Peterson-KFF Health System Tracker report shows stunning variable cost of COVID-19 testing across the US.

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July 17, 2020

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FEATURED STORY

The (COVID-19 Test) Price Is (Not) Right

On Wednesday, the Peterson-KFF Health System Tracker released a report examining the stunning variable cost of COVID-19 testing across the US. At the onset of the pandemic, Congress passed 2 pieces of legislation to ease the financial burden of widespread COVID-19 testing. Despite these efforts, insured and uninsured patients alike are still paying high out-of-pocket costs for testing and related services. This report offers an insight into the true cost of COVID-19 testing and the limitations of the Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

The CARES Act aimed to improve price transparency by requiring out-of-network providers to post COVID-19 test list prices on their websites. Because of this mandate, the research team was able to gather data from the 2 largest hospitals in each state (including Washington, DC), compiling a list of 134 unique COVID-19 test list prices. Tests varied widely in cost between $20 and $850, with the majority priced between $100 and $199. For uninsured patients, a few hospitals offered discounted tests, ranging between $36 and $180, with others offering payment assistance programs. 

The high and ranging cost of COVID-19 diagnostic tests reveals the limitations of the federal government’s regulations. Loopholes in mandated private coverage mean patients who go in seeking treatment for what might be COVID-19 may receive bills if they are not tested. Out-of-network providers are not required to bill directly to a patient’s insurance company, so sick patients may have to navigate the complicated claims submission process on their own. And finally, insurers are not required to cover surveillance testing, particularly for company “back to work” programs, so employers may have to assume that ongoing cost. 

As the COVID-19 pandemic continues to ebb and flow across the nation, it will be increasingly important to address these policy shortcomings and better ensure financial safety from unexpected, high testing costs. Patients may choose to forgo testing due to cost, which puts themselves and public health at risk.

Navigating COVID-19—Simplifying the Path to Better Patient Outcomes (Virtual Event)

The COVID-19 pandemic continues to leave its mark on American life. With the US unemployment rate still at one of the highest we’ve seen in years, many Americans have been without work for months, making it difficult for some to access and afford the therapies they need.

Watch a panel of experts, from Lash Group and Xcenda and led by Tommy Bramley, during the PAP 2020: 21st Annual Patient Assistance and Access Programs Virtual Event on Monday, August 3, from 1:30–2:15 PM ET. The panel will offer insights on how the pandemic will impact insurance coverage, new policies that affect access and affordability, and considerations for manufacturers regarding program design.

Learn more >

LEGISLATIVE UPDATE

Congress is on recess until July 20.

Legislative Bytes


  • The House Energy and Commerce Committee advanced 17 health bills, including:
    • HR 5534 that would permanently remove the 36-month limit for Medicare coverage of immunosuppressive drugs following a kidney transplant
    • HR 7539 that would help improve and strengthen enforcement of existing mental health parity laws
    • HR 4712 that would require drug manufacturers seeking orphan drug designations to demonstrate the absence of any reasonable expectation that the costs they incur in developing and making those drugs available in the US for such disease or condition will be recovered
    • HR 5668 that would give additional authority to the Food and Drug Administration (FDA) to require modifications of outdated labeling for generic drugs
  • A bipartisan group of House members introduced legislation to continue the expansion of telehealth in Medicare beyond the COVID-19 public emergency by making permanent certain flexibilities including to allow Medicare patients to access telehealth from home and extending reimbursement for telehealth for 90 days beyond the pandemic.
  • Rep. David McKinley (R-WV) introduced HR 7593 that would increase the use of telehealth for substance use disorder treatment.
XCENDA PERSPECTIVE

Construdeling the Impact Nein Years Later: Price Regulation in Germany


In 2011, Germany introduced the AMNOG or, as is translated in English, the Pharmaceuticals Market Reorganization Act. This was a gamechanger that came with hard-fought discussions between the pharmaceutical industry and regulators. Depending on which side one listened to, everything was possible—from no new products being introduced in Germany to a perception that nothing will change in the German market.

Regulators were explicit about separating the assessment of available evidence from a health economic evaluation and price negotiation. Many countries in Europe (eg, the United Kingdom or Sweden) were going separate ways in integrating the assessment of clinical and health economic consequences at the same time. Germany was and still is focusing on the (very stringent) assessment of clinical evidence only and subsequent price negotiations. These price negotiations are kept confidential in contrast to the publicly available assessment reports on the clinical evidence.

