CPC+: Opportunities and Challenges for Primary Care Transformation

In recent days there has been a lot of action around CMS’ Comprehensive Primary Care Initiative (CPCI). First, the next phase of the program was announced, expanding the program in size and scope. Several days later, an evaluation of the first two years of the initiative was published in the New England Journal of Medicine.

The original CPCI demonstration began in October 2012 and included 502 practices in seven regions (states or smaller areas within states). The regions were determined largely by payer interest, as commercial and state health insurance plans are essential partners in this multi-payer model. The CPCI involves risk-stratified care management fees for participating practices and the possibility of sharing in net savings to Medicare (if any). In turn, the practices must invest in practice redesign around: access and continuity, chronic disease management, risk-stratified care management, patient and caregiver engagement, and care coordination across a patient’s providers, e.g., managing care transitions and ensuring close communication and collaboration.

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REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Read More

Implied Certification and the Quest for Fraud that “Counts” Under the False Claims Act

By Joan H. Krause

[Cross-posted from Hamilton and Griffin on Rights]

Sometimes, we lie when we speak; other times, we lie when we don’t. Striking the right balance is the essence of the Universal Health Services (UHS) case recently argued before the Supreme Court, which challenged the applicability of the False Claims Act (FCA) to situations in which a claimant falsely “implies” compliance with underlying regulatory requirements.

UHS was brought by the parents of a young woman who died after receiving Medicaid-covered (MassHealth) mental health treatment from a clinic that did not satisfy state licensing and supervision regulations. The parents alleged that the claims for payment were fraudulent because they implicitly represented that the clinic was in full compliance with relevant state requirements. The district court dismissed the suit, finding that the staffing and supervision regulations were not “conditions of payment” whose violation would render subsequent claims false under the FCA. The First Circuit reversed, focusing instead on whether UHS had “knowingly represented compliance with a material precondition of payment.” Noting that preconditions need not be “expressly designated,” the court identified a set of regulations that, read together, appeared to limit MassHealth payment to properly supervised care. While such a fact-intensive dispute might at first appear an unlikely candidate for certiorari, UHS was one of several such “implied certification” opinions issued by the federal appellate courts in 2015. Perhaps because of its emotionally compelling facts – the other cases involved, inter alia, the recruitment practices of a for-profit college and a military contractor that falsified marksmanship scores – UHS was chosen as the vehicle to resolve a growing circuit split. Read More

Variability of US State Workplace Wellness Program Laws

A team of researchers led by Jennifer Pomeranz, JD, MPH, Clinical Assistant Professor of the College of Global Public Health at New York University, have released a new set of resources that detail characteristics of laws related to workplace wellness programs and identify trends in these laws across the United States: interactive maps for public and private employers at LawAtlas.org and a paper published in the American Journal of Public Health.

Workplace Wellness Program Laws in US

A few key findings:

  • Thirty-three states and the District of Columbia have laws related to workplace wellness programs.
  • Four states (Georgia, Indiana, Maine and Massachusetts) provide tax incentives for work place wellness programs.
  • State laws addressed public and private employers differently, for example, five states permit rewards (e.g., discounts, rebates and waivers) by public employers, whereas 16 states expressly permit positive rewards for participation in programs by private employers.

The research was funded by the Robert Wood Johnson Foundation’s Public Health Law Research Program.

Fraudulent Concealment by Nonfeasance as an Exception to the Statute of Repose

By Alex Stein

As a general rule, malpractice suits against physicians and hospitals must be filed within the repose period that starts running on the day of the alleged malpractice. Expiration of that period kills the plaintiff’s suit regardless of whether she was able to file it on time. Unlike statutes of limitations, this absolute time-bar does not depend on the accrual of the plaintiff’s cause of action nor is it subject to the discovery rule and equitable tolling. Typically, states recognize only one exception to the statute of repose: fraudulent concealment. Under that exception, when a negligent doctor or hospital intentionally gives the aggrieved patient (or her successor) false or misleading information about the treatment, the patient (or her successor) becomes entitled to toll the repose period until she becomes aware of the true facts. Many courts have ruled that this exception was only available to plaintiffs who could establish affirmative misrepresentation on the part of the doctor or the hospital. According to these decisions, fraud capable of tolling the repose period could only be committed by misfeasance, that is, by active conduct rather than by failure to disclose the relevant facts. More recent court decisions, however, obliterate the omission-commission distinction in the context of fraudulent concealment by doctors and hospitals: see, e.g., DeLuna v. Burciaga, 857 N.E.2d 229, 245-46 (Ill. 2006).

A recent decision of Michigan’s Court of Appeals, In re Estate of Doyle, 2016 WL 857204 (Mich.App.2016), continues this trend. Read More

LGBT Backlash Legislation and the Politics of Biology

By Maayan Sudai

Of the many responses to the monumental victory of the gay marriage movement in Obergefell v. Hodges in 2015, one was a backlash of legislative proposals submitted by conservative groups. A popular target was the regulation of sex-segregated public spaces like bathrooms, schools, etc. – also called “bathroom bills” – in TexasFloridaKentucky, and other states. The anti-LGBT bills are meant to either block the extension of anti-discrimination protections that could accommodate free use of sex-segregated public spaces, or strictly ban Transgender people from entering public bathrooms that fit their self-identified gender.

In South Dakota, failed bill HB1008 would have made it illegal for schools to provide accommodations for Transgender students and would have required every public bathroom, shower, or locker room be “designated for and used only by students of the same biological sex.” The bill did not pass, as Governor Dennis Daugaard vetoed it last March, affirming the authority of local municipalities to determine their own standards. Nevertheless, a few weeks later a similar bill was passed in North Carolina. The new law, also known as HB2 or the “Charlotte Bill” (more formally: “Public Facilities Privacy and Security Act”) came as a response to a local non-discrimination ordinance issued by the Charlotte City Council which provided protections and accommodation to the LGBT community in public bathrooms. HB2 affectively repealed the Charlotte ordinance, and restricted the ability of other cities in the state to expand equality measures beyond the standard determined by HB2.[1] Rich Schragger said that HB2 is “thus an anti-LGBT law masked as an anti-discrimination provision.”

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What do doctors know about FDA drug approval standards and the breakthrough therapy designation? Less than we’d hope.

By Dalia Deak

A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary.

For the study, Kesselheim et al. conducted a national survey of board-certified internists and specialists. They selected a random sample of 300 clinically active internists and 900 specialists in endocrinology, hematology, and infectious diseases from the American Board of Internal Medicine’s diplomate list. Of the 1,148 physicians contacted, 692 physicians, or 60%, responded.

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Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Read More

Monday, 4/18, HLS Health Law Workshop with Robert Cook-Deegan

April 18, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

The materials for the presentation, “Mining the Genomic Data Mountain: Legal and Policy Challenges,” can be downloaded here.

Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology (Trinity College of Arts & Sciences). He was the founding director for Genome Ethics, Law & Policy in Duke’s Institute for Genome Sciences & Policy from July 2002 through December 2012.  He is the author of The Gene Wars: Science, Politics, and the Human Genome and an author on over 250 articles.

Dr. Cook-Deegan’s areas of expertise include genomics and intellectual property, history of genomics, global health, science and health policy, and health research policy. His current research focuses on policy implications of genomics, bioethics, intellectual property, and innovation.