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8 posts from October 2011

October 31, 2011

Accountable Care Organization Regulations - The ACO is a Camel, Not a Unicorn


The final Accountable Care Organization regulations are out, the initial flurry of commentary is out (including my own ACO webinar with simultaneous #ACOchat tweetchat - available for replay; slides here : "ACOs, Bundled Payments and the Future of Health Care"), and we can now all catch our collective breath and contemplate the draft vs. final ACO regulation comparisons, the meaning of this new, final set of regulations, guidances and statements from CMS, FTC, DOJ, OIG, and IRS on ACOs and Medicare Shared Savings Programs, and all of the attendant antitrust, antikickback, Stark, and other fraud and abuse matters, and of course tax issues.

So, now that these final regulations are out, and the mythical characteristics of the ACO will soon be dispelled (see under: unicorn), I propose a new animal kingdom metaphor for discussion of Accountable Care Organizations:

The Camel's Nose is in the Tent.

The definition of a camel, as those of you who tuned into my ACO webinar already know, is a horse designed by a committee.  And, given the nature of the legislative and rulemaking processes, that's exactly what we have before us - a camel.  

The clincher, though, is the way in which the final regulations have been engineered.  

CMS would have ACOs, by virtue of participating in the MSSP, diffuse all the ACO goodness of care management, quality and cost control, etc., into the broader Medicare population.  This conclusion is inescapable.  CMS is focused on the question of how to do more with less, and the ACO conceptual framework, if not the details, will permeate many arenas across the health care lansdscape.

ACO assignment is still retrospective (even if there is a nod to prospective assignment, that nod is provisional, and reconciliation must be done after the close of the contract year). Since an ACO never knows for sure which patients' experience will form the basis of its gainsharing or risksharing, it must behave as if each Medicare benefiicary who receives care form its providers will ultimately be attributed to the ACO.

In addition, the slimmed-down set of 33 ACO quality measures focus in part on "better care for individuals" (through CAHPS scores for patient/caregiver experience, also care coordination/patient safety measures, too), and in part on "better health for populations" (vaccinations, screenings, diabetes management). 

These are just two examples of the ways in which CMS is leveraging its MSSP authority to engineer provider focus on improving population health.

Another "proof text," if you will, is the fact that at most, CMS anticipates that no more than two million Medicare beneficiaries will be seen by no more than 270 ACOs in the initial three to four years of the program.  (Compare those figures to the roughly 47 million Medicare beneficiaries and 6000 hospitals, and you will quickly get the sense that the MSSP / ACO is a test probe, not a wholesale shift.)  Even if the maximum anticipated ACOs are established and beneficiaries are served, projected savings to Medicare will top out at less than $1 billion over four years.  In a $2.5 trillion a year health care economy, this is bupkes (a technical term).

So, the idea of the ACOs under the MSSP is the camel's nose in the tent -- the forerunner, the disruptive innovation that is intended to set the rest of the system off-kilter until it reaches a new status quo on the other side of the Triple Aim.

Given the emphasis on a wholesale departure from fee-for-service payment (even if it's done through workarounds thanks to the inertial forces of the "assets in place" of existing law and the systems built up around it), which will reverberate throughout Medicare and the rest of the health care system, it is critically important for health care providers to begin now -- if they have not already begun -- to take a broader view of the patient encounter, to get a firm grasp of their own costs and the costs of their partners, and to start thinking about the power of collaboration.  Physicians, hospitals and all other sorts of health care providers need to think about episodes of care, bundled payments, care management, cost control and the path forward to a win-win-win for patients, providers and payors in a blown-up-and-put-back-together high-performing health care system.

Oh -- camels spit, so be prepared!

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 25, 2011

David Harlow presents two webinars this week: one on health care social media, the other on accountable care organizations

I am presenting two webinars this week, one on health care social media and the other on accountable care organizations, or ACOs.


Health Care Social Media: An Introduction to Engaging Intelligently and Legally

(Title links to registration information)

Webinar: Tuesday, October 25, 2011 

Time: 12:00 p.m. to 1:30 p.m. ET

Health care organizations, professionals and patients alike are embracing the social media movement with vigor as online tools like blogs, Facebook, Twitter and YouTube grow in popularity. It is no longer a question of whether you should be using social media tools to promote your practice and institution and connect – effectively, legally and ethically -- with patients and referral sources; it is a question of when, and how.  

