On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The original Common Rule had been in place for almost 30 years, with little change despite significant research and technology advances during that time. Further change is on the horizon for the Common Rule, as the 21st Century Cures Act (Cures) includes a mandate for HHS and the Food and Drug Administration (FDA) to harmonize long-standing differences between the Common Rule and FDA Human Subject Protection regulations. Continue Reading The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act
Last week, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties.
The draft includes many small changes to the Marketing Guidelines, including but not limited to those in the following areas:
- Multi-language inserts – CMS wants to defer to the more robust requirements established by Section 1557 of the Affordable Care Act
- Non-English Language Disclaimer – Plan Sponsors will be required to include the non-English language disclaimer on ANOC/EOC, LIS Rider, Comprehensive or Abridged Formulary, Star Ratings, Summary of Benefits, Part D Transition Letters.
- Use of Star Ratings – The draft includes multiple changes relating to how and when a Plan Sponsor can use its Star Ratings, including that CMS will provide a Gold Star icon each fall to 5 Star Plans that the Plans can use on their marketing material. Plans may not create their own gold star icon.
- Unsolicited Electronic Communication – Plan Sponsors will be required to include an opt-out process for enrollees and the draft instructs Plan Sponsors that an individual “liking” the Plan’s social media page does not constitute the individual agreeing to receive communications from the Plan Sponsor outside of the social media forum.
- Provider Affiliation Announcements – Plan Sponsors and providers will be allowed to announce new or continuing affiliations only once an agreement between the parties has been approved and the draft clarifies that such announcements that describe plan benefits, premiums, or cost sharing are marketing materials and must be submitted to HPMS, and that the Plan Sponsor is responsible for ensuring that providers comply with the MMG distribution and mailing guidance for Provider-Based Activities.
- Review of Materials in the Marketplace – Plan Sponsors are reminded that they must report to CMS all self-identified errors in all marketing materials.
- Third-Party Websites – This is a new section, at 100.7. The draft requires Plan Sponsors to submit third-party marketing websites to HPMS, even if there is no benefit information included on the third-party website. CMS recognizes that website owners may work with multiple Plan Sponsors and recommends that the Plan Sponsors coordinate the multi-plan submission. The section also lists activities that third-party websites are prohibited from doing.
CMS explains that it is interested in comments on all sections and changes, but is particularly interested in comments regarding changes to provider-affiliation announcements and the newly added section regarding third-party websites. Comments on the draft are due to CMS by 5:00pm (ET) Friday, February 3, 2017 and may be submitted through CMS’s survey site.
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health, a health care network in Illinois, discovered a breach of unsecured personal health information (PHI) on October 22, 2013. After reporting the breach to OCR over three months later on January 31, 2014, OCR determined that Presence Health failed to notify OCR, each of the affected individuals, and prominent media outlets of the breach without unreasonable delay and within 60 days of learning of the breach, as required of Covered Entities under HIPAA. The violation resulted in a $475,000 settlement between OCR and Presence Health.
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.
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations (shown here compared against the draft revisions.) Approved by the Massachusetts Public Health Council (PHC) on January 11, 2017, DPH anticipates that the DoN regulations (105 CMR 100.000, et seq.) will be published in the Massachusetts Register on January 27, 2017, which will be their effective date.
Commissioner Monica Bharel, M.D., MPH emphasized that the overarching goal of these revisions is to meaningfully infuse public health and population health principles within this longstanding health care regulation. The Commissioner noted that it is her belief that successful cost containment must occur in the context of tackling social determinants of health. Our previous blog post, published at the time the draft revisions were presented to the PHC, reviews in some detail the DoN Program’s public policy goals underpinning these revisions, and we refer you to that post for more information.
At the presentation of the draft revisions to the PHC on August 23, 2016, DPH announced its intent to solicit and encourage robust public comment, and the public did not disappoint. A January 11, 2017 memorandum from senior DPH staff to Commissioner Bharel and members of the PHC requesting approval of the final proposed DoN regulations stated that DPH received over 100 comments, submitted at two public hearings and in writing during the 45-day public comment period. The memorandum summarizes not only the comments received, but the stakeholders who submitted the comments and DPH’s public policy rationale for its reaction to many of the comments. Materials (available here and here) accompanying the presentation of the final proposed DoN regulations also summarize the draft revisions, comments received and final proposed DoN regulations.
