Friday, November 13, 2015
Matt Bevin will soon become Kentucky's Republican Governor, which has created consternation regarding his plans for discontinuing Kentucky's successful implementation of the Affordable Care Act (ACA). While on the campaign trail, Governor-Elect Bevin first promised to end the Medicaid expansion; then he promised to cap new Medicaid enrollment; and then he promised to reject "Obamacare" but keep Medicaid expansion on Kentucky's terms. Governor-Elect Bevin also promised to dismantle Kynect, widely considered a model state-run health insurance exchange. Each of these promises leads to a complex realm of statutory provisions, governance choices, and inter-governmental dynamics. Each also has real implications for the neediest in our health care system as well as the ongoing negotiations between the federal government and the states in a post-ACA, post-NFIB federalism world.
First, could Governor-elect Bevin completely end the Medicaid expansion in Kentucky? Yes, but not instantaneously. The Medicaid Act creates a right for any person who meets its eligibility requirements to be enrolled upon approval of her application. The Medicaid Act has mandatory eligibility categories and optional eligibility categories, and the federal government must match state funding by at least 50 cents on each Medicaid dollar. As enacted, the ACA built on this design by expanding eligibility to anyone under age 65 earning less than 133% of the federal poverty level, and the expansion was mandatory. States would have been required to enroll the newly eligible population and could not alter the expansion without a waiver from the Department of Health and Human Services (HHS). The ACA funded 100% of the cost for newly eligible beneficiaries until 2017, then decreases the match gradually to 90% over the next several years.
States that complied with the ACA submitted State Plan Amendments to HHS to expand eligibility; Kentucky was one of them. But, NFIB v. Sebelius made the ACA's Medicaid expansion unenforceable by HHS, or "optional." HHS issued guidance after NFIB explaining that states could opt-in to expansion at any time and that they could subsequently opt-out. Although HHS opined that post-expansion opt-out (my phrase) is consistent with NFIB, it has not clarified how such an opt-out would work. Because Governor Beshear expanded Medicaid by executive order, Governor-Elect Bevin would be able to reverse expansion at the state level with another executive order. But, Kentucky would also need to submit a State Plan Amendment to HHS for approval, which can take 2-3 months when non-controversial. The state would also need to determine whether the newly eligible beneficiaries (approximately 400,000 people) are eligible for Medicaid through another category of eligibility, such as pregnancy or disability. Some would qualify for tax credits to purchase insurance in the exchange, but many would not qualify for Medicaid or tax credits at that point. Beneficiaries have a right to appeal dis-enrollment, but for most that appeal will not lead anywhere. So, post-expansion opt-out would not occur immediately or without cost, but it is possible.
Second, could Bevin cap enrollment? No. States cannot limit enrollment of Medicaid beneficiaries under the Medicaid Act; they may only do so if they have a specific waiver granted by the Department of Health and Human Services (HHS). HHS has explained that capped enrollment will not be approved because it is inconsistent with the universal coverage goals of the ACA.
Third, could Kentucky amend Medicaid expansion like Indiana, which Bevin has admired in public remarks? A waiver from HHS is necessary to expand Medicaid differently than the ACA required. So far, such waivers have been granted to seven states, underlining states' empowerment after NFIB to negotiate a version of health care reform that Congress never envisioned. In addition to that vertical cooperative federalism, states are experiencing noticeable horizontal federalism, learning from one another what concessions can be won from HHS. Republican governors of waiver states have touted that they expanded Medicaid their way, spinning the waivers as a win for red state values. And, many of the concessions granted by HHS have reflected a more typically conservative agenda. For example, Arkansas, Michigan, Iowa, Indiana, Pennsylvania, New Hampshire, and Montana have negotiated compromises such as placing the newly eligible population in the exchanges with federal Medicaid dollars supporting their purchase of private plans ("premium assistance"); required premiums and co-payments, especially for people earning more than 100% of the federal poverty level; wellness requirements; limiting payment for non-emergency use of ambulances and imposing co-payments for ER use; private third-party administration; and other adjustments. Notably, HHS rejected work requirements, which reflect "able-bodied" rhetoric that is so politically prevalent. (In a forthcoming paper with Jessica Roberts, I debunk the myth of self-reliance in health care, which underlies the work linkage proposals.)
