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APPLIED POLICY INSIGHT
Administrative law judges in the
Office of Medicare Hearings and Appeals
Federal Administrative Law Judges (ALJs) exercise considerable authority in our national healthcare system. ALJs in the Food and Drug Administration routinely make adjudicatory decisions regarding drugs and medical devices. Those working within the Department of Labor may render decisions impacting a healthcare provider’s workforce or workplace. And the determinations of ALJs within the Drug Enforcement Administration can deny a provider the ability to dispense controlled substances.
 
Perhaps most important for healthcare providers contracted with Medicare are the ALJs affiliated with the Office of Medicare Hearings and Appeals (OMHA), who oversee appeals associated with coverage and payment for items and services furnished under Medicare Parts A, B, C, and D. As adjudicators in the third level of the five-level Medicare appeals process, OMHA’s ALJs are positioned to make decisions regarding the disposition of millions of Medicare dollars.
 
Yet, despite the considerable power wielded by OMHA’s ALJs, the source of their authority and the branch of government with which they are affiliated is frequently misunderstood. This month, we briefly survey the history of these ALJs, the process by which they render their decisions, and how the likelihood of a favorable outcome for appellants has shifted in recent years.
Prior authorizations and health equity
In our series on prior authorizations, we have previously considered the administrative burden which prior authorizations present for healthcare providers, as well as their potential to delay definitive care for individual patients. This month, we examine prior authorizations within the context of health equity.

There is increasing concern and growing evidence that the use of prior authorizations can perpetuate health disparities through disproportionate impact on poor and minority populations.

A “perennial concern” of the American Medical Association (AMA), prior authorizations are more than just a nuisance for providers. In addition to delaying access to treatment—especially new pharmaceuticals and biologics—prior authorizations are associated with higher rates of patient abandonment of treatment plans. 

Defined by the Centers for Disease Control and Prevention (CDC) as “the state in which everyone has a fair and just opportunity to attain their highest level of health,” health equity is the first pillar of the Centers for Medicare & Medicaid Services’ (CMS’s) strategic plan. It requires recognizing and addressing the impacts of racism, gender oppression, classism, and other forms of institutionalized discrimination on health outcomes.

Many patient advocacy and provider groups see the use of prior authorizations as being in direct opposition to this goal. The American Academy of Family Physicians is among those who contend that prior authorizations “can worsen health disparities and create barriers to care for medically underserved patients, patients of color, LGBTQ+ patients, patients in rural areas, and those at risk for poor health outcomes.”

When prior authorization requirements are imposed unequally, their impact on historically marginalized groups can be magnified, postponing the realization of a fair and equitable healthcare system.
CMS publishes long-awaited proposed pathway for Medicare coverage of emerging technologies
On June 22, 2023, Centers for Medicare & Medicaid Services (CMS) released the highly anticipated proposed Medicare device coverage pathway for breakthrough medical devices, known as Transitional Coverage for Emerging Technologies (CMS-3421). 

Rather than a newly proposed rule, CMS released a proposed notice, which describes the process CMS will use to provide transitional coverage for emerging technologies (TCET) through the existing national coverage determination (NCD) process. CMS states TCET pathway can be implemented faster and modified more easily if established through a procedural notice.
Applied Policy attends ADA's Scientific Sessions
Applied Policy’s Simay Okyay McNutt was among the over 12,000 attendees at the 83rd Scientific Sessions of the American Diabetes Association (ADA) in San Diego, California, in June.
 
ADA’s Scientific Sessions, the world’s largest diabetes meeting, attracted registrants from over 115 countries. With 2,000 research presentations and an exhibit hall with more than 100 exhibitors, the event offered valuable opportunities for Applied Policy to promote and pursue client interests while keeping abreast of the latest in diabetes research.

As part of the event, Sessions attendees were asked to write down their reasons for their involvement in diabetes research and care and to post them on a wall in the San Diego Conference Center’s Sails Pavilion.

Applied Policy’s reason is captured in our mission: Improving Lives.  

Diabetes is one of the United States’ top ten leading causes of death and directly impacts over 11 percent of the country’s population. Applied Policy recognizes that through effecting changes in diabetes policy and payment, we can improve the lives of millions of Americans. 

The ADA’s Sessions allowed us to catch up in person with colleagues and partners who share our goal, including those with whom we collaborated in the development of Formal Request for Reconsideration of Local Coverage Determination for Continuous Glucose Monitors (CGMs), which eventually led to CMS’s historic expansion of CGM coverage in March. 

The hybrid conference offered over 200 individual sessions with topics ranging from Overcoming Barriers to Diabetes Technology to U.S. Rurality and Diabetes. Because it was not possible for registrants to attend each of the event’s sessions, ADA is offering on-demand access to session recordings through August 28 and online registration to secure this access is still open. 

