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OCR Issues Guidance on HIPAA and Same-Sex Marriage

September 22, 2014 | Blog | By Kimberly Gold

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance last Wednesday to help covered entities and business associates understand the privacy implications of the 2013 Supreme Court decision in United States v. Windsor (“Windsor”).
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CMS Continues to Struggle with How to Provide High Quality Care to Dual Eligibles

September 21, 2014 | Blog | By Theresa Carnegie

Last week CMS announced that it would not execute its option to terminate its 2015 contracts with Medicare Advantage Plans and Part D plans that had scored three stars or less for three consecutive years.
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Department of Justice Criminal Division Will Increase its Review of False Claims Act Cases for Criminal Prosecution

September 19, 2014 | Blog | By Samantha Kingsbury

On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced that her office will be stepping up its review of False Claims Act (FCA) qui tam complaints for potential criminal prosecution.
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ML Strategies Posts Weekly Health Care Update on September 15, 2014

September 18, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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NIST Vetting Guidance Valuable for Health Care Organizations Seeking to Use Third-Party Apps

September 17, 2014 | Blog

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share user’s health and fitness data with the new Health app and with each other.
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Upcoming Webinar on September 23, 2014: What Your Company Needs to Know to Protect Itself from FCPA Liability

September 12, 2014 | Blog | By Theresa Carnegie

Please join us on September 23rd, 2014 at 1:00 p.m. for a webinar where we’ll discuss the recent statements from the Department of Justice and the U.S. Securities and Exchange Commission describing the susceptibility of pharmaceutical and medical device companies in regards to FCPA enforcement.
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Federation of State Medical Boards Releases Interstate Licensure Compact

September 10, 2014 | Blog

As previously reported by the team from ML Strategies, one of the many telehealth developments to watch this year has been the Federation of State Medical Board’s (FSMB) Interstate Licensure Compact. 
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Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide Contraceptive Coverage

September 3, 2014 | Blog | By Theresa Carnegie

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments).
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The Increasingly Murky World of 340B: What’s Next?

September 2, 2014 | Blog | By Theresa Carnegie

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier.
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Health Care Providers Among Those at Risk from “Backoff” Malware

August 28, 2014 | Blog | By Dianne Bourque

If your health care organization swipes credit cards, such as for the collection of copayments, parking fees, or even gifts in a gift shop, you should read this important update regarding “Backoff” Malware, which includes practical steps for protecting your credit card data. 
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Another Court Weighs in on Rule 9(b)'s Requirements Under the False Claims Act

August 27, 2014| Blog|

ML Strategies Posts Weekly Health Care Update on August 25, 2014

August 27, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 
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Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

August 25, 2014 | Blog | By Theresa Carnegie

Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations.  While manufacturers are likely not out from underneath the microscope, it seems as though the lens may have shifted slightly to focus on the rest of the prescription drug transaction. 
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OIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal

August 22, 2014 | Blog

In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal anti-kickback statute and would pose a risk of fraud and abuse. 
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CMS Re-Opens Open Payments System

August 18, 2014 | Blog

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and teaching hospitals.
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Acute Care Hospitals Settle FCA Lawsuits for $98 Million

August 18, 2014 | Blog | By Brian Dunphy

Community Health Systems, Inc. (CHS) and Community Health Systems Professional Services Corporation, together a national owner and operator of acute care hospitals, and 119 of their hospitals, agreed to pay $98 million to settle seven False Claims Act (FCA) lawsuits filed by qui tam relators around the country. 
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Federal Court Rejects Relator's Swapping Allegations in False Claims Act Case

August 15, 2014 | Blog | By Samantha Kingsbury, Karen Lovitch

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country's largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former employee, Kevin P. McDonough. 
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OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

August 13, 2014 | Blog | By Theresa Carnegie

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program.
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ML Strategies Posts Weekly Health Care Update on August 11, 2014

August 13, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
Read more

CMS Temporarily Closes the Open Payments System

August 12, 2014 | Blog | By Brian Dunphy

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act.
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