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Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

OIG Issues Compliance Oversight Guidance for Governing Boards of Health Care Organizations

On April 20, 2015, the Office of Inspector General (OIG), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association, issued...more

Expedited Access Program Begins For Medical Devices

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate...more

FDA Finalizes Guidance Documents on Biosimilarity

On Tuesday, and over three years after the initial guidance documents were released, the US Food and Drug Administration released final versions of three guidance documents discussing how FDA will evaluate applications for...more

FDA Finalizes Key Guidance Documents on Biosimilars

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

Challenge to DSH Adjustment Estimates Barred by Statute

In a decision issued on March 31, the United States District Court for the District of Columbia dismissed a challenge by Florida Health Sciences Center, Inc., also known as Tampa General Hospital, to the calculation of its...more

CMS Amends Ruling 1498-R Regarding Remedy for Recalculation of Medicare DSH Payment Adjustments

On April 22, 2015, CMS issued Ruling 1498-R2 (the Revised Ruling), a modification of the prior ruling governing Medicare Disproportionate Share Hospital (DSH) payment adjustments. The Revised Ruling addresses the...more

Proposed Updates to FY 2016 IRF PPS Would Increase Payments by $130 Million

On April 23, 2015, CMS issued (and this morning, published) a proposed rule that would update Medicare payment policies and rates for the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) for FY 2016. ...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

Chinese Legislature Adopts Amendments to Drug Administration Law

China’s top legislature, the Standing Committee of National People’s Congress, recently approved the amendments (the “Amendments”) to the Drug Administration Law. The Amendments, effective as of April 24, 2015, cover the...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

HHS Settlement: Dumpster-Diving Leads to Settlement for Improper Disposal of Documents Containing Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (HHS) recently announced that it has reached an agreement with a small pharmacy to resolve potential HIPAA violations. The settlement arose from the...more

New Postings on the Reed Smith Health Industry Washington Watch Blog - April 2015

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following...more

OIG Issues Board Guidance on Compliance Oversight

On April 20, 2015, the Inspector General of the Department of Health and Human Services (OIG), the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care...more

Pharmacy Pays $125,000 for Failure to Properly Dispose of Paper Records

Cornell Prescription Pharmacy (“CPP”), a Colorado single-location pharmacy, has agreed to pay $125,000 to the United States Department of Health and Human Services, Office for Civil Rights to settle alleged violations of the...more

OIG Releases New Guidance Offering “Practical Tips” to Health Care Boards for Overseeing Compliance Program Functions

On April 20, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), together with industry leaders, released a new educational resource to help governing boards of health care...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and...more

Amidst Increasing Security Concerns, Medicare to Drop Social Security Numbers from Cards

In an effort to combat growing concerns of identity left, President Obama signed into law last week a bill that will require the removal of Social Security Numbers (SSNs) from all Medicare beneficiary cards. The change, which...more

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

On April 20, 2015, the HHS Office of Inspector General (HHS OIG), in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance...more

New Compliance Guidance for Health Care Boards

New compliance guidance for Boards of health care organizations was issued April 20, 2015. The document – “Practical Guidance for Health Care Governing Boards on Compliance Oversight” – was a joint effort of the Office of...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

OIG Issues Practical Guidance for Health Care Governing Boards on Compliance Oversight

On April 20, 2015, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

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