PCORI was established as a result of the Patient Protection and Affordable Care Act in 2009.
PCORI has recently released it’s research agenda for public comment.Release of approximately $125 million dollars for the research will occur this year. The proposed research agenda includes:
1.Comparative assessments of prevention,diagnosis and treatment options. The research goal is to determine which options work best for distinct populations with specific health problems.
2.Improving Healthcare Systems. Focuses on ways to improve healthcare services,such as coordination of care for patients with multiple chronic conditions
3.Communication and dissemination. Looks at ways to provide information to patients so that they,in turn,can make informed healthcare decisions with clinicians.
4.Addressing disparities. Assures that research addresses the healthcare needs of all patient populations.This needed as treatments may not work equally well for everyone.
5.Accelerating Patient Centered and Methodological research. Includes patients and caregiviers in the design of research that is quick,safe,and efficient.
The recently announced research consortium that is a partnership of theThedacare Center for Healthcare Value and the Stanford Clinical Excellence Research Center is focused on several of these research priorities. Testing the hypothesis “does lean work in healthcare when compared to other methods” is clearly related to priority number two. Priority number 5 covers our hypothesis “can the implementation of lean primciples and practices be simplified so that any organization can be successful at implementation”
See the following attachment to view the large number of healthcare reserch institutions that are participating in the consortium. Also read below for the recent PCORI proposal.
Kim Barnas has become a national leader in implementing lean. Her recent article in the Joint commission’s Journal of Quality and Patient Safety describes the work she initiated on the Business Performance System which is the lean management system at ThedaCare. The results of this new leader standard work are phenomenal. It includes leaders improving their quality,delivery,people and cost metrics more than 80% of the time.
The management system is the support process for frontline workers solving problems daily. There are several components described in the above article. This system has been so successful that the Center has begun to train external mangers and executives as well. Kim is the architect behind developing this training as well as one of the teachers. It is taught similarly to how ThedaCare trains it’s own managers.
Congratulations to Kim Barnas on her appointment, read the following article for more details – 01-barnas_387-399
Don Berwick’s tenure as CMS administrator was short but one thing he came away with was the fact that American healthcare must become radically more efficient. He called out a few high performers. “If you doubt that we know what to do, visit Denver Health or ThedaCare or Virginia Mason, and see the Toyota principles of lean production learned, mastered, adapted, and deployed through entire systems and into the skills and psyches of entire workforces.”
Don recognizes lean delivers better value to customers but value is determined by customers and in this case the customer is our patient.“But, I am not going to apologize. That’s because if you are a student of lean thinking or quality, itself – if you have taken the time to study the work of Noriaki Kano, or Jim Womack, or Taichi Ohno, or Dr.Deming, you know that great leverage in cost reduction comes directly – powerfully – exactly from focusing on meeting the needs of the person you serve. “Waste” is actually just a word that means, “Not helpful.” So, that initial wave of reaction – “Who wants to work on efficiency” – is actually off the mark. In very large measure, improving care and reducing waste are one and the same thing.”
But here is something I don’t agree with in the speech. “I would go so far as to say that, for the next three to five years at least, the credibility and leverage of the quality movement will rise or fall on its success in reducing the cost of health care – and, harder, returning that money to other uses – while improving patient experience. “Value” improvement won’t be enough. It will take cost reduction to capture the flag. Otherwise, “cutting” wins”.
My disagreement is that quality and cost are fundamentally connected. The lean methodology focuses on eliminating waste which improves quality and lowers cost at the same time. We absolutely need to deliver better value(Q/C) to our customers. Isn’t it about time the healthcare industry embraces the lean methodology so we don’t resort to “cutting wins”.
This article describes why ThedaCare and Bellin Health in Green Bay have decided to participate in the pioneer ACO program. The bottom line is these organizations believe they need to provide leadership for the rest of country on lowering cost and improving quality. This is something they have been focused on for years anyway and now will take it to a formal level for 23000 Medicare beneficiaries.
