House Ways and Means Committee Advances Opioid Bills

On Wednesday, May 16, the House Ways and Means Committee advanced four opioid crisis-related packages. The bipartisan measures, which are expected to move with other House bills under consideration, largely focus on combating the epidemic through strengthened prevention, provider and beneficiary education, and treatment options.

During the markup, Ways and Means Chairman Kevin Brady (R-TX) did not offer an exact date for bill consideration by the full chamber. However, he expressed his commitment to “working together to move these important proposals to the House floor in the weeks ahead.”

The following bills were each approved by voice vote:

  • H.R. 5773, Preventing Addiction for Susceptible Seniors (PASS) Act (H.R. 5773), authored by Rep. Peter Roskam (R-IL) – requires Medicare prescription drug plans to establish management programs for at-risk beneficiaries.
  • H.R. 5774, Combatting Opioid Abuse for Care in Hospitals (COACH) Act (H.R. 5774), authored by Rep. Carlos Curbelo (R-FL) – directs hospitals receiving Medicare Part A funding to develop guidance for treating pain and opioid use disorders.
  • H.R. 5775, Providing Reliable Options for Patients and Educational Resources (PROPER) Act (H.R. 5775), authored by Rep. Erik Paulsen (R-MN) – requires Medicare Advantage and Part D prescription drug plans to offer educational resources on opioid-related risks.
  • H.R. 5776, Medicare and Opioid Safe Treatment (MOST) Act (H.R. 5776), authored by Rep. Richard Neal (D-MA) – orders Medicare to cover a variety of opioid treatment services.

On Thursday, May 17, the House Energy and Commerce Committee (E&C) will hold a markup to consider a second batch of bills related to the opioid crisis. The proposals are anticipated to solicit somewhat contentious debates and include provisions related to public health, Medicare Part B and D programs, and Medicaid.

Key Health Care Technology Privacy and Cybersecurity Considerations

In a podcast interview with Healthcare InfoSecurity, Squire Patton Boggs Partner Elliot Golding addresses evolving healthcare privacy and security issues, particularly complex issues involving Internet of Things (IoT) devices.  This includes addressing new risks when connected devices link to legacy systems, the applicable regulatory environment, and other key issues companies operating in the health care space need to consider when using new technologies.  The interview concludes with practical recommendations to help companies identify and address these privacy and cybersecurity risks and compliance obligations.  Listen to the segment here.

 

 

EU’s proposed eHealth measures focusing on broadening the availability and sharing of health data

Digital HealthOn 25 April 2018, the European Commission (EC) issued a Communication on enabling the digital transformation of healthcare, outlining the European Union’s (EU) priorities and actions towards digital health. The EU’s plan focuses on the following core priorities:

  • Ensuring citizens’ access to their health data and introducing the possibility to share their data across borders;
  • Promoting the usage of larger data sets to enable more personalized diagnoses and medical treatment, and better anticipate epidemics;
  • Promoting appropriate digital tools, allowing public authorities to better use health data for research and for health system reforms.

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Recent UK hospitals merger clearance confirms recent high degree of willingness to accept efficiencies/customer benefits arguments in hospitals merger reviews

Hospital MergerThe UK’s Competition and Markets Authority (CMA), has recently cleared a second hospital merger after only a Phase 1 review (involving an initial 40-day review period) based on the parties’ efficiencies/customer benefits arguments, despite the fact that the CMA believed that the merger may result in a substantial lessening of competition (SLC).

It is quite unusual for the CMA to clear a merger believed to give rise to an SLC risk on the basis of efficiencies/customer benefits without a detailed Phase 2 review (taking an additional 24 – 32 weeks).  The CMA’s willingness to do so in this case confirms a trend for the CMA being prepared to apply the merger control rules more flexibly for hospital mergers, recognizing the unique market features in this sector and demonstrating the CMA’s willingness not to allow the merger control regime to obstruct efforts to improve NHS patient care via mergers.

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HHS Final Rule Scales Back Affordable Care Act Regulations

Earlier this month, the US Department of Health and Human Services (HHS) published a Final Rule in the Federal Register that will scale back regulations applicable to health insurance subject to the Patient Protection and Affordable Care Act (ACA). In issuing the Final Notice of Benefit and Payment Parameters for 2019 Rule (Final Rule), HHS observed that premium rate increases and health insurance company market exits have threatened the stability of individual and small group Exchanges in many regions. According to HHS, the Final Rule enhances the role of the states in regulating health insurance, provides states with additional flexibilities, reduces unnecessary regulatory burdens and improves affordability.

