May 30, 2016,
Dear Mr. Slavitt, Acting CMS Administrator,
I submit my 8th dissent to the CMS proposed MACRA rule on Memorial Day. Those who made the ultimate sacrifice for their country deserve our strength and courage to stand against an increasingly overbearing government that is intent on commandeering our blessings of liberty. Your proposed rule makes it crystal clear that MACRA must be repealed, as it possesses trap doors that pave the way for flagrant violations of individual human rights and the Fourth Amendment of the United States Constitution.
The Center for Medicare and Medicaid Services (CMS), an agency of the Department of Health and Human Services (HHS), has been expanding scope and strength of power on an unprecedented scale since passage of the HITECH Act (Health Information Technology for Economic and Clinical Health), hidden deep in the hastily passed American Reinvestment and Recovery Act of 2009. The Office of the National Coordinator for Health Information Technology (ONC) is becoming increasingly powerful and threatening under the HITECH Act and the Affordable Care Act (ACA) of 2010. MACRA, passed in 2015, under your proposed rule would propel the power of HHS, ONC, CMS, and numerous other Departments and agencies of the Executive Branch of the U.S. government to a level that shatters the system of checks and balances and collapses the balance of powers between the Executive, Legislative, and Judicial branches of government as established in the Constitution. Here is how the MACRA proposed rule enables CMS,ONC,HHS, and others to work in tandem to achieve such unprecedented and irreparable damage.
- The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was passed in the wake of the defeat of Hillarycare. HIPAA defines protected health information (PHI). PHI includes individually identifiable demographics, all physical and mental health information past, present, and future, including all treatment and medications and more.
- The ONC under HITECH creates ONC-ACBS (Office of the National Coordinator for Health Information Technology- Authorized Certification Bodies).
- MACRA creates the Merit Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). MACRA also creates the Composite Performance Score (CPS), which is a grade from 0 to 100 given to each physician and eligible clinician (EC) by the Secretary of HHS for reporting their patient data to her in four performance categories. Physicians and ECs are then rewarded or penalized monetarily based on their compliance with the desired government metric.
- ONC published the 2015 Edition Health Information Technology Health IT Certification Criteria, 2015 Edition Base EHR Definition, and ONC Health IT Certification Program Modifications final rule. The final rule made changes to the ONC Health IT Certification Program that strengthens the testing, certification, and surveillance of Health IT. The final rule clarified and expanded the responsibilities of ONC-ACBs with respect to the surveillance of certified EHR technology and other health IT under the ONC Health IT Certification Program, including requirements for ONC-ACBs to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in-the field.” The purpose of in-the-field surveillance is to provide greater assurance that health IT meets requirements not only in a controlled setting but also when used by health care providers in actual production environments (page 33/625).
- ONC published ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule, which expands ONC’s role to strengthen oversight under ONC by providing a means for ONC to directly review and evaluate the performance of certified health IT.
- The proposed MACRA rule on page 33/625 proposes to require all eligible professionals (this includes everyone from physicians, PAs, CRNA’s, Nurse Practitioners, Clinical Nurse Specialists, Nurse Midwives, Speech Pathologists, Audiologists, Physical and Occupational Therapists, Dieticians, and so forth), Eligible hospitals, and critical access hospitals to attest that they have cooperated with the surveillance of certified EHR (electronic health records) under the ONC Health IT Certification Program. The rule further requires such attestation from all eligible clinicians under the advancing care information performance category of MIPS and as part of an APM Entity group under the APM scoring standard. Page 34 of the proposed MACRA rule requires eligible professionals and hospitals to be actively engaged with the authorized surveillance and oversight of their technology, including by granting access to and assisting ONC and ONC-ACBs to observe the performance of production systems.
- Page 35 requires cooperation with in-the–field surveillance prioritizing time and other resources in response to the conduction of randomized surveillance at a location chosen by the ONC-ACB.
