House Energy and Commerce Committee Clears Opioid-Related Measures

On Thursday, May 17, the House Energy and Commerce Committee (E&C) cleared 32 additional opioid-related measures during its second markup on the issue. In total, E&C has now advanced 57 bills to combat the opioid overdose crisis.

While most measures were easily approved on a bipartisan basis, committee members disagreed over a number of bills related to expanding buprenorphine prescribing authorities, lifting a decades old ban on Medicaid payments for mental health and substance use disorder (SUD) residential treatment facilities with more than 16 beds, and permitting physicians to more easily access and share medical records related to patients’ SUD therapies.

During the hearing, E&C Chairman Greg Walden (R-OR) suggested that Majority Leader Kevin McCarthy (R-CA) has committed to reserving House floor time in June to consider a comprehensive legislative package.

A summary of the various bills is presented here.


The New Federal Blueprint to Lower Drug Prices

On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges:

  1. Excessively high drug prices
  2. Seniors and government programs overpaying for drugs
  3. High out-of-pocket costs for consumers
  4. Lack of transparency in drug pricing
  5. Free-riding by foreign nations as to US investment in innovation

This piece provides analysis of the Blueprint and its proposed reforms.  Read PDF.

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29

The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as the “Medicare EHR Incentive Program”). This new process intends to involve stakeholders in the evolution of the PI Program.

Measure proposals will be accepted until June 29, 2018 and will be considered for inclusion in rulemaking in calendar year (CY) 2019. If adopted through the rulemaking process, a measure would be optional for CY2020 and required for CY2021.

While all measures are welcome, CMS is particularly interested in adding measures that:

  • Build on the advanced use of certified EHR technology (CEHRT) using 2015 Edition Standards and Certification Criteria;
  • Increase CEHRT health information exchange and interoperability;
  • Continue improving program efficiency, effectiveness, and flexibility;
  • Measure patient outcomes; and
  • Emphasize patient safety.

CMS will utilize certain criteria as part of the selection process for new measures:

  • Would the measure reduce reporting burden?
  • Is the measure duplicative of existing or previously removed objectives and measures?
  • Would the measure include an emerging certified health IT functionality or capability?

To propose a measure, send the completed application to  Applications can be found on the Promoting Interoperability Programs website.  Be sure to complete fully the application of a proposed measure since CMS will disqualify incomplete applications.

Additional information related to the 2018 Call for Measures can be found on the CMS website.

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. (