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The Legal Stuff
Barnes & Thornburg's Healthcare Blog
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11 May 2015 Amarin Pharma Preemptively Sues FDA over First Amendment Rights

On Thursday, May 7, Amarin Pharma took the unprecedented step of proactively suing the U.S. Food and Drug Administration (FDA) over the agency’s alleged infringement of the company’s First Amendment Rights.  The case arises from Amarin’s desire to market its product, Vascepa, for uses broader than what the FDA has previously approved. While other companies have raised their First Amendment rights as a defense to enforcement actions brought by the FDA and the Department of Justice (DOJ), none so far has taken the step of…

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05 May 2015 Office of the Inspector General Issues Report Finding Medicaid Rebates Exceeded Medicare Part D Rebates by a Significant Margin

In April 2015, the Office of the Inspector General (OIG) of the U.S. Department of Health & Human Services issued a report analyzing and comparing drug rebates collected by State Medicaid programs and Medicare Part D plan sponsors. Requested by a Member of Congress, the analysis concluded that there were substantial differences in the rebate amounts collected under Medicaid and Medicare Part D.  It was the second such report; the OIG conducted a similar analysis in 2011.   OIG analyzed total Part D and Medicaid…

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27 Apr 2015 FDA Holds Public Hearings to Seek Comments on Regulatory Framework for Homeopathic Products

On April 20 and 21, 2015, the Food and Drug Administration (FDA) held public hearings to obtain information and comments on the regulatory framework governing homeopathic drugs and products. Citing the tremendous growth of the homeopathic drug industry, the FDA issued a public notice announcing the hearings and seeking comments on enforcement policies related to drug products labeled as homeopathic. 80 Fed. Reg. 16327 (March 27, 2015).   The Food, Drug, and Cosmetic Act (FD&C Act) defines a “drug” to include (i) articles recognized in…

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17 Apr 2015 HHS Issues HIPAA Guidance on Workplace Wellness Programs

On April 16, the U.S. Department of Health and Human Services (HHS) issued guidance on whether the HIPAA Privacy and Security Rules apply to workplace wellness programs. Whether HIPAA applies depends on how the specific wellness program is structured. As a reminder, HIPAA applies to “covered entities” which is defined to include health plans. An employer is not covered by HIPAA, but the employer-sponsored health plan is covered by HIPAA. Therefore, HHS explains that when a workplace wellness program is offered by an employer directly…

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15 Apr 2015 Senate Passes Bipartisan ‘Doc Fix’ Medicare Bill

The U.S. Senate, by a 92-8 vote late April 14, passed a bipartisan bill that includes a permanent solution to the “doc fix,” a method utilized by the government to ensure payment to Medicare providers kept pace with inflation. The U.S. House of Representatives approved the same bill more than two weeks ago, and President Barack Obama is expected to sign it. Had the Senate failed to pass the bill, Medicare rates to physicians would have decreased by 21 percent, as required under current law….

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02 Apr 2015 Certificate of Need Requirements in Georgia Preclude Divestiture Requirement in Federal Trade Commission Settlement

The Federal Trade Commission (FTC) recently announced that, after four years, it has reached a settlement agreement with the Phoebe Putney Health System and the Hospital Authority in Dougherty County, Georgia. The settlement is in regards to the FTC’s 2011 challenge of Phoebe Putney and the Hospital Authority’s acquisition of its competitor, Palmyra Park Hospital Inc., as anticompetitive.   In its April 2011 complaint, the FTC alleged that Phoebe Putney attempted to shield its anticompetitive acquisition of Palmyra Park through a deal specifically structured to…

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27 Mar 2015 Office of Inspector General Concludes Proposed Lab Fee Waiver Arrangement Poses Anti-Kickback Concerns

The Department of Health and Human Services Office of Inspector General (HHS OIG) has issued another advisory opinion in a long line of guidance from the agency regarding lab business practices.  On March 25, 2015, OIG published Advisory Opinion No. 15-04 concluding that a regional medical laboratory’s (Laboratory) proposed arrangement to provide free lab services to certain patients of physician practices, with whom the lab had exclusive referral arrangements, raised kickback concerns and potentially could violate the Social Security Act’s “substantially in excess” provision.  …

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23 Mar 2015 Illinois Department of Financial and Professional Responsibility Adopts Long-awaited Amendments to Controlled Substances Regulations

The Illinois Department of Financial and Professional Regulation (IDFPR) has adopted amendments to its regulations governing Illinois controlled substance licensees (77 Ill. Adm. Code 3100). The adopted amendments, published in the March 13, 2015, Illinois Register (39 Ill. Reg. 3656) were effective Feb. 28, 2015, and bring the regulations up to date with the Illinois Controlled Substances Act (last amended in 2012) and federal law.   The changes: (a) clarify the registration requirements for med-level practitioners and temporary medical license holders; and (b) address procedural,…

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Judges Gavel
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16 Mar 2015 Courts Reject Attempts to Limit Whistleblower Suits

On Feb. 25, 2015, the Court of Appeals for the Sixth Circuit ruled in United States ex rel. Whipple v. Chattanooga-Hamilton County Hospital Authority (No. 13-6645) that a government audit and investigation into the alleged submission of false claims to a federal health care program did not constitute a “public disclosure” of those allegations. Acting on an anonymous tip received in 2006, the Office of the Inspector General (OIG) and a federal Medicare contractor had conducted an administrative investigation into claims for inpatient admissions at defendant Erlanger…

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27 Feb 2015 CMS Revises Standards on Nursing Home Quality Reporting

On Feb. 20, 2015, the Centers for Medicare & Medicaid Services (CMS) revised quality standards for nursing homes, causing ratings to change on the Five Star Nursing Home Quality Rating System, a part of the CMS Nursing Home Compare website.   The Nursing Home Compare website features a rating system that gives nursing homes an overall composite rating of one to five stars based on several facility performance measures. Each performance measure is also given a rating of one to five stars. The performance measures…

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