Administrative Law, Health Law, Commercial Law & Contracts

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

by Frederick Ball, Elinor Hart, Michael A. Swit | Duane Morris LLP on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

by King & Spalding on 2/4/2013

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

by Darby C. Allen, Donna S. Clark | BakerHostetler on 1/20/2013

On January 7, 2013, the HHS OIG released Advisory Opinion 12-22 concerning a rural hospital's (Hospital) proposal to pay a cardiology group (Group) a performance bonus for achieving certain patient service, quality and cost...more

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

by King & Spalding on 1/9/2013

On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

by King & Spalding on 1/9/2013

On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”). Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

by King & Spalding on 1/9/2013

On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket...more

FDA Issues Final Guidance on Filing PMAs and 510(k)s

by Seth Mailhot, Peter Reichertz | Sheppard Mullin Richter & Hampton LLP on 1/5/2013

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

Summary Of HUD’s New Draft LEAN Loan Documents, December 21, 2012

by Christine Waldmann Carmody, Blair L. Schiff | Pepper Hamilton LLP on 1/5/2013

On September 7, 2012, the Federal Housing Administration (FHA) published new regulations for the Section 232 Healthcare Facility Insurance Program in the Federal Register. FHA had previously proposed new regulations and loan...more

Summary Of HUD’s LEAN 232 Program E-Mail Blast: Office Of Residential Care Facilities (ORCF), December 19, 2012

by Christine Waldmann Carmody, Blair L. Schiff | Pepper Hamilton LLP on 1/5/2013

In an effort to summarize the highlights of the LEAN E-mail Blasts that we receive, and rarely have time to review in a timely fashion, we at Pepper are providing this quick synopsis of the latest LEAN update. Our aim is to...more

Insurance Antitrust Legal News - January 2013 • Volume 2, Number 1

by James M. Burns | Dickinson Wright on 1/4/2013

In This Issue: - Michigan Governor Vetoes Legislation Banning Health Insurers From Utilizing Most Favored Nation Clauses In Provider Contracts - DOJ Antitrust Division Approves Wellpoint’s Acquisition Of...more

Trends to Watch in 2013: Physician-Owned Distributors

by Eric Kintner | Snell & Wilmer L.L.P. on 1/2/2013

Physician-owned distributors (PODs) that sell medical devices have seen substantial growth over the last few years as well as increased regulatory scrutiny. We expect both trends to continue in 2013. PODs are arrangements in...more

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

by Scott D. Alfree, Lawrence P. Burns, Pamela Emenheiser, Zachary J. Meyer | Varnum LLP on 12/28/2012

Beginning January 1, 2013, manufacturers and importers of certain medical devices will be required by the U.S. Internal Revenue Service (IRS) to pay a new 2.3 percent medical device excise tax on the sales of taxable medical...more

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

by Thomas Barker, Ross Margulies | Foley Hoag LLP on 12/24/2012

Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more

FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies

by Rachael G. Pontikes | Duane Morris LLP on 12/21/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) and officials from all 50 states' boards of pharmacy met to discuss their views on state and federal roles in regulating compounding pharmacies. The meeting...more

Health Reform + Related Health Policy News Update - December 19, 2012

by Polsinelli on 12/20/2012

In This Issue: - President Opposes Medical Device Tax Repeal or Replace - Senators Call for Extension of Comment Period on ACA Proposed Rules - AHA Urges U.S. District Court to Expedite Case Involving CMS' Payment...more

BLG Monthly Update for December 2012

by Neil Guthrie on 12/19/2012

UGG boots, thieving drug addicts, misappropriated sheep and the usual neat contracts cases: all this and more in the BLG Monthly Update for December....more

IRS Releases Final Rule on Medical Device Tax

by King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

Mississippi CON Report - December 13, 2012

by Bradley Arant Boult Cummings LLP on 12/15/2012

In This Report: - I. November 29, 2012 - Mississippi Certificate of Need Meeting - II. 2013 State Health Plan Approved - III. Certificate of Need Program Report – Filings/Reports Since October 2012 CON Meeting -...more

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

by Theresa C. Carnegie, Carrie Roll | Mintz Levin - Health Law on 12/13/2012

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes...more

Telemedicine: Physicians Need to Know State Requirements

by Simi Botic, Thomas Hess | Dinsmore & Shohl LLP on 12/13/2012

As telemedicine grows in popularity, it is important for physicians to be aware of the state-by-state requirements when practicing in this revolutionary area of healthcare....more

New Rules Will Be “Taxing” On Medical Device Manufacturers

by Christine J. Kim, Richard (Rich) E. Peterson | Perkins Coie on 12/13/2012

The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any...more

Alabama CON Report - December 12, 2012

by Bradley Arant Boult Cummings LLP on 12/13/2012

In This Issue: - I. Certificate of Need Program - II. For Informational Purposes Only - III. OLD BUSINESS - IV. NEW BUSINESS - Excerpt from Certificate of Need: A. Emergency Application...more

Update on Federal and State Developments: Regulation of Financial Interactions between Health Care Providers and Pharmaceutical...

by Ropes & Gray LLP on 12/13/2012

Recent weeks have seen two significant developments with respect to federal and state laws regulating financial interactions between pharmaceutical and medical device companies and health care providers: (1) the Centers for...more

IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

by Frances Emmeline Babb, M. Elizabeth Bierman, Michele L. Buenafe, Roderick K. Donnelly | Morgan Lewis on 12/12/2012

Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered. On December 7, the Internal Revenue Service (IRS)...more

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Administrative Law › Health Law › Commercial Law & Contracts

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

FDA Issues Final Rule Regarding CGMPs for Combination Products

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

FDA Issues Final Guidance on Filing PMAs and 510(k)s

Summary Of HUD’s New Draft LEAN Loan Documents, December 21, 2012

Summary Of HUD’s LEAN 232 Program E-Mail Blast: Office Of Residential Care Facilities (ORCF), December 19, 2012

Insurance Antitrust Legal News - January 2013 • Volume 2, Number 1

Trends to Watch in 2013: Physician-Owned Distributors

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies

Health Reform + Related Health Policy News Update - December 19, 2012

BLG Monthly Update for December 2012

IRS Releases Final Rule on Medical Device Tax

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

Mississippi CON Report - December 13, 2012

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

Telemedicine: Physicians Need to Know State Requirements

New Rules Will Be “Taxing” On Medical Device Manufacturers

Alabama CON Report - December 12, 2012

Update on Federal and State Developments: Regulation of Financial Interactions between Health Care Providers and Pharmaceutical...

IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

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