Weekly Spotlight
SHP is a little short on hot takes this week. CMS continues its consistent drumbeat of modest advances or defense of a number of topics including defending IRA drug price negotiations, promoting quality standards, and Medicare Advantage reforms while policies like site-neutral payments, reforming CMMI, and PBM reform scramble for purchase in an escalating political season. Although we can expect the administration to try to slide a few reforms in under the wire so that they would not be subject to Congressional review under a new administration, expect policy-makers to target the easiest lifts and / or the more politically divisive policies as election season approaches. It seems increasingly unlikely most anything will be accomplished with the abortion rights battle remaining top of mind for many voters. Meanwhile, Republicans can be expected to cling to the fiscally conservative right after acquiescing to massive spending last week.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Azar and Sebelius to Congress: Pass Site Neutral Payment Policy
According to the former HHS Secretaries, site-neutral payments represent a commonsense policy that will reduce costs for patients and taxpayers. It will diminish perverse incentives for consolidation, and incentivize care delivery in the right place for the right price. It’s a no-brainer that we believe could reduce costs for patients and payers.
#All
McDermott+ Consulting IPPS Dashboard
This dashboard from McDermott+ Consulting shows the actual costs to hospitals for providing care to Medicare fee-for-service inpatients based on data published by the Centers for Medicare & Medicaid Services (CMS) as part of its rulemaking cycle. CMS uses this information to set payment rates for individual Medicare Severity-Diagnosis Related Groups (MS-DRGs), and it can be used by device manufacturers, hospitals and the general public to understand the resources needed to care for different types of inpatients. According to McDermott, up until recently, total knee and hip replacements were the most common Medicare claim submitted by hospitals. But those cases have come crashing down over the past few years after Medicare said those surgeries no longer had to be done exclusively as an inpatient procedure. What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How has Medicare inpatient volumes changed over time for inpatient hip and femur procedures?
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CMS Publishes: Quality in Motion Acting on the CMS National Quality Strategy
In 2022, the Centers for Medicare & Medicaid Services (CMS) launched the CMS National Quality Strategy (NQS), a plan aimed at improving the quality and safety of health care for everyone, with a special focus on people from under-served and under-resourced communities. The CMS NQS builds on CMS’ efforts to improve health care quality for individuals across their lifespan and continuum of care by using all the Agency’s levers, including value-based payment programs and models; health and safety standards (including conditions for coverage and conditions of participation); survey and certification programs; quality measurement and public reporting; and quality improvement technical assistance. In this “Call to Action,” CMS invites all partners to:
- Prioritize the use of Universal Foundation measures.
- Commit to improving health care safety and reducing harm.
- Advance health equity to improve health outcomes and eliminate disparities.
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CMS Restricts Marketing Companies From Sharing Medicare Beneficiary Data
Manatt takes a look at the role of third-party marketing organizations (TPMOs) in the growth of Medicare Advantage (MA). TPMOs are organizations and individuals, including agents and brokers, that are compensated to perform lead generation, marketing, sales and enrollment-related functions on behalf of MA plans. TPMOs include first tier, downstream or related entity (FDRs) to MA plans, but can also include entities that may not be considered an FDR under existing rules.
Half of Medicare beneficiaries are enrolled in Medicare Advantage (MA) plans. This extensive growth, which represents a doubling of MA enrollment since 2010, has been driven in part by an extensive network of insurance agents and brokers, field marketing organizations and lead generators that identify beneficiaries and assist them in selecting and enrolling in plans. To address some of these practices, the Centers for Medicare & Medicaid Services (CMS) released a final rule on April 4 that puts substantial limits on the ability of TPMOs.
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Telehealth linked to modest quality, cost increases, study finds
A new study published in Health Affairs shows the benefits of telehealth. The findings suggest it would be challenging to restrict telehealth payment in Medicare. Some pandemic flexibilities are set to expire at the end of 2024. See also
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Feds Open Another PBM Probe
CMS is auditing vertically integrated Medicare Part D sponsors, including pharmacy benefit managers and payers, according to HHS’ Office of Inspector General. The agency said the probe is in response to “a wave of vertical integration between PBMs, health insurers, and pharmacies” over recent years. A common concern for vertically integrated models is inflated drug prices, the OIG said, so CMS is investigating a few unspecified insurers and PBMs on their prices for Part D medications.
#Drug, #Payer
Wave of Amicus Briefs Back Drug Price Plan at Trial Court Stage
The Biden administration’s efforts to fend off legal challenges from the pharmaceutical industry battling Medicare drug price negotiations has drawn reinforcements from officials and academics defending the program. Former government officials, legal and economic scholars, and patient advocacy groups have become “friends of the court” in lawsuits by pharmaceutical giants and industry groups fighting the constitutionality of the Medicare Drug Price Negotiation Program. The plan, which is considered one of President Joe Biden’s signature health initiatives under the Inflation Reduction Act, is expected to slash the costs of 10 Medicare Part D drugs beginning in 2026.
#DRUG, #PATIENT
Food and Drug Administration (FDA)
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability
FDA warns drug makers in a new draft guidance not to imply in their promotional and advertising materials that reference drugs are superior to their biosimilars, or that interchangeable biosimilars are clinically distinct from other biosimilars. The warning that such statements could be “false or misleading” comes as the Biden administration takes regulatory steps to increase use of biosimilars, and asks Congress to remove the distinction between biosimilars with interchangeability status and those without.
