Next week, the Massachusetts House will continue the budget process and debate over 1000 amendments that members filed to the House Ways and Means Committee’s proposed $40.3 billion FY2018 budget. The Committee’s budget includes some notable departures from Governor Baker’s proposed budget, including changes to budget items impacting the health care industry. In an Alert released earlier this week, my ML Strategies colleagues Julie Cox, Steven Baddour, Dan Connelly, Caitlin Beresin, Max Fathy and Haejin Hwang describe some of the variances in health care and public health spending proposals. Continue Reading Massachusetts Budget Process Continues with Impact on Health Care
Rachel Irving Pitts is an Associate in the firm and is based in the Boston office. She focuses her practice on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance review, telemedicine issues, and provider and service contracting matters. Her clients include hospital systems; dialysis, long-term care, and retail providers; individual providers and practice groups; management companies; independent practice associations; and third-party administrators and payors.
The Stark Law has caused angst for many a physician and many a health care lawyer over the years. The Stark Law has also troubled hospital and health system CEOs looking for ways to align incentives with physicians. Some stakeholders say Congress should do away with the myriad statutes and regulations that comprise the strict liability federal law banning physician self-referral. Those stakeholders suggest either repealing it altogether and letting other fraud and abuse laws do the work, or – as its namesake former-Representative Pete Stark has suggested – replace it with a much simpler prohibition on soliciting referrals for kickbacks or other special treatment.
My colleague, Tom Crane, suggests another approach – revamp the Stark Law’s advisory opinion process so the Centers for Medicare and Medicaid Services (“CMS”) can protect arrangements from sanctions, similar to the Office of the Attorney General’s (“OIG’s) Anti-Kickback Statute (“AKS”) advisory opinion process. Continue Reading Changes Needed to Stark Law Advisory Opinion Process
The Massachusetts health care industry is facing policy changes from state and federal decision makers. In a recent Alert, my ML Strategies colleagues Julie Cox, Steven Baddour, Dan Connelly, Caitlin Beresin and Max Fathy consider how state and federal government action will affect a wide variety of health care stakeholders.
In addition to certain health care aspects of Governor Baker’s proposed FY2018 budget, the Massachusetts legislature is expected to debate a number of health care issues during the 2017-2018 legislative session. And while Massachusetts is a national leader in health care, federal health care law and policy will always impact the Commonwealth, so ML Strategies is watching how the new presidential administration and Congress move forward with their plans to reshape the nation’s health care policy.
Two key Massachusetts budget items relating to health care are controversial amongst industry:
- A $2,000 per employee “fair share” assessment for certain Massachusetts employers that fail to meet certain enrollment or contribution thresholds for their employee health insurance plans.
- Permanent tiered caps on the rate of growth for all acute hospitals and most professional service providers.
My colleagues also highlight several bills that Massachusetts legislators have introduced relating to drug pricing transparency, recognizing that pharmaceutical spending is a key driver of total health care expenses. We can also expect recommendations from both the Health Policy Commission and the legislature’s Special Commission on Provider Price Variation this spring.
Read the full Alert, and stay tuned as ML Strategies continues to monitor health care in the Commonwealth.
For Health Care stakeholders, ML Strategies considers priorities that have been identified by the Trump Administration and the Republican-controlled Congress, and forecasts possible legislative and administrative actions to move their agendas along. We all know that the ACA is a target, and whether the chosen path forward is repeal and replace, or repair and rebuild, there are some key components of the law that are vital to a healthy marketplace. ML Strategies outlines some strategies and tactics we might see in the coming weeks.
In addition to ACA repeal, the Health Care Outlook also discusses key Administration appointees for HHS, CMS and FDA, as well as potential policy advisors. There are also a number of Congressional acts up for reauthorization – the “UFAs” for FDA, CHIP and Medicare outpatient therapy caps – each important in its own right, but which also creates opportunities for ‘ride-along’ policy initiatives.
Finally, ML Strategies looks to what may happen to the ACA cost-sharing reductions with the House v. Burwell litigation, and considers whether Telemedicine might provide an opportunity for this new Congress to work together, across party lines.
As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry.
Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry,” when they will take a deep dive into important provisions for industry to consider.