The Final Rule continues actions by the Administration to eliminate previously adopted requirements that implement the ACA. Last year, the Administration repealed the penalties associated with the individual mandate to purchase health insurance and began the process to repeal certain ACA regulations. The Final Rule further reduces regulations associated with the ACA, with some reforms taking effect immediately and others taking effect in future years. Although the reforms are comprehensive and far-reaching, they generally fall into the following categories:

  • Enhancing the Role of States
  • Reducing Regulatory Requirements
  • Making Exchanges More Efficient
  • Increasing Regulatory Oversight

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States Increase HIPAA Enforcement

A recent blog post summarized Health Insurance Portability and Accountability Act (“HIPAA”) enforcement settlements for Virtual Medical Group (“VMG”) in New Jersey and EmblemHealth in New York that may signal a broader trend of increased state HIPAA enforcement.  Under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act’s amendment to HIPAA, codified at 42 U.S.C. § 1320d-5(d), state attorney generals have authority to bring civil actions in federal district court to enforce HIPAA when the interests of state citizens have been affected.  Although states also have authority to bring civil actions under state law Unfair and Deceptive Acts (“UDAP”) laws, their additional authority under HIPAA provides an independent vehicle to enforce data privacy and cybersecurity practices.  This increased enforcement trend provides yet another reason that health care entities subject to HIPAA need to ensure they have taken steps to ensure HIPAA compliance. For more detailed information, please read the Security and Privacy blog post.

Using Data Mining to Promote Compliance

Government uses data mining to select targets for enforcement actions. Your company can use data mining to promote compliance. For tips and insights listen to an eleven minute podcast in “Compliance Perspectives,” from the Society of Corporate Compliance and Ethics (SCCE).  SCCE is a member-based association providing education and news updates for ethics and compliance professionals. To listen to the podcast, click here. ( http://complianceandethics.org/tom-zeno-on-data-mining-and-compliance-podcast/)

 

Negotiating A Deal? Ensure You Respond Appropriately To Union Requests For Information

Mergers, acquisitions, and sales can be a common event for health systems. These types of deals involve many moving parts, from both legal and operational perspectives. Given how complex deals can become, it can be easy to overlook obligations to labor unions when they arise. One recent National Labor Relations Board (“Board”) decision illustrates a key obligation for unionized health systems, the duty to furnish information, and how entities should address that obligation during deals. Crozer Chester Medical Center, 366 N.L.R.B. No. 28 (2018).

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FDA Approves Marketing of Clinical Decision Support Software for Stroke Triage in Midst of Renewed Focus on Digital Health Applications

The U.S. Food and Drug Administration (“FDA”) recently approved the Viz.Ai Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. In an article published March 8, 2018 as a PG Alert Email from the American Health Lawyers Association (“AHLA”), associate Jennifer M. Tharp discussed the recent approval of the software and its relation to the FDA’s increasing attention to digital health applications.  The alert also explores the FDA’s digital health application approval process, and the agency’s intention to reduce the time and cost of market entry of digital health technologies.

Copyright 2018, American Health Lawyers Association, Washington DC. Reprint permission granted.

Narrow TCPA Healthcare Exemption Upheld by D.C. Circuit

On March 16, 2018, a unanimous panel of the US Court of Appeals for the District of Columbia Circuit issued its long-awaited and much-anticipated decision in ACA Int’l v. FCC, Case No. 15-1211. Though the Court vacated certain portions of the Federal Communication Commission’s 2015 omnibus declaratory ruling and order (2015 Omnibus Order) concerning the Telephone Consumer Protection Act (TCPA), the Court upheld the Commission’s approach regarding an exemption for time-sensitive healthcare calls. We represented one of the petitioners challenging the FCC Order, and all petitions challenging the order were consolidated in front of the DC Circuit. The DC Circuit’s 51-page opinion can be found here.

By way of background, in the 2015 Omnibus Order, the FCC created a healthcare exemption for wireless calls that involved an “urgent” healthcare purpose, including, but not limited to, appointment and exam confirmations, wellness checkups, hospital preregistration instructions, lab results, and prescription notifications. The FCC had previously exempted pre-recorded calls to landlines for these purposes in a prior order. For this exemption to apply to wireless calls, however, the messages could not include telemarketing or advertising content, the calls had to be free to the end-user, and callers would have to promptly honor opt-out requests, among other restrictions.

On appeal, the DC Circuit rejected petitioner Rite Aid’s arguments that the FCC exemption for selected healthcare-related calls was arbitrary and capricious and that it violated the Health Insurance Portability and Accountability Act (HIPAA). The Court also disagreed that all healthcare-related calls fall within an exemption, such as those with “telemarketing, solicitation, or advertising content, or which include accounting, billing, debt-collection, or other financial content ” because such calls “do not arise from the sorts of emergencies that would justify suspending the TCPA’s consent regime.” In short, the Court upheld the narrow exemption in the 2015 Omnibus Order and suggested that only the enumerated “exigent” purposes would fall within the exemption. To review the discussion of the healthcare exemption in the 2015 Omnibus Order, see pages 68-72 here.

The DC Circuit also addressed three additional rulings from the 2015 Omnibus Order. For an analysis of all four rulings in the DC Circuit’s 51-page opinion and a discussion of the impact the decision may have on pending and future TCPA litigation, read our alert here.

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