Many comments addressed the requirements for DoN review of ambulatory surgery, transfer of ownership, Community Health Initiative (CHI) projects, as well as application requirements, review process and criteria, and standard conditions. Two areas that generated many of the public comments, and which resulted in adjustments to the proposed DoN regulations, are discussed below. Continue Reading Massachusetts Determination of Need Program – Final Regulations
As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.
First, since being signed into law by former President Obama on December 13th, we’ve been writing and speaking about the myriad provisions of the 21st Century Cures Act. This wide-ranging law has many mandates for agency actions and new guidance documents, which FDA will be working on beginning this year, but far beyond 2017 as well. Drug, biologic, and medical device stakeholders are also awaiting the outcome of the upcoming reauthorization of all the major User Fee Acts that are “must-pass” legislation before the end of the current fiscal year (FY17 ends on September 30th), in order to ensure FDA’s continuing operations. Many other policy changes that are expected to result from the switch from a Democratic-led to a Republican-led Executive Branch, the latter also being supported by a GOP-controlled Congress, will likely have major impacts on medical product developers. Continue Reading FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”
Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated that its $465 million settlement resolved all potential liability to government programs over EpiPen’s classification for Medicaid Drug Rebate purposes, DOJ would not confirm the specifics of the settlement and it appeared that no actual settlement documents had even been drafted. We blogged our thoughts that the “settlement” was actually a handshake deal that had not been reduced to writing, had not been agreed to by the states, and had left the extent of any releases and future compliance to be negotiated. And we said Congressional scrutiny would not end due to the announced settlement.
Multiple state and government officials decried the announced settlement as inadequate. Senator Grassley went so far as to schedule a Senate hearing on the settlement, but was forced to postpone it when no one from DOJ or Mylan would agree to attend and testify.
Then the election intervened, and EpiPen rebates were yesterday’s news. However, Senator Grassley, for one, is not letting go. But at this point, his focus is more on government action, or inaction, over drug classifications. And depending on what his inquiry reveals, it may end up hurting, not helping, any government case against Mylan, and potentially other drug manufacturers, based on classification of drugs for purposes of Medicaid Drug Rebates.
On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what regulations apply. The final rule also excludes products derived from tobacco from regulation as “tobacco products” if such products are intended for use as a drug, device, or combination product. (We’ll be discussing the tobacco products portion of the rule in a separate post.) While this rule could have a profound effect on marketing schemes for tobacco products, drugs, and medical devices, Congress’s passage of the Midnight Rules Relief Act could eliminate the rule before it ever takes effect.
In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.
The False Claims Act continued to generate large civil settlements.
Continuing the trend from recent years, the False Claims Act (“FCA”) remained the primary civil enforcement tool against health care providers as well as pharmaceutical, life sciences, and medical device companies, predominantly driven by qui tam FCA complaints filed by relators. In fiscal year 2016, the Department of Justice obtained more than $4.7 billion in settlements and judgments from FCA cases, $2.5 billion of which it obtained from the health care industry. Continue Reading Health Care Enforcement Review and 2017 Outlook: Significant Health Care Fraud and Abuse Civil Settlements and Criminal Resolutions
While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016, including:
- A Department of Justice (DOJ) Interim Final Rule that significantly increases penalties under the False Claims Act (FCA), making already high stakes litigation even higher.
- An Interim Final Rule from the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and other agencies increasing civil penalties for violations of various statutes and regulations, including the Civil Monetary Penalties Law (CMPL) and its implementing regulations.
- A Final Rule that addresses the OIG’s expanded authority under the CMPL.
- A long-awaited Final Rule from the Center for Medicare & Medicaid Services (CMS) concerning the “60 Day Rule” for returning overpayments.
- A Final Rule from the OIG that amends the safe harbors under the federal Anti-Kickback Statute (AKS) and adds exceptions under the CMPL’s beneficiary inducement prohibition.
Below we discuss the highlights of each rule and how we expect each to impact the enforcement environment in 2017 and beyond. Continue Reading Health Care Enforcement Review and 2017 Outlook: Significant Regulatory Developments