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Health Care Weekly Preview from ML Strategies – Week of July 17, 2017
July 17, 2017 | Blog
Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week’s preview describes the Better Care Reconciliation Act (BCRA), the User Fee Acts (UFAs), the National Defense Authorization Act (NDAA), and the health care Minibus.
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FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements
July 13, 2017 | Blog | By Joanne Hawana
Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA).
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Health Care Weekly Preview from ML Strategies - Week of July 10, 2017
July 10, 2017 | Blog
Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus.
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FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention
June 30, 2017 | Blog | By Joanne Hawana
It appears that - at least for now - the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch's efforts to tackle the increasingly contentious debate about prescription drug prices.
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Drug Makers Not Off the Hook as States Continue to Take Action to Control Drug Prices
June 29, 2017 | Blog | By Carrie Roll
Earlier this month, two states – Maryland and Nevada – passed legislation aimed at controlling drug prices.The two laws are being touted by proponents as decisive action against pharmaceutical manufacturers.
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Massachusetts House & Senate Tackle Marijuana
June 28, 2017 | Blog | By Daria Niewenhous
The Massachusetts legislature has targeted July 1, 2017 as the date by which it will have legislation on Governor Charlie Baker’s desk regarding the commercial cultivation, processing, and sale of non-medicinal cannabis products for adult use.
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Capitol Hill Update: Affordable Care Act Repeal on the Ropes?
June 27, 2017 | Blog
The Senate bill to repeal the Affordable Care Act is currently being poured over by Senate Republicans and their staff, but the early prognosis for a vote this week is not good. Senate leadership had set a goal of voting on this legislation – known as the Better Care Reconciliation Act (BCRA) – before the Fourth of July recess, which means by this Friday.
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What’s CHIP Got to Do With It?
June 27, 2017 | Blog
Children in United States receive their health insurance from multiple sources: the Children’s Health Insurance Program (CHIP), Medicaid, employer-sponsored insurance, or a qualified health plan on the Marketplace.
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Join us July 12th - Webinar on Qui Tam Relators
June 26, 2017 | Blog
Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year. Join our upcoming webinar - “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET.
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CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016
June 26, 2017 | Blog | By Tara E. Dwyer
On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of July 31, 2017. As explained in our earlier post, CMS publishes Part D DIR Reporting requirements each year and sets the deadline for DIR submissions.
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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3
June 20, 2017 | Blog | By Benjamin Zegarelli
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion.
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Antitrust Class Action Against the American Osteopathic Association Survives Motion to Dismiss
June 20, 2017 | Blog | By Dionne Lomax
A New Jersey district court recently denied a motion to dismiss Talone, et. al. v. The American Osteopathic Association, an antitrust class action. The suit alleges that the physician association violated the Sherman Act by illegally tying osteopaths’ board certification to association membership.
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Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In
June 19, 2017 | Blog
Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court ("SJC") ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating.
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Health Care Weekly Preview from ML Strategies – Week of June 19, 2017
June 19, 2017 | Blog
Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week’s preview describes health insurers' marketplace applications as well as the American Health Care Act (AHCA).
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SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
June 14, 2017 | Blog | By Joanne Hawana
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported.
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OCR Publishes Checklist and Infographic for Cyber Attack Response
June 14, 2017 | Blog
OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities, these guidance documents are a useful reminder of best practices that health care entities should have in place in case of a cybersecurity incident.
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Exclusive Network Agreements Gets Stamp of Approval from Seventh Circuit
June 12, 2017 | Blog | By Dionne Lomax
In an opinion written by Judge Posner, the Seventh Circuit on Friday, June 9, 2017, affirmed OSF Saint Francis Medical Center’s summary judgment win in a $300 million antitrust suit brought by a smaller competitor alleging unlawful exclusive dealing and attempted monopolization.
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Healthcare Weekly Preview from ML Strategies - Week of June 12, 2017
June 12, 2017 | Blog
As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.
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OIG Publishes Semiannual Report to Congress
June 9, 2017 | Blog | By Ryan Cuthbertson
Earlier this month, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) published its Semiannual Report to Congress covering the period from October 1, 2016 to March 31, 2017. The report describes OIG’s work and accomplishments during the 6-month reporting period.
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Antitrust Suit Against Michigan Hospital Moves Forward After Federal District Court Denies Both Sides’ Motions for Summary Judgment
June 9, 2017 | Blog | By Samantha Kingsbury
Earlier this week, my colleagues Bruce Sokler, Robert Kidwell, Dionne Lomax, and Farrah Short published an alert about the federal district court for the Eastern District of Michigan’s recent decision to deny both the government’s and defendant hospital’s respective motions for summary judgment in a suit filed by the Department of Justice and the Michigan Attorney General in 2015.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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