About Covid-19
End of a Declared Public Health Emergency — Implications for U.S. Emergency Use Authorizations “Despite the planned ending of the Covid-19 public health emergency in the United States, medical products approved under emergency use authorizations will remain available for the foreseeable future.”
About health insurance/insurers
CMS to raise Medicare Advantage pay rates by 3.3% in 2024; phase in risk adjustment changes “The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed.
The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year…
CMS will still transition the coding system from Internal Classification of Diseases (ICD)-9 to ICD-10 more commonly used by physicians.”
Medicaid redeterminations begin April 1 “After more than three years, the nation's continuous Medicaid enrollment policy has come to an end, setting off a pivotal redetermination period that will present unprecedented challenges for payers, health systems, and state Medicaid agencies alike.
The redetermination process threatens the nation's record low uninsured rate of 8 percent, with the most recent studies estimating that up to 18 million people could lose Medicaid coverage over the next 12 to 14 months, including more than 6 million children — 3.8 million people are estimated to remain uninsured entirely. Not only are commercial payers facing a loss of members through their managed care programs, hospitals could encounter millions of newly uninsured patients.”
CVS-Oak Street deal clears federal regulatory hurdle “The Justice Department and Federal Trade Commission allowed the antitrust waiting period to lapse on Monday without taking action to prevent the two companies from combining, Chicago-based primary care provider Oak Street reported in a filing to the Securities and Exchange Commission Thursday. That doesn't prevent those regulators from taking action at a later time, but it does clear the way for the deal to advance.”
Changes in Medicare Accountable Care Organization Spending, Utilization, and Quality Performance 2 Years Into the COVID-19 Pandemic “In Medicare’s largest ACO program, non–COVID-19 health care spending per capita in 2021 recovered to the pre–COVID-19 baseline after a steep decline in 2020 but with a relative shift from acute inpatient to outpatient spending. The $1.7 billion in net savings to Medicare compared with MSSP [Medicare Shared Savings Program] cost targets seem to come from sustained reductions in inpatient, postacute facility, and ED utilization into year 2 of the COVID-19 pandemic. Despite a decrease in postacute facility discharges, the lack of statistical reduction in postacute care spending is explained in part by a coinciding increase in hospice spending. Notably, initial concerns about a post–COVID-19 surge in admissions from delayed care have thus far not materialized in the MSSP.
Quality performance decreased in 2021 vs 2019, reflecting a reduction in patient experience scores (reintroduced for 2021 after a 2020 suspension due to the COVID-19 pandemic). Notable declines occurred in scores for timely care, specialist access, and shared decision-making, which may reflect system challenges with managing the rebound in outpatient utilization amid workforce shortages and fatigued clinicians. Nevertheless, 99% of ACOs met the quality threshold for shared savings eligibility.”
About pharma
Vanda Prevails in Jet Lag Litigation Against the FDA “On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the Food and Drug Administration ("FDA") during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz® (tasimelteon)…
Vanda had repeatedly attempted to obtain these records from the FDA pursuant to a FOIA request it submitted in December 2019, but the FDA had refused to disclose those records, invoking the deliberative process exemption under FOIA.
The court rejected the FDA's claim that it would suffer ‘foreseeable harm’ if it disclosed to Vanda its reviews relating to Vanda's sNDA. In particular, the court held that in the context of this case, contrary to the FDA's assertion, ‘[d]isclosure cannot chill’ the ‘deliberations’ of agency staff.”
Comment: The specifics of the care are far less important than the precedent it sets for release of such records.
About the public’s health
MPP Inks Licensing Pacts With Three Generic Drugmakers Over HIV PrEP Drug “The Medicines Patent Pool (MPP) has signed licensing agreements with Aurobindo, Cipla and Viatris to manufacture generic versions of cabotegravir, ViiV Healthcare’s long-acting drug for HIV pre-exposure prophylaxis (PrEP).
MPP is a United Nations initiative aimed at facilitating the development of life-saving medicines for low- and middle-income countries through voluntary licensing and patent pooling.”
About healthcare IT
FDA Says New Applications for Cyber Devices Need a Security Plan “Starting March 29, new applications to the FDA for a ‘cyber device’ must identify any vulnerabilities and include a plan for ongoing security throughout the device’s life, the FDA said in a final guidance released yesterday.
’Cyber device’ means a device that includes software, can connect to the internet and has any technology that could be vulnerable to cybersecurity threats.”
About healthcare personnel
Association of Clinician Practice Ownership With Ability of Primary Care Practices to Improve Quality Without Increasing Burnout “In this cross-sectional study, clinician-owned practices were more likely to achieve improvements in cardiovascular quality outcomes without increasing staff member burnout than were practices owned by a hospital or health system. Given increasing health care consolidation, our findings suggest the value of studying cultural features of clinician-owned practices that may be associated with positive quality and experience outcomes.”