FDA & CMS Indicate Alignment on
Regulatory Approach to LDTs
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On January 18, 2024, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) communicated an aligned stance on the regulation of laboratory-developed tests (LDTs). In a joint statement, leadership from both agencies emphasized the need for increased oversight of LDTs (i.e., tests developed and utilized within a single laboratory).
Originally considered lower-risk due to their simplicity and localized production, LDTs were typically crafted in small volumes by individual labs, often on an as-needed basis. However, in recent years, technological advancements and the increased commercial presence of LDTs have led FDA and CMS to emphasize the evolving nature of these tests.
In October 2023, FDA issued a long-anticipated proposed rule aimed at aligning LDTs with the regulatory framework applied to other in vitro diagnostic (IVD) tests. The proposed multi-year timeline, extending through 2028, outlines a phased approach to reviews and regulatory requirements.
Underscoring the critical role of accurate and reliable diagnostic tests, the joint statement focuses on three areas: (1) the clinical role of laboratory tests, (2) FDA and CMS oversight/proposed changes, and (3) the importance of reliable testing/regulatory adaptation.
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Federal Strategies to Protect
Medical Devices from Cyber Attacks
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Advances in technology continue to expand the capabilities of medical devices. Previously limited to basic items such as bedpans, bandages, crutches, and wheelchairs, the category now encompasses technologies once unimaginable, including cardiac implantable electronic devices and closed-loop artificial pancreas systems.
As medical devices become more sophisticated, the stakes of their potential failure increase. Moreover, as advanced devices become more interconnected through shared networks, the risk of a single device’s failure can extend to multiple patients or entire health systems.
In response to the escalating potential for harm associated with cyber threats targeting medical devices, Congress, FDA, and other federal agencies have intensified their focus on cybersecurity, enacting legislative initiatives and establishing regulatory frameworks to mitigate risks. This governmental push towards stronger cybersecurity measures is paralleled by the medical device sector’s own efforts to enhance the security of their products through the adoption of industry best practices.
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Bipartisan Legislation Would Limit CMS's Forward Movement on Minimum Staffing for Nursing Homes |
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The debate over the establishment of minimum staffing ratios in nursing homes continues.
As Applied Policy reported in its September summary, the rule is a cornerstone of the Biden Administration’s nursing home reform initiative. It would require that nursing homes maintain a registered nurse on-site around the clock, seven days a week, and adhere to a minimum staffing ratio of 55 registered nurse hours per resident day (HPRD) and 2.45 nurse aide HPRD.
CMS has recognized that approximately 75 percent of nursing facilities across the country would need to increase their staffing levels to comply with these proposed standards. The administration has proposed a phased implementation approach, allowing most nursing homes a three-year period to meet these new requirements, with an extended five-year period for facilities in rural areas.
In its comment letter—one of over 46,000 received by CMS—the Medicaid and CHIP Payment and Access Commission (MACPAC) asked that CMS consider the "several potential unintended consequences" the proposed minimum staffing standards could have on Medicaid programs
In November, a coalition of Republican governors cited healthcare workforce shortages and described the proposed rule as an imposition of "unnecessary, one-size-fits-all staff requirements." But opposition to the bill is not limited to one side of the aisle. Some Democratic members of Congress have joined in saying that it is "overly burdensome and will result in additional closures and decreased access to care."
Opponents are placing their hope in congressional support for The Protecting Rural Seniors’ Access to Care Act (S. 3410/H.R. 5796), which was introduced in both chambers at the end of last year. In addition to prohibiting “the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities,” the legislation would establish an advisory panel on the nursing home workforce.
The legislation is endorsed by a number of trade groups including, the American Health Care Association.
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Applied Policy's Latest Summaries |
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CMS has released its Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies that would update program policies for Medicare Advantage and Medicare Part D beginning in 2025, if finalized. CMS also issued its Draft Calendar Year (CY) 2025 Part D Redesign Program Instructions which center on implementing provisions of the Inflation Reduction Act of 2022 (IRA) related to the Part D benefit for 2025.
