On March 29, 2021, the Federal Communications Commission (“FCC” or “Commission”) adopted an Order establishing rules and procedures for Round 2 of the COVID-19 Telehealth Program (the “Program”) to continue supporting...more
Over the summer, we wrote about why health care companies may want to consider buying assets out of bankruptcy, taking advantage of the Bankruptcy Code Section 363 sale process (a “363 Sale”). We are back with our second...more
This two-part blog series discusses why buyers looking to make strategic purchases in the health care industry might want to take advantage of the Bankruptcy Code Section 363 sale process (363 Sale) and the pros and cons of...more
7/28/2020
/ 363 Sales ,
Anti-Assignment Clauses ,
Bankruptcy Code ,
Commercial Bankruptcy ,
Contract Terms ,
Coronavirus/COVID-19 ,
Due Diligence ,
Free and Clear Transactions ,
Health Care Providers ,
Purchase Agreement ,
Sale of Assets
In the past couple of days, the Department of Health and Human Services Office of Inspector General (HHS-OIG) and the Department of Justice (DOJ) each issued warnings about fraudulent schemes relating to COVID-19. And last...more
Artificial Intelligence (AI) is everywhere. At least five articles in my inbox this morning had an AI hook. And whether people are singing its praises (“AI will improve your speed, efficiency, and quality of work!”) or...more
The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth...more
10/25/2018
/ Electronic Medical Records ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Mental Health ,
Opioid ,
Popular ,
Prescription Drugs ,
Telemedicine ,
Transparency
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
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
12/12/2016
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Co-payments ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Generic Drugs ,
Hospitals ,
Inducements ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors
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
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
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
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
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
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
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
11/2/2015
/ Competition ,
Fee-for-Service ,
Governor Baker ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Licensing Rules ,
Medicaid ,
Nurse Practitioners ,
Pending Legislation ,
Performance Improvement Plans ,
Prescription Drugs ,
Public Health ,
Rebuttable Presumptions ,
Reimbursements ,
Substance Abuse ,
Telehealth ,
Telemedicine ,
Value-Based Payments
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
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
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
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
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
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
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
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
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
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