Some of these waiver concessions may improve insurance coverage; for example, a person who earns close to 133% of the federal poverty level is likely to "churn" between Medicaid coverage and private insurance coverage, and the premium assistance model may make that movement smoother and less likely to result in loss of coverage (time will tell). But, some concessions have harmful effects, such as enforceable premiums that drop coverage for anyone who does not pay, as studies have shown that cost sharing is a barrier to care for low-income Americans. Further, Indiana's waiver is arguably the most complex, raising questions as to why a complicated system should replace one that is relatively simple and working well (other than ideology). Bevin says it's economics, but a Deloitte study performed for Kentucky showed that is not true.
If one thing is clear from states' negotiations with HHS, the agency is strongly motivated by increasing enrollment and by universal coverage policy entrenchment. This could cut both ways for Kentucky, which would be in uncharted waters as a waiver-seeking state that could be the first post-expansion opt-out. Kentucky's Medicaid expansion covers nearly 10% of the state's population, and HHS surely would take a very hard look at any waiver application that makes the already-insured lose coverage. HHS would also be aware that timing is tricky, and Medicaid enrollment could disappear and then reappear for the newly eligible in Kentucky, leaving needy people with gaps in coverage (and thus gaps in care).
Finally, could Governor-Elect Bevin dismantle Kynect? Yes, a state-based exchange can be disbanded, but not immediately. The open enrollment for 2016 that is underway cannot be stopped, and HHS wants a year's notice before a state moves to the federally-run exchange. Dismantling Kynect will cost tens of millions of dollars according to current estimates. And, the state must ensure that privately insured people do not lose coverage in an exchange transition.
Kentucky has experienced the largest drop in uninsurance in the nation due to Governor Beshear's implementation of the ACA, and modifications enacted without due care could result in hundreds of thousands of people losing health care coverage. Change for the sake of change may be an interesting political experiment to some, but it has real world implications for the low income individuals relying on regulatory stability for their health insurance access.
Friday, October 30, 2015
The AALS Section on Law, Medicine & Health Care has issued a call for nominations for section officers. The Section would like to encourage anyone who is a faculty member at an AALS member school to apply. The Section is seeking to fill these two officer positions for the year beginning in January 2016:
(1) The Secretary, who is expected to become Chair-Elect, and then Chair, and serve over the next three years, and
(2) One of two Section At Large Board Member, for a two-year term.
The Section has simplified the application process. If you are interested in serving in either position, please complete the brief form linked here. If you would like to nominate others to serve in either of these positions, please encourage them to apply. Please fill out the very brief application form by November 20, 2015.
The Section is sponsoring two programs this year. At the main section program, on "Whither Medicaid?", speakers will be Mary Beth Musumeci (Kaiser Family Foundation), Laura Hermer (Hamline), John Jacobi (Seton Hall), and Sidney Watson (St. Louis). The section is also sponsoring a junior scholars workshop with Wendy Epstein (DePaul), Elizabeth McCuskey (Toledo), and Jessica Mantel (Houston). Anyone interested in participating in workshopping these junior scholars' papers, please contact Leslie Francis, firstname.lastname@example.org.
We look forward to seeing you all at the AALS annual meeting in January in New York City.
Saturday, August 15, 2015
TWIHL presents its first Back to School Special. We asked some wonderful health lawyers what were the compelling additions to this Fall’s health law curriculum. The answers are diverse and fascinating. To hear their explanations look for episode 22 when you subscribe at iTunes, listen atStitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app.
We are extremely grateful to the following (with links to their recommended topics):
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc.
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.– Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw
Tuesday, August 11, 2015
Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.
But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law.
Wednesday, August 5, 2015
THE UNIVERSITY OF TENNESSEE COLLEGE OF LAW invites applications from both entry-level and lateral candidates for as many as two full-time, tenure-track faculty positions to commence in the Fall Semester 2016. The College is particularly interested in the subject areas of business law, including business associations and contracts; gratuitous transfers/trusts and estates; and health law. Other areas of interest include legal writing, torts, and property.
