HealthLawProf Blog

TWIHL Podcast # 13!

As Nic and Frank are traveling, I wanted to alert everyone to TWIHL Podcast number 13: http://twihl.com/ 

I made my second guest appearance, and we discuss some recent ACA-related litigation, Armstrong v. Exceptional Child Center (which I blogged about here and here), and Florida's most recent lawsuit against HHS.  Enjoy!

Position Opening: Yale Clinical Fellowship in Global Health Justice

The Yale Clinical Fellowship in Global Health Justice is a two-year position designed for graduates of law and public health schools as well as other health professionals with experience in domestic and/or international health policy and advocacy who are interested in preparing for a career in global health justice or interdisciplinary clinical teaching. The Fellow will supervise the experiential learning component of the Global Health Justice Partnership (the “Practicum”) and help to coordinate the activities of the Global Health Justice Partnership (GHJP—www.yaleghjp.org). The Fellowship is supported through the Gruber Project for Global Justice and Women’s Rights.

Working under the supervision of the GHJP faculty director and co-directors, the Clinical Fellow in Global Health Justice will supervise student work on Practicum projects and will participate in the planning and conduct of the Practicum, including the development of the curriculum and course materials and the selection of projects.  Amy Kapczynski, is the Faculty Director, and Gregg Gonsalves and Alice M. Miller are the co-directors of the GHJP.

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Developments of Interest on the Health IT Front Part 3: the 21st Century Cures Act

The CURES bill, HR6, https://www.opencongress.org/bill/hr6-114/text, was introduced in the House of Representatives on May 19 and referred to the Committee on Energy and Commerce and the Ways and Means Committee.  The bill received unanimous support two days later in the Energy and Commerce Committee and has bipartisan support although at this point it is unclear whether it really is likely to go anywhere.  Its actual content is in flux as new provisions continue to be added.

Central provisions of the bill include increased funding for NIH, use of patients' protected health information without HIPAA authorization for research, provisions allowing pharmaceutical companies to share cost information with health plans' formulary committees, replacing the Health IT Standards Committee with a charter organization to define standards of interoperability, a requirement that the standards be met by 2018, and vendor publication of their application program interfaces (APIs). 

The bill has drawn criticism from both privacy advocates and by industry advocates.  John Halamka’s critique of the CURES bill can be found here.  A discussion of the concerns of privacy advocates can be found here.

Stay tuned.

Leslie Francis

Developments of Interest on the Health IT Front Part 2: EHR Certification 2015 NPRM

HHS published the NPRM for the 2015 edition of certification for EHRs on March 30, 2015, https://www.federalregister.gov/articles/2015/03/30/2015-06612/2015-edition-health-information-technology-health-it-certification-criteria-2015-edition-base.  Comments are due May 29, 2015.  The goals of this rulemaking are supporting interoperability with new vocabulary and content standards for structured recording of health information; facilitating data portability through enhanced application programming interface (API) capabilities; making the certification program open to more types of health IT; aligning certification with Meaningful Use (MU) stage 3; addressing disparities by providing certification for collection of social, psychological, and behavioral data and the segmentation of sensitive health information; ensuring privacy and security capabilities; improving patient safety through increased reliability and transparency of certified health IT products; and providing developers with increased capabilities for innovation.  In my judgment, it is fair to say that the NPRM is quite friendly to innovation and less so to methods for addressing health disparities or ensuring relevant privacy and security capabilities.  But it does include some very important advances that I detail in the remainder of this post.

On data segmentation of sensitive information for privacy, ONC proposes that for certification a health IT module must be able to send data with tagging at the document level for indication that the document is subject to restrictions.  Segmentation must meet ONC’s Data Segmentation for Privacy (DS4P) standard implementation guideline technical requirements. Thus providers will be able to send information protected by the SAMHSA regulations, 42 CFR part 2. While clearly an important first step in protecting sensitive information, tagging at the document level has significant shortcomings.  It will not permit separate management of data elements within documents, such as mental health or STD information within an internist’s medical history.  It is most likely to be useful for records created for special purposes by providers, such as the substance abuse treatment records protected by SAMHSA. ONC clearly recognizes these challenges.

On the public health front, certified health IT modules must meet updated guidelines for transmission to immunization registries; because bidirectional exchange is a goal so that providers can get patients’ immunization histories, certification must also enable a provider to request a patient’s immunization history from a registry.  Certification requirements for syndromic surveillance reporting in the ambulatory care setting are far more flexible than in the emergency department setting; for example, they make optional inclusion of any demographic data. Other public health reporting capabilities are also updated.  Although MU-3 only requires “moving forward” towards effective interface with public health, these capabilities should help pave the way towards more robust public health capabilities.