A skilled user of social media has the opportunity to become a trusted source, a convener, an influencer; and can effectively and efficiently utilize these tools for reputation enhancement and building strong relationships with existing patients and referral sources while “expanding the sales funnel” to attract new patients and referral sources.  However, the use of these tools requires interaction and engagement at a level that many health care organizations find uncomfortable. Balancing the inherent tension between transparency and privacy, openness and control, can be difficult. While the legal land mines are there, you can make your way through and emerge unscathed if you have a clear understanding of HIPAA and other relevant rules – and how they apply to social media initiatives.  

Learn more during this interactive 90-minute webinar about the value of social media tools, the range of issues they present, and some key strategies for using these tools effectively while steering clear of trouble by social media expert and charter member of the Advisory Board of the Mayo Clinic Center for Social Media, David Harlow.  Become comfortable with social media for your facility!

Learning Objectives:

  • Gain greater familiarity with social media tools and tactics and their value to the health care enterprise.
  • Achieve understanding of legal, regulatory and risk management issues related to the use of social media in health care.
  • High-level introduction to best practices.

Accountable Care Organizations, Bundled Payments, and the Future of Health Care

(Title links to free registration information)

Webinar: Thursday, October 27, 2011

Time:  1:00 p.m. to 2:00 p.m. ET

David Harlow previews HCPLive Webinar on ACOs

In the future (starting tomorrow!) health care providers will have to do more with less. Total reimbursement by both public and private sector payors is dropping, and the metrics for success are changing. Instead of thinking about this as a zero-sum game, payors and providers are moving away from fee-for-service payment systems to bundled payment systems. The health reform law spells out one such program in detail -- the ACO, or shared savings, program -- and created the CMS Center for Innovation, and funded it with $25 billion. The Center for Innovation’s mandate is to run experiments on how to do more with less, and to scale up successful experiments quickly.  

In this webinar, noted attorney, consultant, blogger and speaker David Harlow will describe the future contours of the health care market, defined by emerging federal and private sector programs in a post-fee-for-service environment, and identify ways in which provider organizations should be preparing themselves in order to succeed in this brave new world.

Join the simultaneous tweetchat at #ACOchat.

See you later this week.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 21, 2011

Health Care Social Media Summit - Mayo Clinic Center for Social Media - Wrapup

I'm back from my pilgrimage to Rochester, MN for the Third Annual Health Care Social Media Summit at the Mayo Clinic, presented by Ragan Communications.  I had a great time, and want to share the experience with you.  So please take a look at the archived #mayoragan tweets, my presentation on health care social media and the law, and my blog posts about the pre-conference and the summit itself posted at HealthWorks Collective.  Here are some excerpts:

Mayo Ragan Social Media Summit Pre-Conference

A recurring theme in my hallway conversations [today] was that it is impossible to transplant a successful program from one location to another without taking into account myriad local conditions (social media program, heart transplant program – same problem).  As I always say to folks who just want to copy, say, the Mayo Clinic’s, or the Cleveland Clinic’s, social media policy, change the names and be done with it, it is critical to take the measure of local conditions and customize an approach.  As I discuss[ed] in my presentation later in the conference, there are risks – manageable risks – inherent in the use of health care social media, but the risk tolerance of each organization is different, born of a whole host of factors, and those differences must be respected.

Mayo Ragan Social Media Summit:

This was multimedia day at Mayo Clinic.

Lee Aase, Director of the Mayo Clinic Center for Social Media, kicked off the meeting with a rundown of the Mayo Clinic’s experience with social media, highlighting the “MacGyver” (i.e., jerry-rigged) approach he advocates, using free and low-cost tools.

He then premiered a soon-to-be viral video produced as part of the Mayo clinic's Cardiac health "Know Your Numbers" campaign:

Know Your Numbers Video

Chris Boyer closed out his presentation with a little song he wrote (he accompanied himself on the ukulele), about social media ROI.

Mayo Ragan Social Media Summit - Final Day

My gloss on the imperative to pursue [the] lofty goals [articulated by e-Patient Dave in his closing keynote, summarized in an understated way as "Let Patients Help"] is born of a stark economic reality: in the future (the very near future), health care providers will have to do more with less.  (Consider, for example, impending deep Medicare cuts.)  [Consider, also, the patient-centeredness and patient engagement laid out in the final ACO regulations.]  In order to do so successfully, they will need to work collaboratively with patients – and with each other -- in ways that many have not (in large part) to date, because economic incentives to do so have not necessarily been there.  Social media will be a part of the solution to this problem.

I enjoyed meeting up with my fellow MCCSM external advisory board members, and I look forward to continuing the conversation with so many of you whom I met in person at the conference, including many folks whom I've known for years - but only online.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 20, 2011

Ladies and gentlemen, the final Accountable Care Organization regulations!

