Site moved to, redirecting in 1 second...

50 posts categorized "Participatory Medicine"

July 29, 2013

Diabetes Innovation: We Get to "Ask Manny" a Few Questions

Manny HernandezI spoke with Manny Hernandez (@askmanny) about the diabetes online communities he founded at TuDiabetes (Engligh) and EsTuDiabetes (Spanish) -- which include tens of thousands of people with diabetes and their family members -- as well as his experience attending the Diabetes Innovation conference last year, and his thoughts on communications regarding diabetes.

Manny was a keynote speaker at last year's conference and will take part in a social media panel discussion this year.

I am working with the Joslin Diabetes Center to get the word out about Diabetes Innovation 2013, October 3-5, 2013 in Washington, DC. Follow the link for the best rate available on conference registration. This interview first appeared on the Diabetes Innovation blog,

I asked Manny whether social media can play a role in effecting clinical improvements in diabetes management, and he pointed to the Big Blue Test, an initiative of his Diabetes Hands Foundation. He's presented data from this project at the American Diabetes Association annual meeting: Folks who participate by posting their blood glucose readings before and after 15-20 minutes of exercise, and engaging in online conversation, see long-term benefits in terms of better management of their conditions. (The before-and-after glucose readings showed a 20% drop on average.) Over 40,000 PWD have participated to date. Look for a social media campaign this fall to promote participation in the Big Blue Test in the month leading up to World Diabetes Day.

Continue reading "Diabetes Innovation: We Get to "Ask Manny" a Few Questions" »

June 24, 2013

Hacking HIPAA


Join me in attacking an endemic problem in health care today by Hacking HIPAA. I am crowdfunding the development of a new legal form to be used on and after September 23, 2013 to allow patients to opt-in to easier health care communications - a Common Notice of Privacy Practices that is patient-focused. (Text me, please! Email me, please! etc.) Depending on how much support this project garners, we can attack some related problems as well. Contributions at any level are welcome; contributions at the levels designated on the Hacking HIPAA Medstartr page get you a seat at the virtual table, voicing your concerns that need to be met in the CNPP and in follow-on projects.

I'm working on this project with two leading health care open source software developers, Ian Eslick and Fred Trotter. Check out Fred's video intro to the project on the Medstartr page - you can find Ian and Fred online via the links on the project page, too.

Here's an excerpt from the crowdfunding project page:

Continue reading "Hacking HIPAA" »

May 16, 2013

Angelina Jolie, BRCA1, Public Health and Patent Law

Going public with her story of a prophylactic double mastectomy after testing positive for BRCA1 (a gene linked to breast cancer) via an op-ed piece in the New York Times, Angelina Jolie is clearly trying to get the message out that radical choices must sometimes be made in order to increase one's chances of survival, chances of spending more years with family and friends, and continuing to do one's work on this earth. She is seeking to advance the public health conversation, and to empower women to make a choice that may otherwise be frowned upon, by giving her surgeon carte blanche to blog about her surgeries as well. 

The questions that came to mind immediately for me when I first heard about this story (via radio talk shows as I was driving to and from meetings) included: Isn't that the gene that was patented? Isn't that test incredibly expensive and probably not accessible to most women? How is this story relevant to most women?

Later on, I was glad to see that I wasn't the only one asking these questions. Marketplace explored some of these issues in its coverage.

The price for the test is now about $4000, though most insurance that covers it yields an out of pocket cost to the patient of $100 (according to Myriad, the company that holds the patents). Experts outside the company have said that the test costs less than $200 to run. The test is only recommended for women with risk factors (family history, Ashkenazic Jewish heritage, etc.) -- about 2% of women in the US per the CDC.

The patents for the BRCA1 and BRCA2 genes have been challenged, and the case was recently argued before the Supremes.