#DRUG, #PATIENT
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development May 29 – 30, 2024
This session will provide a perspective of the current state at the FDA, both with current activities and what’s to come. Innovation of medical products, whether it be drugs, devices, or biologics, is a continual journey that advances the needs of patients today and of future generations. Innovation takes the form in many spaces such as research, product design, data collection and analysis, and we’re currently bearing witness to a golden age of technology involving artificial intelligence and genomics.
#Device, #Drug
Opinion: Bashing accelerated approval isn’t supported by the data Peter J. Pitts and Timothy R. Franson
The writers posit that FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall survival (progression-free survival). Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer. So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story.
#Drug
Health and Human Services (HHS)
AHRQ Publishes Evidence- and Consensus-Based Digital Healthcare Equity Framework
AHRQ is taking on health equity challenges presented by the availability of new digital healthcare innovations. The advancement of digital healthcare technologies has resulted in many viable solutions that can improve healthcare delivery and outcomes. But all too often, the designers and implementers of these technologies have not intentionally considered the unique needs and capabilities of all applicable patient groups. Omitting equity considerations throughout the lifecycle of digital healthcare technologies can create new or exacerbate existing healthcare disparities.
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HHS unveils latest health data-sharing update
HHS and its nonprofit partner, the Sequoia Project, took another step Monday in implementing a nationwide data-sharing network for patient health data, requiring support for a standard for how the data must be formatted. The Office of the National Coordinator for Health Information Technology at HHS hopes the move will bolster data exchange and better connect providers, public health agencies, researchers and others in medicine. HHS believes the project can bolster patient care by allowing providers to have a longer-term picture of patients’ medical history, enhance research and ensure patients have ready access to their health records.
The Trusted Exchange Framework and Common Agreement SM (TEFCASM) has 3 goals:
- to establish a universal governance, policy, and technical floor for nationwide interoperability;
- to simplify connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value; and
- to enable individuals to gather their health care information.
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HHS Publishes 340B Drug Pricing Program; Administrative Dispute Resolution Regulation Final Rule
The drug industry and health providers are divided over a freshly revised review process for resolving price fights after years of back-and-forth between presidential administrations and federal courts. The Health and Human Services Department on Thursday announced a final rule (RIN 0906-AB28) that updates the administrative dispute resolution process for drugmakers and health providers participating in the federal 340B drug discount program. Under the program, drugmakers are required to discount their products to covered medical providers such as hospitals, community health centers, and others supporting low-income populations.
#Drug, #Hospital, #Patient
Hill Happenings
Arrington and Burgess Ask GAO to Look into CMMI
house Budget Committee Chairman Jodey Arrington (R-TX) and Budget Committee Health Care Task Force (HCTF) Chair Michael C. Burgess, M.D. (R-TX) sent a letter to Comptroller General Gene Dodaro of the U.S. Government Accountability Office (GAO) requesting an updated report on the cost of the Center for Medicare and Medicaid Innovation (CMMI) and its effect on the federal budget.
#PATIENT, #PROVIDER
CBO Director: Presentation at a conference organized by the Economic Policy Innovation Center and the Paragon Health Institute
The Congressional Budget Office breaks down its long-term projections for federal health care spending, options for reducing that spending and more in a presentation for a conference organized by the Economic Policy Innovation Center and the Paragon Health Institute.
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Why some conservatives are targeting healthcare consolidation
Modern Healthcare takes a look at conservative lawmakers who share concerns about trends in health system consolidation and vertical integration.
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Arrington Offers Site Neutral Payments Amendment as Offset
According to his statement, a proposed amendment from Budget Chair Jodey Arrington establishing site neutral payments would have fully offset the cost of the national security supplemental, with an additional contribution of at least $50 billion towards federal deficit reduction. He said the proposed amendment would have had the added benefit of reducing out-of-pocket health care costs for millions of seniors. Under the current system, Medicare’s higher payments for services delivered in hospital outpatient departments lead to higher out-of-pocket expenses for seniors.
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Notable Notes
GAO Report: Prescription Drugs: Selected States’ Regulation of Pharmacy Benefit Managers
A new GAO report looks at private health plans’ contracts with pharmacy benefit managers and the impact of state laws that regulate these companies. State regulators also shared lessons learned about pharmacy benefit manager laws. One suggested that emerging issues could be better addressed with broad regulatory authority than with specific provisions in laws.
#Drug, #Patient, #Payer, #Provider
Alzheimer’s drug adoption in US slowed by doctors’ skepticism
In interviews with Reuters, seven doctors treating patients for Alzheimer’s attributed their own reluctance to prescribe Leqembi to concerns about the drug’s efficacy, cost and risks.
#Drug, #Patient, #Provider
FTC Announces Rule Banning Noncompetes
The Federal Trade Commission issued a final rule to promote competition by banning noncompetes nationwide, protecting the fundamental freedom of workers to change jobs, increasing innovation, and fostering new business formation. The American Medical Association has a long-standing position opposing non-compete clauses in physician contracts.
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