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
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Crystal Ball Perspective: Will Healthcare Reform be Repealed if Romney Wins the Presidential Election?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
Is there a way to safely use social media in the interview process?
Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug...more
Last week, in Styrene Information and Research Center v. Sebelius, Judge Reggie Walton of the District Court for the District of Columbia rejected challenges to the decision by HHS Secretary Kathleen Sebelius to list styrene...more
In This Update:
- 1. Statewide Health Coordinating Council’s Freestanding Emergency Department (FED) Study Committee Meeting
- 2. Full Statewide Health Coordinating Council (the “Council”) Meeting
- A. ...more
In This Article:
Federal Government; Alberta; British Columbia; Manitoba; New Brunswick; Newfoundland; Northwest Territories; Nova Scotia; Nunavut; Ontario; Prince Edward Island; Québec/Quebec; Saskatchewan; and...more
Executive Summary -
On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more
The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more
The United States District Court for the Eastern District of Pennsylvania’s opinion in Nazareth Hosp. v. Sebelius, slip op. no. 10-3513 furnished a surprising victory to two providers that challenged the calculation of the...more
The OIG released an updated self-disclosure protocol this week, about ten months after putting out a call for comments on the old protocol. The new protocol imposes some new burdens on the disclosing entity, such as a shorter...more
Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more
Recovery Audit Contractors (“RACs”) and other Centers for Medicare and Medicaid Services (CMS) contractors are charged with identifying overpayments made by Medicare to healthcare providers. However, with the increase in RAC...more
For many years, CMS policy has been that, if an inpatient admission was denied for medical necessity reasons, the hospital could bill under Part B for only a limited set of services that, significantly, did not include...more
On March 13, 2013, the Centers for Medicare & Medicaid Services (CMS) issued a ruling contrary to its traditional billing policy regarding payment of Part B inpatient services following denial of a Part A claim. Ruling...more
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
As Republicans and Democrats conitnue to bicker over how much to spend or not spend on Medicare, Medicaid is receivingly alarmingly little attention—attention it desperately needs. As our guest on LXBN TV explains the program...more
On February 13, CGS Administrators, the Parts A and B Medicare Administrative Contractor for Kentucky and Ohio, relayed instructions to Medicare hospitals paid under the Inpatient Prospective Payment System from the Centers...more
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
This Daily Journal article analyzes the United States Supreme Court decision of Federal Trade Commission v. Phoebe Putney Health System, Inc, which held that a state's grant of general corporate powers to government entities...more
Last week, the U.S. Department of Health and Human Services (HHS) and the DOJ jointly released a report concluding that, for every dollar spent on healthcare fraud investigations in the last three years, the government...more
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more
The United States Supreme Court issued a decision limiting antitrust immunity for state-sanctioned conduct. The Court unanimiously overturned the Eleventh Circuit's ruling allowing Phoebe Putney Health System, Inc. to acquire...more
Before a Medicare contractor can use extrapolation to determine an overpayment amount, the Medicare statute requires that it must make a finding that there is a sustained or high level of payment error or that documented...more
In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more
Under the Medicare statute and implementing regulation, providers have 180 days from the issuance of a Notice of Program Reimbursement (NPR) in which to file an appeal to the Provider Reimbursement Review Board (PRRB). This...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
The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a...more
JD Supra gets your content noticed, increases your visibility and makes your marketing efforts hassle free...
Learn More or Schedule a demo