partner Alliances at Xcenda, the expert panel will give perspective and guidance on the early, effective exchange of information in light of these latest changes as well as highlight tools that can help in this endeavor.

Register today >

HPW Rebuild

 
THE VALUE CORNER
 

Boy, This Party Really Died: ICER “Eh” on New Migraine Treatments

 
 

Last Friday, the Institute for Clinical and Economic Review (ICER) announced the release of its revised Evidence Report assessing 3 therapies for the acute treatment of migraine: lasmiditan (REYVOW), ubrogepant (UBRELVY), and rimegepant. Among patients with migraine who are not able to take triptans, ICER concluded there is moderate certainty that lasmiditan, ubrogepant, and rimegepant offer a small or substantial net health benefit, with high certainty of at least a small net health benefit, compared to placebo. For patients who are able to take triptans, the evidence provides moderate certainty that the 3 treatments offer only a comparable or inferior net health benefit relative to triptans. The evidence also suggests that these treatments provide comparable net health benefits when compared to each other. The value-based price benchmark for lasmiditan, ubrogepant, and rimegepant ranged between $2,200 and $3,200 per year, which would require net prices to be considerably less than sumatriptan (IMITREX). This assessment will be reviewed at a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) next Thursday, January 23.

Last week, Applied Health Economics and Health Policy published an article titled, “Do Research Groups Align on an Intervention’s Value? Concordance of Cost-Effectiveness Findings Between the Institute for Clinical and Economic Review and Other Health System Stakeholders,” which compares the cost-effectiveness (CE) findings from ICER reports to the results from other research groups (ie, “non-ICER” researchers). Of the 14 interventions evaluated, a more favorable valuation would have been recommended for 10 therapies if the CE ratios from other research groups had been used for decision making instead of ICER’s findings, representing a 71.4% (10/14) discordance rate. These discrepancies were found in each of the 6 evaluated disease states, indicating high discordance between ICER and non-ICER researchers. As such, the authors recommend considering CE findings from multiple sources when assessing the value of new interventions.

If you need assistance with all things ICER or value-related, please reach out to Michelle.Friedman@xcenda.com.

HPW Rebuild

 
REGULATORY UPDATES
 

So You’re Telling Me There’s a Chance: AHA Sues HHS, Again

 
 

On Monday, the American Hospital Association (AHA) filed a lawsuit against the Department of Health and Human Services (HHS) over the policy that reduces payments to off-campus hospital outpatient departments under the 2020 Outpatient Prospective Payment System final rule. The Centers for Medicare & Medicaid Services (CMS) refers to the policy to pay the same rates to hospital outpatient clinics as independent physician offices for the same services as “site-neutral” payments—the purpose of which is to curb healthcare costs.

If this story looks familiar, that’s because you read about it last year in Health Policy Weekly, when we described how the AHA, the American Medical Colleges, and 3 hospitals filed the same suit, arguing that HHS exceeded its statutory authority to implement site-neutral payments and ignored congressional budget-neutral requirements. In September 2019, the litigants won the lawsuit; however, they were unable to avoid the policy from being included in the 2020 final rule. CMS agreed to reprocess claims paid to hospitals at the reduced rate; however, the decision is being appealed, and payment amounts are not clear.

Hospitals state the site-neutral payments outlined in the 2020 final rule could force hospitals to reduce services and subsequently impact patient access to vulnerable patient populations. Alternatively, CMS believes the $800 million in savings from the site-neutral policy would position patients “better able to receive care that is provided safely and is clinically appropriate.”

Manufacturers should track this lawsuit and future rulemaking for impact on site-of-service shifts and corresponding utilization of drugs and biologics to ensure support, messaging, and services are aligned to customers appropriately.

 

We Got No Food, We Got No Jobs, Our Pets’ Heads Are Falling Off!
And Why Aren’t ACOs Saving Money?

 
 

According to CMS results, the Next Generation accountable care organizations (ACOs) saved Medicare over $184 million, about 1.11%, in 2018. With the program results, CMS also published the second evaluation report for the Next Generation ACO model on January 10 to address performance in 2016 and 2017. Prepared by the National Opinion Research Center (NORC) at the University of Chicago, the report states the program actually increased spending in those years. This differs a great deal from the figures CMS reported earlier, and the difference is due to the structure of the analyses, CMS Administrator Seema Verma explained in a blog post accompanying the release of the report. The evaluation report uses different methods than the actuarial results.

According to the study, Medicare did not save money in the first 2 years of the program because it had to pay out more in savings than it recouped. Prior to accounting for the payouts, the model appeared to have decreased Medicare spending by $123.2 million during 2016 and 2017. In reality, there was a $93 million increase to Medicare spending for the 2 years. Verma said the findings show the importance of evaluating results of value-based payment models after shared savings are administered. The 2018 results of saving $184 million accounts for payouts of approximately $285 million in shared savings.     