Applied Policy looks forward to attending the ADA’s 84th Scientific Sessions in Orlando, Florida, in 2024.
Please join NVHPF on
Tuesday, August 22,
for
Reauthorizing the SUPPORT Act:
The Future of the Fight Against Addiction
The massive bipartisan SUPPORT Act, originally passed in 2018 to provide addiction and recovery programs nationwide, is due to expire September 30th. There is bipartisan agreement in both the House and Senate on the need to reauthorize the bill, providing new momentum to stem the overdose crisis that now kills more than 100,000 Americans each year. Major questions now focus on what the renewed bill will cover, what it might offer to support non-opioid pain relief and what the implications will be for public health services in both urban and rural areas. 

We invite you to join the Northern Virginia Health Policy Forum at noon Eastern Time on Tuesday, August 22, as we host Megan Meacham, Director of Rural Strategic Initiatives at the Health Resources and Services Administration (HRSA), and Andrew Cosgrove, Senior Director for federal healthcare coverage reimbursement policy and health economics issues at the Biotechnology Innovation Organization (BIO), in conversation about the reauthorized legislation and the future of the war on drugs.
From the NVHPF archives:
Hospitals and COVID-19
In October 2020, families were pondering what a COVID-19 Halloween would look like, and precinct chairs across the country were preparing to conduct an election during a pandemic.

As hospitals struggled under the third wave of the coronavirus, the Northern Virginia Health Policy Forum hosted a discussion of Hospitals and COVID-19: Lessons Learned from the Early Epicenters featuring William "Bill" Rogers, M.D., Applied Policy's Chief Medical Officer.

Click below for highlights of an important and prescient conversation.
Applied Policy Insight on hiatus in August
Applied Policy will not be publishing a separate issue of Insight in August, as the editorial staff takes a few weeks off for summer break. We will resume publication right after Labor Day. 

In the meantime, the Applied Policy team will continue to follow rule releases from CMS, as well as other healthcare news, and we invite you to follow us on LinkedIn for the latest policy analysis. 
A closer look at that quote about the stethoscope...
That it will ever come into general use notwithstanding its value is extremely doubtful: because its beneficial application requires much time and gives a good bit of trouble to the patient and the practitioner; because its hue and character are foreign and opposed to all our habits and associations.

John Forbes
Physician to the Penzance Dispensary
Secretary of the Royal Geological Society of Cornwall
writing about the stethoscope in1821
When faced with doubt about the value of new medical devices or emerging technologies, inventors and early adopters often invoke the preceding quotation to demonstrate how damning skepticism can look in retrospect.

Two centuries after they were written—and with the stethoscope now ubiquitous in medicine—it is tempting to chuckle at Forbes's words and their author's limited foresight. We might even flatter ourselves into believing that we would have immediately recognized the value of the curious cylindrical device developed by French physician René Theophile Hyacinthe Laënnec.
 
In fact, Forbes's words are frequently taken out of their original context. They were part of the introduction to his translation of Laënnec's book on the stethoscope and prefaced by an acknowledgement of the device's value:

… I have no doubt whatever, from my own experience of its value, that it will be acknowledged to be one of the greatest discoveries in medicine by all those who are of a temper, and in circumstances, that will enable them to give it a fair trial. 

But Forbes also recognized the limitations of the device's design and the questions with which it would be met. After all, the original stethoscope was essentially a solid wooden tube, one end of which was placed upon the patient’s chest while the other end was held to the physician’s ear. There were bound to be skeptics.
 
Often portrayed as the consummate naysayer, oblivious to the merits of a new medical device, Forbes actually played a critical role in introducing the stethoscope to the English-speaking world.
On our calendars
Under review/On the docket
Applied Policy is paying particular attention to the following rules under review at the Office of Management and Budget:

  • Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS-1785)
  • FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs
  • FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1787)
  • FY 2024 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program
  • FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1783)

See all rules under OMB review here.
From the headlines
Insight joke of the month for July and August
Why do ophthalmologists live so long?
A podcast recommendation:
Searching for Medicine's Soul
Searching for Medicine’s Soul, a podcast from Washington, D.C.’s Ethics and Public Policy Center (EPPC), bills itself as exploring “key themes in the relationship between human flourishing and the medical field.”

Hosted by Aaron Rothstein, a neurologist and fellow in bioethics and American democracy at EPCC, Searching regularly features thought provoking conversations at the intersection of medicine, bioethics, and economics. 

Previous guests have included Dr. Elisabeth Rosenthal, senior contributing editor at Kaiser Health News; Jim Capretta, Senior Fellow and Milton Friedman Chair at the American Enterprise Institute; and Meghan O'Rourke, the author of the New York Times bestseller The Invisible Kingdom.

Find Searching for Medicine's Soul wherever you listen to podcasts and expect discussions on a wide variety of issues, from relative value units to the use of psychedelics.
Applied Policy, L.L.C., is a health policy and reimbursement consulting firm strategically located minutes from Washington, D.C.