Two problems with the patent lock-in highlighted by the story on the appeal:

  • Patients can't get a "second opinion" and the test sometimes misses mutations of the genes present in some families
  • Researchers have gotten a pass from Myriad thus far, but if the patent is upheld, Myriad could potentially block publication of research or sharing of research with patients and families (the concern would be greatest if Myriad were to block publication of research critical of the test)

The Court has to decide between the two sides of the argument. As boiled down by Nina Totenberg:

[Myriad's lawyer] ... contends that by locating the gene and isolating it — snipping it out from the rest of the genetic material — Myriad has created a new and patentable thing. He says it's "no different than allowing a baseball bat or cast iron fence to be patented as a new invention," even though those items "originated in a tree" or a "rock." The baseball bat and cast iron fence are still "human inventions" and thus are patent eligible.

"We do know Myriad did a lot of work," says New York University law professor Rochelle Dreyfuss, a nationally known patent expert who is not associated with either side in this case. But that's not enough, she says, because the court still has to answer this question: "Is the thing that's isolated significantly different from the way that it was when it was in nature?"

[The attorney] representing the patent challengers contends that Myriad is merely following nature's instructions about where to snip out the gene.

"The structure of the gene, the constituent elements of the gene, the significance of the gene ... where the gene starts, where the gene ends, all of those are decisions that nature made," he says. "Myriad just uncovered the fact that nature had made those decisions."

This case will likely have wide-ranging ramifications, however it is decided, and will affect health care costs and quality of care in realms far beyond breast cancer.

Jolie, unlike most patients, did not really have to consider cost in her decisionmaking process. She also has the attention of a surgeon who apparently makes house calls. These factors, along with the risk factors and other issues that went into her decisionmaking process mean that this is still a personal decision, and that it will be difficult, if not impossible, to standardize a best practice regarding prophylactic double mastectomies and oopherectomies (the genes are also indicators for ovarian cancer). Nevertheless, kudos to Jolie for going public, for demonstrating powerfully the role of the patient in self-determination, and for making her choice a more acceptable choice for many women who may be affected.

Here's hoping the pendulum doesn't swing too far and result in "too many" surgeries. And -- perhaps a little further off in the future -- here's hoping that the BRCA1 finding can result in genetic therapy to "turn it off" rather than surgery to remove healthy tissue. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting  

May 14, 2013

The FDA Patient Network Website - Pretty Darn Patient-Centered

FDA Patient Network 2
The FDA launched an impressive patient network website this month, after nearly four years of research, focus groups, usability testing and more. The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically. James Valentine, Program Analyst in the Office for Health and Constituent Affairs put it simply and forcefully in a recent telephone conversation: “The idea is to engage the patient community, to have the patient voice heard at the FDA.”

Historically, the agency has been working with patients one-on-one, by phone and email, often when an extremely ill patient is seeking information on clinical trials or access to investigational products. The goal is to broaden the field of engagement. The agency has had patient representatives on its advisory committees since the late 1980s — an innovation that came about as part of the response to AIDS/HIV — and patient involvement in the FDA’s processes were further formalized in the late 1990s, as part of Clinton-era cancer initiatives. There are now about two hundred patient representatives involved in over 110 disease areas.

The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year, according to Valentine. Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants — just as scientific and clinical experts brought into the FDA process are recognized as consultants — and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses.

Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.

While the new website is a gateway to the FDA, Valentine assures us that “the Office of Health and Constituent Affairs is still here to help patients navigate the agency.”

The first FDA Patient Network live chat will be a town hall meeting with staff from the Office of Health and Constituent Affairs on May 21 at 3:00 p.m. EDT. Future chats will feature staff from throughout the agency.

Here’s hoping that the FDA will carry through on the promise of online openness.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

A version of this post first appeared on, the blog of The Society for Participatory Medicine.

May 06, 2013

Massively Open Online Medicine: Bad Idea or Just Before Its Time?