Thank you Don for trying, it’s too bad politicians never understood the value you bring to the administrator position at CMS. It’s remarkable how a few comments over an entire career can be misinterpreted by people who never go to the gemba to find out the truth.
Thanks for your sacrifice leaving IHI and your family to spend many of your days with government lawyers and accountants but staying optimistic and focused on doing the right thing. On the other hand, look what you accomplished. A new division of medicare focused on running the right experiments in payment and transparency to change the industry. A new set of insurance exchanges. A big improvement in the original regulations regarding ACOs and primary care payments. There are many other things too.Maybe the biggest of which is helping to change the culture of CMS to one of improvement. It’s too early to tell whether it will stick but it’s the right idea and we will need to achieve savings soon.
We wish you the best in the future.
Don and I chatted for a few minutes at the IHI forum, I’m happy to report he looked relaxed and satisfied. He should be.
CMS has changed a number of rules regarding data release.There are still many problems and concerns from the perspective of the leadership of the Wisconsin Health Information organization which is the All Payer Claims Data Base created for Wisconsin. These problems,unless corrected, may not allow for significant intergration of the Medicare data with other claims data and may not allow for physician performance to be compared on key cost and quality attributes.
Overall, we believe this rule makes some minor improvements and responds to some of the concerns that WHIO expressed in its comment letter. However, major barriers exist in this program to accessing Medicare data in a way that is useful for WHIO and the other all-payer claims databases (APCDs). Specifically, the restrictions on downstream disclosures that remain in the Final Rule are particularly problematic in permitting the database search function and individualized reports for subscribers. In addition, much of the program rigidity in terms of prior approval of measures and methodologies are maintained. These and other primary concerns are described in greater detail below.
Primary Concerns:
Inability for APCDs to use Medicare data for subscriber reports. Our primary concern with the proposed rule was whether the Medicare data released under this program could be integrated and used consistent with the APCD business model (meaning subscribers could search the database and develop tailored reports). The final rule makes no improvements in this regard. In fact, the final rule states at page 4 that although commenters requested that qualified entities be able to use the Medicare data for other purposes, in CMS’ view, the Affordable Care Act bars the re-use of Medicare claims data for purposes other than the performance reports on providers and suppliers. The final rule provides that Medicare data cannot be used for any purpose other than to produce the prototype reports that have been previously approved by CMS.
Program costs and resource investment. The three years of data would cost approximately $104,000. Note this does not encompass any cost associated with formatting the data for WHIO use.
Obtaining Data. CMS estimates that it would cost $40,000 for the first year of the program and $32,000 for each subsequent year of the program (down from an estimated $200,000 per year in the proposed rule).
Formatting data and creating reports. We anticipate, based on the rule, that the data will need to be formatted from CMS format to WHIO format. CMS estimates that the QE will spend 5,500 hours processing the data and creating reports.
Applications. CMS estimates that the initial application process will take each applicant an average of 500 hours per applicant at an estimated cost of $23,102. Re-application is estimated to take 120 hours at a cost of $5,544.
Monitoring Reports. CMS requires that QEs submit annual reports to CMS as part of CMS’ ongoing monitoring of qualified entity activities. The total estimated burden associated with this requirement is 150 hours at $6,819.
Financing mechanisms. CMS states in the final rule that QEs may not charge providers or suppliers for the confidential copies of the pre-publication reports that QEs are required to provide in advance of publication. QEs must make the required public reports available free of charge.
Rigidity of the requirements relating to submitting and updating prototype reports. WHIO had expressed concerns that the requirements relating to specifying the measures set in the prototype report and CMS approval for subsequent changes to measures sets was too rigid. Although the final rule contains some minor modifications, we believe the final rule maintains the basic problem of a rigid structure that would inhibit the APCD’s ability to rapidly respond to the evolving needs of health care providers.
