An Open Letter To Donald Berwick, CMS Administrator

August 4, 2011

Donald Berwick, MD, MPH
Administrator
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
Room 445–G, Hubert H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201

RE: Availability of Medicare Data for Performance Measurement Proposed Rule http://www.ofr.gov/OFRUpload/OFRData/2011-14003_PI.pdf Medicare data for performance measurement regulation, as created by Section 3001(a) of the Patient Protection Affordable Care Act (PPACA).

Dear Dr. Berwick:

The Niagara Health Quality Coalition (NHQC) appreciates the opportunity to submit comments regarding the above referenced proposed regulations intended to make Medicare more transparent about its dealings with providers, insurers and other stakeholders. In that context, NHQC feels it is important to be candid.

As currently drafted, CMS is proposing a regulatory Rube Goldberg machine to govern release of the CMS dataset. A Rube Goldberg machine is often defined as “a deliberately over-engineered machine that performs a very simple task in a very complex fashion.” The needless complexity of these proposed regulations limits transparency by artificially driving up the cost of obtaining the CMS data; and it puts a virtual stranglehold on using the CMS data effectively to improve quality and/or to inform the public debate about health care in this country.

NHQC believes that CMS data release can be accomplished with far less complexity, at a far lower cost, with far wider public access, and with much more respect for free speech and the scientific method. To that end, we are submitting specific problems and solutions to improve the draft regulations in this letter.

NHQC firmly believes that access to all payer and CMS “billing and discharge data” by a wide array of stakeholders is essential. The list of essential stakeholders includes but should not be limited to: 1) independent consumer groups, 2) media, 3) states, 4) industry-led collaborations like CVEs, 5) employer groups, 6) Medicare staff, and 7) others supporting the industry.

The Patient Protection and Affordable Care Act (PPACA), while flawed in its nearly complete abandonment of existing freedom of information laws as the proper way to disclose de-identified, patient-level “billing and discharge information”, still has the potential to take some important steps in the right direction in terms of improving informed free speech by increasing measurement, transparency and accountability for how CMS manages taxpayers’ money. Care must be taken; however, to ensure that final regulations governing release of the CMS data do not move transparency backwards inadvertently.

Background: Established in 1995, NHQC is recognized as one of the nation’s most effective health care consumer watchdog and policy research groups. NHQC also is a recognized national research leader in the science of measuring health care performance and public reporting. The cornerstone of our work is focused on ensuring an accessible, high quality health care delivery system and ensuring that access to “billing and discharge data/information” through existing, cherished freedom of information laws is not extinguished.

PROBLEMS/SOLUTIONS

Problem One: CMS’ proposed regulations attempt to exert undue and excessive and costly bureaucratic control over who can see the CMS data, and over how media, payers, providers, employers, consumers and others can measure health system performance. This will stultify much needed innovation in the industry and slow current progress toward higher quality more affordable care.

Solution One: We must allow innovation to flourish by crafting more modern regulations that are minimalist and respectful of citizens’ right to become informed about the operations of their own government programs.

Problem Two: The regulations do not put enough emphasis on continuously improving the robustness of the de-identified CMS databases.

Solution Two: [Examples] As the industry evolves, and as lines blur between providers and insurers (e.g., ACOs), we must ensure that identifiers for insurance companies, ACOs, medical homes, group practices, imaging centers, lab companies, etc., all remain (or become) linked to individual patients’ de-identified records, especially within the CMS’ billing and discharge dataset, which sets the standard for all of the states to follow. We also need an encrypted unique patient identifier that remains consistent across calendar and fiscal years so that we can evaluate quality and efficiency across a continuum of care over time (i.e., without putting patients unencrypted ID at risk). Also, CMS must – finally — adopt fundamentally lacking database normalization standards for every entity that bills or otherwise creates patient-level data for CMS. Every other industry employs database normalization standards in modern database design. Database normalization is more than 40 years old and should, I think, begin to be employed by CMS. For example, diagnosis and procedure codes should never be reused in a different context from year to year; and when the patients within a procedure or diagnosis code are changed, the change should be made to ensure a seamless crosswalk is possible and is made available.

Problem Three: Qualified entities will have to submit prototypes of their performance reports during the application process to obtain the Medicare data set. It is proposed that any changes to the reports must be approved by CMS before bringing those reports to market. History tells us that government-led public reporting programs are not as useful to consumers because they are complicated by politics and subject to regulatory capture. For example, Hospital Compare does not effectively delineate performance variation between institutions and it was years behind NHQC in publishing results rather than effort measures. This limits the utility of sites for all stakeholders; hospitals can’t tell if they are performing better than their peers, employers can’t leverage the information in their contracting process, and consumers can’t use the information to inform their care decisions, etc.

