Read Administrative Law updates, alerts, news, and legal analysis from leading lawyers and law firms:
Konczal: Dodd-Frank Reforms Get Roughed Up in Court
Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare
Obama Administration Calls for Free Access to Federally Funded Research
Can Virginia Block Non-Residents from FOIA Requests? Supreme Court Hears Oral Arguments
Should Wall Street Fear Mary Jo White?
Looking Ahead to Washington State’s Legalized Marijuana Marketplace
4 Things to Know About Michigan’s New Right-to-Work Laws
Congressman: My Plan Would Reduce Student Loan Defaults: Video
Local Governments Continue to Fight States for Right to Govern Fracking
Tax Questions to Ask Yourself with the End of 2012 and the Fiscal Cliff Approaching
Obama Blocks Chinese-Owned Wind Project Out of Concerns for National Security
Crystal Ball Perspective: Will Healthcare Reform be Repealed if Romney Wins the Presidential Election?
Stewart Baker, Former GC of NSA, on Why the Cybersecurity Act Failed & Threat of Tomorrow’s Terrorism
Not Prepared for Healthcare Reform? Three things employers need to focus on now.
Who pays for road damage in Pennsylvania after ACT 13?
Smartphone Data Solution: Sharing Airwaves
The Apellate Process Explained - Kathi Sandweiss discusses the appeals process and what it can and can't do for your situation.
Marcellus gas fuels Natural Gas Vehicles
Natural gas encourages industrial and large commercial end-users to revisit their operational plans
NLRB Posting Rule Delayed Again, Will We Ever See Resolution?—McKenna Long's Seth Borden
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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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