So, 9 years later, what was the impact on pricing, and did many products withdraw from the market? In Health Affairs, Lauenroth et al recently published a study looking at the assessment results and price discounts in oncology. Overall, oncology products had to be discounted 24% in the negotiations. These prices are used for all 100+ health insurers. The study found that few products left the market after the assessment and/or failed price negotiations. Interestingly, the authors also found no evidence that manufacturers factored in the discount in the initial pricing, which is still up to the discretion of the manufacturer for the first year.

In a nutshell, after initial turmoil, almost everybody—even the industry—should be at peace with the very stringent evidence assessment and the AMNOG process in general. But more recently, regulators modified the regulation to also allow the G-BA (Federal Joint Committee) to ask for the set-up of additional phase 4 trials in situations where no comparative evidence is available (eg, only single-arm trials). This will have a significant impact on orphan indications with only limited available data or very small patient populations. Historically, these products have higher per-patient cost of the therapy combined with the first gene therapies entering the market having 7-digit price tags. 

How this new regulatory initiative will have an impact is not clear now; what is clear is that the number of Advice Meetings with the G-BA rose significantly on these topics recently.

Xcenda has been involved, to date, in 200+ AMNOG assessments and is a recognized leader in consulting services in Germany for 10+ years, with a dedicated team of 50+ associates located in Germany.

ORIGINAL RESEARCH REDUX

Let’s (Not) Make a Deal: Potential Access Implications of National Formulary in Part D


While drug pricing proposals may seem a little distant given the current environment, it is likely we will see legislative proposals resurface sooner rather than later. Drug pricing is still a major populist issue, and polls consistently show the public has real concern. 

As part of our planning to understand how some proposals might impact patient access, we wanted to revisit research we did a few years ago on the differences between patient access in Medicare Part D and the Veterans Affairs (VA) national formulary.

There continues to be some who favor government-negotiated prices in Part D, but we wanted to gauge the potential impact on access. For this updated analysis, Xcenda again compared 25 FDA-approved, first-in-class drugs among all Part D plans and the VA national formulary, with the premise that a government-run or government-set formulary would likely be necessary for any proposal to be effective. We also looked at the top 200 Part D brand drugs in terms of total spend. 

  • Of 25 FDA-approved, first-in-class therapies, Part D plans covered 62% on average, whereas coverage under the VA was 40%.
  • The VA could cover 103 (52%) of the top 200 Part D brand drugs compared to an average of 151 (75%) for Medicare Advantage prescription drug (MA-PD) plans and 139 (70%) stand-alone prescription drug plans (PDPs), or 149 (74%) under Part D overall.

The results suggest that moving to a national formulary would hinder patient access (and provider choice). The balance of risk-reward needs to be part of any conversation.

The full report can be found here.

COVID-19 RESOURCES AND BULLETIN

COVID-19 Resources


Coronavirus Task Force Resources and Updates

Centers for Disease Control and Prevention (CDC) Information for Healthcare Professionals

Centers for Medicare & Medicaid Services (CMS) Current Emergencies (Coronavirus)

Food and Drug Administration (FDA) COVID-19 Information

Medicaid and Children’s Health Insurance Program (CHIP) Resources

American Medical Association (AMA) Physician’s Guide to COVID-19

Health Affairs COVID-19 Resource Center

National Foundation for Cancer Research (NFCR) Coronavirus Resource Center for Cancer Patients and Caregivers

COVID-19 Bulletin


  • Rep. Frederica Wilson (D-FL) introduced HR 7607 that would condition the receipt of funds with respect to COVID-19 on requiring the use of face coverings in public.
  • CMS Administrator Seema Verma convened a roundtable discussion with Detroit healthcare leaders, representatives from long-term care facilities, and other community stakeholders to discuss the impact of and response to COVID-19 in nursing homes.
VALUE CORNER

The Match Game: Looking for Ways to Take Health Disparities Into Account


On Wednesday, Health Affairs published an article emphasizing the need to take health disparities into account when assessing the value of healthcare interventions. Several mainstream value frameworks currently operate under the assumption that improvement in overall population health means that health benefits are distributed equally among people of varying racial or socioeconomic backgrounds. The authors describe 2 existing methods that incorporate the value of reduced inequality in health technology assessments: multi-criteria decision analyses (MCDAs), and distributional cost-effectiveness analyses (DCEAs). With MCDAs, stakeholders can “trade off” various treatment attributes and prioritize treatments based on factors other than the cost per quality-adjusted life-year (QALY). Using DCEAs, stakeholders can choose to place a greater emphasis on QALYs gained by patient populations with disproportionately poorer outcomes. The authors suggest that leveraging these methods in value assessment frameworks would be a step in the right direction for addressing health inequality.

