Advocacy Update

March 1, 2022

In this Issue:

Federal Judge Agrees with Physicians on No Surprises Act Lawsuit

A federal district court judge in Texas on February 23 vacated specific provisions pertaining to the independent dispute resolution process of the government’s regulations for the No Surprises Act. In a lawsuit filed by the Texas Medical Association (TMA), US District Court Judge Jeremy Kernodle granted the association’s motion for summary judgement and provided nationwide relief for all physicians and other health care providers who use the independent dispute resolution process.

The decision is a victory for physicians, including pathologists, who have fought against the unjust regulations. In a similar case led by the American Medical Association (AMA) and American Hospital Association (AHA), the CAP filed an amicus brief that warned the government’s requirements for the independent dispute resolution process heavily favored insurers and would cause substantial harm to physicians. The AMA-AHA case has yet to be decided.

Neither the lawsuit, nor the judge’s decision in the Texas Medical Association case, will affect provisions banning surprise medical bills. The CAP and other physician groups strongly advocated to include these patient protections in the law.

No Presumption in Law Favors Qualified Payment Amount

Importantly, the decision simply removes the rulemaking that required arbitrators in the independent dispute resolution process to begin with the presumption that the qualifying payment amount (median-in-network rate) for an out-of-network service is the appropriate amount. In the TMA case, the judge agreed with the Texas physicians’ claims the Biden administration did not follow procedural obligations for the federal rulemaking process and that no presumption to give more weight to the qualified payment amount existed in the law.

The physician and hospital groups, along with the CAP, have challenged the flawed regulations for the independent dispute resolution process. The law clearly established a fair and impartial process where physicians and other providers can settle claims with insurers without patients receiving unexpected large medical bills. The TMA, and AMA and AHA lawsuits state that the federal government’s regulations deviated from the law and ensured that commercial insurers can routinely undercompensate physicians.

The government has 60 days to make a decision on appeals, and it is unclear if they will do so or not.

The CAP will continue tracking this case and report additional updates to members as they develop.

Transition: Robert Califf Confirmed as FDA Commissioner

Robert Califf, MD, a cardiologist, was confirmed by the Senate on February 15 as the Commissioner for the Food and Drug Administration (FDA). Dr. Califf will lead the FDA, which is the regulatory agency overseeing pharmaceuticals and medical devices.

Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, health care quality, and cardiovascular medicine. He brings nearly four decades of experience as a doctor, researcher, leader, and public servant, including previous service as the FDA Commissioner from 2016-2017.

Dr. Califf was a professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute. He also worked as the head of Clinical Policy at Verily Life Sciences, a research and development organization that’s a subsidiary of Alphabet, Inc.

CAP Joins New Alliance to Support the US Blood Supply

The CAP, along with 16 other hospital, medical and laboratory groups, has joined the Alliance for a Strong Blood Supply, which is a coalition of organizations committed to ensuring sufficient blood is available for all patients during the pandemic and beyond. The Association for the Advancement of Blood & Biotherapies (AABB) recently launched the Alliance to better address current challenges with the nation’s blood supply. The CAP advocates for a safe blood supply for patients and communities across the United States.

The initial 17 organizations comprising the Alliance collectively represent the nation’s hospitals and blood collectors, as well as more than 200,000 physicians who routinely provide blood to patients in need. Alliance members have pledged to facilitate communications on the state of the blood supply and to work together on coordinated advocacy and communications campaigns to champion the importance of blood donation, the value of blood transfusions and why a robust blood supply is critical to patient care. Member organizations have also committed to sharing best practices aimed at supporting the stewardship of the blood supply.

Regions throughout the United States are currently facing significant blood supply challenges, with many blood collectors operating with less than a one-day supply on hand, which is below the ideal goal of at least a three-day supply. As a result, hospitals have been forced to delay life-saving blood transfusions and postpone nonessential surgeries.

The initial members of the Alliance are: AABB, Alliance for Community Transfusion Services, America’s Blood Centers, American College of Emergency Physicians, American College of Surgeons, American Hospital Association, American Red Cross, American Society for Transplantation and Cellular Therapy, American Society of Anesthesiologists, American Society of Clinical Pathologists, American Society of Hematology, Association of American Medical Colleges, Association of Donor Recruitment Professionals, Blood Centers of America, College of American Pathologists, Federation of American Hospitals, and Society for the Advancement of Patient Blood Management.

Georgia Association of Pathology and CAP Oppose Pathologists’ Assistants Licensure Bill

On February 17, the Georgia Association of Pathology (GAP) and the CAP submitted a memorandum of opposition to Senate Bill 525, which would establish licensure for pathologists’ assistants. The CAP works with state pathology societies to oppose state licensure for pathologists’ assistants, cytotechnologists, and histotechnologists in accordance with CAP’s model criteria for the state licensure of clinical laboratory personnel.

As delineated, the GAP and the CAP oppose the licensure of pathologists’ assistants based on CLIA’s robust regulatory oversight of laboratory personnel and laboratory operations and to deter state-imposed regulatory burdens on pathologists’ ability to direct the laboratory and laboratory personnel subject to supervision.