Solution Three: CMS should give data users all possible discretion allowed in the law over what types of performance reports qualified entities are allowed to publish using the Medicare claims data. Note: NHQC acknowledges the potential to pursue a nationally standardized core-set of nearly perfect measures as part evaluating healthcare in the future. However, the illusive promise of such an ideal core-set in the future must not be used as a weapon by industry or government insiders to evade scrutiny using measures and data that are perfectly adequate for that purpose and available right now.

Problem Four: The proposed measure-appeals process will stifle innovation by driving up the cost for organizations bringing new measures to market. CMS estimates that it will take an organization 2,100 hours to propose an alternative performance measure. At an estimated average cost of $60 per hour, organizations will face an additional cost of $126,000 to apply for permission to use a measure not specified in the regulation. And after spending an estimated $126,000 to apply, there is no guarantee.

The federal government could, at its discretion, choose to deny the entity permission to disclose its findings to consumers, if for example providers object to being measured in a new way.

Solution Four: Weaken this provision to the fullest extent allowed in the law.

Problem Five: The requirement that applicant entities have at least three years experience will artificially limit access to the data. Worse, it will keep people with new ideas from participating in the research or in informed public speech about health care.

Solution Five: CMS should soften its interpretation of this part of the law.

Problem Six: The statute requires qualified entities to combine the Medicare claims data with “other claims data” for purposes of reporting; however, the regulations give government bureaucrats too much discretion to determine who qualifies under this requirement. This could result in some special interests exerting undue control over which entities are allowed to obtain the CMS datasets. For example, the Chartered Value Exchange program has defined “additional claims data” needed to retain their charter  designation narrowly as being comprised only of ‘claims data that is voluntarily shared with the CVE by the private insurance companies.’ This absurdly narrow interpretation of “other claims data” should not be used for release of the CMS data because it is so limiting in terms of transparency that the health insurance industry gains absolute control over what can be measured and even over who can see the federal data needed to evaluate performance by providers, insurers and the government.

Solution Six: Regulations must clearly delineate all of the potential sources of “other claims data” that will meet this requirement. Data that should be defined as “qualifying” should include, but should not be limited to, states’ claims data, individual employers’ claims data, business coalition claims data, patient experiences of care data that report experiences for recent claims, lab data, imaging data, pharmaceutical data, etc., etc. CMS data is adequately robust for many important types of public reporting without combining it with any other databases, so this entire provision should be treated as a special-interested-created barrier in the legislation that is intended only to limit transparency to “trusted” entities. Thus, the impact of this provision in the law should be minimized to the greatest extent possible in the regulations.

Problem Seven: CMS is required by law to provide the data set in a cost-neutral way — that is, at the all-in cost of administering the proposed regulations as well as the cost of bringing the data to market.

In theory, this requirement presents no inherent barrier to transparency because copying the entire CMS de-identified database could cost no more than $25.00 for an entire year of nationwide data including staff time. However, the cost of these proposed regulations is anticipated to skyrocket what should be a nominal cost of obtaining one-year of CMS data to stratospheric levels (estimated by CMS itself at approximately $200,000 annually).

Solution Seven: CMS should redesign the administrative burden of its own regulations so as to bring the cost of obtaining one year of data in line with what other government agencies charge to copy large government data sets for citizens (i.e., CMS’ goal should be to match the cost of accessing the census data which is less than $2,000 for one calendar year of the entire national data set. The MedPar database costs about $5,000.)

Summary:
Participating in informed free speech should not cost $200,000 per year; and should not be subject to such an onerous regulatory stranglehold by the very government and industry special interests that need to be measured, understood and discussed. These CMS data are the only way for citizens to evaluate the quality and cost effectiveness of government funded services from providers, insurance companies, government bureaucrats, law enforcement, and fraud prevention stakeholders, to name a few.

In the end, I believe the Niagara Health Quality Coalition should be CMS’ canary in the coal mine. If we qualify for and can afford to fund ongoing access to the CMS data for reasonably unfettered use in publishing our independent report cards for consumers and the media, then the regulations have been repaired enough to work.

Feel free to call me with any questions or if I can assist in any way further. CMS has an awesome responsibility in repairing these draft regulations; and I am hopeful CMS will succeed primarily because CMS has never, never had better leadership.

Sincerely,

Bruce Boissonnault

President and CEO

Niagara Health Quality Coaliton

Amherst, NY

About Brian Klepper

Brian Klepper is a health care analyst and the Chief Development Officer of WeCare TLC onsite clinics.
This entry was posted in Analytics, Consumerism, Innovation, Policy/Law/Regulation, Quality, Reform, Tools and tagged , , , . Bookmark the permalink.

One Response to An Open Letter To Donald Berwick, CMS Administrator

  1. Pingback: The Tug-of-War Over Health Care Data | Care And Cost

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