Saturday, August 1, 2015
On July 30, the White House announced the updated 2020 HIV/AIDS strategy. The admirable vision of the strategy is that “The United States will become a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”
This said, the strategy reflects continuing concerns about the numbers of people who do not know their HIV status, who do not have access to effective treatment, and who do not take advantage of preventive strategies. Demographic groups especially at risk include men having sex with men, African American men and women, Latino men and women, people who inject drugs, youth age 13-24, people in the Southern United States, and transgender women. The strategy emphasizes care coordination, coordination between health care and other social services such as housing, treatment as prevention, and pre-exposure prophylaxis. Notable initiatives since the 2010 HIV/AIDS strategy include interagency efforts to address the intersection of HIV and violence against women, a DOJ and CDC collaboration to publish a comprehensive examination and best practices guide on the intersection between HIV and criminal laws, and demonstration projects funded through the HHS Minority AIDS Initiative Fund.
Another major improvement since the 2010 strategy is implementation of the Affordable Care Act. The 2020 strategy takes due note of the coverage expansions the ACA has brought: the end to pre-existing condition exclusions for people seeking coverage, Medicaid expansion, and access to marketplace plans. Yet given the demographic groups at greatest risk, there is a far darker side: what ACA has not yet achieved and possibly will not achieve.
In 2014, the Kaiser Family Foundation published a report estimating the impact of ACA on health insurance coverage for people with HIV. The 2020 strategy relies on the estimates in this report: that of 70,000 persons with HIV who were uninsured, about 47,000 would become eligible for Medicaid if that program were expanded in all states and that another 23,000 would qualify for subsidized private coverage in the marketplaces. These estimates, however, refer only to people with HIV who are uninsured and are already in care. The KFF report (relying on CDC estimates) also guesses that about 700,000 people with HIV are not yet in care and that an additional 124,000 people in this group could gain new coverage were the ACA Medicaid expansion and marketplace subsidies to be in effect in all states.
By my calculation, this leaves out over 500,000 people who are not yet in care and who still would not gain coverage even with the full deployment of ACA. Half a million—not a trivial figure in view of the importance of encouraging testing, treatment as prevention, and pre-exposure prophylaxis. To be sure, Ryan White funds pay pick up some of the slack—but only for those who know their HIV status.
Monday, July 27, 2015
Interesting article in today’s Wall Street Journal about a lawsuit over limits on payments by fertility clinics to women who supply eggs for infertile couples. Under influential, though not mandatory, guidelines issued by the American Society for Reproductive Medicine, payments to egg “donors” above $5,000 “require justification,” and payments greater than $10,000 “are not appropriate.” (When I was in the Indiana legislature, a statute was passed limiting payments to $4,000, plus out-of-pocket expenses.)
In one view, payment caps are needed to “prevent coercion and exploitation in the egg-donation process.” But one also can view the guidelines as an “illegal conspiracy to set prices in violation of antitrust laws.” More to come in a case that could go to trial next year.
In the meantime, there are other important concerns about payments for eggs and the costs to infertile persons. As with other assisted reproductive treatments, insurers generally do not cover those costs. This encourages the infertile to seek multiple births in one treatment cycle rather than single births over multiple treatment cycles, which puts mothers and their infants at greater risks to health. In addition, lack of coverage leaves treatment unaffordable for many of the infertile. As I have argued elsewhere (here and here), social policy treats infertile persons unfairly when coverage is denied for assisted reproductive services.
[cross-posted at Bill of Health and orentlicher.tumblr.com]
Wednesday, July 22, 2015
A reminder that a call for papers has been issued for the session of the Section on Law, Medicine and Health Care at the 2016 AALS meeting. Here's the information about the session: 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@example.com, section chair-elect, by September 1, 2015. If you have any questions, please feel free to contact me at firstname.lastname@example.org.
Please feel free to contact me if you'd like further information about the session or submissions.
Many thanks, Leslie Francis
The Section on Law, Medicine & Health Care will be holding a workshop session for junior scholars at the upcoming AALS meeting in New York, Jan 6-10, 2016. Here's the call--please circulate widely:
Call for Papers
AALS Section on Law, Medicine & Health Care
Works-in-Progress for New Law School Teachers
AALS Annual Meeting, 2016
The AALS Section on Law, Medicine and Health Care is pleased to announce a Call for Papers for a special Works-in-Progress for New Law School Teachers Program. The Section will run the Program at the AALS 2016 Annual Meeting in New York, Jan. 6-10.
