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Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

OCR to Increase Investigations of Smaller HIPAA Breaches

HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect...more

8/19/2016  /  Data Breach , HHS , HIPAA , OCR , PHI

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

6/24/2016  /  Clinical Trials , Federal Funding , IRB , NIH

CMS Increases Oversight of Medicaid Managed Care Contracts

As noted in a post published yesterday, CMS issued the final rule regarding Medicaid managed care earlier this week. With this rule, CMS is taking a much more active role in overseeing states’ Medicaid managed care...more

Opioids, FDA and Medicare Advantage Spending on the List for Congress

As Congress is back to Washington for its next work period, ML Strategies has published an Advisory outlining health care issues on the radar for the upcoming weeks. Highlights include: legislative initiatives on opioid...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

MA Health Policy Updates – Moves to Strengthen HPC and Expand Telemedicine

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission...more

FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products....more

Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long...more

Supreme Court Decides Qui Tam First-to-File Issues

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss. Since...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases

Trends & Analysis - ..We have identified 67 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of those cases, 29 were filed before January 1, 2014, with seven...more

States Doubling Down on Delivery and Payment Reform Efforts

Although health care reform implementation via the Affordable Care Act (ACA) has focused mostly on federal changes to the health care marketplace, individual States are getting some much needed help to design and implement...more

No Private Right to Recoup Funds Based on Corporate Practice of Medicine Violation

The United States District Court for the Western District of Washington ruled recently that the state’s corporate practice of medicine doctrine does not provide a private right of action, either express or implied, and...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases: November 2014

Trends & Analysis - In the period covered by this issue, we have identified 68 whistleblower cases related to health care that were unsealed. In this Qui Tam Update, we analyze the trends and take an in-depth look at...more

Ebola Update–CDC Issues New Protocols

The response to Ebola continues to evolve as additional resources for providers and the public have been made available over the last several days. The Joint Commission (TJC) launched an Ebola Preparedness Resources webpage,...more

“Access Denied” – Understand How Your Electronic Health Records Are Controlled

Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in...more

OIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal

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...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments & Unsealed False Claims Act Cases

Trends & Analysis: - We have identified 31 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only six were filed in 2013. The majority (14 cases) were filed in 2011 or 2012, with the...more

1/16/2014

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

Report Highlights Record-Breaking Year of Enforcement for HHS and DOJ

Yesterday, the Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) released their Annual Report for the Health Care Fraud and Abuse Control Program (the “Program”). The report highlights the...more

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