Today, CMS released the final ACO regs, after many months and after reviewing something north of 1300 comments filed.  For now, I wanted to share the CMS presser and links.  Analysis and discussion to follow....  For background, the draft regs, and commentary on ACOs over the past few months, please see all HealthBlawg posts on Accountable Care Organizations.  

I will be presenting a free webinar on ACOs and other CMS initiatives next Thursday, October 27, 2011, 1:00 p.m. ET via HCPLive.  You may learn more about it and register here: ACOs, Bundled Payments & the Future of Health Care.

Reproduced below is today's CMS presser with links to today's government publications -- including regulations and fact sheets -- on Accountable Care Organizations (aka Medicare Shared Savings Program) and the Advance Payment Model for physician-owned and rural providers who need assistance with start-up costs associated with ACO / MSSP participation.  You should read CMS Administrator Don Berwick's perspective on the ACO final regulations, too.

If you'd like to, you can jump right in to the full text of the final ACO regulations, or take a quick look at a table comparing the final ACO regs to the proposed regs.

The helping hand extended by the federales through the Advance Payment Model is encouraging to me, because -- as I've written before -- I believe that having physicians lead in this arena is of critical importance in order to achieve the Triple Aim and to effectively bring costs down in an era of constrained resources.

I hope you can join me for the webinar.  If you have any specific questions you'd like me to address in the webinar or otherwise, please note them as comments to this post on HealthBlawg and/or in the course of registering for the webinar.


For Immediate Release: Thursday, October 20, 2011
Contact: CMS Office of Public Affairs


New tools help doctors and other health care providers improve quality of care

People with Medicare will be able to benefit from a new program designed to encourage primary care doctors, specialists, hospitals, and other health care providers to coordinate their care under a final regulation issued today by the Department of Health and Human Services (HHS).  Created by the Affordable Care Act, these final rules on Accountable Care Organizations add to the menu of options for providers looking to better coordinate care for patients and will make it easier for providers to deliver high quality care and use health care dollars more wisely.

The initiatives announced today are just two of several efforts made possible by the Affordable Care Act to help bring better health, better care and lower costs not just to Medicare beneficiaries, but to all Americans.  For example, the Bundled Payments for Care Improvement Initiative and Comprehensive Primary Care Initiative offer alternatives to coordinate and improve health care.

“Today we have taken another step to improve health care for people with Medicare,” said HHS Secretary Kathleen Sebelius.  “We are excited to give doctors, hospitals and other providers the flexibility and support they need to work together and focus on making sure patients get the care they need.”

“This model of delivering care may not be right for everyone, but it provides new incentives for doctors, hospitals, and other health care providers to work together in new ways,” said Secretary Sebelius.

The two initiatives launched today – the Medicare Shared Savings Program and the Advance Payment model – will help providers form Accountable Care Organizations and reflect the significant input provided by stakeholders as well as lessons learned by innovators in care coordination in the private sector. 

  • The Medicare Shared Savings Program will provide incentives for participating health care providers who agree to work together and become accountable for coordinating care for patients.  Providers who band together through this model and who meet certain quality standards based upon, among other measures, patient outcomes and care coordination among the provider team, may share in savings they achieve for the Medicare program.  The higher the quality of care providers deliver, the more shared savings the providers may keep. 
  • The Advance Payment model will provide additional support to physician-owned and rural providers participating in the Medicare Shared Savings Program who also would benefit from additional start-up resources to build the necessary infrastructure, such as new staff or information technology systems.  The advanced payments would be recovered from any future shared savings achieved by the Accountable Care Organization.

“As a physician I understand the complexities of caring for a patient who may have multiple providers,” said Donald M. Berwick, M.D., administrator of the Centers for Medicare & Medicaid Services (CMS).  “This opportunity to coordinate care among providers could greatly improve the quality of care Medicare beneficiaries receive.”

Both the Medicare Shared Savings Program and Advance Payment model create incentives for health care providers to work together to treat an individual patient across care settings – including doctors’ offices, hospitals, and long-term care facilities.

Unlike a managed care plan, Medicare beneficiaries will not be locked into a restricted panel of providers.  Rather, a determination of whether an Accountable Care Organization was responsible for coordinating care for a beneficiary will be based on whether that person received most of their primary care services from the organization.

“We listened very carefully to the more than 1,300 comments we received on the proposed rule released this spring, and this final rule includes a number of improvements suggested by those comments that will strengthen the program,” Dr. Berwick said.  “For example, the final rule will increase the incentives and streamline the Shared Savings Program, extending the benefits of the new program to a broader range of beneficiaries.”