To address disparities, the NPRM proposes that certification require standardized methods for recording sex, race and ethnicity.  There must be an option for selecting one or more racial designations.  Designations must use the “Race & Ethnicity—CDC” code system which allows recording data at a high degree of granularity to further accurate identification of disparities.  The NPRM invites comments on methods for recording industry and occupation data, the usefulness to providers of this information, and whether other social, psychological and behavioral data should be included for certification.  Standards for clinical quality measures to be reported to CMS will require filtering by identification of provider and practice site, patient insurance, patient age, patient sex, patient race and ethnicity, and patient problem list.  This will allow accountable care organizations to report quality measures at the group and provider level and to identify disparities by patient demographic characteristics. 

Leslie Francis

Developments of Interest on the Health IT Front Part 1: Meaningful Use NPRM

The NPRM on Meaningful Use (MU) stage 3 is out and comments are due shortly (May 29), https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#h-14.  MU-3 is the final stage of the program and although it contains some very real progress it continues the current approach to the interoperability of electronic health records and leaves much to be developed through the certification process.   In the language of the NPRM it will “focus on the advanced use of EHR technology to promote improved patient outcomes and health information exchange.”  It will also streamline reporting processes for providers. 

The MU program incentivizes providers to use certified electronic health information technology.  The program’s ultimate goal is a health IT infrastructure that improves care quality, reduces costs, and promotes patient safety.  Development of the MU program has sought to balance these goals with minimizing burdens on health care providers.  Accordingly, compliance with stage 3 requirements will be optional for providers in 2017 and mandatory in 2018.  The NPRM does stipulate that providers will not be able to qualify partially by meeting some of the standards, or to pick which standards to meet from an optional menu as they were able to do in MU stages one and two. But the stage 3 objectives and criteria are disappointing.  Here are the objectives:  protecting patient health information, eprescribing, clinical decision support, computerized provider order entry, patient electronic access to health information, coordination of care through patient engagement, health information exchange, and public health and clinical data registry reporting.  And here are the most important measures under the objectives: 

            For privacy: annual security risk assessments for ePHI in the certified EHR.

            For eprescribing: continuation of the Stage 2 standard with the goal of still higher compliance than the current 80% level.  In states where eprescribing of controlled substances is legal, providers may include these prescriptions in their calculations of the percentages of prescriptions transmitted electronically but are not required to do so.

            For clinical decision support: the NPRM continues the stage 2 approach of giving providers considerable flexibility about which clinical decision supports to implement and at what junctures in their practices.  Providers must implement at least five interventions related to clinical quality measures.  A required implementation is functionality for drug-drug and drug-allergy interactions. Providers are not required to report improvement. Rather, they are to set goals internally and are urged to set these goals in terms of outcome rather than process measures.

            For computerized provider order entries: continuation of the stage 2 objective requiring CPOE of medication (80% of orders), laboratory (60%), and radiology orders (60%).  Radiology orders are expanded to include all diagnostic imaging.

            For patient electronic access to health information: providing the ability of patients (or their personal representatives) (80%) to view, download, and transmit their health information and to identify relevant patient-specific education resources (35%).  These measures recognize the importance of personal representatives in care as well as the need to authenticate these representatives and their authority but do not propose any means for implementing this central privacy protection.  The NPRM also proposes to permit providers to use a variety of certified application-program interfaces (APIs) to support patient data access and exchange.  This will enable patients to receive information in a variety of formats that may be useful to them—but raises significant privacy questions if patients are enabled to transfer information to entities not within the scope of HIPAA protection. ONC seeks comments on several possible alternatives with respect to APIs.

            For coordination of care through patient engagement:  functionality for secure dialogue and communication with patients including that 25% of patients either view, download, and transmit their PHI or access their health information through a certified API; that 35% of patients receive secure messages; and that 15% of patients enter patient-generated health data or other data from a non-clinical setting into the EHR.  These measures also rely heavily on APIs.  ONC’s discussion does not consider the privacy issues raised by patients entering their health information into the myriad of devices available in non-clinical settings.  ONC is more interested in comments addressing providers’ ease in measuring patient access to health information through APIs, in standardization of patient-entered data, and in providers’ ability to verify the provenance of the data.

            For health information exchange: ensuring that a summary of care record is captured electronically and incorporated into the EHR for patients seeking care among different providers.  Summaries of care must include current problem list, medications, and allergies. Required percentages vary depending on whether the patient is a new patient or a referral.  ONC seeks comments on governance structures for information exchange.

            For public health and clinical data registry reporting:  demonstrating “active engagement” with public health agencies or clinical data registries (such as cancer registries) by “being in the process of moving towards” sending data generated through clinical processes to these agencies. Ways to meet this objective are completing registration to submit data, testing and validating electronic submission of data, or actually submitting data electronically. Types of reporting include immunizations with bidirectional functionality so that providers can also receive information about a patient’s immunizations, syndromic surveillance, case reports, public health registry reports, clinical data registry reports, and electronic reportable laboratory results. ONC also plans to develop a central repository on public health readiness.

