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APPLIED POLICY INSIGHT
Sexual equality in clinical testing
With holiday gatherings commencing and COVID-19, flu, and respiratory syncytial virus (RSV) cases rising, it’s reasonable to expect that, in addition to sharing infections, many families will soon be trading observations on how men and women manage illness differently.

While this may offer fodder for dinner table debates and good-natured ribbing between spouses or siblings, the difference in men and women’s manifestation of illnesses and their responses to medicines has important scientific implications. Yet, women—and females of other species—were long systematically excluded from investigative clinical trials of drugs, biologics, and medical devices. 

Many factors contributed to this exclusion, including limited understanding of the contribution of sex and gender to health, societal biases, and government policy.

This month, Applied Policy looks at the history of this exclusion, its impact, and the progress which has been made in rectifying it.
MCOs brace for realignment in Medicaid
The end of the COVID-19 Public Health Emergency will result in a historic realignment of Medicaid funds and enrollees as state Medicaid programs shed beneficiaries they have previously been obligated to keep. 

While a great deal of attention has been paid to how this will impact states and individual enrollees, less attention has been paid to how this will impact the managed care organizations which serve as the means of delivery for the majority of Medicaid coverage. 
HHS, HRSA propose changes to 340B Administrative Dispute Resolution process
On November 29, the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) released a 340B Drug Pricing Program; Administrative Dispute Resolution Period proposed rule, which proposes changes to the administrative dispute resolution (ADR) process for the 340B Drug Pricing Program (340B Program).

This process is intended to resolve disputes arising under the 340B Program, including overcharge claims by 340B covered entities or diversion and duplicate discount claims by manufacturers after good faith efforts have been exhausted by the parties. This rule would replace the existing 340B ADR Final Rule (2020 Final Rule) and would apply to all covered entities and drug manufacturers that participate in the 340B Program.
Key takeaways from MDMA Conference on Reimbursement and Health Policy
Members of the Applied Policy team attended the Medical Device Manufacturers Association's Reimbursement and Health Policy Conference in Washington, D.C., last month.

Our key takeaways:

  • CMS is still revising its processes due to the Azar v. Allina Supreme Court decision. One of the changes is the inclusion of benefit category determinations in the HCPCS process. 
  • CMS officials highlighted challenges the Medicare program is facing as it adjudicates coverage and payment for innovative technologies, AI, and digital therapeutics. 
  • Budget neutrality has been a constraint for making payment decisions on non-opioid pain management products and new technologies. There is a cost associated with rule making. 
  • Coverage for emerging technologies (TCET) is still a CMS priority and policy development is ongoing. The expected timeline for the proposed rule is early 2023. 
  • There are 15 NCD requests on CMS’s waitlist and it will take CMS approximately 5 years to get through this list. 
  • There are major concerns with Medicare Advantage plans not covering services and items provided for Medicare FFS beneficiaries and a desire for more CMS oversight over MA plans. 
CMS webinar looks at communicating upcoming cliff in Medicaid coverage
Twenty million or more enrollees could lose their Medicaid or Children’s Health Insurance Program (CHIP) coverage when the COVID-19 Public Health Emergency (PHE) ends. Yet, research from the Centers for Medicare & Medicaid Services (CMS) and the Urban Institute shows that many Medicaid enrollees are not aware that states could reinstate regular Medicaid renewals as early as April.

The implications of this knowledge gap and means for addressing it were among the key points discussed in CMS’s seventh monthly webinar on unwinding the PHE flexibilities for Medicaid and CHIP eligibility held on December 7.
Final MACPAC meeting of 2022 addresses Medicaid race and ethnicity data collection, DSH payments, and more
The Medicaid and Children’s Health Insurance Program (CHIP) Payment Advisory Commission (MACPAC) held a virtual public meeting on December 8 and 9.

The meeting included sessions on possible recommendations for improving Medicaid race and ethnicity data collection and reporting, required annual analysis of Disproportionate Share Hospital allotments, recent developments in Section 1115 demonstration waivers and implications for future policy, in-lieu-of services and value-added benefits and implications for managed care rate setting, and Medicaid coverage based on Medicare national coverage determination.
Register for January's NVHPF webinar
Hospice Help Before You “Need” It:
A Better Way to Deliver Home Care
How can we prevent decline in the health of Medicare and Medicaid recipients before they experience a crisis or reach a terminal state? Currently, many of these individuals resort to 911 for chronic conditions that are not well served by traditional emergency medical services, simply because they have no other options. This places a financial burden on the health care system and fails to address patients' long-term needs. 
 
Starting at noon on January 11, 2023, panelists of the Northern Virginia Health Policy Forum will propose their approach for a better way: empower Medicare to prevent declines in health by providing hospice care before it is conventionally viewed as needed. They will discuss the practical challenges involved, the potential savings that might accrue to the Medicare and Medicaid programs, and the better care that could benefit millions of patients.

Our guests will be Edo Banach, formerly CEO of the National Hospice & Palliative Care Organization; Tonya Saffer, Division Director, Healthcare Payment Models, CMS Innovation Center; and Catherine Hamel, Executive Vice President of Continuing Care and President of Gilchrist Hospice Care based in Hunt Valley, Maryland.
Highlights from the December NVHPF webinar
with Rep. Don Beyer (D-VA)
On Friday, December 9, Applied Policy President and CEO Jim Scott welcomed U.S. Rep. Don Beyer (D-VA) to the Northern Virginia Health Policy Forum (NVHPF) for a discussion of what we might expect in the upcoming congressional session. 

Beyer, who will commence his fifth term representing Virginia’s 8th Congressional District in January, currently serves as chairman of the Joint Economic Committee. Having dealt with congressional brinksmanship in the past, Beyer was prepared to discuss both the process and the politics of the looming debt ceiling.

An advocate for mental health initiatives, Beyer spoke of the importance of communicating the existence of the 988 dialing code which routes callers to the National Suicide Prevention Lifeline and which has the potential to save thousands of lives. He observed that the United States currently does not have enough psychologists or psychiatrists to address an “unparalleled epidemic of anxiety and depression among our young people” and spoke of the value of telehealth and potential of peer-to-peer counselors. He also expressed an eagerness to address maternal health and racial disparities in maternal mortality.

The only certified automobile mechanic currently serving in Congress, Beyer asked the audience to indulge his “nerdy” side as he expressed optimism that fusion would enable the country to move away from fossil fuels in the foreseeable future. 

Watch highlights of the wide-ranging discussion below or click the link to watch the event in its entirety.
On our calendars
From the headlines
Insight Joke of the Month for December
What is Santa Claus's favorite type
of durable medical equipment?
December's book recommendation
In Under the Skin: The Hidden Toll of Racism on American Lives and on the Health of Our Nation, Linda Villarosa shines a light on racial bias in healthcare. And while the glare of that light can sometimes be uncomfortable, it is worth keeping your eyes open.

As Jerald Walker observed in the Washington Post, Under the Skin is "meticulously researched, sweeping in its historical breadth, damning in its clear-eyed assessment of facts and yet hopeful in its outlook."

Villarosa, who teaches journalism at the City University of New York, previously addressed the question of Why America’s Black Mothers and Babies are in a Life-or-Death Crisis in the New York Times Magazine.

Under the Skin isn't easy read. Or a comfortable one. But if you're one to start the New Year with a challenge, this detailed study of racism in healthcare is a great option.
Applied Policy, L.L.C., is a health policy and reimbursement consulting firm strategically located minutes from Washington, D.C.