This program will bring together junior and senior health law scholars for a lively discussion of the junior scholars’ works-in-progress. Junior health law scholars will submit papers that they expect to submit in the spring 2016 law review submission cycle. After they briefly present their papers in a concurrent roundtable setting, senior scholars will provide oral comments and critiques. This new program presents an opportunity for the audience to hear cutting edge health law scholarship by recent members of the academy.
We will limit our selection to two to three papers.
Form & Length of Submission
Eligible faculty members are invited to submit either manuscripts or abstracts dealing with any aspect of health law or policy. Abstracts should be comprehensive enough to allow the committee to meaningfully evaluate the aims and likely content of the papers proposed. Papers may be accepted for publication but must not be published prior to the Annual Meeting.
Deadline & Submission Method
To be considered, manuscripts or abstractsand a CV must be submitted electronically to both:
Chair, Section on Law, Medicine, and Health Care, Thaddeus Pope, Hamline University School of Law, email@example.com
Chair-elect, Section on Law, Medicine, and Health Care, Leslie Francis, University of Utah, firstname.lastname@example.org
The deadline for submission is September 1, 2014.
Selection & Notification
Papers will be selected after careful review and discussion by the Executive Board of the AALS Section on Law, Medicine, and Health Care.
The authors of the selected papers will be notified by October 1, 2015.
If a selected author has only submitted an abstract for review, the author must submit the corresponding manuscript by December 15, 2015.
The Call for Paper participants will be responsible for paying their annual meeting registration fee and travel expenses.
Full-time untenured faculty members of AALS member law schools are eligible to submit papers. The following are ineligible to submit: foreign and adjunct faculty members, graduate students who are not also enrolled in a qualifying J.D. program, fellows, non-law school faculty, and faculty at fee-paid non-member schools. Papers co-authored with a person ineligible to submit on their own may be submitted by the eligible co-author.
Please forward this Call for Papers to any eligible faculty who might be interested.
Thursday, June 25, 2015
For those who feared that the Supreme Court’s Hobby Lobby decision would open the door for employers to block contraceptive access for women in the workplace, welcome reassurance has come this week from the U.S. Court of Appeals for the Fifth Circuit. According to the Fifth Circuit, when the Affordable Care Act requires that contraception coverage be available for workers at religiously-affiliated institutions, the Act also accommodates the scruples of employers who have religiously-based objections to contraceptive use.
As the Fifth Circuit observed, employers with religious objections to contraception can shift the responsibility for coverage to their insurers or the federal government. Hence, there is no unlawful burden on those employers from the mandate that health care plans cover the costs of contraception.
Of course, the decision was rendered by a panel of three judges rather than the full court, and the panel included two judges appointed by Democratic presidents. But the third judge, Jerry Smith, who wrote the opinion and was appointed by President Reagan, is a staunch conservative who has not been sympathetic to reproductive rights in other cases.
If this case is an accurate guide, it may well turn out that the Hobby Lobby Court was correct when it observed that its decision recognized the interests of both employers and employees.
[cross-posted Bill of Health, orentlicher.tumblr.com]
Today, in King v. Burwell, the Supreme Court upheld a key provision of the Affordable Care Act, handing a major victory to the Obama administration. The decision was 6-3, with Chief Justice John Roberts delivering the court's majority opinion. Roberts and Justice Anthony Kennedy joined the court's liberals.
As co-blogger Davis Orentlicher explained: "the challengers cite to two lines in the Affordable Care Act (ACA) that authorize subsidies for insurance bought on state-operated health insurance exchanges, without mentioning federally-operated state exchanges. Hence, argue the challengers, subsidies should be provided only for insurance purchased on state-operated exchanges, which means in only about 1/3 of states."
The Court disagreed with the challengers. In its syllabus the Court explained that
[w]hen analyzing an agency’s interpretation of a statute, this Court often applies the two-step framework announced in Chevron, 467 U. S. 837. But Chevron does not provide the appropriate framework here. The tax credits are one of the Act’s key reforms and whether they are available on Federal Exchanges is a question of deep “economic and political significance”; had Congress wished to assign that question to an agency, it surely would have done so expressly. And it is especially unlikely that Congress would have delegated this decision to the IRS, which has no expertise in crafting health insurance policy of this sort. It is instead the Court’s task to determine the correct reading of Section 36B. If the statutory language is plain, the Court must enforce it according to its terms. But oftentimes the meaning—or ambiguity—of certain words or phrases may only become evident when placed in context. So when deciding whether the language is plain, the Court must read the words “in their context and with a view to their place in the overall statutory scheme.”