Changes and proposals include the following:
- Technical changes to effective growth rates for calculating MA payments,
- Changes related to implementing the IRA Part D benefit redesign for 2025,
- Changes to MA risk adjustment methodology,
- Continued risk adjustment model for Program of All-Inclusive Care for the Elderly (PACE) Organizations,
- Continued Part D risk adjustment model with plans for 2025 IRA-related changes,
- Continued End Stage Renal Disease risk adjustment model,
- Introduction of a frailty adjustment for PACE and Fully Integrated Dually Eligible SNPs,
- Adjustments to Fee-for-Service per capita costs in Puerto Rico, and
- Solicitation of feedback on MA star ratings measure concepts for future years.
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On January 17, 2024, CMS released the Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies final rule, which finalizes policies to streamline prior authorization processes for medical items and services and improve healthcare data electronic exchange standards and adds a new Medicare Promoting Interoperability Program measure for eligible hospitals and critical access hospitals (CAHs) and for Merit-based Incentive Payment System (MIPS) eligible clinicians.
This rule finalizes the following:
- Streamlined policies to make the prior authorization process more efficient,
- A requirement for payers to include prior authorization information in the patient access application programming interface (API),
- A requirement for payers to implement a provider access API,
- A new electronic prior authorization measure for MIPS-eligible clinicians under the Promoting Interoperability performance category of MIPS, as well as for eligible hospitals and CAHs under the Medicare Promoting Interoperability Program,
- A requirement for payers to exchange, with patient consent, certain patient data, prior authorization requests and decisions when a patient changes health plans, and
- Recommended but not required Implementation Guides for implementing the APIs.
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Medicare Advantage Plans –
Exploring Their Growth, Future, and Pitfalls
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Over the last decade, more seniors have been choosing Medicare Advantage (MA) plans, the private plan alternative to traditional Medicare. Although private plans have been an option in Medicare since the 1970s, the Medicare Modernization Act of 2003 changed the program substantially and propelled their growth. Medicare beneficiaries have increasingly gravitated toward MA plans, and MA enrollment recently passed 50 percent. The average MA beneficiary can choose from 43 privately administered plans, which attract seniors with their lower costs and extra benefits. Along with the increasing MA enrollment rates, there are also growing concerns about claims denials, out-of-pocket copay costs, and limited networks of doctors and hospitals.
Michelle Millerick, Senior Associate Director for Health Insurance Coverage and Policy at the American Hospital Association, and Meredith Freed, Senior Policy Manager at KFF’s Program on Medicare Policy, will join the Northern Virginia Health Policy Forum on Wednesday, February 28. Our panelists will discuss the burgeoning landscape of MA plans and what that means for beneficiaries, providers, and policymakers.
The conversation starts at noon ET.
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Highlights from NVHPF's January Event:
Exploring Tomorrow's Pain Relief
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On January 23, the Northern Virginia Health Policy Forum hosted a discussion of non-opioid approaches to pain control and the necessary steps to ensure their availability to patients who might otherwise be put at risk for opioid abuse.
Our guests were Sanjay Sinha, MD, Founder and Chief Innovation Officer of Gate Science and Lead Anesthesiologist at the Connecticut Joint Replacement Institute, and Dru Riddle, PhD, DNP, CRNA, FAAN, President of the American Association of Nurse Anesthesiology.
Watch highlights above or find a link to the event in its entirety here.
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Patricia Bath: Seeing a Brighter World |
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Dr. Patricia Era Bath was an African American ophthalmologist, inventor, and public health activist whose life and work paralleled some of the most critical decades in the Civil Rights Movement. Yet even though many of us have family members whose lives have been impacted through her discoveries, few Americans know her name.
Born in Harlem in 1942, Bath would later say that her parents, a father who immigrated from Trinidad and a mother raised in the American South, expected nothing less than 100 percent from her. She made it her aim to never disappoint them.
In high school, Bath was recognized as a National Science Foundation Scholar. She went on to graduate from Hunter College and earn her medical degree from Howard University College of Medicine in Washington, D.C. in 1968.
While working as a medical intern in New York City, Bath observed a disturbing disparity in the rates of vision impairment between the patients she treated at Columbia University Hospital and the predominately Black patients she saw during her work at Harlem Hospital. This would inform her work going forward.