Somewhat less fully addressed in the NPRM are robust capacities for comparative effectiveness research, quality improvement, or successful collection of information for public health purposes.  There is no assurance that by meeting certification standards EHRs will be genuinely interoperable. And why is patient engagement the primary method for improving coordination of care?  These are all left to the ongoing process for certifying EHRs, which to date has arguably responded to the interests of providers and industry rather than to overall improvement of critical public goals, although ONC’s most recent certification NPRM contains some impressive advances.  The NPRM for EHR certification (published in the same issue of the Federal Register as the MU-3 NPRM) is the subject of Part 2 of these posts on developments in health IT.

Enter Congress with the CURES bill, for better or for worse.  I will write more about CURES in Part 3 of these posts.

Leslie Francis

Call For Papers - AALS Section on Law & Mental Disability

AALS Sections on Law and Mental Disability

and Disability Law (co-sponsor) 

Call for Papers/Presentations for 2016 Annual Meeting

 

Call for papers and presentations, up to 2 papers to be published:

The AALS Section on Law and Mental Disability hereby issues the following call for papers and presentations for the 2016 AALS Annual Meeting to be held in New York, New York, January 6-9, 2016.  Up to two selected papers will be published in the Law and Psychology Review (if the author so desires).

Program title:  The ADA at 25: Implications for People with Mental Disabilities

Program Description: The Americans with Disabilities Act of 1990 (the “ADA”) is now 25 years old.  Its sweeping prohibitions and mandates have, both figuratively and literally, restructured American society.  Some argue that it went too far; some not far enough.  Still others advocate change in different directions.  This panel focuses on one category of protected individuals: people with mental disabilities.  Though there may be fewer physical barriers for this group, social barriers like stigma and tolerance for discrimination are generally more pronounced.  We take stock of what the ADA and its amendments have accomplished for people with mental disabilities and what has been left undone. 

Paper/Presentation Requirements and Submission Instructions: Presentations and papers may explore any issue at the intersection of the ADA and mental disability, from, for example, discrimination and accommodation to least restrictive treatment modalities.

Up to two selected papers will be published in the Law and Psychology Review, a journal edited by students at the University of Alabama School of Law.  Please indicate when submitting a paper whether you want it to be considered for publication in the Law and Psychology Review or whether you are submitting the paper for presentation only.  Preference will be given to papers of 20,000 words or fewer and that have not been published or accepted for publication elsewhere.

Submitters may also choose to submit an abstract of presentation instead of a full paper.  Such abstracts will be considered for presentation, but not for publication. 

Proposed papers or abstracts of presentations should be submitted to Fred Vars, AALS Law and Mental Disability Section Program Chair, at [email protected] no later than Monday, August 17, 2015. A sub-committee of the Section Executive Committee will select up to 2 papers and/or presentations. Authors will be notified no later than September 7, 2015. 

Call for papers for the section on Law, Medicine, and Health Care session at the 2016 AALS meeting

I'd hoped by now that King v. Burwell, argued March 4, would have been decided by now (but unsurprisingly it has not).  Armstrong v. Exceptional Child Center was decided in late March.  InArmstrong, the Court rejected the 9th Circuit's approach to challenges to low Medicaid reimbursement rates.  The 9th Circuit had held that providers could bring suit under the Supremacy Clause arguing that state decisions conflicted with federal law, specifically section 30(A) of the Medicaid Act's requirement that reimbursements be sufficient for Medicaid recipients to receive care to the same extent as others in the community. The Court held that the Supremacy Clause is a rule of decision about which law to apply, not a source for substantive rights.  But the Court went further, also concluding that section 30(A) leaves discretion about approval of Medicaid reimbursement with the Secretary of HHS and does not permit courts to consider equitable remedies in these cases. Medicaid providers are understandably disturbed by the decision, and advocates for Medicaid recipients are worried that broad language in the decision will preclude remedies for them as well. Whatever happens in King v. Burwell, Medicaid is sure to remain a thorny legal issue for the near future at least.

Our section program for the 2016 meeting will address challenges to Medicaid availability and access and what legal means might be available to meet these challenges.  Confirmed speakers are MaryBeth Musumeci, from the Kaiser Family Foundation; John Jacobi, Seton Hall University; and Sidney Watson, Saint Louis University.  We are issuing a call for papers from which one or two additional speakers will be selected for the session.  The St Louis University Journal of Health Law & Policy has agreed to publish a symposium issue featuring the papers from the session. Abstracts (up to 500 words) should be submitted to Leslie Francis, [email protected], section chair-elect, by September 1, 2015.  If you have any questions, please feel free to contact me at [email protected]. 

 

Thanks, Leslie Francis