Health Care

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. 

As is well known, drug prices have been widely discussed nationally. They have been the subject of Congressional hearings and, in the case of Mylan, a high profile settlement.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act.  Repeal and Replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend. 

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act (ACA). Repeal and Replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.

Last week, the OIG posted its Work Plan for 2017.  In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start.  Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act. Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.

On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have character space limitations, such as sponsored links and microblogs.

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”). The Protocols have been updated based on the over 500 comments CMS received in response to the draft released in June.

For the last six years, Republicans have talked about repeal and replacement of the Affordable Care Act. The election outcome now puts Republicans in a position of authority to take action on the Affordable Care Act.  As we look ahead to the 115th Congress, it is important to move away from political rhetoric and consider what can actually be achieved as a matter of public policy.

Last week, the Massachusetts Department of Public Health issued another round of proposed amendments to its regulations, continuing the Baker Administration’s regulatory reform efforts. Today, we take a closer look at the proposed amendments to the proposed regulations governing the licensure of hospice programs.

Today, our colleagues at ML Strategies released their first look at what the results of Tuesday's election mean for health care. The client alert addresses both the lame duck session and what to expect in 2017 and beyond.

At yesterday's Public Health Council meeting, the Massachusetts Department of Public Health (DPH) released yet another round of proposed regulatory amendments. On deck were regulations concerning Long Term Care Facilities, Hospice Programs, and Temporary Nursing Service Agencies, as well as requirements for Training of Nurses’ Aides in Long-Term Care Facilities.

Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019.

Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework.

Continuing our current coverage of health policy issues and trends, Mintz Levin's Health Law Practice and ML Strategies have issued a joint Alert regarding the Massachusetts Health Policy Commission’s Annual Cost Trends Hearings.

The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry.

Pharmaceutical industry enforcement has been one of the hottest topics in the news in the past month. Last week, Ellyn Sternfield and Rodney Whitlock were quoted by cnbc.com regarding the recent Mylan settlement.

If you missed the Mintz Levin Privacy and Security Practice Webinar last week, you can still get it! The current Privacy Webinar Series is focusing on the EU General Data Protection Regulation (GDPR), which will impact how US businesses handle and process personal data from the EU, including possible changes to business processes.

In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations.

On October 7, 2016, the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance.