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FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
May 14, 2018 | Blog | By Joanne Hawana
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a roller coaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago.
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President Trump Delivers Much Anticipated Drug Pricing Speech
May 14, 2018 | Blog | By Theresa Carnegie, Tara E. Dwyer
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
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Congress Holds Hearings and Proposes Legislation to Combat Vexing Opioid Crisis
May 10, 2018 | Blog
On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry.
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Warner Chilcott HIPAA Lesson Revisited – Mass. Physician Convicted of Criminal Violation
May 10, 2018 | Blog | By Ryan Cuthbertson
Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and Accountability Act (HIPAA). That physician has now been convicted of the HIPAA violation, as well as an unrelated charge of obstructing a federal health care investigation.
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ML Strategies Health Care Preview - May 7, 2018
May 7, 2018 | Blog
This week, Congress is back in session with the House continuing its work on addressing the opioid crisis. There are three hearings and a markup on several pieces of legislation intended to address the ongoing epidemic.
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50 Reasons to Download the Newly-Updated Mintz Data Breach Matrix
May 4, 2018 | Blog | By Dianne Bourque
Mintz Levin has updated the Mintz Matrix, a comprehensive summary of the data breach notification laws that now exist in all 50 states (South Dakota and Alabama finally caved and enacted their own laws). It’s critical that HIPAA-regulated entities monitor these state laws because they apply simultaneously, and often conflict with, HIPAA.
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Will CMS Drive Further Changes to 340B?
May 1, 2018 | Blog
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming?
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ML Strategies Health Care Preview - April 23, 2018
April 23, 2018 | Blog
This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after the President's speech on drug pricing was postponed. Both committees of jurisdiction in the House and Senate are moving on opioid legislation this week, so that has our immediate attention.
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CMS Continues to Focus Medicare Plans on Preventing Opioid Abuse
April 23, 2018 | Blog | By Bridgette Keller
As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time, so there is a lot of information for Medicare Advantage organizations and Part D plan sponsors to absorb.
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Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
April 18, 2018 | Blog | By Benjamin Zegarelli
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.
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CMS Benefit and Payment Rule: What is Success for the ACA?
April 17, 2018 | Blog
On Monday, CMS published a number of policies changing the dynamics of the individual market, including the Benefit and Payment Parameters for 2019 Final Rule, guidance on hardship exemptions, and a bulletin on transitional (grandmothered) plans. When interpreting all of these policies it’s important to keep in mind the following: What is success? And who is defining it?
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Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative Remedies
April 17, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman
The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.
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ML Strategies Health Care Preview - Week of April 16th
April 16, 2018 | Blog
Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention.
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Report Details Uneven Implementation of the New Drug Tracing Law
April 13, 2018 | Blog
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.
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State Action on Potential 1115 Medicaid Waivers
April 11, 2018 | Blog
In a previous blog, we reviewed pending and approved 1115 waivers in 8 states. We also highlighted the trends we see in 1115 waivers, such as changes to coverage requirements, a time limit on how long certain beneficiaries can receive Medicaid coverage, lock-outs if an individual fails to pay a premium or meet the work requirement, and drug testing requirements.
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ML Strategies Health Care Preview - Week of April 9th
April 9, 2018 | Blog
This week, Congress returns from recess with its eyes set on addressing the opioid crisis. We expect to see some form of bipartisan legislation considered between now and Memorial Day. We will also see Congress dive into appropriations which will eat up plenty of time, not to mention nominations of Cabinet officials and appointments to the federal bench.
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Federal Commission Recommends Streamlining Medicaid Waiver Authorities
April 9, 2018 | Blog
In March, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its biannual report to Congress. MACPAC is an independent congressional agency that advises Congress on issues relating to Medicaid. In its report, the Commission made a three part recommendation in regards to streamlining Medicaid managed care authorities.
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Alabama Enacts Data Breach Notification Law
April 5, 2018 | Blog | By Ryan Cuthbertson
Earlier this week, Mintz Levin’s Privacy & Security Matters blog posted an update that Alabama has become the 50th state to enact a data breach notification law.
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MedPAC Recommends Significant Changes to MACRA
April 5, 2018 | Blog
In March, the Medicare Payment Advisory Commission (MedPAC) released its biannual report to Congress on matters affecting the Medicare program. MedPAC is an independent congressional agency that advises Congress on issues relating to Medicare.
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The California Attorney General and Sutter Health Face Off in an Antitrust Lawsuit
April 5, 2018 | Blog | By Dionne Lomax
On March 29, 2018, the Attorney General of California filed an antitrust action against Sutter Health and its affiliates (“Sutter”) alleging Sutter engaged in various anti-competitive conduct in violation of California’s Cartwright Act.[1] According to the Complaint, healthcare costs in California have rapidly increased, and prices in Northern California are higher than in other areas of the State.
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