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Preparing for HIPAA Compliance Audits

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), the office responsible for administering and enforcing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), will...more

D.C. Circuit Upholds Contraceptive Coverage Mandate

Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14,...more

Government turns up the heat with the False Claims Act – 5 action steps for healthcare providers

Forbes magazine has dubbed 2014 “The Year of the Whistleblower.” For healthcare providers, this designation has translated into millions of dollars in fines and penalties and the initiation of criminal investigations. ...more

CFO’s Thirst for Wine Club Invitation Costs Hospital Millions

You can’t make this stuff up. Last Monday a federal court in Rhode Island ordered two insurance companies to pay a $30 million claim by hospital management company Lifespan Corp. Lifespan filed the claim after being ordered...more

Regulatory Risk Update: Tougher penalties for corporate manslaughter and health and safety offences proposed

On 13 November 2014, the Sentencing Council opened its 14 week public consultation on draft guidelines for corporate manslaughter and health and safety offences. If implemented, the guidelines will mean that large...more

Proposed Mega Rule Abandoned Under the 340B program

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources...more

Health Insurer Antitrust Claim Against Drug Company Remanded to State Court

Over the last several years, several health insurers have brought antitrust claims against drug companies, contending that they were overcharged for drugs as a result of agreements reached by the drug companies in the...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

District Court Weighs in on Level of Integration Required to Shield Health Care Collaborations from Section 1 Scrutiny

In Medical Center at Elizabeth Place v. Premier Health Partners et. al, Case No. 12-cv-26 (S.D. Oh. Oct. 20, 2014), the Southern District of Ohio held that previously-competing health care systems who join together in a...more

Behavioral Managed Care Organizations Do Not Have Unbridled Discretion – Providers Have Rights

Here is a common scenario: A behavioral healthcare provider has committed substantial resources into developing specialized behavioral healthcare services in the counties managed by a Managed Care Organization (“MCO”) under...more

California Court of Appeals Holds That the California Mental Parity Act Covers Residential Care for Anorexia Nervosa Even When the...

In Harlick v. Blue Shield of California (9th Cir. 2012) 686 F.3d 699, the Ninth Circuit interpreted the provisions of the California Mental Health Parity Act (Health and Safety Code § 1374.72) and its implementing regulation,...more

Ohio District Court Deems Hospital Alliance a Single Entity Incapable of Conspiring Under the Antitrust Laws

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners (“Premier”) and its affiliate hospitals, Atrium Health...more

IRS provides interim guidance for ACO participation in Medicare Shared Savings Programs and expands safe harbors for management...

On October 24, 2014, the IRS published Notice 2014-67, which expands the Revenue Procedure 97-13 safe harbors regarding management contracts and further provides interim guidance related to a health care organization’s...more

Post-Acute Care Summary Report - 2014: Benesch Health Care Market Intelligence

In this Issue: - Key Findings - Subsector Activity - Regulatory/Legal - Reimbursement - Excerpt from Key Findings: • The post-acute care (PAC) sector has seen an increase in mergers...more

ACO Participation By Tax-Exempt Healthcare Organizations – Is Tax-Exempt Financing at Stake?

Does A Tax-Exempt Healthcare Organization’s Participation in an Accountable Care Organization (ACO) Adversely Affect Its Tax-Exempt Financing? IRS Notice 2014-67 Provides Guidance....more

The Medical Device Tax in the Wake of 2014 Midterm Elections

Repeal of the medical device tax has seen frequent news coverage since the tax’s enactment in 2010 as part of the Affordable Care Act. The tax, which went into effect in January, 2013, imposes a 2.3% sales tax on a range of...more

Employment Law Reporter – November 2014: The Impact of Burwell v. Hobby Lobby

Has the Supreme Court “ventured into a minefield,” by its “decision of startling breadth,” as Justice Ruth Bader Ginsburg wrote in her dissent to Burwell v. Hobby Lobby? In Hobby Lobby, the Court held that the contraceptive...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

IRS Provides Increased Flexibility on Management Contracts for Tax-Exempt Bond-Financed Property

On October 24, 2014, the Internal Revenue Service issued Notice 2014-67 (the “Notice”), which provides important guidance and increased flexibility for issuers and conduit borrowers of tax-exempt bonds regarding contracting...more

Is Your Facility Ready for Ebola?

Polsinelli presents Crisis Management: a multi-part series (culminating in a webinar on 11.20.2014) on what companies must know to stay ahead of external interruption that risks serious impact to their business concerns....more

Florida's Amendment 2 Did Not Pass – What's Next?

Is any form of medical marijuana legal in the State of Florida? Yes – In June 2014, Governor Scott signed into law The Compassionate Medical Cannabis Act, known as the Charlotte's Web law. Unlike Amendment 2, the...more

IRS Releases Guidance on Private Business Use, and ACOs and Management Contracts

On October 25, 2014, the Internal Revenue Service (the IRS) released Notice 2014-67 that provides interim guidance on (i) participation in the Medicare Shared Savings Program through an accountable care organization (ACO) and...more

Property Insurance May Mitigate Ebola-Related Losses

With cases of Ebola now in the U.S., concerns have been raised as to the safety of public places visited by a person infected with the virus. Despite assurances from health officials that it is nearly impossible to contract...more

Licensing Boards Face Antitrust Laws

States rely heavily on licensing boards to “police” various professions and industries. In the past, these boards have been immune from antitrust claims. But a significant case is about to impact state licensing boards...more

Arbitration Agreements in Nursing Home Admission Agreements

In response to increasing runaway verdicts with large awards for punitive damages, many nursing homes are including arbitration clauses in their admission agreements. The U.S. Supreme Court’s decision in Marmet Health Care...more

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