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New OIG Special Fraud Alert Aimed at Laboratory Payments to Referring Physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled "Laboratory Payments to Referring Physicians."...more

OIG Report: Questionable Billing for Medicare Part B Clinical Laboratory Services

Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Strategic Perspectives: When is Telemedicine "Practicing Medicine" in Violation of the Law? An Emerging Framework for Compliance

Telemedicine is the future of health care, but under current law there is an open question: when does telemedicine constitute the unlawful “practice of medicine” in violation of state or other law? This question is critical...more

New OIG Special Fraud Alert Focuses on Suspect Practices of Labs and Referring Physicians - Certain Payment Arrangements May Be a...

The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a new Special Fraud Alert on June 25, 2014, that focuses on certain compensation arrangements between laboratories and referring...more

Anti-Kickback Laboratory Enforcement Actions – Special Fraud Alert

There has been significantly enhanced scrutiny of financial relationships between referring physicians by both the Office of Inspector General (OIG) and Pennsylvania authorities....more

Florida Information Protection Act of 2014 - Florida Means Business When It Comes to Protecting Customers' Personal Information

On June 20, 2014, Governor Rick Scott signed into law the Florida Information Protection Act of 2014 ("FIPA"), which became effective July 1, 2014. FIPA expands the obligations of businesses and government entities that...more

The American Medical Association Releases New Telemedicine Recommendations

Recently, the American Medical Association (AMA) released a report on telemedicine (Report) that, among other things, (i) outlines coverage and payment rules; (ii) summarizes various specialty society practice...more

Has your business seen medical identity theft?

Last year, medical identity theft affected nearly two million Americans - 32% more than the year before. This is a staggering number! And considering that today, medical identity theft accounts for 43% of all identity theft...more

District Court Applies FCA's First-to-File Rule to Determine Relator's Entitlement to Settlement Proceeds

On June 23, 2014, a U.S. District Court in Pennsylvania held that the first relator to file a qui tam complaint under the FCA is the only relator eligible to recover a portion of the settlement, notwithstanding the existence...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

CMS Proposes Changes to Physician Payments Sunshine Act Implementing Regulations

On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) released four proposed changes for comment to the implementing regulations for the Physician Payments Sunshine Act. The proposed changes would amend the...more

Telemedicine and Mobile Health Innovations Amid Increasing Regulatory Oversight

The growing mobile health market is rapidly transforming health care delivery. More than 80 percent of physicians use mobile technology to provide patient care, and more than 25 percent of commercially insured patients use...more

HIPAA Violation Results in $4.8 Million Settlement

While most healthcare providers know to pay close attention to the HIPAA rules when setting up their information technology systems, recent events have demonstrated that this close scrutiny should also be applied to computer...more

CMS Proposes Elimination of CME Exception to Sunshine Act Reporting

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more

HIPAA Data Breaches

HIPAA has been on the books since 1996. With the advent of electronic health records, HHS adopted security regulations to require covered entities to protect the integrity, confidentiality, and availability of electronic...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

Coming Soon To A (Computer) Screen Near You: Your Doctor

Both wellness visits and behavioral health visits would be added to the list of Medicare-covered telemedicine services. And it’s not just follow-up wellness visits that would be covered. Even initial visits qualify,...more

California Court Limits Liability for Loss of Certain Patient Information under CMIA

California appellate courts are clarifying potential liability under California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”) of health care providers, health plans, pharmaceutical...more

OIG issues Special Fraud Alert on laboratory payments to referring physicians

The Health and Human Services Office of the Inspector General (OIG) recently issued a Special Fraud Alert on laboratory payments to referring physicians. Specifically, the alert is concerned with Specimen Processing...more

Patient Records: Increasing Exposure for Privacy Breaches

Healthcare providers and businesses that store or process protected health information ("PHI") face increased scrutiny and significant fines for data privacy breaches and security lapses in the coming months....more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

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