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4 posts from May 2011

May 31, 2011

ONC Federal Health IT Strategic Plan: Comments filed on behalf of the Society for Participatory Medicine

We e-patients are an impatient lot, and therefore we may not be big fans of the Five-Year Plan approach to creating change.  The Office of the National Coordinator for Health IT released a draft federal health IT strategic plan in late March, via blog post (the plan itself is linked to from the post; a copy is posted here).

The ONC post says:

The Plan demonstrates how we will build off the foundation of meaningful use to unlock the power of information to:

  • Enhance our ability to study care delivery and payment systems
  • Empower individuals to improve and participate more in their care
  • Improve care, efficiency, and population health outcomes, through tools such as clinical decision support, real- time feedback of performance to clinicians, and targeted public health campaigns

The Plan has five Goals, laid out in the post.  The Society’s comments on the ONC Strategic Plan focus on one of these Goals.  A brief excerpt follows:

Our comments focus on Goal IV of the Federal HIT Strategic Plan – “Empower Individuals with Health IT to Improve Their Health and the Health Care System.” This Goal breaks down into three Objectives, and a number of Strategies to achieve each Objective. The Goal and Objectives are laudable, but we would seek to strengthen the Strategies — by involving patients in the development of the system — so as to increase the likelihood of achieving the Goal in a meaningful way, and to do so sooner than five years from now.

One overarching comment on this Goal is that it is not integrated with the concept of care coordination, which is discussed elsewhere in the strategic plan. In order to fully realize the goal of patient centeredness, the patient must be involved in the coordination of his or her care. This omission highlights the perspective of the ONC on health care as something that is provided to patients rather than as a partnership process that involves patients, clinicians and non-professional caregivers. The patient-centeredness criteria promoted as part of the proposed rule on Accountable Care Organizations should be incorporated into the Strategies used to achieve this Goal. While these criteria are not all health IT-specific, the ONC makes the point in the strategic plan that that health IT enables patient empowerment, transparency, and achievement of the Triple Aim. Thus, all process, systems and standards improvements called for in the patient-centeredness portion of the ACO rule should be brought to bear on the health IT strategic plan.

(You may read more on this last topic at an earlier post on ACOs and patient-centeredness.)

The Objectives in play here are as follows:

  • Engage individuals with health IT
  • Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse
  • Integrate patient-generated health information and consumer health IT with clinical applications to support patient-centered care

Can’t argue with the Objectives; as noted above, though, some of us e-patients are impatient, and would like to see these Objectives reached sooner rather than later. 

One key thread running through our comments is that policymakers must remember that health care is not something done to patients, it is something done with patients, so a strong patient voice must be heard, and must be built into the system.  This is the time to do it, as we are framing out a brave new health care system.

Finally, as an added incentive to read the comments, please note that they include a link to a post by Regina Holliday containing her explication of a recent allegorical painting of hers — well worth the read, as it is an eloquent statement of the health IT and patient engagement issues at hand.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

This post first appeared at, the blog of The Society for Participatory Medicine.  Please check out the blog, the site, the listserv, and consider joining the Society.

May 18, 2011

Why do 10% of cancer patients on oral meds stop taking them?

Ten percent of cancer patients failed to fill their initial prescriptions for oral anti-cancer drugs, according to a new study published jointly today in the Journal of Oncology Practice (JOP) and American Journal of Managed Care (AJMC)[, based on data] . . . from 2007 to 2009. . . .

The study, “Patient and Plan Characteristics Affecting Abandonment of Oral Oncolytic Prescriptions,” finds that patients were primarily abandoning their anti-cancer drugs due to two key factors: high cost-sharing and higher prescription activity. For example, claims with cost-sharing over $500 were four times more likely to be abandoned than claims with cost-sharing of $100 or less. Across the sample of prescription claims studied, Medicare coverage and lower income were also related to higher rates of abandonment when each were compared individually.

The study shows that while anti-cancer medicines offer benefits to patients, access to them is difficult due to high rates of cost-sharing. While 73 percent of newly initiated oncolytic patients had a cost-sharing amount of $100 of less, 16 percent required an out-of-pocket cost of greater than $500. The study found that the abandonment rate increased with cost-sharing amounts. Claims with cost-sharing above $500 had the highest abandonment rate – 25 percent – as compared with an abandonment rate of six percent for claims with cost-sharing of $100 or less.

(Source: presser from Avalere Health, which conducted the study.)

In the bad old days, most cancer meds were delivered through infusion therapy (chemotherapy), but a sizable chunk of those now in use, and likely more of those that are in the pipeline (25-35%) are oral meds.

IV meds administered in a health care facility are, generally speaking, not subject to the same level of cost sharing by patients now common for prescription medications.  Thus, the confluence of changes in drug therapy and changes in insurance coverage has led to a dangerous drop in medication adherence for cancer patients, due to higher out-of-pocket costs, even if the total cost of a given course of treatment is lower than the cost of a comparable course of IV chemo.

This should be understood intuitively, but apparently it is not.  A couple months ago, we were treated to another study showing that as high deductible health plans become more prevalent, use of preventive services declines.

The solution being adopted to deal with this latter problem, across many commercial plans as well as Medicare, is the elimination of copays for certain primary and preventive care services.  This makes economic sense to payors, even as it makes eminent sense for individuals as well.  For short money up front, expensive care down the road may well be avoided.

While we need not return to the bad old days of infusion therapy only for cancer meds, payors should examine the results of this study carefully and reconsider coverage rules.  Reducing out-of-pocket costs for these meds will increase adherence, and would likely reduce the incidence of complications and relapses requiring more expensive care . . . good for everyone.

