News & Analysis as of

Pharmacies

Health Plans and Pharmacy Benefit Managers – Past and Future

Historically, health plans and pharmacy benefit managers (“PBMs”) have been uncomfortable neighbors. Plans provide drug coverage, but contract out the provision of such drugs to independent PBMs. PBMs in turn earn market...more

Report Details Uneven Implementation of the New Drug Tracing Law

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA...more

Private Equity Firm Named As Defendant In False Claims Act Case Targeting A Portfolio Company

A recent complaint filed by the United States against a private equity firm regarding an alleged kickback further illustrates new concerns private equity should be aware of in the healthcare arena and working with counsel to...more

CMS releases Medicare Advantage/Part D final rule

by Hogan Lovells on

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

CMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D). ...more

Second Circuit Affirms Exception for Flu Shot Reminder

Doubling down on the healthcare exception to the Telephone Consumer Protection Act (TCPA), the U.S. Court of Appeals for the Second Circuit ruled that Rite Aid was not liable for flu shot reminder calls....more

CMS Releases 2019 MA and Part D Final Rules and Call Letter

Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter. The Final...more

Pharmaceutical Reforms in 2018-19 New York State Budget

by Farrell Fritz, P.C. on

Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more

Rx IP Update - March 2018

by Smart & Biggar on

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

DC Circuit Turns Away Healthcare Challenges to TCPA Declaratory Ruling

In ACA International v. Federal Communications Commission, 2018 U.S. App. LEXIS 6535 (2018), the DC Circuit rejected a series of challenges to the FCC’s 2015 Declaratory Ruling brought by Rite-Aid related to the...more

2018-19 New York State Healthcare Budget

by Farrell Fritz, P.C. on

In the wee hours of the morning on March 30, almost two days ahead of the April 1 deadline, the Legislature passed and the Governor signed a $168.3 billion State Budget for the 2018-19 fiscal year. ...more

Wisconsin and West Virginia Pass Biosimilar Legislation

by Goodwin on

Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on...more

OIG Advisory Opinion 18-01: Excluded Individual May Serve as Marketing Liaison to LTC Pharmacies

by Baker Ober Health Law on

In OIG Advisory Opinion 18-01, published February 27, 2018, the OIG concluded a proposed employment arrangement between an excluded individual and a for-profit company selling discounted emergency medications to long term...more

Investor, Beware: New Prosecutorial Scrutiny of Private Equity Investment in Healthcare Companies

A bedrock principle of private equity investment is that investors expect to make money on their investments. A recent lawsuit by the Department of Justice (DOJ), however, might force private equity investors in healthcare to...more

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

D.C. Circuit Shuts Down Rite Aid’s Challenge to Expand Healthcare Exemptions under the TCPA and HIPAA

by Dorsey & Whitney LLP on

On March 16, 2018, the U.S. Circuit Court of Appeals for the District of Columbia issued a groundbreaking decision in ACA Int’l v. FCC, No. 15-1211, 2018 U.S. App. LEXIS 6535 (D.C. Cir. Mar. 16, 2018) (“ACA Int’l“) that...more

Health Care E-Note - March 2018

by Burr & Forman on

Matt Kroplin and Adam Overstreet expand on the Department of Justice’s surprising announcement that it will begin seeking dismissal of meritless qui tam cases brought under the False Claims Act. This announcement signifies a...more

The State AG Report Weekly Update

by Cozen O'Connor on

2018 AG Elections- Democrat Kwame Raoul and Republican Erika Harold Win Illinois AG Primary Races- Democratic State Senator Kwame Raoul defeated seven opponents, including former Illinois Governor Pat Quinn, to win the...more

United States Intervenes in Suit Against Private Equity Firm Based on Health Care Portfolio Company's Alleged False Claims Act...

• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more

5 Key Points on Retail, Specialty, Compounding, and Other Pharmacy Investment Opportunities

by McGuireWoods LLP on

The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference focuses on investing in pharmacy businesses. The pharmacy industry has been...more

Class III Hospital Permits – Efficient Drug Management May Become a Reality

At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

No US? No big deal. At least when it comes to the once-and-future TPP pact, which Japan, Canada, Australia, and 8 other US allies signed yesterday in Santiago, Chile....more

Cigna Announces Proposed Acquisition of Express Scripts, Quickening the Pace of Vertical Mergers in the Healthcare Industry

Late last year, CVS and Aetna announced a merger, combining one of the nation’s largest health insurance companies and a large PBM, that being CVS’ Caremark division. The trend continues, as on March 8, Cigna announced its...more

K&L Gates Triage: The Opioid Epidemic: DEA’s Role in Regulating Individuals and Entities Handling Controlled Substances

by K&L Gates LLP on

In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more

Rx to save patients money: Lift Big Pharma ‘gag orders’ on pharmacists

Big Pharma’s notorious middle-men, aka prescription benefit managers or PBMs, are coming under yet more fire — this time over so-called gag orders that they impose on pharmacists they work with, preventing these front-line...more

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