Provider review prior to public release of report. The final rule maintains the requirement from the proposed rule that providers and suppliers be afforded an opportunity to review the QE’s measures, methodologies, and results at least 60 days before the report is made public. A QE must allow providers and suppliers the opportunity to request the data or request error corrections within a specific timeframe. CMS requires that the measures be publicly reported on the stated date whether or not appeals have been resolved.
CMS estimates 5,000 hours for handling provider appeals for data or measurement correction in year 1.
Data Use Agreement (DUA). CMS indicates that it will use the current research data use agreement (DUA) for this program but will use the “addendum feature” provided in that DUA to address the specific needs of the Medicare data sharing program. We remain concerned that this DUA will not be flexible enough to accommodate the business needs of APCDs.
Areas of Improvement or Change from Proposed Rule:
Beneficiary Crosswalk. In the proposed rule, CMS considered potential options for sharing beneficiary identifiers with qualified entities. CMS acknowledges the need for qualified entities to match private payer claims data and Medicare claims data for the same patient. In the final rule, CMS states that it will adopt the policy of automatically releasing a crosswalk file with appropriate privacy and security protections linking the encrypted ID to both the beneficiary name and the beneficiary Medicare HICN to all qualified entities. This is minimally sufficient but better than none at all.
Timeliness of data. CMS proposed providing QEs with the most recent three calendar years of Medicare data available at the time the QE is approved for participation in the program. WHIO commented that data must be much timelier in order to be useful. CMS amends its proposal to make more timely data available to QEs. CMS will provide the most recent available historical data. For QEs approved at the beginning of the program, CMS expects this to include CY 2009, CY 2010 and the first two quarters of 2011. CMS will provide quarterly data updates on a rolling basis.
Availability of nationwide data set. CMS clarifies in the final rule that nationwide data access would be provided as long as the QE can produce a sufficient data set from other claims sources.
Application deadline. In its comments, WHIO had expressed concerns about the feasibility of a March 31, 2012 application deadline. In the final rule, CMS changes this requirement and implements a rolling, electronic application process.
Provider matching. Provider matching will be possible via the NPI. This will be less effective on older data but improve over time.
Practical Considerations for WHIO Business Model:
WHIO (the QE) will need to produce the reports and share them publicly (with everyone – not just members). It may be possible to somehow apply jointly as a QE with all WHIO members and subscribers listed as contractors for reporting purposes however I do not think this is within the spirit of the rules.
Any organization currently working with a physical copy of the data set (WMS or Thedacare for example) could not receive a copy of the data mart that included Medicare claims. It would seem inadvisable (cost wise as well as administratively) and confusing to have multiple versions of the data mart in distribution.
Member matching and provider matching will not be as high quality when incorporating the Medicare data as we currently achieve with Commercial and Medicaid data because the amount of individually identifiable information about each beneficiary or provided is limited.
Public reports can be used to design payment reform initiatives or tiered networks, if we obtain approval for and develop the right set of public reports.
It seems there is much more to be done with CMS if this data will be meaningful to anyone let alone individual patients.Read the CMS release from December 5th below.
A billion dollars will be awarded in grants open to providers,payers,local government,public-private partnerships,and multi-payer collaboratives.
Yesterday, the Innovation Center announced the Health Care Innovation Challenge. On the call, ThedaCare was mentioned by Dr. Gilfillin as an example of an innovative organization.
This new program will award up to a total of $1 billion in grants to applicants who implement new ideas to achieve the three part aim for people enrolled in Medicare, Medicaid and CHIP, particularly those with the highest health care needs.
Proposals submitted should include three elements: (1) workforce development and deployment; (2) speed to implementation (must be operational or capable of rapid expansion within 6 months) and (3) model sustainability. Awards will range from $1 million to $30 million for a three-year period. Applications are open to providers, payers, local government, public-private partnerships, and multi-payer collaborative.
Important Dates:
Informational webinar on November 17th at 2:00 to 3:30 ET. A link to the webinar is available on the Innovation Center website (provided below)
Letter of intent due December 19th
Applications due January 27, 2012
Anticipated award date for the first round of grants is March 30, 2012.