The conflicting figures lead one to continue questioning whether CMS will determine the proper mix of carrots and sticks for ACOs to lower Medicare program expenditures. Verma admitted that the Medicare Shared Savings Program (SSP)—a precursor to the Next Generation ACO model—did not lower costs. Next Generation ACOs were supposed to incorporate lessons learned from the SSP, but they have not yet succeeded.

 

Going to Hang by the Bar. Put Out the Vibe: Access to Healthcare Is Good

 
 

On Monday, the Journal of Policy Analysis and Management published a study showing the importance of patient access to quality healthcare. The study found a direct correlation between early detection of certain cancers and increased life expectancy following a cancer diagnosis when looking at those insured by Medicare and Medicare Advantage. (Read the press release.)

The research looked specifically at cancer detection and mortality rates of breast, colorectal, and lung cancer incidence, as cancer screening for these disease states are recommended both before and after age 65. These tumor sites also represent the leading causes of cancer mortality in the US. Regarding these types of cancers, they found that after age 65, when Medicare coverage is near universal:

  • Detection increased by 50 diagnoses per 100,000 people, a 10% increase compared to people 63 and 64 years old, with early-stage cancer accounting for much of the increase.
  • Mortality decreased by 9 per 100,000 population for women (with no significant change for men), a 4.5% decrease compared to women 63 to 64 years old.

The results are even more staggering for black women after becoming Medicare eligible:

  • Early-stage cancer detection increased to 62 diagnoses per 100,000 individuals (15%), whereas non-black women showed an increase of 47 per 100,000 (11%).
  • Black women also saw a mortality decrease of 20 per 100,000 population (9%).

The importance of access to healthcare is evident, but where we go next as a country is not likely to be solved soon.

 

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:

  • HHS issued a notice on its annual update of poverty guidelines.
  • The Government Accountability Office found weaknesses in the Health Resources and Services Administration’s oversight that may result in some hospitals receiving 340B discounts for which they are not eligible.
  • Those are as good as money. Those are IOUs. CMS released the CMS Comprehensive Care for Joint Replacement Model: Performance Year 2 Evaluation Report, showing the program succeeded in obtaining some savings in its first 2 years. See the summary.
  • CMS reported Medicaid and Children’s Health Insurance Programs (CHIP) enrollment data highlights for October 2019.
  • Let’s put another shrimp on the barbie. The Food and Drug Administration (FDA) posted draft guidance on Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of [FDA Reauthorization Act of 2017] FDARA Section 504 Questions and Answers.


 

Have Questions on the Impact of AMCP Format v4.1?
Xcenda Has Answers.

 
 

The Academy of Managed Care Pharmacy (AMCP) released its new Format for Formulary Submissions (Version 4.1). The Format provides updated guidance on the evidence and information exchange between industry and payers for unapproved products and for new indications under US FDA review for approved products. It is anticipated these changes will impact the content manufacturers can share and the method by which they will provide this kind of pre-approval information.

Xcenda and the FormularyDecisions team closely tracked the development of the new Format and are available to address questions and provide additional guidance surrounding these updates.

Turn to us to help align your organization’s information dissemination process with payers according to the new Format.

Contact us today >

 
HEARD ON THE STREET
 

“The annual outrage over the increases in the meaningless list prices fails this criterion and distracts policymakers from focusing on the reforms that would actually solve the problems afflicting the pharmaceutical market.”

 – Wayne Winegarden, Senior Fellow in Business and Economics at the Pacific Research Institute, commenting on the criticism levied against the pharmaceutical industry over a report of manufacturers increasing list prices for drugs an average of 5%

Source: “Lies, Damn Lies, and Drug Price Increases,” Forbes, January 9

 
POLICY BY NUMBERS
 

53%

 

According to a Kaiser Family Foundation chart, hospitals (33%) and physician services (20%) represent more than half of all healthcare spending. Prescription drugs account for 9%.

Source: “Hospitals and Physicians Represent More Than Half of Total Health Spending,” Kaiser Family Foundation, January 10

 
UPCOMING MEETINGS & CONFERENCES
 

AMCP Webinar: Embracing Format v4.1 for Early, Effective Exchange of Information With Payers

Tuesday, January 28, 2020 | 2:00 PM ET

With the recent release of AMCP Format v4.1, what does it mean for the preapproval information exchange between payers and manufacturers? Join Xcenda’s Evelyn Sarnes, PharmD, MPH, Vice President of Medical Communications, and other key stakeholders for a live webinar on January 28. Moderated by Elizabeth Sampsel, PharmD, MBA, BCPS, Senior Director of Payer, Provider, and Partner Alliances at Xcenda, the expert panel will give perspective and guidance on the early, effective exchange of information in light of these latest changes as well as highlight tools that can help in this endeavor. 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
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

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 | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Dan Cadle | Jason Eaton | Scott Shields | Diane Smith | Linnea Tennant

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Jan. 17, 2020

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