News & Analysis as of

Medical Supplies

Eleventh Circuit Affirms Two Grants of Summary Judgment in Favor of Diabetic Experts

by Bass, Berry & Sims PLC on

A unanimous panel of the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit) recently affirmed two grants of summary judgment in favor of defendant Lincare, Inc. d/b/a Diabetic Experts of America (collectively,...more

District Court Rules Online Auction for Medical Supplies Violates Anti-Kickback Statute

by Jones Day on

On March 6, 2017, the U.S. District Court for the District of Connecticut held that an arrangement between a company operating an online portal for purchases of medical equipment and a supplier of medical products violates...more

FDA: The Powdered Gloves Come Off

by Stinson Leonard Street on

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

Second Circuit Affirms Preliminary Injunction of "Identical" Gray Goods

by Proskauer Rose LLP on

Earlier this month in Abbott Laboratories v. Adelphia Supply USA et al, the Second Circuit affirmed a district court's grant of a preliminary injunction halting the alleged sale of gray-good diabetes test strips made by...more

Many Big Announcements for the UAS Industry and its Safety and Privacy Initiatives

The commercial drone industry is projected to generate over $82 billion for the U.S. economy and over 100,000 new jobs by 2025. Last week, at the White House Office of Science and Technology Policy’s (OSTP) “Workshop on...more

Round Up The Usual And Customary Suspects: Insurers May Determine UCR Prices By Shopping At Retail Outlets

by Carlton Fields on

For more than a decade, medical providers have tried to limit the discretion of automobile insurers to pay less than the billed amount for services and equipment offered to injured insureds. Most of these efforts involve...more

News Flash: It’s Not Illegal to Tie Sutures!

by Faegre Baker Daniels on

You have to hand it to Kansas federal judge Daniel Crabtree. He played it completely straight in his April 7 decision rejecting the claim by Suture Express that two national medical supply distributors were guilty of...more

CMS Finalizes Medicaid Home Health and Medical Equipment Policy Changes, Including Face-to-Face Encounter Requirements

by Reed Smith on

CMS published a final rule on February 2, 2016 to implement statutory requirements regarding documentation of face-to-face encounters with Medicaid beneficiaries within certain timeframes as a condition of Medicaid coverage...more

US expands list of medical items authorized for export or re-export under Iran general license

by Dentons on

On November 2, 2015, the US Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) updated and expanded the list of “medical supplies” that can qualify for export or re-export to Iran under the existing...more

OFAC Expands List of Medical Supplies Eligible for Export to Iran under General License

On November 2, 2015, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) updated the List of Medical Supplies eligible for export or reexport to Iran under the general license set forth at Section...more

Is Iran Open for Business for U.S. Exporters?

by Baker Donelson on

On August 7, 2015, the U.S. Government issued a revised Guidance regarding Iran and also issued a Third Amended Statement of Licensing Policy on Activities Related to the Safety of Iran’s Civil Aviation Industry. The bottom...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

by Cooley LLP on

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Tax Alert: 'Medical Device Tax' Now in Effect

by Nexsen Pruet, PLLC on

The accounting departments of many hospitals and medical practices are preparing for increased costs on medical supplies. Beginning January 1, 2013, new Section 4191 of the Internal Revenue Code (the “Code”) now imposes a...more

The Sunshine Act Final Rule: CMS Sheds Light on Reporting Physician and Teaching Hospital Payments

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing the Physician Payment Sunshine Act (the “Act”). The Act requires certain manufacturers of covered drugs, devices, and...more

Here Comes the Sun: Final Rules Implementing the Federal Sunshine Law

by Ropes & Gray LLP on

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal...more

Physician Payment Sunshine Rule is Finalized

by Baker Donelson on

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

CMS Issues Final Rule for Implementing Sunshine Act

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Physician Payment Sunshine Act Regulations

by Perkins Coie on

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

The Physician Payment Sunshine Act Final Rule A Summary Of Key Provisions

by Foley Hoag LLP on

On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act. The...more

CMS Releases Final Rule on Physician Payment Disclosures

by Ballard Spahr LLP on

Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Health Law Alert: Final Sunshine Act Regulations Released

by Stinson Leonard Street on

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more

CMS Publishes Final Sunshine Act Rule

This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more

China Trade Marks – Inclusion of Retail and Wholesale services relating to medicines and pharmaceuticals

by K&L Gates LLP on

The China Trade Marks Office (CTMO) recently announced that from 1 January 2013 it is accepting applications to register trade marks in relation to retail or wholesale services for pharmaceutical, veterinary and sanitary...more

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