The Innovation Center hosted a stakeholder call to announce the new program and answer stakeholder questions. Dr. Gilfillan began by saying the Innovation Center is looking for partners in the private sector to engage in, identify and test new care delivery and payment models developed in the field, new models of workforce development and deployment, and support innovators through expansions of existing efforts or rapidly deploying new efforts.
Dr. Gilfillan commented that high-cost, high-risk groups should be the focus of the applications and that the Innovation Center is looking for applicants that will engage a broad set of partners. Dr. Gilfillan stated that every project will have to demonstrate how it will meet the three part aim of better health, better care and lowering cost. The line was then opened for questions.
Questions and Answers
Q: Is there a role for states in this solicitation?
A: Generally, this initiative is targeted to other awardees, rather than states. But, there may be an instance in which a particular applicant has state agency as part of what they are doing.
Q: Are QIOs eligible to partner in this collaboration?
A: Conceivably yes, QIOs are not excluded.
Q: Is the technical assistance likely to include analysis of Medicare data in as close as possible to real time?
A: The Innovation Center recognizes the importance of providing claims information as rapidly as possible and looking for proposals that include a description of an approach with Medicare claims data. CMMI is open to it and recognizes the value of it and the specifics of ability of organization to use the data will vary and will be evaluated as part of overall evaluation of proposals.
Q: If a hospital participates in another demonstration program, are they excluded from this one?
A: Not necessarily. There may be some overlap depending on the specific proposal – the fact of participation in another Innovation Center program does not disqualify an entity from participation. However, the Innovation Center is not looking to duplicate efforts, so would likely not pick a project for an alternative ACO, medical home or bundled payment.
Q: What is the relationship between this initiative and Partnership for Patients?
A: The Partnership for Patients program has a variety of operating activities that are coming online on either care transitions or patient safety. The Innovation Center is not looking to duplicate those activities, but there may be some proposals that have an impact on patient safety that CMMI would evaluate for the criteria in the funding announcement to decide if there is additional value added.
Q: Will there be a second round of funding?
A: No. There will be $1 billion dispersed over two grant cycles. The second cycle will be later in 2012.
Q: How would such a project be sustainable in the future?
A: The Innovation Center intends for this approach to give people the opportunity to create a model that demonstrates long-term sustainability so that over the course of the 2-3 years of support through this program, they can build the case that their activity adds value. Then down the road, the project could attract an ongoing supportive mechanism through a commercial payer, Medicare, or Medicaid.
Q: The funding announcement focuses on populations with highest health care needs, which are those?
A: Some examples might include individuals with multiple disabilities or rural communities that provide care coordination and community based care specific to a rural setting.
Q: Are cities and counties disqualified or discouraged from participating?
A: No, they are not discouraged from participating.
Q: Can multiple applications come from same institution?
A: Yes.
Q: How will applications be reviewed?
A: Independent review panels will look at the applications and score against criteria in the announcement. CMS will review the high scorers and determine awardees.
Q: Is there capacity for smaller projects?
A: The Innovation Center is not closed off to the idea of considering smaller projects, but cannot support an infinite number of small projects.
Q: Are small startup companies eligible to apply?
A: This program is not specifically a venture capital for private sector startups. But the Innovation Center is interested in ideas that are presented and will review all applications based on criteria in the funding announcement.
Q: Are HMO patients eligible for this type of innovation?
A: The Innovation Center is charged with addressing Medicare, Medicaid and CHIP populations. However, the Innovation Center will be looking for organizations that have track record of success with these kinds of initiatives in other populations, including HMO patients.
Q: Can we use the grant to broaden base of a new Independence at Home organization?
A: The Innovation Center would look at a proposal and see what it entails. It is not the Innovation Center’s intent to duplicate other programs in place, so we would have to be convinced that it is something beyond what we expect from Independence at Home demonstration
An article released November 9th compared the U.S. to 10 other countries and found that care is more costly and not as good as most of the comparison countries
The United States ranks near the bottom of many measures in caring for the sickest patients compared to other nations, according to a study of 11 economically advanced countries released 11/09/11 by the Commonwealth Fund.