MP900425552The new darling of the online educational community is Massively Open Online Courses (MOOCs). The example which figures most prominently in the popular imagination is the Khan Academy, though its founder says otherwise, noting that MOOCs are merely online transplantations of traditional courses, while Khan Academy offers something different. 

Others would take issue with his conclusion, or characterization. A "connectivist" MOOC is based on four principles:

  • Aggregation. The whole point of a connectivist MOOC is to provide a starting point for a massive amount of content to be produced in different places online, which is later aggregated as a newsletter or a web page accessible to participants on a regular basis. This is in contrast to traditional courses, where the content is prepared ahead of time.
  • Remixing, that is, associating materials created within the course with each other and with materials elsewhere.
  • Re-purposing of aggregated and remixed materials to suit the goals of each participant.
  • Feeding forward, sharing of re-purposed ideas and content with other participants and the rest of the world.

Sounds great, but is it working? Can it work? A piece in the current issue of The Washington Monthly took a look and concluded:

Given the current 90 percent dropout rate in most MOOCs, an 8-point gap in completion rates between traditional and online courses offered by community colleges, the 6.5 percent graduation rate even at the respected Western Governors University, and the ambiguity of many other higher education reform ideas, there’s good reason to think that an unbound future might not be so great.

The best American innovations in education were the Land-Grant College Act of 1862, which helped create a system of public universities, and the GI Bill of 1944, which ensured that an entire generation had the money to attend college. This widespread access to the college experience enabled people from working-class backgrounds to advance en masse into professional jobs that required reasoning and logic and extensive knowledge of the world. The question is whether or not we will continue this trend or simply give up and say that a few online classes and specialized training are good enough for the majority of Americans.

In other words: Democratization of higher education - good; MOOCs - not so much.

Why is this relevant to you, gentle reader?

The question is whether the promise of MOOCs, or their inability to deliver, will characterize MOOM -- Eric Topol's neologism, "Massively Open Online Medicine," used in his HIMSS 2013 keynote.

In health care, a perfect implementation of big data and data analytics, combined with open access for clinicians and patients, would yield a success in MOOM along the lines of a connectivist MOOC.

We are not there yet, but Topol (who, by the way, has joined me and a growing number of others as a member of The Walking Gallery, dedicated to the very relevant themes of patient empowerment and data liberation ... see his jacket, Bursting from Within and mine, Friendship Pins) continues to call for a move to population health practiced based on individualized information, which would tend to rely on a population of quantified self adherents and e-patients. Unfortunately, at present these are vanguard groups, the minority blazing the way for the majority. There are numerous initiatives afoot seeking to leverage big data, analytics and the health care system to provide population health (a more traditional example: the Accountable Care Organization). Indeed, the future probably holds an even more radical shift away from the health care delivery system as we know it today (Topol spreads the meme of 80% of physicians not being needed in the future) with home-based and wearable sensors replacing much of the current way of practicing diagnostic medicine.

Given the FDA's recent smoke signals about mHealth guidance being issued in the near future, perhaps that future is in fact inching closer, but it seems to me that it will take some time before the democratization of medicine, or health care, or health can truly take hold. The current health care data privacy and security rules -- like so many regulatory constructs -- are designed to fight the last war, not for the current field of maneuver. Technology, delivery systems and rules all need to change before real improvement can bloom. Just as in the case of education there remains a high value in traditional higher education that has not yet been replicated in the MOOCs, MOOM has not yet delivered on its promise.

Here's hoping we don't have to wait as long as the time between the land grant college act and the GI Bill.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

April 23, 2013

Response to ONC RFI on advancing interoperability of EHRs and HIE

Open DoorAt last weekend's #healthfoo I proposed that one unconference session be devoted to preparing a comment letter responding to the ONC RFI on Advancing Interoperability and Health Information Exchange.

We discussed three possible sub-regulatory changes (which is what ONC asked for), and reiterated the value of a specific regulatory change that would not require a new rulemaking process, because it may be incorporated into the final rule on patient access to lab results (draft rule released in 2011, no final rule yet).

