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Searcy Denney Scarola Barnhart & Shipley

Side Effects of Prescription Drugs: What You Should Know

Many prescription drugs have side effects. In fact, drug companies frequently include a list of side effects on their drugs’ labels and packaging (not because they want to, but because they are required to do so under federal...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Life Sciences and Food + Agriculture

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the sixth episode of When Your Life Sciences Are on the...more

Goodwin

Watch the Clock! CMS Makes Important Changes to Medicare Overpayment Rules

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The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2024 #3

News Briefs - New FDA Guidelines Aim to Make TV Drug Ads Clearer, More Direct - The ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look, as new rules...more

Knobbe Martens

CDRH Announces Pilot Program to Improve Recall Communication

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On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls. The CDRH intends for the pilot...more

Smart & Biggar

Generic not required to address patent submitted before ANDS filing but listed after

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On November 20, 2024, the Federal Court dismissed EMD Serono (Serono)’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 3,087,419 (419 Patent) on the Patent Register one week after it was...more

Smart & Biggar

Federal Court denies motion to add infringement counterclaim to ustekinumab impeachment action

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After filing a new drug submission for its ustekinumab biosimilar PYZCHIVA (Janssen’s STELARA), Samsung commenced the underlying action against Janssen for impeachment of Canadian Patent No. 3,113,837. Janssen sought to add a...more

Jackson Lewis P.C.

Potential Shifts in Employee Benefits: A Guide for Employers Under Trump

Jackson Lewis P.C. on

As we prepare for another change in Administration in the White House, it is crucial for employers and plan sponsors to stay informed and prepared. While much of what lies ahead is speculative, understanding these possible...more

Morgan Lewis - Health Law Scan

Falling Stars Ratings in Medicare Advantage Lead to Meteoric Payment Losses

The enormous impact of Medicare Stars Ratings on payments received by Medicare Advantage plans cannot be overstated. And with billions of dollars in bonus payments at stake, it may come as no surprise that stringent standards...more

Quarles & Brady LLP

New York Passes Much-Anticipated Law Authorizing Pharmacy Shared Services Arrangements

Quarles & Brady LLP on

On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more

Haight Brown & Bonesteel LLP

Evidence of the Reasonable Value of Medical Services for Non-Emergency Care Provided by a Hospital is governed by the Howell...

In David Yaffee v. Joseph Skeen, et al., (Filed 11/25/2024, C097746 and C097988), the California Court of Appeal, Third Appellate District, held that evidence of the reasonable value of medical services rendered to an insured...more

Dechert LLP

Dechert Re:Torts - November 2024

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EPA to Expand PFAS Reporting and Delay Separate PFAS Reporting Rule - EPA’s recent regulations highlight the complexities in its expanding oversight of hundreds of PFAS compounds....more

King & Spalding

OIG Issues Nursing Facility Compliance Guidance

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On November 20, 2024, OIG released new compliance program guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (the Nursing Facility ICPG or the Guidance). The...more

King & Spalding

End of Year Compliance Updates

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On June 25, 2024, the Office for Civil Rights and the U.S. Department of Health and Human Services issued the HIPAA Privacy Rule To Support Reproductive Health Care (the “HIPAA Final Rule”) aimed at strengthening privacy...more

McGuireWoods LLP

Senior Living Alert: Senior Care Impact — Results From 2024 Elections

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The 2024 elections brought significant shifts and challenges at both state and national levels, with senior care emerging as a key focus in some regions while remaining underemphasized in others. From California’s ongoing...more

Bond Schoeneck & King PLLC

Changes Are Likely on the Horizon for the Federal Healthcare Portfolio in Areas Including Cybersecurity and Regulatory Enforcement

Federal healthcare administration undoubtedly will look different in 2025 than it does as we close 2024. In the aftermath of the Republican party victories during this month’s Federal elections – and if the past is...more

Groom Law Group, Chartered

DOL & Treasury Extend Certain ERISA-Related Deadlines for Helene and Milton Impacted Areas

On November 8, the Departments of Labor and Treasury (the “Departments”) issued guidance extending certain deadlines related to retirement, health, and welfare plans in response to Hurricane Helene, Tropical Storm Helene, and...more

Dinsmore & Shohl LLP

Deadline Approaching for Compliance with New HIPAA Reproductive Health Care Privacy Rule

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The deadline for compliance with the Department of Health and Human Services Office of Civil Rights’ (“OCR”) recent update to the HIPAA Privacy Rule is December 22, 2024 -- less than thirty days away. Last spring, OCR...more

Rivkin Radler LLP

Third-party biller fraud may hook your practice, unless you protect yourself

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A November 25 article in Part B News, “Third-party biller fraud may hook your practice, unless you protect yourself,” discussed the federal government’s recent fraud investigation of a medical biller in New York State and...more

Dentons

Ep. 41 – Remind Employees of Your Gift Policy

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Holiday gifts are a common marketing tool used by many businesses; however, in healthcare, they can create compliance issues. Most healthcare providers have a gift policy that limits the type of gifts and other business...more

Manatt, Phelps & Phillips, LLP

CMS Approves New 1115 Waiver Demonstrations for Continuous Coverage

On November 14, the Centers for Medicare & Medicaid Services (CMS) announced approval of Section 1115 demonstration amendments for Colorado, Hawaii, Minnesota, New York, and Pennsylvania —all of which will provide multi-year...more

Manatt, Phelps & Phillips, LLP

J&J Sues HRSA Over Agency’s Challenge of its Rebate Model

On November 12, Johnson & Johnson (J&J) filed suit against the Health Resources and Services Administration (HRSA) in D.C. federal district court, arguing that the 340B statute explicitly provides flexibility for...more

Holland & Knight LLP

CDPAP Fiscal Intermediary Takes Aim at DOH's Competitive Bidding Process

Holland & Knight LLP on

Another day, another legal challenge to New York's overhaul of the Consumer Directed Personal Assistance Program (CDPAP). In an emergency petition filed Nov. 25, 2024, by the state's largest fiscal intermediary (FI), Freedom...more

Smart & Biggar

Health Canada releases notice on aligned reviews between Health Canada and health technology assessment organizations

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On November 5, 2024, Health Canada released the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations.According to the notice, effective immediately, the option for aligned...more

Knobbe Martens

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

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A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

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