This work was published on the Health Affairs website and was based on patient reported data regarding their care.
American patients bear much more cost than in the other countries. 42% of seriuosly ill patients say they skipped care because of cost.
One of the most alarming results was the United States had one of the worst track records on medical errors. Twenty-two percent of seriously ill patients reported experiencing an error with their care, medication or a lab test in the past two years. Only Norway did worse, with 25 percent of patients reporting medical errors.
On this blog we have reported a study done by Health and Human Serices showing at least 15000 Medicare patients die of iatrogenic(caregiver induced injuries) every month. This patient reported data is actually consistent,therefore, with what this and other studies have found.
The above is all the more reason that we must transform the healthcare industry in this country. As I have outlined in a new book which will be released in January entitled Lifeline: a Collaborative Cure for Healthcare, the focus of the industry should be placed on three key components. They are care delivery redesign to reduce errors and cost, payment systems that reward value(Q/C), and transparency of healthcare performance data so patients can make informed choices. This suggestion is not based on esoteric theory but on real experience in Wisconsin and the remarkable results the payer,provider,government, and employer communities have achieved with these approaches.
CMS released the final ACO rule on 10/20/11. The following is a summary of the conference call CMS held and the documents that were released regarding the final rule.
MedPak, the committee which recommends Medicare payment changes to Congres has recently suggested that in order to move more providers off of fee for service there may need to be bigger fee for service cuts in payments to physicians and hospitals. That’s why this recent final rule on ACOs and medicare shared savings is important as it may be the beginning of the new payment system in American healthcare. In following blogs we will be addressing the Physician Self Referral law and anti-trust regulations associated with ACOs.
The following is a summary of the call Dr. Berwick led on 10/2011.
“CMS Administrator Dr. Donald Berwick gave opening remarks highlighting the importance of the ACO program. He stated that ACOs represent a major step forward in transforming not only Medicare but Medicaid, CHIP and the entire health care system.
Dr. Rick Gilfillan, Acting Director of the CMMI, then introduced the ACO Advance Payment Model. He stated that the model will help support shared savings ACOs with up front investments. The program will provide payment in advance, which will be recouped as the ACO achieves shared savings. This is intended to provide an “on-ramp” for organizations that want to achieve the three part aim. Dr. Gilfillan stated that through the shared savings program, advance payment model, pioneer program and accelerated learning sessions, CMS is seeking to meet providers where they are in terms of their ability to deliver safe, seamless care.
Jonathan Blum, Deputy Administrator and Director of the Center for Medicare, then described a high level overview of the changes in the final rule. He stated that the agency sought to make a stronger business case for organizations to participate in the program. He stated that there are still two tracks, but track one now has only one-sided risk while a second track has two-sided risk. He said that combined with the Pioneer program, these options create multiple opportunities for participation. He stated that they have scaled back the quality measures in response to comments and have selected 33 key quality measures for organizations to focus on. CMS has changed the rules for governance to provide more flexible governing structures. The final rule will allow services provided by FQHCs to count for beneficiary assignment to give those organizations the opportunity to participate. He stated that there is a more flexible beneficiary assignment process and what he called “preliminary prospective assignment” that seeks to strike a balance between providing information up front, protecting beneficiaries, and not holding an organization responsible for care when the beneficiary is no longer receiving care from that organization. He said that they are providing more up to date Part A, Part B and Part D claims information while maintaining patient privacy.
The call was then opened for questions and answers.
Q: If a primary care physician (PCP) is on staff at two hospitals and invited by both to participate in their ACOs, can the PCP participate in both?
A: Yes, a PCP could participate in more than one ACO under the assignment methodology in the final rule. The assignment algorithm looks at Medicare-enrolled TINs that bill Medicare. The TINs that join together to create an ACO and those that bill primary care services must be exclusive to single Medicare shared savings ACO. As a practitioner that bills through a TIN, it’s the one with the ACO that has to be exclusive.