Specifically, we proposed:

  • Leverage existing regulatory requirements by building meaningful use of EHRs and HIE into the lexicon of the health care facility surveyor; a Meaningful User should be cited with a deficiency specifically citing the EHR use or misuse or non-use if proper meaningful use would have eliminated the root cause of the deificency.
  • Advance provider directories to support HIE by using the attestation process to link a provider's Direct address with other contact information in the National Plan and Provider Enumeration System (NPPES, NPI system).
  • Increase patient access and use of EHR information by developing patient education programs as well as improving usability of the patient interface.
  • Increase standards-based electronic exchange of lab results; see Keith Boone's reg change proposal and my reply to Farzad Mostashari's tweet ("Lawyers: Would this work?") about Keith's post.

Here is the Health Foo letter to ONC on its EHR interoperability RFI.

The discussion that yielded this comment letter followed hard on the heels of a discussion about Meaningful Use Stage 3 facilitated by Claudia Williams of ONC, so we certainly hope that ONC is listening.

(Click on the image above to see Regina Holliday's painting, Open Doors, painted over the course of the unconference.)

I was also involved in the preparation of the ONC comment letter filed by the Society for Participatory Medicine, which covers most of the same ground, and also promotes adoption of Blue Button Plus as a means to empower patients to a degree that current systems do not allow.

These letters are addressed both to ONC and to CMS, in response to their joint request for information. This collaboration within HHS is encouraging, and it may well point to greater interest in leveraging EHRs within CMS. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 


March 17, 2013

Electronic Exchange of Lab Results: A social-media-prompted response to the ONC RFI on interoperability

The final question posed in the recent request for information posted by ONC reads as follows:

What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results?

Keith Boone, aka @motorcycle_guy, self-proclaimed GE standards geek and fellow member of the Society for Participatory Medicine, blogged about his thoughts on the subject in a post entitled: Promoting Laboratory Result Exchange through CLIA. Farzad Mostashari, aka @Farzad_ONC, the National Coordinator of Health IT, tweeted a link to Keith's post, asking lawyers whether this would work:

Jodi Daniel (Director of the Office of Policy Planning at ONC) and Keith (among others) retweeted the request, and Keith tweeted it directly to me, so I thought I'd weigh in on the question.

Keith observes in his post that labs do not receive any meaningful use incentive payments for making their reports standards-compliant, and suggests that other incentives might be useful:

Currently, laboratories covered under CLIA do not receive incentives for using standards specified under meaningful use. One of the requirements of clinical laboratories under CLIA is the production of a test report that meets requirements under 42 CFR 493, subsection 1291.

One possible way to promote use of the standards would be to providing a deeming clause in subsection 1291 such that if transmission of test results is performed with Health Information technology that has been certified to conform to the criteria in 45 CFR 170, subsection 314(b)(6) [ . . . ] could be an incentive for laboratories to use those standards.

I have a three-part response:

1.    ONC, in its RFI, specifically requested suggestions for sub-regulatory policy changes that could catalyze interoperability of EHRs. Keith's suggestion is a regulatory amendment.  However, since Farzad and Jodi have expressed an interest in this suggestion, and since there is a long-pending proposed rulemaking process out there connected to lab test results (see Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0), this flaw is not fatal, and the recommended change could be made through that rulemaking. In fact, it could help move that rulemaking along (it's been stalled since late 2011) by identifying a mechanism through which the lab test results may be communicated.

2.    The basic suggestion, which is to deem compliance with one standard to be compliance with another standard, is a reasonable one - assuming that the meaningful use standard for lab results applicable to inpatient EHRs (LOINC v. 2.40 + HL7 v. 2.5.1 + S&I Framework Lab Results Interface) referenced in 45 CFR 170.314(b)(6) is substantially equivalent to the lab test report standard in 42 CFR 493.1291. I would ask Keith to confirm that the two are substantially equivalent, or to explain in layman's terms the differences and why they are unimportant. 

