mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

by Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report)

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.

As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:

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Twitter Round-Up (11/25-12/1)

By Casey Thomson

From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics.

  • Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies. (11/26)  He also included a link summarizing key information on H.R.6118, newly passed in the House and Senate and now being presented to the President. Otherwise known as the Taking Essential Steps for Testing (TEST) Act 2012, the bill gives the Centers for Medicare and Medicaid Services (CMS) “greater flexibility in enforcing CLIA [Clinical Laboratory Improvement Amendments] proficiency testing violations” (as noted by Vorhaus). (11/26)
  • Daniel Goldberg (@prof_goldberg) included a post on the inequality in self-rated health as considered by gender. The study, done in Spain, found that females’ lower sense of self-rated health is a reflection of the higher burden of disease in women, and encouraged systems of health to reconsider the approach towards afflictions with lesser impact on mortality that are possibly receiving less attention than is deserved. (11/26)
  • Daniel Goldberg (@prof_goldberg) additionally included a report on the problems parents with disabilities are facing in terms of retaining (or even gaining) their right to be a parent. Such bias against parents, the article notes, may not recognize that ensuring essential support may be all that is needed to discourage problems or eradicate risks for the majority of cases. (11/26)
  • Frank Pasquale (@FrankPasquale) linked to a blog post on the recent protests by AIDS activists in the office of House Speaker John Boehner. The protesters, stripped naked in order to reveal the painted “AIDS Cuts Kill” written on their chests, were there to protest the possible cuts to HIV/AIDS program funding that may follow a fiscal cliff deal.  (11/28)
  • Arthur Caplan (@ArthurCaplan) featured his talk with Boston Public Radio on the fine line politicians must walk when balancing their struggle with a health crisis along with the responsibilities of being a public official. The recent health concerns facing Boston’s Mayor Thomas Menino served as inspiration for this discussion. (11/28)
  • Frank Pasquale (@FrankPasquale) added a news article detailing the recent speech made by principal deputy national coordinator David Muntz of HHS’ Office of the National Coordinator for Health Information Technology. Muntz, in addition to discussing the need to better incorporate technology for fostering stronger communication between patient and doctor, mentioned some striking statistics: “only 15% of patients have renewed a prescription online,” while “just 10% have a personal health record.” (11/29)
  • Arthur Caplan (@ArthurCaplan) posted a link to a new feature on concierge medicine, where appointments can be paid for solely through cash and not through insurance. While previously considered an option only for the rich, concierge medicine has possible implications for the greater body of patients: as the article noted, it may become a more viable option especially as threats of regulation and backlash in a doctor shortage encourage traditionally high-priced firms to backtrack. (11/29)
  • Arthur Caplan (@ArthurCaplan) also shared a video by Canadian comedian Rick Mercer on getting flu shots. (12/1)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Meaningful Scrutiny for Meaningful Use

By Nicolas Terry

Today the Office of the Inspector General (OIG) in the Department of Health and Human Services released a report, here, that is decidedly critical of CMS and ONC oversight of the Electronic Health Record (EHR) subsidy program.

Over the last couple of years there have been growing criticisms of the Meaningful Use program and its disbursement of potentially $30 billion in ARRA funds. I have detailed many of these concerns, such as the overall effectiveness of electronic records, my doubts as to the robustness of the first two Stages of Meaningful Use requirements, the safety record of the technologies, their ability to actually save money, their real-world interoperability, and their general usability in the healthcare workflow, here.

Recently, additional questions have been raised that go to the very heart of the subsidy program. First, the Center for Public Integrity, here,  and the New York Times, here, set off a firestorm with allegations of EHR use leading to extensive upcoding. This led to a scolding letter to the healthcare industry from Secretary Sebelius and the Attorney-General, here, and combative words back from some of the addressees, here.

Questions have also been raised about the apparent laxity of CMS in approving payment to providers claiming subsidy funds, leading to CMS announcing a hastily designed audit process, here.

Today’s OIG report elaborates on the same basic issue of lax payment safeguards. First, the report finds that CMS has not implemented strong pre-payment safeguards (either by verifying self-reported data or requiring supporting documentation). Second, it suggests that CMS’s proposed post-payment audit program is limited and potentially flawed. Fortunately, CMS/ONC are in broad agreement with the OIG that the EHR technology itself must step up and meaningfully test for meaningful use. In the meantime increased Congressional scrutiny seems a less elegant but likely surrogate.

Open Access to Health Research: Highlights from the NIH Public Access Policy panel

By Adriana Benedict

As of 2008, the NIH Public Access Policy requires “that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.”  Four years later, approximately 80% of NIH-funded research articles make their way into PubMed Central.  Institutional Open Access resolutions such as Harvard’s Open Access Policy have helped accommodate the NIH Public Access Policy requirements, but Harvard Medical School and Harvard School of Public Health have yet to adopt it.

In May, the Harvard Library Faculty Advisory Council issued a public letter calling on faculty to promote open access scholarly publishing, noting that “Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive”.  In a Petrie-Flom Center-sponsored Open Access Week panel (moderated by Open Access Liaisons Scott Lapinski and June Casey), Peter Suber, Amy Brand, Winston Hide and Patrick Taylor discussed the challenges and opportunities for progress towards achieving open access to health research.  Highlights from the panel are presented below, and the video should be available on the Petrie-Flom website shortly.

