Suppliers

News & Analysis as of

FTC Scrutinizes Dual Distributor Communications

A dual distribution relationship does not protect against Section 5 liability for an invitation to collude. For the first time, the Federal Trade Commission (FTC) has charged a company with violating Section 5 of the FTC...more

The End of the Wild West

Many say the Wild West ended on this day in 1895 when John Wesley Hardin was gunned down in El Paso by the town’s sheriff. Hardin was a legendary gun slinger who is purported to have gunned down over 40 men in his career. He...more

CMS Proposes Sweeping 'Episode Payment Models' for Cardiac Care, Hip/Femur Fracture Cases, Plus Changes to 'Comprehensive Care for...

Proposed Rule to Impact Hundreds of Hospitals and Post-Acute Providers - Building on the current mandatory Comprehensive Care for Joint Replacement (CJR) bundled payment initiative, the Centers for Medicare & Medicaid...more

Technology Companies Continue Their Automotive Invasion

As we have written about before, the difference between technology companies and automotive companies is getting smaller and smaller. That trend continues to progress. Samsung Electronics Ltd. is closer to becoming an...more

CMS Announces Changes to HHA/Ambulance Supplier Enrollment Moratoria, New Exception Process Demo

CMS has announced a number of changes to its temporary Medicare enrollment moratoria for certain provider types in select geographic areas as a mechanism to address fraud, waste, and abuse. First, CMS is extending for six...more

Selling Your Business? 5 Steps To Maximize Your Return

When a business owner makes the decision to sell a company, numerous factors can affect the price a buyer is willing to pay. Even relatively small oversights raise the prospect that a business owner will leave money on the...more

California Adopts the Sophisticated Intermediary Doctrine

In a recent opinion, the Supreme Court of California formally adopted the Sophisticated Intermediary Doctrine, clarifying what circumstances may permit a raw materials supplier to discharge its duty to warn consumers. Webb...more

DME MACs Warn Suppliers Not to Rely on Manufacturer Coding Advice

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have issued a Correct Coding article on “HCPCS Coding Recommendations from Non-Medicare Sources,” which discusses Medicare supplier responsibility...more

What You Need to Know About Mergers and Acquisitions Involving Government Contractors and Their Suppliers: Volume VII—Investing in...

Numerous government contracts programs support small businesses. There are prime contracts set aside for various categories of small business entities. Agencies have small business contracting goals and take them very...more

CMS Unveils New Mandatory Medicare Bundled Payment Models for Cardiac & Hip Fracture Cases, Plus Proposed Refinements to CJR...

On July 25, 2016, CMS announced ambitious, multi-pronged plans to expand mandatory Medicare coordinated care/bundled payment programs, promote the use of cardiac rehabilitation services, refine current Comprehensive Care for...more

CMS Proposes Medicare Physician Fee Schedule Update for 2017

The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2017. The proposed rule contains numerous Medicare payment and...more

A right in Germany to sell through online marketplaces?

On 18 July 2016, Germany moved another step closer to enshrining a right for distributors in selective distribution systems to sell over online marketplaces. This is not sudden move by the German courts, in fact we have...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

Federal Circuit Helps Clarify What Constitutes a Commercial Sale under Pfaff

In The Medicines Co. v. Hospira Inc., Appeal No. 2014-1469 (Fed. Cir. July 11, 2016), the Federal Circuit issued a unanimous en banc decision ruling that the on-sale bar was not triggered by a supplier’s sale of manufacturing...more

CMS Finalizes Plan to Expand Medicare/Private Claims Data Available for Care Improvement

CMS has published a final rule to allow organizations approved as “qualified entities” to confidentially share or sell analyses of Medicare and private-sector claims data to providers, employers, and other groups who can use...more

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Federal Circuit Clarifies the “Commercial Offer for Sale” Prong of the On-Sale Bar

On July 11, 2016, a unanimous Federal Circuit en banc affirmed that The Medicines Company’s (“TMC”) use of third-party contract manufacturing services did not invalidate U.S. Patent Nos. 7,582,727 and 7,598,343 (the...more

Federal Circuit Limits On-Sale Bar’s Reach

If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

Sixth Circuit Tri County Decision Provides Much-Needed Clarity on “Successor” Provision in Ohio Franchise Law

I attach a copy of the US Court of Appeals for the Sixth Circuit’s recent decision in Tri County Wholesale Distributors v. Labatt USA Operating Company, Nos. 15-3710/3769 (6th Cir., July 6, 2016). For students of the...more

CMS Proposes Changes to Medicare DMEPOS Competitive Bidding & Fee Schedule Update Policies

CMS has proposed a series of complex and detailed revisions to Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) policies for 2017, including changes to the competitive bidding program (CBP)...more

Bigger Apparently is Better in DOJ’s Eyes – DOJ Piles On as False Claims Act CMPs Set to Almost Double on August 1, 2016

On June 30, 2016, the Department of Justice published an interim final rule with request for comments that applies an inflation adjustment to civil monetary penalty (CMP) amounts assessed by the Department, as mandated by the...more

So You’re an Overpaid Medicare Part C/D Provider or Supplier: Can You Keep the Change?

The Centers for Medicare & Medicaid Services (“CMS”) published the long-awaited final rule February 12, 2016, clarifying the specific procedures applicable to the statutory requirement under the Affordable Care Act (“ACA”)...more

Your Customer Just Declared Bankruptcy: Recent Decision That All Suppliers/Vendors Should Be Aware Of

Suppliers and vendors sometimes find themselves unpleasantly surprised by the bankruptcy of a customer, leaving a trail of unpaid invoices and little hope of recovery. To make matters worse, after licking their wounds and...more

New Qatar Public Procurement Law

Last week the State of Qatar implemented a new public procurement law. The new law further aligns Qatar's public procurement laws with international best practice and should streamline public procurement in Qatar....more

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