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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
A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated the federal False Claims Act (FCA) and the New York FCA resulting from alleged violations of the Anti-Kickback Statute (AKS) and the Stark Law.
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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.
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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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ML Strategies Posts Weekly Health Care Update on July 28, 2014
August 1, 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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Keep the Benefit of the Bargain - Reps and Warranties Survival in Healthcare Deals
July 28, 2014 | Blog
In recent healthcare mergers and acquisitions, we have seen the parties increasingly focus on the survival length of the representations and warranties in the purchase agreements.
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Charting the Future of Premium Subsidies under the Affordable Care Act: Halbig v. Burwell and King v. Burwell
July 24, 2014 | Blog | By Roy Albert
On July 22nd, 2014, two federal appellate courts issued conflicting decisions, within hours of each other, regarding the IRS final rule published on May 23, 2012 (the “IRS Rule”), intended to implement the exchange-related tax credit provisions of the Affordable Care Act (“ACA” or the “Act”).
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ML Strategies Posts Weekly Health Care Update on July 21, 2014
July 22, 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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New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services
July 18, 2014 | Blog | By Karen Lovitch , Samantha Kingsbury
The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals.
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ML Strategies Posts Weekly Health Care Update on July 14, 2014
July 15, 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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