Each presenter will bring their unique experience to the webinar to help illuminate opportunities the legislation presents to the med tech community, along with certain hurdles to clear. They will discuss the politics behind the law, from its passage to anticipated issues with its execution, before plunging in to some device-related details. Some specific items they will consider include:
- the creation of a breakthrough device pathway,
- FDA’s use of the least burdensome review requirements, and
- a new “medical device” definition.
Mark your calendars and register today!
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP). These amendments and updates to the AKS and CMP regulations attempt to clarify the OIG’s enforcement position in light of changes due to health reforms, to streamline the OIG’s advisory opinion workload, and to implement long-existing mandates enacted in statutes. This post discusses the amendments to the beneficiary inducement provisions of the CMP codified in 42 C.F.R. Part 1003 (CMP Regulations). Continue Reading At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors
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. The healthcare industry is no stranger to privacy and data protection, but any business that deals with personal data from the EU needs to understand the reach and scope of the GDPR, so they can prepare for this potentially game-changing privacy regulation.
In the webinar focusing on Accountability, Data Security, Data Impact Assessments and Breach Notification, our colleague Sue Foster covers the practical implication of the GDPR for your business.
And register now for the next webinar in the series on November 10, which will focus on the new restrictions around relying on user consent to data processing and data transfers.
Join us this Friday at 1:30 pm EDT for a webinar with two of our Antitrust colleagues, Robert Kidwell and Bruce Sokler. They will discuss recent events in the Hershey Hospital merger and their impact on FTC’s hospital merger enforcement program. Learn more about these recent updates from the comfort of your computer in our one-hour webinar.
Hershey Hospital Merger Blocked
Yesterday, the Third Circuit granted a preliminary injunction preventing the merger between Penn State Hershey Medical Center and Pinnacle Health System. Previously, the district court had denied the FTC’s and State of Pennsylvania’s motion challenging the merger. The district court found that the merger challenge was not meritorious, particularly in light of Affordable Care Act policies. But the FTC’s hospital merger enforcement program was revived with yesterday’s Third Circuit’s decision, which is significant to healthcare lawyers and providers.
During the webinar, Rob and Bruce will review this important decision and the court’s approach to:
- Geographic markets in hospital merger cases
- The central role of the FTC’s hypothetical monopolist test
- Renewed emphasis on the testimony and role of insurers
- Using the efficiency defense in merger litigation
- Relevance of merging parties’ forward-looking contracts with payers
- The capital-avoidance justification for mergers
- The place of the ACA in hospital merger analysis
Possible Impact on Advocate Merger
And because Pennsylvania can’t have all the fun, Rob and Bruce will also discuss how the Hershey decision might impact the FTC’s pending challenge to the Advocate merger in Chicago, which we have blogged about before.
Mintz Levin’s TCPA & Consumer Calling Practice team has issued its first monthly newsletter with legal updates and trends in this area. As we have pointed out before, the healthcare industry is not immune from litigation and enforcement based on the Telephone Consumer Protection Act (TCPA). Pharmacies and providers have been subject to settlement payments resulting from calls to consumers, and the FCC has addressed so-called “robocalls” made by healthcare providers in its rulings.
We are excited to present this inaugural Monthly TCPA Digest – Part I highlights TCPA Regulatory updates and considerations (including information about an FCC Public Notice seeking comment on a petition relating to the interaction between FCC rules and HIPAA), and then Part II explores TCPA Litigation developments. You can also learn more about our TCPA & Consumer Calling Practice from the newsletter.
With the continuing compliance challenges faced by health care industry participants and the overlay of sometimes competing regulatory frameworks, we hope this TCPA newsletter helps keep you informed of the risks and opportunities in this area. In an industry where timely and confidential communication is key, many providers and other industry participants are trying to navigate the legal landscape and keep an open line of communication with their patients and customers.
HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect fewer than 500 individuals. OCR Regional Offices already investigate every reported breach affecting 500 or more individuals, and will continue to do so, but now they will intensify efforts to scrutinize smaller breaches.
Investigations into the root cause of even a small breach can discover system- and enterprise-wide noncompliance and security and privacy shortcomings. An investigation into a single stolen laptop that held PHI of 80 individuals may uncover an entity’s failure to encrypt any of the data it stores and uses. And just as easily as a larger breach, a small breach can reveal that a covered entity has not completed a full risk assessment of its organization and its PHI protections. Continue Reading OCR to Increase Investigations of Smaller HIPAA Breaches