Petitioners’ plain-meaning arguments are strong, but the Act’s context and structure compel the conclusion that Section 36B allows tax credits for insurance purchased on any Exchange created under the Act. Those credits are necessary for the Federal Exchanges to function like their State Exchange counterparts, and to avoid the type of calamitous result that Congress plainly meant to avoid.
759 F. 3d 358, affirmed.
Bottom line: Individuals who get their health insurance through exchange established by federal government will be eligible for tax subsidies.
Wednesday, June 24, 2015
How will the Supreme Court rule on the challenge to the Affordable Care Act’s subsidies that help millions of lower- and middle-income Americans afford their health care coverage? According to FantasySCOTUS’s court watchers, who have correctly predicted more than 70 percent of Supreme Court decisions so far this year, Obamacare should remain intact.
This result is not surprising. The arguments in favor of the government are much stronger than are those for the challenger. To be sure, the challengers cite to two lines in the Affordable Care Act (ACA) that authorize subsidies for insurance bought on state-operated health insurance exchanges, without mentioning federally-operated state exchanges. Hence, argue the challengers, subsidies should be provided only for insurance purchased on state-operated exchanges, which means in only about 1/3 of states. But other language in ACA indicates that the subsidies are available for insurance purchased on all exchanges. When a statute’s language is ambiguous and there are reasonable alternative interpretations, courts are supposed to defer to the executive branch’s interpretation, not substitute their own interpretation.
And if one looks beyond the specific references to the subsidies to the broader context of ACA and the intent of Congress, it becomes even clearer that the subsidies should stand. Several other sections of ACA assume that subsidies are available on all exchanges, as did members of Congress when they passed the law. Indeed, it wasn’t until nine months after ACA was passed that anyone noticed the language in the bill suggesting that subsidies might be available only on state-operated exchanges.
Of course, these arguments have not persuaded all federal judges, and they are not expected to have persuaded at least three Supreme Court justices. But if precedent prevails, ACA will survive its latest challenge.
[cross-posted Bill of Health and orentlicher.tumblr.com]
Tuesday, June 23, 2015
Members of the House Committee on Energy and Commerce and the Senate Committee on Finance sent a letter today to Secretary Burwell, urging HHS to issue the Equal Access regulations that have been in limbo since 2011. This is an important and much-needed call for action in the wake of Armstrong v. Exceptional Child Center, which shut down private rights of action for Medicaid providers seeking fair reimbursement from states in federal courts. The letter explicitly recognizes the harm that the Court's recent decision will inflict on the Medicaid program, which I've written about on this blog (most recently here) in the context of both Armstrong and Douglas v. Independent Living Center.
Though the draft regulations were not perfect, and in fact would benefit from putting some real teeth into HHS's review of states' payment decisions on equal access to care for Medicaid beneficiaries, they would at least ensure that HHS is actively overseeing states' payment rate decisions. Currently, states are able to change rates with very little intervention from HHS, which often involves decreasing payment rates to balance state budgets. Now that the Court has tasked HHS with enforcing the equal access provision, rather than the providers who HHS admittedly relied on to raise flags about states' low payment rates, HHS must complete the draft regulations. Perhaps this direct plea from members of key committees will refocus HHS's attention on these important regulations.
Monday, June 15, 2015
For the second time, a state court of appeals has given a woman permission to use frozen embryos over the objections of her former partner who supplied the sperm. In both cases, the new one from Illinois, the previous one from Pennsylvania, cancer chemotherapy left the women infertile and therefore unable to create new embryos with another man.
The results seem reasonable. As a general matter, courts have not been willing to impose unwanted parenthood on people who participate in the creation of frozen embryos via in vitro fertilization (IVF). However, when the frozen embryos provide the only chance for one of the embryo creators to have a genetically-related child, the desire of one person to have a child can trump the desire of the other person not to have a child.
Thursday, May 28, 2015
As Nic and Frank are traveling, I wanted to alert everyone to TWIHL Podcast number 13: https://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!
Wednesday, May 27, 2015
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.
Tuesday, May 26, 2015
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.
Monday, May 25, 2015
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.
Sunday, May 24, 2015
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.
Saturday, May 23, 2015
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@example.com 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.