Monday, May 23, 2016
Dear CMS Acting Administrator Mr. Andy Slavitt,
My daily dissent focuses today on C. 2. Meaningful Use Prevention of Information Blocking and Surveillance Demonstrations for MIPS Eligible Clinicians, EPs, Eligible Hospitals, and CAHs, found on pages 33 to 37 of the MACRA proposed rule as published in The Federal Register on May 9, 2016.
The proposed rule for prevention of information blocking and surveillance applies to all MIPS Eligible Clinicians (this definition includes physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians), EPs (this definition-according to the SSA as amended by MACRA last year-includes all EC’s, a certified nurse-midwife, a clinical social worker, a clinical psychologist, a registered dietician or nutritional professional, a physical or occupational therapist or a qualified speech-language pathologist, a qualified audiologist), eligible hospitals, and critical access hospitals: translation of rebranded terminology- this applies to virtually anyone and everyone. Of note, under section E. “The statute also provides flexibility to specify additional eligible clinicians in the third and subsequent years of MIPS”- and volunteers can participate with this. Such “flexibility” in who is required to cooperate with unblocked surveillance of other people’s private health information is dangerous and must be struck from the rule.
All of the entities I just listed are required to demonstrate to CMS that they cooperate with surveillance of certified EHR technology under the ONC (Office of the National Coordinator for Health Information Technology) Health IT Certification Program. These rules require attestation to surveillance of certified EHR technology under the MIPS performance category, “Advancing Care Information”, per your “rebranded key terminology” effort, whereby Meaningful Use Certified EHR is now Newspeakingly called “Advancing Care Information.” AND such attestation of cooperation with your surveillance will also include those who report as part of an APM Entity Group under the APM Scoring Standard. In summary, physicians (and virtually anyone who encounters anyone else) will be graded by you via a Composite Performance Score, which you will post on a public CMS website, and then apply a payment adjustment factor, based on your grade, for which you require cooperation with your surveillance. Those who cooperate and attest to cooperation with your unblocked surveillance of their Electronic Health Records will be graded highly and rewarded monetarily. Those who will not cooperate with your surveillance of their Electronic Health Records will be graded harshly and be penalized monetarily or worse. In fact, the first requirement for even being designated a Qualified Alternative Payment Entity or Model by you is using Certified EHR.
The ONC in its (2015 Edition final rule) expanded the responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) with respect to the surveillance of certified EHR technology and other health IT, including requirements for ONC-ACBs to conduct more frequent and more rigorous surveillance of certified technology and Capabilities “in the field”…not only in a controlled testing environment but also by health care providers in actual “production environments” AKA in doctors’ private offices and exam rooms, and so forth. And by your definition of production environment- could this government agency on-site surveillance practice be construed to include patients’ homes, where the interoperable, bidirectional, unblocked EHR that you require is used as well? The ONCs oversight role was expanded again March 2, 2016.
Your claim at the bottom of page 33 that stronger surveillance and oversight of Health IT including expanded in-the-field surveillance and ONC direct review is critical to the success of HHS programs and initiatives is precisely why these intrusive, Stalinist programs, initiatives, and rules must be struck down by the American people if we are to secure our blessings of liberty, upon which you so egregiously infringe. (1848 and 1886 of the SS Act must be scrutinized after you and fellow Executive Branch agency bureaucrats continue to tamper with the law in your overreaching rule making.)
On page 34 you make it necessary that we the people demonstrate to you, an agent of the federal government, that we are using certified EHR technologiy per your rules and that we engage with you and cooperate with authorized surveillance and oversight including granting access to and assisting ONC and ONC-ACBs to observe us using EHR in our offices and exam rooms and by your definition, perhaps even patient’s homes. And what is your definition of “assisting ONC and ONC-ACBs”? Does such assistance include flying your agents to our offices, feeding them, and housing them?
You propose that we must demonstrate cooperation with surveillance and oversight activities. You revise the definition of a Meaningful EHR user and attestation of cooperation requirements and apply this to requirements for the “Advancing Care Information” performance category, upon which you will grade us, post our scores, and either reward or punish us monetarily. So, we are coerced or bribed to allow you into our offices and homes, where we work as well, to view our patients’ private health information without their knowledge or consent. This is unethical and criminal.
Eligible Clinicians, Eligible Professionals, hospitals, and CAH’s must attest to cooperation with your surveillance and direct review- such cooperation includes responding in a “timely manner” to your requests, including ONC or ONC-ACBs access to our EHR technology and data stored in such certified EHR technology in-the-field, on-site ( our offices, exam rooms, and places of work, which may include our homes?) This first paragraph on page 35 is chilling.
In the very next paragraph you state ONC-ACBs will conduct randomized surveillance including that they can select the locations at which the surveillance will be performed. This is a “beyond concerning” rule: “Moreover, if an ONC-ACB makes a good faith effort but is unable to complete in-the -field surveillance at a particular location, it may exclude the location and substitute a different location for surveillance.” The potential for abuse here is beyond words.
The third paragraph on page 35 is the most overreaching, ironic, Orwellian, regressive thing I have read in the rule thus far: to paraphrase “we note that ONC has clarified, in consultation with the Office for Civil Rights, that ONC-ACB’s engaging in surveillance 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 OCB-ACB during the time and as necessary to perform the required on-site surveillance of the certified EHR technology. You request public comment on this, and I can fathom no individual living in the USA who would support such unprecedented legalization of allowing government agents to have unfettered access to our most private information, papers, and effects in our workplaces (and think about it, bidirectional use of EHR requires use by the patients in their homes- which is a “place of production” by your terms).
In this rule you are granting government access to patients private data without their knowledge or consent in their homes or doctors’ offices and exam rooms or any location you decide, and you justify this by saying you ran it by the Office for Civil Rights? This is truly astounding and a flagrant violation of the Fourth Amendment and our basic human rights. Will you and your agents look at our naked bodies in our homes if necessary to verify validity of your certified EHR documentation? Will you target us if we resist or based on our beliefs, donations, or your findings with respect to government’s determination of who can receive care and who should “allow natural Death?” There is no limit to the potential for abuse of power here.
I must go see my patients now. Tomorrow I will address your next requirement that we must attest we will not block your efforts to enter our EHR and take our data without the consent of our patients. I implore you to rethink what you are setting forth in these rules. You are changing the intent of the law and violating the Fourth Amendment and infringing on the life and liberty of the people. I implore the U.S. citizenry to dissent with massive opposition to this rule. The deadline is June 27, 2016.