In 1976 Bath cofounded the American Institute for the Prevention of Blindness, in a belief that “Eyesight is a basic human right and that primary eye care must be a component of basic health services.” Three years later, she cited “excessive rates of blindness otherwise preventable or curable” in Black populations in calling for the development of “community ophthalmology”, a discipline for “promoting eye health and blindness prevention through programs utilizing methodologies of public health, community medicine, and ophthalmology.”
But Bath’s work went far beyond activism and public health. She was a practicing surgeon and researcher, becoming the first female faculty member of the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA) and the first Black woman surgeon at the UCLA Medical Center.
In addition to her work in the United States, Bath also conducted research in affiliation with England’s Loughborough Institute of Technology, the Rothschild Eye Institute of Paris, and the Laser Medical Center of Berlin.
In 1988, Bath received a patent for the Laserphaco Probe, a surgical tool that uses a laser to vaporize cataracts. It revolutionized cataract surgery, one of the most common surgical procedures in the world.
The first African American woman to receive a patent for a medical purpose, Bath eventually held five patents. In recognition of her contributions to medicine and public health, the Tribeca Film Festival honored Bath with its Disruptor Award in 2012.
Bath acknowledged that her career path was not easy. At UCLA, Bath was originally assigned an office "in the basement next to the lab animals," a location she declined as “inappropriate” for her work.
“I had a few obstacles, but I had to shake it off. Just like Taylor Swift says,” Bath said in a 2018 interview on Good Morning America. “You know hateration segregation, racism. That's the noise and you have to ignore that [and] keep your eyes focused on the prize.”
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The U.S. Department of Health and Human Services hosted its first-ever Food is Medicine Summit in Washington, D.C., on January 31. The event included the announcement of public-private partnerships with Instacart, the Rockefeller Foundation, and Feeding America.
Applied Policy delved into the growing interest in the Food as Medicine philosophy last year, exploring both its potential and its challenges. We invite you to revisit our story for a better understanding of the discussions that are shaping this growing movement.
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MACPAC holds January 2024 meeting |
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The Medicaid and CHIP Payment and Access Commission (MACPAC) held a virtual public meeting on January 25 and 26, 2024. It included sessions on Denials and Appeals in Medicaid Managed Care; Policy Options for Improving the Transparency of Medicaid Financing; Findings from Expert Roundtable on Evaluating the Effects of Medicaid Payment Changes on Access to Physician Services; Medicaid Coverage of Physician-administered Drugs; and Highlights from Duals Data Book.
In addition, the commissioners approved seven recommendations aimed at improving Medicaid MCO denial and appeals processes.
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MedPAC holds first meeting of 2024 |
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The Medicare Payment Advisory Commission (MedPAC) held a virtual public meeting on January 11 and 12, 2024. It included the following sessions:
- Assessing payment adequacy and updating payments: Physician and other health professional services;
- Assessing payment adequacy and updating payments: Hospital inpatient and outpatient services;
- Assessing payment adequacy and updating payments: Outpatient dialysis services; hospice services; skilled nursing facility services; and home health agency services;
- Assessing payment adequacy and updating payments: Inpatient rehabilitation facility services; and improving the accuracy of payments in the IRF prospective payment system;
- Medicare Part D: Status report;
- Ambulatory surgical centers: Status report;
- The Medicare Advantage program: Status report; and
- Standardized benefits in Medicare Advantage plans: Policy options.
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February 13
February 29
March 1
March 7-8
March 7-8
March 11-15
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Gallup
MIT Tech Review
Nature
San Diego Union-Tribune
STAT
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Insight Joke of the Month for February |
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What type of doctor is Dr. Pepper? |
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What We are Listening to in February:
The People Behind the Science Podcast
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Have you ever wondered what motivates leading scientific researchers, how they juggle competing priorities, or how they cope with personal and professional setbacks? People Behind the Science has you covered.
In addition to asking scientists to describe their work, the show's host Marie McNeely, PhD, invites them to share their personal stories. The result is a series of engaging conversations that are as entertaining and inspiring as they are illuminating.
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Applied Policy, L.L.C., is a health policy and reimbursement consulting firm strategically located minutes from Washington, D.C.
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