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Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import prescription drugs from Canada. These “Section 804 Importation Programs” (SIPs), if approved, would enable states to import prescription drugs from Canada, often at significantly lower prices than those available in the United States.

After years of legal and other challenges to the rule, on January 5, 2024, the FDA authorized Florida’s SIP proposal. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country. Following Florida’s example, Colorado and other states are moving forward with their own SIP plans.

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Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

The Centers for Medicare & Medicaid Services (CMS) announced in March that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.

In Wegovy’s case, the FDA recently approved an additional indication “to reduce the risk of major cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal strokes) in adults with established cardiovascular disease and either obesity or overweight” in combination with a reduced caloric diet and increased physical activity. As a result, Wegovy can be available for Medicare beneficiaries who have an established cardiovascular disease and are either overweight or obese. Part D coverage is still not available for weight-loss medications in beneficiaries who do not have the additional medically accepted indication.

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OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities

On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated entities and the public.” While the update appears to narrow the scope of what OCR considers to be HIPAA-protected health information (PHI) in the context of online tracking technologies, it largely reconfirms prior guidance in the 2022 bulletin and will likely have limited practical impact for HIPAA-covered entities and business associates that have already heeded the 2022 bulletin.

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IRS Announces 2025 Limits for Health Savings Accounts, High-Deductible Health Plans and Excepted Benefit HRAs

The Internal Revenue Service (IRS) recently announced (see Revenue Procedure 2024-25) cost-of-living adjustments to the applicable dollar limits for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted benefit health reimbursement arrangements (HRAs) for 2025. All of the dollar limits currently in effect for 2024 will change for 2025, with the exception of one limit. The HSA catch-up contribution for individuals ages 55 and older will not change as it is not subject to cost-of-living adjustments.

See the adjustments here.




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CMS Releases FY 2025 IPPS Proposed Update

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the Hospital Inpatient Prospective Payment System (IPPS) proposed update for fiscal year (FY) 2025, along with proposed policy and regulation changes. The proposed rule would update Medicare payment policies and quality reporting programs relevant for inpatient hospital services, and build on key agency priorities, including advancing health equity and improving the safety and quality of care.

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340B Remedy Rule and Medicare Advantage Rates: Navigating Shifting Payments

On April 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, otherwise known as the rate announcement. The rate announcement is released annually and includes updates to the methodologies used to calculate MA plan payments, as well as other payment policies that impact Part D. The CY 2025 rate announcement finalizes the policies proposed in CMS’s January 2024 advance notice.

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New UK Employment Law Changes Taking Effect

This spring sees the introduction of a number of important changes to employment laws in the United Kingdom. These include:

  • Expansion of the existing right to request flexible working
  • New rules for the calculation of holiday and holiday pay entitlement for irregular hour workers and part-year workers
  • A new unpaid leave right for carers
  • Greater flexibility in respect of paternity leave
  • Enhanced redundancy protection for pregnant employees and employees taking certain family leave
  • Increases in minimum wage limits
  • Increases in the value of certain potential tribunal awards and other statutory payment entitlements
  • Increases in the value of potential injury to feeling awards in discrimination cases

Read about the changes here.




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Indiana Enacts New Law Requiring Notice of Healthcare Transactions

On March 13, 2024, Indiana enacted Senate Bill No. 9, which establishes that the Office of the Indiana Attorney General must receive prior written notice of certain transactions involving Indiana healthcare entities. This new law goes into effect July 1, 2024, and has a more expansive reach than many of its peer transaction notice laws. It expressly identifies private equity firms as qualifying entities, applies to a broad scope of transactions and sets a lower threshold for reportable transactions than other states at $10 million. Indiana has not yet promulgated regulations, rules or guidance related to the law.

Parties interested in Indiana’s healthcare landscape should closely monitor developments, as the $10 million threshold and broad definition of “health care entities” is likely to capture healthcare transactions that previously would not have been subject to review.

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FTC Issues Rule Banning Worker Noncompete Agreements

On April 23, 2024, the Federal Trade Commission (FTC) voted 3-2 along party lines to ban all new noncompete agreements nationwide and render existing noncompete agreements binding most workers unenforceable. The Final Rule, slated for publication in the Federal Register, provides that employers’ use of noncompete agreements amounts to an “unfair method of competition” that runs afoul of Section 5 of the FTC Act.

Read more here.

COMING UP

For a deeper dive, join our multidisciplinary team of employment and antitrust lawyers for a webinar covering what employers need to know about the Final Rule and what to do next.

FTC’s Final Noncompete Rule: What It Means and Next Steps for Employers
Wednesday, May 8, 2024
Webinar | 2:00 – 3:00 pm (EDT)

Register for the webinar here.




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