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Massachusetts Long Term Care Facility Regulations – Proposed Amendments

November 21, 2016 | Blog | By Daria Niewenhous

The Massachusetts Department of Public Health (DPH) continues its efforts to revise its regulations to comply with Executive Order 562, which requires all state agencies to review its regulations.
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Promise to Repeal the ACA Poses Threat to MACRA Implementation

November 21, 2016 | Blog

Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal government's strategy to try to reign in health care costs by reducing volume and promoting quality.
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Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

November 21, 2016 | Blog | By Joanne Hawana , Benjamin Zegarelli

As we’ve previously reported, the FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications.
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Will Republicans Embrace CMMI’s Authority?

November 18, 2016 | Blog | By Lauren Moldawer

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.
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OCR Reminds Companies that Authentication is Key

November 17, 2016 | Blog

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. 
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Recent Developments Around Pharmaceutical Drug Spending In Massachusetts

November 17, 2016 | Blog | By Brian Dunphy

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.
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Transitioning the ACA: Republicans Must Make Hard Choices

November 17, 2016 | Blog

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. 
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Transitioning the ACA: Republicans Must Avoid Disruption

November 16, 2016 | Blog

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.
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2017 OIG Work Plan: For Medicare Plans

November 16, 2016 | Blog | By Tara E. Dwyer

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.
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Transitioning the Affordable Care Act: Republicans Must Talk to Insurers

November 15, 2016 | Blog

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.
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FDA to Study Social Media Promotion

November 15, 2016 | Blog | By Benjamin Zegarelli

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.
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2017 MA and Part D Audit Protocols and Data Requests are Open for Comment

November 14, 2016 | Blog | By Lauren Moldawer, Tara E. Dwyer

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.
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It’s Not Really ”Repeal and Replace”; It’s Transition

November 14, 2016 | Blog

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.
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Massachusetts Licensure of Hospice Programs Proposed Regulations - Key Take-Aways

November 14, 2016 | Blog | By Ellen Janos

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.
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What the Election Means for Health Care - Insight from ML Strategies

November 11, 2016 | Blog

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.
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Massachusetts Regulatory Overhaul Continues

November 10, 2016 | Blog | By Daria Niewenhous

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.
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CMS Delays Enforcement of Part D Prescriber Enrollment Requirements

November 8, 2016 | Blog | By Lauren Moldawer

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.
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HOSPITAL ADVERSE EVENT REPORTING SYSTEM TO BE INTEGRATED INTO FDA NEST PROGRAM

November 1, 2016 | Blog

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.
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Massachusetts Health Policy Commission's Annual Cost Trends Hearings

November 1, 2016 | Blog | By Daria Niewenhous

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.
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FCA Settlement Involves Waiver of Medicare Coinsurance Amounts

October 25, 2016 | Blog | By Karen Lovitch

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.
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