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APPLIED POLICY INSIGHT
Prior authorizations in Medicare Advantage
As the Centers for Medicare & Medicaid Services (CMS) has contracted with private health insurance plans for the provision of managed care options under the Medicare Advantage (MA) program, these plans have brought commercial insurance’s utilization management practices to Medicare.

Chief among these is prior authorization, the process under which health plans can refuse payment for treatment or services unless healthcare providers secure plan approval first. Designed to prevent the delivery of inappropriate or low-value care, prior authorizations can also be leveraged as a cost-saving measure by establishing the health plan, not the clinician, as the gatekeeper to care.

With the MA model now the preferred choice of Medicare beneficiaries, the use of prior authorizations by MA organizations has come under increased scrutiny. 

CMS instituted new restrictions on prior authorizations in MA in a final rule released in April.

But for patient advocates, legislators, and even some in the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) CMS’s changes don’t go far enough in protecting MA members from inappropriate denials or in guaranteeing the agency access to the data it needs to properly assess the extent and impact of prior authorizations requirements.
As we join in observing Juneteenth, we remember what President Biden said when signing the legislation which established June 19th as a federal holiday: “Great nations don’t ignore their most painful moments... they embrace them. Great nations don’t walk away, they come to terms with the mistakes they’ve made."
 
Even as we actively pursue health equity, America continues to grapple with the legacy of slavery, and egregious racial disparities persist throughout healthcare. 

According to the Centers for Disease Control and Prevention (CDC), Black women are three times more likely than White women to die from a pregnancy-related cause. Black infants die at twice the rate of White infants. The National Cancer Institute reports that Black/African American women are more likely to die of breast cancer than White women, despite developing the disease at a similar rate. And Black men are 60% more likely to die of stroke than White men.
 
In 2021, as the pandemic illuminated the extent and implications of the nation’s health disparities, the CDC declared racism “a serious health threat.” Today, a growing appreciation for the social determinants of health is allowing us to address health disparities in new and holistic ways.
 
Beyond being a day for celebration, Juneteenth is an appropriate time to reflect upon the work we have yet to do to achieve true health equity.
The debate over step therapy
Step therapy is the process under which a health insurance plan requires a patient to try one or more alternative—typically lower cost— drugs or treatment options before they can access the prescription which their physician has identified as the optimal treatment for their diagnosis.

For AHIP, the association representing America’s health plans, step therapy is an important tool for improving care and reducing expenditures in the face of rising drug costs. But detractors have disparagingly characterized step therapy as it is currently employed as “fail first” and are calling upon state and federal governments to take action to regulate its use.

Clinicians argue that being forced to prescribe treatment options they have already rejected before they can prescribe their first choice of medicine limits their autonomy and puts cost-cutting before clinical evidence. Many have joined with patient advocacy groups in contending that step therapy harms patients by delaying effective treatment.
NVHPF Recap:
Negotiating Drug Prices: What Should CMS Do Next?
By September 1, CMS is slated to announce the first ten drugs for price negotiation under the Medicare Drug Price Negotiation Program. This program, created by the Inflation Reduction Act of 2022, has been characterized by the Department of Health and Human Services as historic progress in drug pricing. But there remain many unanswered questions about the way forward.

As part of Applied Policy’s commitment to convening thought leaders and industry experts to discuss key health policy issues, Jim Scott, Applied Policy’s President and CEO, hosted the Northern Virginia Health Policy Forum's conversation on “Negotiating Drug Prices: What Should CMS Do Next?” on May 24.

Scott’s guests were John M. O’Brien, Pharm.D., MPH, President and Chief Executive Officer of the National Pharmaceutical Council (NPC); Jason Spangler, MD, MPH, FACPM, Chief Executive Officer of the Innovation and Value Initiative (IVI); and Monét Stanford, Pharm.D., Director of Policy, Association for Accessible Medicines.

O’Brien, Spangler, and Stanford offered their thoughts on what the process looks like so far and how it could impact the organizations they lead and the patients they serve.   
 
Watch highlights of the event below or click here to watch the event in its entirety.

Applied Policy welcomes
Caitlyn Bernard, MPH
‌
Applied Policy is pleased to announce the addition of Caitlyn Bernard, MPH, as a Health Policy Associate. Caitlyn will be undertaking health policy research for various healthcare clients with an emphasis on pharmaceutical companies.

While finishing her degree, Caitlyn was a practicum student with the Institute for Safe Medication Practices where she performed epidemiological analysis of chronic diseases and completed a project evaluating the Centers for Medicare & Medicaid Services Open Payments Database. 

