Health Care

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule"). 

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).

Just as the Centers for Medicare & Medicaid Services (CMS) began holding federal health care plans accountable for their provider network transparency obligations, the New Jersey legislature stalled in its bid to pass a law that would require hospitals and physicians to disclose whether they are in or out-of-network with a patient’s insurance plan before providing treatment. 

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech.

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule”).  As a result, the final 60-day rule will likely be published soon.

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing. 

Today, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under Medicare.

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation.

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called "Internet of Things." Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked.

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example.  Acme Drug Company brings a drug to the market as a single source innovator. 

This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today to more than 80 million by 2036.

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings.

In 2012 Massachusetts adopted the most recent in a series of comprehensive legislative approaches to health care reform, Chapter 224 of the Acts of 2012 (Chapter 224), which focused especially on addressing the drivers of health care costs in the Commonwealth. 

FDA lacks the appropriate data to effectively conduct post market surveillance and safety tracking activities, according to two reports released earlier this month.

The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).

An ophthalmologist cooperative in Puerto Rico settled charges with the Federal Trade Commission (“FTC”) last week that it orchestrated an illegal boycott of a health plan.

In keeping with the boom of telehealth legislation introduced last year at both the state and federal level, the Senate Finance Committee is considering several policy changes that, if ultimately enacted, could make telehealth the preferred method of care delivery for millions of Medicare beneficiaries living with chronic conditions.

Earlier today, my colleagues at ML Strategies published the Washington Outlook for 2016, offering their insights about what we might expect from Capitol Hill and the Administration in the coming year.

On Tuesday, our colleague, Patricia Moran, discussed the importance of employers using “wrap” documents for certain health and welfare plans on Mintz Levin’s Employment Matters Blog.

My colleagues Hope Foster, Larry Freedman, and Bridget Rohde, members of Mintz Levin’s Health Care Enforcement Defense group, recently published a report surveying health care enforcement trends and developments in 2015 and forecasting what these developments herald for 2016.