- This is the worst, in ultimate irony, The ONC clarified, in consultation with the Office of Civil Rights, that ONC-ACBs engaging in authorized surveillance of certified EHR technology under the ONC Health IT Certification Program meet the definition of a “health oversight agency” in the HIPAA Privacy Rule and as such a health care provider is permitted to disclose protected health information (PHI) without patient authorization and without a business associate agreement) to an ONC-ACB.
- MACRA creates the Composite Performance Score (CPS) whereby government will grade physicians based on their Certified EHR transmission of patient data in 4 performance categories: quality, clinical improvement activities, resource use, and advancing care information (MU-CEHRT). Physicians will be rewarded on a sliding scale with a 10% increased pay or penalized with a 9% decrease in pay based on how well they report the patient data the government wants from them. Scores will be posted publicly on the CMS website to glorify compliant physician data collector/reporters and disparage/humiliate non-compliers. After a few short years of a compounded 19% government-imposed pay disparity between complying and noncomplying physicians, non-compliers will be forced out of business and government will be left with a select group of compliant, beholden data-gathering/reporting physicians going forward.
- The MACRA Rule creates multiple intermediary entities, such as Qualified Clinical Data Registries (QCDRs), that will collect data from physicians and report it to CMS. These entities can collect additional data, called non-MIPS data on all patients, and government can get access to this data. CMS will give Clinical Performance Scores based on MIPS data and can sell the MIPS data as well as non-MIPS data to outside entities.
- MACRA establishes the ALL-Payer Combination Option that applies the data collection to all payers, not just Medicare, including commercial payers. Physicians must report on 90% of their patients in the quality category to qualify for points for their Composite performance score.
- Per the proposed CMS MACRA rule, the Clinical Practice Improvement Activities Category proposes activities for which physicians can be scored and rewarded under a subcategory called “population management” including “participation in QCDRs, clinical data registries, or other registries run by other government agencies such as FDA or private entities such as a hospital or medical or surgical society”(page 613/625). Under the subcategory “Patient Safety and Practice Assessment,” physicians are rewarded for participation in Maintenance of Certification Part IV for improving professional practice including participation in a local, regional or national outcomes registry or quality assessment program (page 621/625). Under the subcategory “Integrated Behavioral an Mental Health”, for “use of a registry or certified health information technology functionality to support active care management and outreach to patients in treatment…” and “Enhancements to an Electronic health record to capture additional data on behavioral health populations and use that data for additional decision-making purposes (e.g., capture of additional behavioral health data results in additional depression screening for at-risk patients not previously identified)” (page 625/625), physicians will receive points toward a better CPS for greater pay.
So, to connect the dots, the Executive branch via massive self-anointed authority and self-granted expansion of power undertakes data collection from all patients in the United States of all their protected health information without their authorization and rewards the nation’s physicians, healthcare providers, and hospitals with money for collecting and reporting this data, including data registries that the government can use for whatever purposes it sees fit. That this rule incentivizes physicians to create data registries based on their patient’s protected health information and transmit this data via bidirectional, interoperable, unblocked health IT to CMS is beyond unethical, changes intent of the law, grants unauthorized powers to CMS, and violates the 4th Amendment. The potential for malfeasance and abuse of the people by the federal government under such a scenario constitutes what could only be seen in a totalitarian state and constitutes outright tyranny if allowed to stand under the auspices of the Constitution of the U.S. I never fathomed I would see anything like this in my lifetime, and I will never comply. I will not disclose my patient’ protected health information to agents of government who can potentially target and harm them based on my unethical disclosure.
We must be strong and courageous and do what’s right, even if it is hard. The MACRA rule will force noncompliant physicians out of business, but we must risk our livelihood if we hope to salvage the lives and liberties of our patients. This is the least we can do on this Memorial Day as we remember those who risked it all and gave it all.
The proposed MACRA rule must not stand and MACRA must be repealed.
Kris Held, MD.
Addendum: Please refer to Daily Dissent 6 that points out CMS can audit the records at any time and requires physicians, EPs and data registries to keep all records for a minimum of 10 years, if not a lifetime in selected cases.