3.    Related to item 2, the practical question remains: Given that labs are not provided a financial incentive by HHS to comply with interoperability standards, will the proposed deeming clause make it easier for them to do so? Are the meaningful use standards easier to meet than the lab test report standard? In other words, is the deeming clause enough of an incentive to motivate labs to conform to the meaningful use standard for lab results? I would want to know more about the current compliance profile of the clinical lab community. If labs are complying with the existing CLIA regulation lab test report standard, then perhaps we would want to flip the deeming around so that compliance with 42 CFR 1291 (CLIA) is deemed to satisfy 45 CFR 170.314(b)(6) (Meaningful Use). I'd be interested in feedback on this point from the clinical labs out there and the health care providers that deal with them on a regular basis on the issue of data transfer.

If the proposed change could increase the number of labs that are meaningful use standards compliant, and the labs could therefore significantly increase standards based exchange of lab results, then that would be a win.

I look forward to continuing the conversation with Keith and others and submitting a joint comment on the RFI to Farzad and Jodi. While they've asked for input via Twitter -- which I think is fantastic -- I assume they need to receive the input the old fashioned way so it can be made part of the record and all that.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting  

February 04, 2013

HIPAA Omnibus Final Rule – What’s in it for Patients?

After years of delay, the federales finally finalized the HIPAA Privacy, Security, Breach Notification and Enforcement Rules.


The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a Google+ Hangout taking a first look at the rule as a whole, and a bullet-point summary of the hangout; here you may find a piece I wrote on the Breach Notification Rule.  Some work remains to be done on other parts of the HIPAA rules, such as the accounting of disclosures provisions.)

Before detailing the patient-focused changes, a bit of broad-brush background is in order. The original HIPAA privacy and security rules are all designed to protect the privacy and security of "protected health information" (PHI) of individual patients. PHI may be shared among health care providers and payors (and health care clearinghouses - a type of claims processor) (collectively, Covered Entities or CEs) for purposes of treatment, payment and operations (TPO) without asking patients for permission. Any other use or disclosure of PHI requires patient consent. Some CE operations require dealings with Business Associates (BAs) -- entities that are not CEs, but that end up using PHI to help CEs carry out their TPO responsibilities (e.g., medical records vendors, billing companies, etc.). Every CE is required to give patients a Notice of Privacy Practices (NPP) and to enter into a Business Associate Agreement (BAA) with each of its BAs, under which the BA agrees to maintain the privacy and security of PHI.

The  amendments collected in the Final Rule are promulgated under the HITECH Act (the portion of the 2009 Recovery Act that also funded the Meaningful Use EHR incentive program) and GINA (the Genetic Information Nondiscrimination Act of 2008).  The amendments under the HITECH Act added additional privacy and security protections to HIPAA in order to allay concerns that, with the promotion of more widespread use of electronic health records, there would be more opportunities for breaches of the privacy and security of PHI. Amendments under GINA harmonize HIPAA regulations with GINA regulations.

So, without further ado, here are the highlights:

Business Associates are held to the same strict standards as Covered Entities

Business Associates and their subcontractors are now directly responsible for compliance with HIPAA, not just responsible for signing a BAA. They will now be subject to OCR HIPAA compliance audits, just as CEs are, and should be undertaking risk assessments in order to ensure that their privacy and security compliance is up to snuff.  BAs have always been responsible for compliance under their BAAs, but some BAs, particularly smaller ones, probably have not focused enough on HIPAA compliance. Now they will have to because they are fully accountable -- they can be audited and fined, just like the Covered Entities.

The definition of BA is expanded

Business Associates are now defined to include a broader array of contractors that store and touch PHI -- including, for example, document storage companies and other contractors that "maintain" PHI, even if they do not actually view the information in their possession.