Previously, the GAP with the assistance of the CAP supported Georgia’s repeal of laboratory personnel and laboratory licensure in 2021. The repeal gained the unanimous support of the Georgia legislature and was enacted on May 5, 2021, by Governor Kemp.

The CAP and the GAP continue to work closely with the Medical Association of Georgia to oppose pathologists’ assistants licensure in the state of Georgia.

Dr. Lee: How You Can Champion Health Policy with PathPAC

Periodically, CAP Advocacy features one of the many CAP members who are champions for pathology in Washington through their PathPAC donations or at the state level through our grassroots and PAC programs. If you would like to get involved, you can join PathNET, contribute to PathPAC, or join your state pathology society.

Recently Advocacy Update caught up with PathPAC’s new Junior Member Patricia Lee, MD who is a third year Pathology Resident (PGY-3) at Keck School of Medicine at the University of Southern California.

What made you interested in becoming involved with PathPAC?

I was looking to become more involved in the CAP and read up on the various committees with junior member openings. It was then that I learned about PathPAC and seized upon the opportunity to work with and learn from leaders in the pathology community. As is the case for all citizens, it is incumbent on pathologists to advocate for change in law and policy, not only for the advancement of their profession, but also in the interest of improving patient care.

Before you joined the PathPAC Board as its newest Junior Member, how did you engage with the CAP’s federal advocacy efforts?

To be frank, I was not familiar with all the wonderful work that the CAP in general does on behalf of pathologists, and how PathPAC is specifically involved with federal advocacy efforts. Reversing this unawareness or apathy is what I am most excited to work on...

What are you most looking forward to as a new member of the PAC Board?

I am most looking forward to participating in outreach efforts to residents and fellows. Getting trainees (as well as new practitioners) to recognize the importance and necessity of political engagement and support of PathPAC will be challenging when their focus is on studying for boards, navigating new positions, or carving out career paths. The development and execution of an effective approach is what I am most interested in--laying the foundation for sustained and reliable support over time.

Why do you think it’s important to support and engage with the PAC?

Ours is a small community, and the key to having our goals advanced is working to generate resources that will allow our voices to be amplified and heard above the din. Through increased engagement with the PAC, we can support elected officials who champion our interests and create policies that affect our daily practice.

Who is your favorite U.S. historical figure?

US Supreme Court Justice Sandra Day O'Connor!

Reminder: Provider Relief Fund Reporting Deadline is March 31

Pathologists who received Providers Relief Fund (PRF) payments that exceed $10,000 must comply with reporting and auditing requirements by 11:59 PM ET on March 31, 2022. The CAP had encouraged pathologists to utilize the financial assistance from these federal programs if needed and has provided resources for this and other programs.

The Department of Health and Human Services (HHS) announced that the second reporting period for PRF funds closes on March 31 for those Pathologists who received one or more general and targeted PRF payments exceeding $10,000 from July 1, 2020 to December 31, 2020. This portion is based on providers’ losses and expenses from July 1, 2020, through March 31, 2021, while relief recipients can use the funds to reimburse costs incurred from January 1, 2020, through at least December 31, 2022. The date that provider relief recipients received the Provider Relief Fund determines which spending deadline they must meet. Therefore, providers who received more than $10,000 in relief in the last reporting period, between July 1, 2021, and December 31, 2021, have to spend until December 31, 2022.

The Health Resources and Services Administration (HRSA) has information and reporting instructions.

Make An Impact With this Unparalleled Lineup of Keynote Speakers

To proactively drive change, our members need the tools to make things happen. Just announced—four keynote speakers at the 2022 Pathologists Leadership Summit, April 30 – May 3, will share unparalleled insights into executive leadership in health care that CAP members can leverage in their practices and use to advance patient care in their communities.

Learn more about our four keynote speakers

UnitedHealthcare Responds to CAP About Designated Provider Program Concerns

Editor’s Note: An earlier version of this article was inadvertently published on February 15. The correct version the article appears below.

UnitedHealthcare responded to the CAP’s and six other medical professional organizations’ objections to the insurer’s Designated Diagnostic Provider program. The groups had asked UnitedHealthcare to withdraw the updated program as it continues to undermine the patient-physician relationship, despite recent changes. The CAP works with private-sector insurers, like UnitedHealthcare, to safeguard access to pathology and laboratory services for patients across all settings.

The CAP was successful in getting UnitedHealthcare to make positive changes to the program after meeting with the insurer in 2021 and emphasizing the program’s burden and confusion, lack of transparency, and the potential for financial harm for patients. However, the CAP, along with the American Medical Association, the American Academy of Dermatology, the American College of Obstetrics and Gynecology, the American College of Rheumatology, American Society of Dermatopathology, and the Medical Group Management Association believe these changes did not go far enough and asked UnitedHealthcare to seek stakeholder input from physicians and medical groups on the Designated Diagnostic Provider program.

In its response, UnitedHealthcare refuted several of the objections, saying they want to “improve the quality and affordability of health care,” but are ready to meet and discuss further if needed. The CAP and the other groups remain concerned about the program’s design and unintended consequences for patients and are evaluating next steps.

The CAP will continue to engage with UnitedHealthcare on the Designated Provider Program and will update membership on any developments.

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