Other changes from the proposed rule include making the one-sided model truly one-sided, expanding participation to Rural Health Clinics and Federally Qualified Health Centers and organizations where specialists provide primary care, and providing a flexible starting date in 2012.  Federal savings from this initiative could be up to $940 million over four years.

To aid organizations interested in becoming Accountable Care Organizations, CMS offers a number of learning opportunities for providers, including the third Accelerated Development Learning Session on November 17-18 in Baltimore.  This free session will offer providers the opportunity to learn more about this option for providing care.  For more information, visit

People with Medicare have received information about what an Accountable Care Organization could mean for them in the annual issue of “Medicare & You” and if their current health care provider is participating in an Accountable Care Organization, they will receive additional information from their provider. 

The Shared Savings Program final rule is posted at:

The Advanced Payment solicitation is posted at:

For more information, fact sheets are posted at:

The joint CMS and Department of Health and Human Services Office of Inspector General (OIG) Interim Final Rule with Comment Period addressing waivers of certain fraud and abuse laws in connection with the Shared Savings Program is posted at:

The Antitrust Policy Statement is posted at: and

The Internal Revenue Service (IRS) Fact Sheet, Tax-Exempt Organizations Participating in the Medicare Shared Savings Program through Accountable Care (FS-2001-11), will be posted at: .  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 19, 2011

David Harlow speaks at Third Annual Health Care Social Media Summit

I am speaking today on legal and regulatory issues related to health care social media at the Mayo Clinic Health Care Social Media Summit.  I look forward to keeping in touch with folks I've had the opportunity to meet in real life this week at Mayo.  For my take on the rest of the conference, please see my posts here and here.  Feel free to peruse the #mayoragan tweetstream, too.

Here are my slides:

October 17, 2011

Health Care Social Media Summit at Mayo Clinic

The Third Annual Social Media Summit takes place this week at the Mayo Clinic. There's a pre-conference on Monday, summit sessions on Tuesday and Wednesday, and other events rounding out the week. Follow the tweets right here from Monday through Wednesday. I'll be speaking, as a member of the external Advisory Board of the Mayo Clinic Center for Social Media. If you are on site please be sure to track me down and say hello.

Update 10/21/2011:  Here's my wrapup post: Health Care Social Media Summit - Mayo Clinic Center for Social Media - Wrapup.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 05, 2011

David Harlow's Health 2.0 vlog

At the September 2011 Health 2.0 conference, I asked attendees two questions:

(1) What is Health 2.0?

(2) What are you doing to promote health data liberation?  

Many of the folks I spoke with used Todd Park's locution: ¡data liberación!  I posted recently about one data liberation initiative; HHS, with Todd Park as CTO, is pursuing many more.  Check out this playlist of eighteen very short video interviews, and meet some interesting people with cool ideas.  Block out half an hour, or bookmark this page and listen to a few at a time.

I spoke with Regina Holliday, Jane Sarasohn-Kahn, Ramin Bastani, Janice McCallum, Ash Damle, Sunnie Southern, Mathew Browning, Mark Scrimshire, Alex Fair, Christine Kraft, Lygeia Ricciardi, Andre Blackman, Matthew Holt, Jef Kozloff, Farzad Mostashari, Paulo Machado, Joe Flower and Nikolai Kirienko.  Each of them has something important to say, and each comes at these questions from a different perspective -- patient, entrepreneur, activist, government official, disruptive innovator, thinker, consultant.  Those who were wearing jackets painted by Regina Holliday show them off before starting to answer the two questions. 

Health 2.0 Fall 2011 vlog with David Harlow aka HealthBlawg

Of course, I was not the only person walking around with a video camera; I was caught here at the end of the Health 2.0 pre-conferences, emphasizing my hope that Health 2.0 innovations will increasingly be enabled to communicate with each other and with other platforms so that information collected or generated through use of these tools can be aggregated, analyzed, and actually used by patients, caregivers and health care providers to improve individual and population health: 

David Harlow at Health 2.0

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

October 04, 2011

Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0

On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación!  All lab results will be made available to patients, just like all other health data.  (See the HHS presser and YouTube video from the recent consumer health summit.  Todd Park, HHS CTO, is also the chief activist for what he calls ¡data liberación!)

Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.

When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule45 CFR § 164.524(a)(1): psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including  “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).

(“CLIA” stands for the Clinical Laboratory Improvement Amendments of 1988, which established quality standards for certain laboratory testing.)