Use of Protected Health Information for marketing is limited

Covered Entities may not send marketing materials to patients on behalf of third parties if the communication is paid for by a third party whose products or services are being promoted. Several exceptions to this rule that applied in the past, whether or not the communication was funded by a third party (i.e., communications about (i) treatment, (ii) a health-related product provided by, or covered by a benefit or insurance plan issued by, the CE making the communication, or (iii) case management, care coordination or treatment alternatives) now apply only if the communication is funded internally by the CE.

Sale of PHI is limited

PHI may not be sold, licensed, or accessed in exchange for giving anything of value -- with a handful of exceptions. PHI may be disclosed in exchange for remuneration  (i) for public health purposes, (ii) for research, so long as payment is limited to the sending CE's costs, (iii) for treatment and payment, (iv) in connection with a sale or merger of the CE, (v) to or by a BA where the CE is just paying for the BA's services, (vi) to a patient who requests access to his or her own PHI, (vii) as required by law or (viii) as otherwise permitted under HIPAA where the remuneration covers costs only.

Use of PHI for fundraising is limited

On the one hand, nonprofit health care providers can target their fundraising efforts by using PHI that clues them in to what services were provided to which patients. On the other hand, each contact must allow a patient to opt out of all future fundraising communications.

Use of PHI for research is simplified

A single consent for release of PHI in connection with research study participation can now cover future studies done using the same data. In addition, clinical trial consents can now be combined with retrospective data review consents. (If you like being a lab rat, you won't have to sign as many data release forms.)

Use of genetic information for insurance underwriting purposes is banned

As required by GINA, genetic information may not be used for health insurance underwriting purposes. Thus, genetic information is now included in the definition of PHI. In addition, the underwriting ban is carried forward into regulation. However, genetic information may be used in long term care insurance underwriting decisions.

Patients may access PHI electronically

Upon request, a CE must provide a patient or an authorized representative a copy of a requested medical record, in the format requested, within 30 days.  If, or some reason, the 30-day timeframe is unworkable, the regs give CEs an additional 30 days.  If the CE cannot produce the records in the format requested by the patient, the parties need to get together and agree on a workable compromise solution. Previously, the patient had to make do with whatever format the  CE produced (often a paper printout), and had to allow 60 days plus 30 days for tough situations.  So there is some progress here.  Of course, a CE that is in compliance with the Meaningful Use regulations for EHR implementation is required, in Stage 2, to provide records to patients electronically within just a few days (though the Society for Participatory Medicine called for immediate patient access to EHR information - as soon as a clinician who did not author the entry can see it, the patient should be able to see it).

Patients may restrict disclosure of some information

If a patient pays for a particular service out of pocket, he or she may require that the provider not disclose any information about the service to the patient's health plan. Providers are required to advise patients about potential inferences that payors can make based on other services provided (e.g., "If you pay for lab test A out of pocket, but have us bill your health plan for tests B, C, D and E, your health plan will be able to figure out that you had test A done as well.")  If a visit that a patient pays for out of pocket will generate a prescription, the patient would be well-advised to ask that prescriptions be written by hand, so that no electronic notice of the prescription will get to the health plan. In a perfect world, sharing of treatment information with one's health plan would not be problematic, but some patients have legitimate concerns about the use and misuse of such information by employers, health insurers, life insurers and others.

The HIPAA Omnibus Rule was published on January 25, 2013.  It is effective 60 days later, and (with certain exceptions) regulated parties must come into compliance within 180 days after that, or September 23.

What do you think?

What do you think? Was this rule worth the wait? Are your pet peeves addressed by the final rule? Let us know in the comments.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

This post first appeared on, the blog of the Society for Participatory MedicineDavid Harlow chairs the Society's Public Policy Committee.

January 15, 2013

Meaningful Use Stage 3 – Society for Participatory Medicine Comments on Proposed Objectives

The Health IT Policy Committee of the Office of the National Coordinator of Health IT released its proposed Stage 3 objectives for Meaningful Use.  "Eligible Providers" that meet these objectives share in the federal electronic health record incentive program under the HITECH Act.  (Learn more at; here's some more background on the Stage 1 Meaningful Use regs.)