Q: When will patients receive care in ACO?
A: CMS will begin receiving applications on January 1. The first start dates for the shared savings program are April 1 and July 1. Pioneer ACOs will be announced later this fall. CMS anticipates that new ACOs will join the program in years to come.
Q: Can a subset of PCPs in a large group participate or is it all or nothing for the group in terms of participation?
A: All or nothing. Physicians are assigned to the ACO as a TIN, so the entire TIN has to participate.
Q: With regards to proposed quality measures, must we achieve all 33 to receive funding?
A: CMS is finalizing 33 measures, including clinical outcome and process measures. ACOs will be required to report on all measures each year. However, the measures are phased in over the 3-year period. In performance year 1, the quality requirement is satisfied by complete and accurate reporting of all measures. In subsequent years, quality requirements are phased in to performance on tiered basis.
Q: Can an organization participate in the bundling pilot and shared savings ACO? And if so, how does the discount in bundling initiative apply?
A: CMS expects that organizations may participate in both and will make adjustments to prevent giving double credit for the same patients. More specifics will be forthcoming.
Q: Why is home health excluded from the ACO program?
A: Any Medicare supplier can choose to participate within an ACO, issue is what counts for assignment or how CMS assigns patients to an ACO. However, we hope that ACO participating providers build stronger networks and processes for post acute care and creates opportunities for home health and other services”.
To read more about the ACO rule, please click here – 2011-27461_PI (2)
Today the Innovation Center announced a new initiative – the Innovation Advisors Program. Innovation Advisors will support the Innovation Center in testing new models of care delivery, use their knowledge and skills in their organization in pursuing the three-part aim, work with local organizations and groups to drive delivery system reforms, and gather new ideas for possible testing or diffusion by the Innovation Center. The Innovation Advisors Program consists of face-to-face national and regional meetings, training sessions, seminars, presentations by subject matter experts and individual coaching. A fellowship stipend of up to $20,000 is available to support the activities of individuals selected for the program.
Further details were provided on a conference call hosted by the Innovation Center earlier today. A summary of that call is provided below.
Acting Administrator Berwick provided opening remarks stating that the Innovation Center hopes to engage as many as 200 people across the country in the next year to 18 months to participate as Innovation Advisors. Dr. Berwick stated that the Innovation Advisors will become leaders of national change.
Joe McCannon then summarized the Innovation Advisors program. He said that committed leadership, thoughtful management, and hard work are necessary components to developing the type of change the Innovation Center hopes to achieve. He said that although the Innovation Center can set a theme for change with initiatives and regulations, implementation requires local knowledge. Therefore, the Innovation Center has to invest in skills and capabilities at the local level to stimulate transformation.
Individuals selected to participate in the Innovation Advisors Program will participate in an intensive 6-month orientation phase. During this time, the Innovation Center will assist the Innovation Advisors in developing skill sets in various areas, including: health care financing, economics, public health, systems analysis, process analysis, dynamics of local systems, operations research, and spread of behavior change. Mr. McCannon stated that the Innovation Center hopes that the Innovation Advisors will then support the Innovation Center by bringing improvements and innovations to their home organizations and bringing ideas from their home organizations to the Innovation Center for potential testing.
Teresa Titus-Howard then spoke more specifically about the application process. Ms. Titus-Howard stated that applicants may include any professional employed by a public health or health care facility, institution or department. She said that applicants can be doctors, nurses, allied health professionals or non-clinicians. She said that the Innovation Center is looking for applicants with career achievements and pre-existing skill sets that show their ability to transform the delivery system. The Innovation Center will also look at what the home organization is doing to meet the three part aim. In addition, the home organization’s commitment to this process will be considered as part of the application.
Applications are due by November 15th. The Innovation Center anticipates that it will have selected participants by mid-December. The first meeting of the Innovation Advisors is anticipated to occur in January 2012.
For specific questions about eligibility, interested organizations were encouraged to send an email to iap@orau.org.