Caitlyn also previously interned with PhRMA in the Science & Regulatory Advocacy division. She worked on projects related to clinical trial diversity and rare diseases and supported clients in understanding how regulatory changes may affect patient access to clinical trials. 

Caitlyn graduated with a Master of Arts in Biomedical Sciences from Edward Via College of Osteopathic Medicine at Bluefield College. She holds a Master of Public Health from the Milken Institute School of Public Health at The George Washington University and a Bachelor of Science in Biology from George Mason University.  
Applied Policy at AAPC
The American Academy of Professional Coders (AAPC) recently concluded its national conference, HEALTHCON 2023, held in Nashville, Tennessee, May 22-24.

The event attracted a wide range of professionals from the healthcare industry. Applied Policy's April Gutmann and Meghan Basler attended the conference to gain valuable insights into billing and coding practices across different payment systems and healthcare provider types.

The AAPC stands as the world's largest training and credentialing organization dedicated to the business of healthcare. Its members encompass a diverse array of roles such as medical coding, billing, auditing, compliance, clinical documentation improvement, revenue cycle management, and practice management. With a focus on knowledge enhancement and professional development, the four-day HEALTHCON conference featured numerous informative sessions tailored to various care settings and medical specialties.
Applied Policy's summer intern class
We are delighted to have three interns with us this summer: Lily Fortsch, Andrew King, and Meredith Kozar.

For Lily, this summer represents something of a homecoming—she completed an internship with Applied Policy two years ago. She says that her first stint at Applied Policy gave her an appreciation for the rules process and for the role the executive branch plays in implementing the laws passed by the legislative branch. Having graduated from the College of William & Mary last month with a Bachelor of Arts in public policy with a minor in innovation and entrepreneurship, Lily is pursuing full-time employment at the end of the summer.

Andrew hopes to continue working in health policy in the DC area after he completes his Master of Public Health degree at the University of Virginia (UVA) this summer. A former kicker on the UVA football team, Andrew enjoys watching college football and basketball (he doesn't deny an abiding loyalty to his alma mater) and professional soccer. Andrew admits that he was pleasantly surprised to learn he would be assisted in his work by Fitz Voorhees, Applied Policy's obliging office dog.

Meredith is a rising senior at Miami University studying political science and philosophy, with a minor in marketing. Asked what had impressed her about her internship so far, she replied, “I was surprised by the number of abbreviations in the healthcare world. It’s definitely a learning curve!” Meredith is considering attending law school after graduation in the spring of 2024. And we wouldn’t be surprised if she had her eye set on a seat on the Supreme Court after recently meeting Justice Sonia Sotomayor.
Coming in July: A look at Administrative Law Judges
Administrative Law Judges or ALJs derive their authority from the Administrative Procedure Act of 1946, which was passed in response to public concern that administrative agencies within the U.S. government were growing too numerous and too powerful, often enacting and enforcing rules without public notice or input.

Today, ALJs exercise authority across all areas of federal government, including within CMS. Next month we begin an examination of the role of ALJs as the third step in the appeals process set forth by the Office of Medicare Hearings and Appeals.
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 Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 (CMS-1793)
  • Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442)
  • Request for Information; Episode-based Payment Model (CMS-5540-NC)

See all rules under OMB review here.
From the headlines
Insight joke of the month for June
Why did the bucket go to the doctor?
June's book recommendation
"We the Scientists:
How A Daring Team of Parents and Doctors
Forged A New Path for Medicine"
Looking for an absorbing summer read you're proud to leave face-up on your beach towel? We recommend, We the Scientists: How A Daring Team of Parents and Doctors Forged A New Path for Medicine, by Amy Dockser Marcus, the story of individuals in search of a cure for a devastating disease.

A staff reporter for The Wall Street Journal, Dockser Marcus has previously been recognized with the Pulitzer Prize for her reporting on cancer survivors. In We the Scientists she offers a rich character study of families, doctors, and researchers in search of a cure for Niemann-Pick disease type C (NPC), a disabling genetic condition.

Knowing that patients with NPC rarely live past their teens, the parents in the story operate under a desperate urgency which is often at odds with the pragmatism of researchers. As the title suggests, We the Scientists asks the reader to consider the possibility that science belongs not only to those in laboratories and clinics, but also to patients and families, and, ultimately, to all of us.

Described by The New Yorker as illuminating “the painful tension between the extended time frames of medical research and the life spans of those hoping for a cure,” We the Scientists is a poignant story of lives at the intersection of research, regulation, and time.
Applied Policy, L.L.C., is a health policy and reimbursement consulting firm strategically located minutes from Washington, D.C.