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Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

Congressmen are Concerned that Meaningful Use Stage 2 is Too Weak

By Leslie P. Francis

On October 4, four Republican Congressman, all with powerful positions concerning health care, wrote Secretary Sebelius urging suspension of “meaningful use” Stage 2 payments until a stronger program is in place. The Congressmen, Dave Camp (Chair of the House Ways & Means Committee), Wally Herger (Chair of the Ways & Means Subcommittee on Health), Fred Upton (Chair of the House Committee on Energy and Commerce), and Joe Pitts (Chair of the Energy & Commerce Subcommittee on Health), expressed concern that the Stage 2 regulations are too weak to insure genuine interoperability of electronic medical records.  As a result, the Congressmen contended, a great deal of taxpayer money will be wasted on payments for electronic records that do little to improve care or reduce costs.

The Congressmen have a point, despite the apparant partisanship of the letter.  There is a history of apparent reluctance on the part of the Office of the National Coordinator for Health Information Technology, and with it HHS, to meet head-on industry complaints about the difficulty and costs of meeting standards or industry contentions that regulation will stifle innovation. Models of technology forcing that were employed in furtherance of environmental protection appear not to have been considered by ONC and HHS. The requirement to meet Meaningful Use Stage 2 was delayed by a year, from 2013 to 2014, to allow vendors more time to develop products. As I indicated in an earlier post, ONC has decided not to develop governance rules for health IT exchanges, out of industry concern for impact on innovation.   The stage 2 meaningful use requirements are not very strong, either, as the Congressmen point out. For example, core requirements are only that 50% of prescriptions be electronic, that only 50% of care referrals must be accompanied by electronic care summaries, that only 50% of patients must have access to health information (with 5% using it), and the EHR be capable of generating only one list of patients by condition. (For a handy comparison of stage 1 and stage 2 certification criteria, see here). All of these–and other–requirements are important to anticipated improvements in care to be garnered from the introduction of EHRs.  For example, generation of lists of patients with a specified condition (e.g. diabetes) may be an important way to ascertain the quality of patient management across a practice. Read More

Filing a Complaint with HHS About a HIPAA Violation: A Warning About “How (Not) To”

By Leslie Francis

I posted in June about the fact that my social security number (and possibly other personal information) had been downloaded to an unknown site in Eastern Europe as part of a large security breach from the Utah state health department.  In connection with that breach, I have filed a complaint with the Office for Civil Rights at HHS (OCR).
I thought readers might like to know, however, that the process of complaining about a HIPAA violation to OCR is cumbersome indeed.  There are forms available on line, here.  You can open them, and fill in information, but you can’t save them.  If you close the form, you lose all the data. You also can’t file them online–you have to print them out and fax them off.  (You are helpfully told, however, to “print out a copy for your records.”)  I finally figured out that if you save the form to notepad before you fill it out, you can then email it to HHS–but this required a telephone call to the appropriate regional office of HHS.

When I pointed out to OCR that this process is not exactly user-friendly, they indicated that they are “working on it.” Imagine someone without a home computer, or a home fax machine, or a home printer, using public library computers in the effort to reach OCR about what they regard as a significant problem with their health information. Surely in a world of blue buttons and digital Medicare strategies, see Responsive Design and the New Medicare.gov, the ability to file a complaint about possible violations of health information security or confidentality should be an easier online process.

More Bad News on Electronic Health Records

By David Orentlicher

During the debate over the Affordable Care Act, the Obama administration and other proponents of electronic health records (EHRs) cited a RAND study projecting cost-savings of $80 billion a year from EHRs. More recent data have cast doubt on those estimates. In March, for example, a study in Health Affairs found that physicians with access to electronic records were more likely to order MRI scans and other diagnostic tests. Last week, the New York Times reported that EHRs apparently lead hospitals and physicians to bill more aggressively for their services, using higher billing codes than justified by the services they provide. (For an earlier post on the disappointing impact of EHR, see here.)

[Cross-posted from HealthLawProf Blog]

The Use of Electronic Health Records Is Increasing Medicare Billing: Is It Also Increasing the Amount of Care Physicians Provide?

 By: Katie Booth

The New York Times recently reported that the switch to Electronic Health Records (“EHRs”) may be contributing to rising Medicare costs. The Times described two hospitals where the portion of patients billed at the highest reimbursement rate rose by over 40% when the hospitals adopted EHRs. The Times also reported that in hospitals that switched to EHRs between 2006 and 2010, Medicare payments rose 47%. Medicare payments for hospitals that did not adopt EHRs rose 32%.

There are several potential explanations for this increase in billing. One is that doctors are simply doing a better job electronically recording the same care they’ve always given, leading to higher Medicare billing. Another is that some doctors are abusing the EHR system by upcoding patients or copying and pasting examination histories, fraudulently increasing Medicare billing.

A third explanation is that EHR systems actually change the way doctors practice medicine. In the process of asking doctors for particular data points, EHR systems may remind doctors to look for particular symptoms or to provide particular treatments that doctors may not have considered otherwise. It is thus possible that EHRs have led to higher Medicare bills because they have increased the amount of time doctors spend diagnosing and treating patients.

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ONC Backs Off Rule-making For Governance of Health Information Exchange

By Leslie Francis

Establishment of the infrastructure needed for the efficient, accurate, and secure exchange of health information is a crucial piece of improving care in the US.  Exchange fosters the ready availability of information, reducing redundancy and hopefully improving care quality.  To this end, proposals for a National Health Information Network were highly touted during the Bush Administration and continue to be supported by the Obama Administration, the Office of the National Coordinator for Health Information Technology (ONC) was established in 2004, and several federal advisory committees (the ONC Policy Committee and the ONC Standards Committee) were established by Congress in the HITECH Act in 2009.  Yet progress towards health information exchange remains halting at best–some hypothesize because of resistance within the private sector itself.  Recent developments at ONC are not encouraging.

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