Last week, STAT News published an article highlighting the lack of patient voices in value assessment. Proponents of population-level assessments argue that the only way to have a fair comparison of the benefits and costs associated with healthcare interventions is to use a societal perspective. On the other hand, those who support a more patient-centric approach contend that patient voices must be taken into consideration in order to understand what matters most to those who are directly affected by the intervention. The authors recommended the following steps to lead a national discussion around reconciling the priorities of these dissenting opinions:

  • Reinforce that this conversation needs to take place to advance value assessment methods
  • Recognize that all stakeholders, including patients, need to participate in a public conversation around methods of assessing value
  • Identify what different stakeholders need to know about healthcare valuation in order to be productive contributors to the conversation
  • Set clear aims for the conversation that describe the desired effects on stakeholders and valuation methods

Last month, the Innovation and Value Initiative and the National Alliance for Healthcare Purchasers published an article highlighting the importance of capturing patient and employer perspectives when determining the value of healthcare interventions. In a case study on depression, factors identified as most important to patients and purchasers but not being adequately addressed in mainstream value frameworks include: 1) patient preference factors (eg, functional status, impact on work, accessibility); 2) impact on caregivers or family; and 3) related expenditures elsewhere in the healthcare system (eg, disability payments, Workers’ Compensation claims). The authors outlined several approaches for how employers can be more involved in the value assessment process, including setting expectations for their plans and pharmacy benefit managers to broaden their focus during formulary discussions, as well as requesting real-world data to better understand cost, outcomes, and value.

If you need assistance with all things ICER or value-related, please contact Linnea Tennant.

Xcenda’s MCN Forum in October 2020: Your Path to Actionable Payer Market Insights

Looking for payer input to refine your clinical, market access, and/or health economic and outcomes research plans? Gain real-time, truly interactive, qualitative and quantitative insights only from Xcenda’s Managed Care Network (MCN) Forum.

Xcenda is hosting a 1-day event on October 20, 2020. The event will either be held in Las Vegas, NV or virtually (TBD).

Learn more >

REGULATORY UPDATES

Last Friday, the Journal of the American Medical Association published a study examining the longitudinal health changes in Michigan’s Medicaid expansion enrollees from 2016 to 2017. 

There was a significant reduction in Healthy Michigan Plan (HMP) respondents who reported fair or poor health, 27% in 2017 compared to 31% in 2016. The mean number of days of poor physical health in the past month also decreased from 2016 (6.9) to 2017 (5.7). In contrast, there was no statistically significant difference in the number of days of poor mental health or the number of days missed due to poor physical or mental health.

Overall, findings from the HMP suggest that the health of the vulnerable population is improving with Medicaid expansion. Further policy interventions may continue to improve health outcomes through greater access to primary care, increased uptake of preventive services, and reduced disparity in insurance coverage.

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 case before the Supreme Court challenging the constitutionality of the Affordable Care Act’s individual mandate—California v. Texas (known as Texas v. US in the lower courts)—will not be heard before the election.
  • The Department of Health and Human Services issued a proposed rule that would allow grandfathered group health insurance plans to increase cost-sharing requirements without losing grandfather status.
  • As of July 1, Medicare requires prior authorization for the following hospital outpatient services: blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation. The full list of HCPCS codes requiring prior authorization is available.
  • The Substance Abuse and Mental Health Services Administration (SAMHSA) announced the adoption of a revised rule to “help make it easier for Americans to discuss substance use disorders with their doctors, seek treatment, and find the road to recovery.” See the fact sheet.
  • The Government Accountability Office (GAO) issued a primer on Medicaid financing arrangements.
  • As of July 1, the Texas Health and Human Services Commission started accepting the following information from manufacturers related to wholesale acquisition cost (WAC) price increases as part of Texas Health and Safety Code Chapter 441 (the information reporting is for drugs with a WAC of at least $100 for a 30-day supply that had an increase of 40% or more over the preceding 3 calendar years or 15% or more in the preceding calendar year):
    • The name of the drug
    • Whether the drug is a brand name or generic
    • The effective date of the change in WAC
    • Aggregate, company-level research and development costs for the most recent year for which final audit data are available
    • The name of each of the manufacturer’s prescription drugs approved by the FDA in the previous 3 calendar years
    • The name of each of the manufacturer’s prescription drugs that lost patent exclusivity in the US in the previous 3 calendar years
    • A statement regarding the factor or factors that caused the increase in WAC and an explanation of the role of each factor’s impact on the cost
  • The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid (CMS) in response to the fiscal year 2021 Hospital Inpatient Prospective Payment System proposed rule.
    • ASCO expressed concern that “the reimbursement rate for MS-DRG 018 does not sufficiently cover the cost of CAR-T and related services, especially given CMS’ proposal to discontinue the new technology add-on payment (NTAP) established for CAR-T in 2020, which set the national reimbursement rate for the therapy at $285,594. Under the 2021 proposal, in which a new MS-DRG for CAR-T is established but the NTAP is discontinued, the base reimbursement amount for CAR-T would be $46,104 less than the 2020 reimbursement rate and $133,510 less than the cost of the therapies themselves, which could significantly threaten access for Medicare beneficiaries.”
  • Adam Fein’s Drug Channels found that 28,000 pharmacy locations—almost half of the US industry—now act as contract pharmacies for hospitals and other healthcare providers that participate in the 340B program. Over the past 12 months, the number of pharmacies in the program has grown by more than 3,300 locations.
  • The National Academies of Sciences, Engineering, and Medicine published a summary of the presentations and discussion from its workshop “Applying Big Data to Address the Social Determinants of Health in Oncology,” held in October 2019. The workshop examined social determinants of health in the context of cancer and considered opportunities to effectively leverage big data to improve health equity and reduce disparities.
  • The Annals of Internal Medicine published a paper on the methods the US Preventive Services Task Force uses to incorporate social determinants of health into its evidence-based recommendations.
  • The National Comprehensive Cancer Network explored adoption of biosimilars in oncology in collaboration with Pfizer. 
HEARD ON THE STREET