This carveout of lab results from patient-accessible records has long been a thorn in the side of the e-patient.  This month, the federales announced that they would step forward as Androcles to the e-patient lion (to jumble a reference or two), and pull out the thorn, by proposing to amend both the CLIA regs and the HIPAA regs.  The HIPAA regs include the exception described above: all records must be made accessible upon request except labs and a couple others.  The lab results exception will be deleted from the HIPAA regs if the change is finalized.  The CLIA regs prohibit lab delivery of results directly to patients.  The proposed amendment says that the labs “may” release the results directly to patients.  The net effect is that patients will have the right to request the results, and since labs will be permitted to release them, they will have to do so.

As some readers will recall, HIPAA regs were subjected to a state-by-state “pre-emption analysis” when they came out.  (Generally speaking, Federal law “pre-empts” state law unless state law is more protective of an individual’s rights or health.)  The feds note in the preamble to the proposed rule:

A number of States [most, actually] have laws that prohibit a laboratory from releasing a test report directly to the patient or that prohibit the release without the ordering provider’s consent. If adopted, the proposed changes to § 164.524 [of the HIPAA regs] would preempt any contrary State laws that prohibit the HIPAA-covered laboratory from directly providing access to the individual.

Thus, labs in most states have some work to do in figuring out how they will actually release results directly to patients once the regs are finalized and effective (which could be about a year, gang, so sit tight).

Here’s where it gets fun, folks:

While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.

CMS goes on to say that the HIT Policy Committee at ONC, established by the HITECH Act, says that “CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information.  These stakeholders . . .  believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal health care decisions ” … so we’re going to change them.  [Paraphrase and emphasis mine.]

Let me restate this, folks: the regs are being changed to give greater patient access to health data not because of a recent change in the law, but because patients and patient advocates spoke up, and the HIT Policy Committee got the message.  

I had the opportunity to hear Dr. Farzad Mostashari (National Coordinator for Health IT), Lygeia Ricciardi (Senior Policy Advisor for Consumer eHealth), and Jodi Daniel (Director, Office of Policy & Planning) speak at an ONC town meeting at last week’s Health 2.0 conference in San Francisco and they are nothing if not passionate about promoting patient access to health data. Please take a look at my mini video interviews with Dr. Mostashari and Ms. Ricciardi, if you need any confirmation.  For the wonks and insomniacs: you may be interested in listening to all or part of the ONC town hall meeting at Health 2.0 conference.  It is an unofficial recording, about 45 minutes long, and will start when you click the link; it offers a further window into the thinking of Mostashari, Ricciardi and Daniel, as they discuss ONC's broadening of focus from providers to include patients (the very beginning of recording is clipped, but you didn’t miss much).  Another way in which this broader focus is demonstrated is by the redesign and expansion of the website, which now includes more robust patient-focused content. (“Putting the “I” in Health IT” … You can take the pledge to empower individuals to be partners in their health through health IT.)

This change may improve patient access to lab results, but only if the right to obtain the results is ushered in together with an education campaign that alerts patients to this new right, and if the results are presented in a manner that includes some minimal level of interpretation (and I recognize that too much interpretation will cross the line into the communication that needs to take place between the patient and his or her clinician).  On the question of how lab results should be presented to patients, at Health 2.0, Thomas Goetz, of Wired magazine, presented a patient-friendly lab report tool, to be rolled out soon by his company, 1 + 1 Labs.  Other approaches, of course, are possible, since numerous institutions already provide this data directly to patients.

A certain percentage of lab results never make their way to the patient — and the patient education piece of the rollout could result in that percentage being reduced, or even eliminated.

There is opposition to the proposed rule by some providers, who express a concern that a patient who receives lab results directly may well (a) misintepret a value that is “normal” for the population at large but that might not be “normal” for her and/or (b) fail to communicate with the clinician who ordered the test.  In our fee-for-service world, some cynics may say that some clinicians are being inappropriately incentivized to seek another billable patient encounter for discussion of results.  In the future of bundled, episodic, prospective payment systems, this would not be a concern.  In fact, since we will be asking the entire health care system to be doing more with less as a result of the nation’s fiscal and political environments, frictionless sharing of information should be welcomed by providers.  Providers will continue to receive lab results, and will continue to be expected to discuss them with their patients.

Comments on the draft rule are invited.

If you get a charge out of reading this post and thinking about the changes coming down the pike in access to health data, and you'd like to take part in future grassroots activity that can lead to real change, please consider joining up as an active member of the Society for Participatory Medicine -- which is composed of poviders as well as patients -- and also consider beocming active in the broader Patients 2.0 community.

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 Particpatory Medicine.  I serve as Chair of the Society's Public Policy Committee.