(While we're on the subject of cancer treatment, I would be remiss if I did not offer you the opportunity to sponsor my ride in the 2011 Pan-Mass Challenge -- the two-day, 200-mile annual bicycle fundraiser for the Dana Farber Cancer Institute.  Please follow the link and give as generously as you can.  Tell your friends and neighbors.)

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


May 17, 2011

Is the ACO DOA? Reasonable Minds Can Improve the Draft Regulations

In the current all-ACO, all the time, health care policy news cycle, we've been inundated with declarations that the ACO is dead, because a handful of big boys say they don't want to play.

Today, CMS announced that it is tinkering with the proposed ACO rules by offering three variations on the ACO theme (link to press release; see also CMS ACO fact sheet).  From the fact sheet:

  • Pioneer ACO Model: The Innovation Center is now accepting applications for the Pioneer ACO Model, which will provide a faster path for mature ACOs that have already begun coordinating care for patients.  The Pioneer ACO model is estimated to save Medicare as much as $430 million over three years by better managing care for beneficiaries and eliminating duplication.  And it is designed to work in coordination with private payers in order to achieve cost savings and improve quality across the ACO, thus improving health outcomes and reducing costs for employers and patients with private insurance. 
  • Advance Payment ACO Initiative: The Innovation Center is seeking public comments on whether it should offer an Advance Payment Initiative that would allow certain ACOs participating in the Medicare Shared Savings Program access to a portion of their shared savings up front, helping providers make the infrastructure and staff investments crucial to successful ACOs.  Comments should be submitted by June 17th, 2011.
  • Accelerated Development Learning Sessions: Providers interested in learning more about the steps necessary to become an ACO can attend an upcoming series of Accelerated Development Learning Sessions.  These convenient and free sessions will help providers learn what steps they can take to improve care delivery and how to develop an action plan for moving toward better-coordinated care.

Together with the Medicare Shared Savings Program, the initiatives announced today give providers a broad range of options and support that reflect the varying needs of providers in embarking on delivery system reforms.

CMS has recently hinted that it will be rejiggering the rules to encourage physician-led ACOs, too (an approach I have previously endorsed).

So, I think that the histrionics are more about influencing the final form of the regulations than truly backing away from participation in a Medicare Shared Savings Program.  Now is the time to put pen to paper -- or fingers to keyboard -- in order to get comments on the proposed rule in to CMS.  As ever, the perfect is the enemy of the good, and we clearly need to do something.  Over at the Health Affairs blog today, Ron Klar offers the first of three installments of suggested improvements to the ACO rules.  Food for thought.  In a wonderful display of synchronicity, Governor Deval Patrick offered testimony just yesterday on the all-payor ACO bill that he has filed here in Massachusetts.  The CMS rules -- with any luck -- will be finalized before final action on Patrick's bill, but it is important to keep in mind that the ACO framework, while focused on Medicare today, may well be expanding to all payors in the future.  In an all-payor environment -- and even in the Medicare environment -- there is still time to consider alternative approaches to a variety of the proposals laid out in the proposed ACO rule.

What's your pet peeve about the proposed rule?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


May 13, 2011

FDA and social media ... again ... still .... Thoughts and today's presentation at MassMEDIC

Pushmipullyu Meet the love child of the FDA and the pharma and medical device industries: The Pushmi Pullyu.  ACOs and unicorns, step aside; the is the Pushmi Pullyu's day to shine.  (It is now a commonplace that an Accountable Care Organization -- a creature of the Affordable Care Act -- is like a unicorn: everyone can describe it, but no one has ever seen one.)

It's been 18 months since the FDA listening session on the use of social media in marketing drugs and devices, and after many months of thinking that some sort of guidance was just around the corner, the FDA decided to release for public comment a description of some research studies it would like to conduct before actually reaching a decision point about guidance for the use of social media in marketing drugs and medical devices.  As others have noted, this will take a while.  The studies, as described, are also not likely to yield useful, actionable data, in large part because they are hyper-focused on the web of today and the way people use it, and the online activities of the future (including the near future, say two years from now -- optimistically -- when the studies are complete and guidance is issued) will be different.  The agency has to be willing to articulate general principles, but it seems paralyzed on that front.

On another front, the Pew Research Center has just released a very useful report: The Social Life of Health Information, 2011, by Susannah Fox (with whom I have the honor to occasionally share space with on the blog of the Society for Participatory Medicine).  This study captures a snapshot of the the way we use the internet to solve health problems -- and many, if not most, of us are doing that one way or another.  Research conducted by Susannah and the Pew Internet & American Life Project can help folks tailor messages and tactics to be used in the deployment of health care social media -- both in the realm of health care and in the realm of pharma and devices.  Perhaps some day (soon!), the FDA will call on resources such as the Pew Research Center to turn around some illuminating studies within a short timeframe.  Until then, we're stuck with the pushmi pullyu approach to social media in the FDA-regulated space --regulators and the regulated community looking away from each other and not.  (Another aspect of this approach: the FDA uses social media on its own account, yet is uncomfortable with establishing parameters for tis use by the refualted community.)

Even in this ambiguous environment, folks can use social media for some purposes in the world of pharma and medical devices -- carefully, within some safe zones, following some clear locally-developed policies and procedures.  I'm speaking on the subject this morning at MassMEDIC.  Please let me know what you think:

David Harlow
The Harlow Group LLC
Health Care Law and Consulting