“In light of our new experience with telehealth during this pandemic, CMS is reviewing the temporary changes we made and assessing which of these flexibilities should be made permanent through regulatory action. As part of our review, we are looking at the impact these changes have had on access to care, health outcomes, Medicare spending, and impact on the healthcare delivery system itself.”

– Seema Verma, CMS Administrator, observing that the rapid adoption of telemedicine among providers and patients has shown that telehealth is “here to stay”

Source: “Early Impact of CMS Expansion of Medicare Telehealth During COVID-19,” Health Affairs, July 15

POLICY BY NUMBERS

5.4 Million | 39%

Because of job losses between February and May of this year, 5.4 million laid-off workers became uninsured. These recent increases in the number of uninsured adults are 39% higher than any annual increase ever recorded. The highest previous increase took place over the 1-year period from 2008 to 2009, when 3.9 million nonelderly adults became uninsured.

Source: “The COVID-19 Pandemic and Resulting Economic Crash Have Caused the Greatest Health Insurance Losses in American History,” Families USA, July 13

UPCOMING MEETINGS & CONFERENCES

Virtual Student Shadow Day

Friday, July 31, 2020 | 12:00–2:00 PM ET
Experience a day in the life of an Xcenda expert! Spend a day learning about Xcenda, the healthcare industry, managed care, and more during our Virtual Student Shadow Day.

PharmD, PhD, MPH, and other related fields of study are welcome to join us to explore market access, health economics and outcomes research, clinical software development, and other areas that could be of interest for your future. Please note space is limited.

Read our flyer >

Register here >

Learn more about our student programs >

Navigating COVID-19—Simplifying the Path to Better Patient Outcomes (PAP 2020 Virtual Event)

Monday, August 3, 2020 | 1:30–2:15 PM ET
As the larger healthcare system looks for ways to alleviate challenges brought on by the coronavirus, patient support providers are shifting how they work with manufacturers to increase impact and provide ongoing support for patients.

Join Xcenda and Lash Group leaders at Informa’s PAP 2020: 21st Annual Patient Assistance and Access Programs Virtual Event August 3–7. The keynote session titled Navigating COVID-19—Simplifying the Path to Better Patient Outcomes will be on Monday, August 3, 1:30–2:15 PM ET.

Learn more >

Xcenda’s MCN Forum: Your Path to Actionable Payer Market Insights

October 20, 2020 | Las Vegas, NV or Virtual (TBD)
Looking for payer input to refine your clinical, market access, and/or health economic and outcomes research plans? Gain real-time, truly interactive, qualitative and quantitative insights only from Xcenda’s Managed Care Network (MCN) Forum.

Xcenda is hosting a 1-day event on October 20, 2020. The event will either be held in Las Vegas, NV or virtually.

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:

Herman Chen | Thomas Mittendorf | Scott Shields | Jennifer Snow | Taryn Sohal | Annie Yan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

July 17, 2020

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