Administrative Law, Health Law

China FDA Announces Key Appointments and Restructuring Plan

by Katherine Wang | Ropes & Gray LLP on 5/21/2013

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

A Nice, Straightforward Administrative Law Decision: HHS’s Decision to List Styrene as Reasonably Anticipated to Cause Cancer is...

by Seth Jaffe | Foley Hoag LLP - Environmental Law on 5/20/2013

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

Alabama Statewide Health Coordinating Council Update, May 2013

by James Henry, Kristen A. Larremore, Colin H. Luke, Carey B. McRae | Bradley Arant Boult Cummings LLP on 5/17/2013

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

Legislative Update Report No. 2013-09 -- May 10, 2013

by Osler, Hoskin & Harcourt LLP on 5/15/2013

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

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

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

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

by James S. Cohen, Glenn Engelmann, Michael Ryan | McDermott Will & Emery on 5/7/2013

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Court Grants Unexpected Victory to Providers on Medicare DSH Adjustment

by Thomas W. Coons, Mark A. Stanley | Ober|Kaler on 4/18/2013

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

New OIG Self-Disclosure Protocol

by The Harlow Group LLC on 4/18/2013

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

Compounding Animal Drugs from Bulk Ingredients

by Duane Morris LLP on 4/17/2013

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

Recent Changes Impact Appeal of Medicare Denials and Reimbursement Strategies

by Womble Carlyle Sandridge & Rice, PLLC on 4/17/2013

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

CMS Revises Part B Billing Policy for Unnecessary Inpatient Admissions

by Thomas W. Coons, Carel Hedlund | Ober|Kaler on 3/29/2013

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

CMS Ruling On Part B Rebilling After RAC Audits

by Meredith Duncan, Jason Lundy | Polsinelli on 3/25/2013

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

FDA Emphasizes Patient-Specific Prescriptions

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 3/21/2013

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

Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare [Video]

by LXBN on 3/15/2013

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

Resubmission of Hospital Claims

by Thomas Hess, Tyler N. Williams | Dinsmore & Shohl LLP on 3/13/2013

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

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

High court scales back antitrust exemption

by Jarod Bona on 2/28/2013

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

Federal Healthcare Fraud Enforcement Efforts Yield a 790% Return

by B. Scott McBride, Gregory Saikin | BakerHostetler on 2/28/2013

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

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

by Rachael G. Pontikes | Duane Morris LLP on 2/26/2013

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

FTC v. Phoebe Putney Health System, Inc.: Supreme Court rules state law does not offer blanket protection from antitrust laws

by Jarod Bona on 2/21/2013

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

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Administrative Law › Health Law

China FDA Announces Key Appointments and Restructuring Plan

A Nice, Straightforward Administrative Law Decision: HHS’s Decision to List Styrene as Reasonably Anticipated to Cause Cancer is...

Alabama Statewide Health Coordinating Council Update, May 2013

Legislative Update Report No. 2013-09 -- May 10, 2013

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

Court Grants Unexpected Victory to Providers on Medicare DSH Adjustment

New OIG Self-Disclosure Protocol

Compounding Animal Drugs from Bulk Ingredients

Recent Changes Impact Appeal of Medicare Denials and Reimbursement Strategies

CMS Revises Part B Billing Policy for Unnecessary Inpatient Admissions

CMS Ruling On Part B Rebilling After RAC Audits

FDA Emphasizes Patient-Specific Prescriptions

Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare [Video]

Resubmission of Hospital Claims

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

High court scales back antitrust exemption

Federal Healthcare Fraud Enforcement Efforts Yield a 790% Return

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

FTC v. Phoebe Putney Health System, Inc.: Supreme Court rules state law does not offer blanket protection from antitrust laws

Payment Matters: No Judicial Review of Contractor’s Finding of a High Payment Error Rate, a Condition for Extrapolation

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

Payment Matters: Supreme Court: Providers' Appeal Period Not Extended by Doctrine of Equitable Tolling

FDA Issues Final Rule Regarding CGMPs for Combination Products

HIPAA Omnibus Final Rule - What's in it for Patients?

Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare [Video]

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