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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Foley & Lardner ordered by Published Date Descending.
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1
Site-Neutral Hospitals Find Reprieve For Their Outpatient Departments Through The Courts
On September 17, 2019, the D.C. District Court held that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority...
United States
1 Oct 2019
2
Health Care MarketTrends | September 2019, Issue 2
Welcome to Foley & Lardner LLP's Health Care MarketTrends. In this issue, we examine private equity investment in specialty areas of the health care industry, specifically dermatology and orthopedics.
United States
23 Sep 2019
3
Aseracare 11th Circuit Case Holds Differences In Hospice Clinical Opinions Are Insufficient To Demonstrate Falsity Under The FCA
Tuesday's ruling by the United States Court of Appeals for the Eleventh Circuit in United States v. AseraCare is a win for hospice and other health care providers who have long argued
United States
16 Sep 2019
4
Personalized Therapy Patent Falls As Patent-Ineligible
In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment
United States
12 Sep 2019
5
Is An Employer's Health Plan Required To Count The Value Of Drug Manufacturer Coupons Towards An Employee's Out-Of-Pocket Maximum?
These days, almost all employer-sponsored group health plans require an employee (and any dependents) covered under the plan
United States
11 Sep 2019
6
Statements Of Efficacy And Safety Material Claim Limitations
In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that "wherein" clauses in a patent claim were limitations
United States
4 Sep 2019
7
Federal Circuit Finds Method Withholding Treatment Ineligible For Patenting
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting "excluding"
United States
4 Sep 2019
8
Federal Circuit Contrives Substantially Similar Written Description Test
In contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy's Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement
United States
28 Aug 2019
9
Proposed Changes To Part 2 Rules Ease Substance-Use Disorder Record Sharing
Recently proposed changes to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) would all but eliminate the most significant
United States
28 Aug 2019
10
The Era Of Personalized Medicine Has Arrived - PMC's Annual Progress And Outlook Report
The Personalized Medicine Coalition (PMC) released its annual "Personalized Medicine At FDA: A Progress & Outlook Report" (Report) that monitors current successes and challenges in bringing
United States
28 Aug 2019
11
New Study Concludes Limits On Resident Work Hours Had No Negative Impact On Quality Metrics For Internal Medicine
The implementation of the 2003 Accreditation Council for Graduate Medical Education (ACGME) regulations on physician resident work hours led
United States
27 Aug 2019
12
Florida: Changes To The State Patient Brokering Act
This is an uncomfortable summer for health care providers in Florida! The legal landscape changed dramatically over the 4th of July holiday.
United States
20 Aug 2019
13
New IRS Guidance Expands Preventive Care Benefits An HSA-Qualifying HDHP Can Provide Before Deductible Is Met
On July 17, 2019, the Internal Revenue Service (IRS) issued new guidance that expands the preventive care benefits a high deductible health plan
United States
14 Aug 2019
14
Telehealth: Medicare Moves Forward By Proposing New Telehealth Services For 2020
On July 29, the Centers for Medicare and Medicaid Services (CMS) issued its proposed 2020 Physician Fee Schedule rule, which contains new telehealth services covered under Medicare
United States
14 Aug 2019
15
Remote Patient Monitoring: Medicare Proposes Two Major Expansions
Last week, CMS proposed two significant changes to remote patient monitoring (RPM) services reimbursed under the Medicare program.
United States
9 Aug 2019
16
Radiation Oncology: What You Need To Know About The Long Awaited Bundled Payment Proposal
The deadline for comments on the Notice of Proposed Rule Making is September 16, 2019, at 5 p.m. ET.
United States
8 Aug 2019
17
Senior Living: HUD 232 Program As An Alternative To Traditional Bond Financing
Senior living providers long have considered the bond market to be a primary vehicle for financing. However, not all transactions are a good fit for tax-exempt bonds. State law issuer considerations
United States
1 Aug 2019
18
Drug Pricing: White House Announces Withdrawal Of Proposed Changes To Anti-Kickback Safe Harbors
On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers.
United States
26 Jul 2019
19
Blockchain: A Tool With A Future In Healthcare
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents.
United States
25 Jul 2019
20
Manufacturing MarketTrends | July 2019, Issue 2
Welcome to issue two of Foley's Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue
United States
25 Jul 2019
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