The Committee wrote that it saw the release of these draft objectives as an opportunity “to begin to transition from a setting-specific focus to a collaborative, patient- and family-centric approach.”

The Society for Participatory Medicine filed comments on the draft Meaningful Use  Stage 3 objectives, saying: "We endorse the proposals that further this goal, and offer some focused recommendations intended to ensure that the final regulations are in fact designed to help achieve this goal."

One of the key issues presented in this draft is the opportunity afforded to patients to correct misinformation in their medical records.  The Society's comment:

We feel that patients should be involved in amending, reconciling, and correcting errors in their medical records. Making this possible will require EHRs that support patient assistance, patient portals or other mechanisms for patients to do this online, and workflow tools for both providers and patients. We propose that ONC establish additional working groups or technical expert panels to study these issues and establish relevant standards.

The Society also responded to the Committee's request for information on the use of patient-generated data, endorsing its use, and noting that: "The patient is the most highly qualified expert on his or her own health, and his or her own experience of the health care system."

I invite you to peruse the proposal and comment letter linked to above. Again, the perspective on these matters espoused by the U.S. government agency is that we need to focus on enabling provider-patient collaboration. The Society approves.

A special thanks to Adrian Gropper, M.D., of the Society's Public Policy Committee, and to the members of the Society's Executive Committee, for their contributions to the review and comment process.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

This post first appeared on, the blog of the Society for Participatory MedicineDavid Harlow chairs the Society's Pulic Policy Committee.

December 12, 2012

Can Patient-Centered Care Reduce Hospital Readmissions?

A new Press Ganey white paper highlights an association between HCAHPS performance -- patient experience scores -- and lower rates of readmission. (Performance Insights - The Relationship Between HCAHPS Performance and Readmission Penalties.)

With Medicare payment penalties for excess readmissions now in effect, reducing readmissions has become a top priority for hospitals and other stakeholders. The Centers for Medicare and Medicaid Services (CMS) publicly reports risk-adjusted readmission rates for heart attack, heart failure and pneumonia. The data show significant variation in performance across hospitals, indicating that some hospitals are more successful than others at addressing the causes of readmissions. A new study by Press Ganey suggests that performance on readmission metrics is associated with performance on patient experience of care measures.

This study is an interesting look at the relationship between two value-based purchasing programs used by CMS to calculate Medicare payments to hospitals -- the Hospital Value-Based Purchasing Program and the Readmissions Reduction Program.

The key learning from this study is this:  

Effective communications is fundamental to ensuring that patients become engaged in their care and, consequently, better equipped to follow discharge instructions and self-monitor after leaving the acute care setting.

Coupled with patient-centered practices supported by past studies which have shown that "the single most effective strategy for improving patient satisfaction is purposeful hourly rounding by nursing staff," a "sustainable discharge" strategy is highlighted as a key predictor of avoided readmissions.

A sustainable discharge strategy comprises identifying and addressing patient-specific factors that could lead to readmission, strategic patient education, developing a patient-focused after-care plan and ensuring a smooth transition to a post-acute setting. Tactics that drive success in achieving sustainable discharges include: dedicated patient transition coaches, proactive planning for non-medical barrier to treatment adherence, post-discharge phone calls, scheduled follow-up care, and use of cross-setting discharge planning tools and teams.

In other words, a patient-centered discharge planning process, built on clear communications with the patient, is likely to reduce readmissions.

With more than 20% of Medicare beneficiaries discharged from an acute care hospital being readmitted within 30 days, at a cost of over $15 billion a year, and with over 2000 hospitals looking at readmissions reduction program Medicare payment penalties in FFY 2013 totaling $280 million, this is a significant issue -- but one where a potential solution is clearly at hand.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting