Posted on May 18, 2016
I read the entire ACA in 2010, every word of MACRA last year, and the 962 pages of proposed MACRA rules over the last few weeks. The proposed rules are clearly Obama and Co.’s “Hail Mary” to get socialized medicine over the goal line (while we are distracted by a proxy issue of where people should urinate and defecate).
By the 2019 patient seeing/billing year, which determines physicians’ 2021 payment adjustment factors, the proposed rules allow CMS to expand this perverse, totalitarian system to a new “Other Payer Model” that will include Commercial insurance and combine it with Medicare data for the spanky-new “All-Payer System.” The proposed rule preamble informs us of the rule-makers’ effort to “rebrand key terminology”, such as renaming “Meaningful Use EHR”- “Advancing Care Information.” Clearly, the “All-Payer” System is Newspeak for “Single Payer.”
Further, the Orwellian Feds mandate bidirectional, interoperable, unblocked access to all Electronic Health Records and data, including access to individual private and identifiable patient data without patients’ permission “at all relevant times”, or there will be punishment. They will extract and sell data, engage in ongoing surveillance, and do continuous, random cyber as well as onsite audits. They create a whole new breed of intermediaries to do this, such as QCDR’s (qualified clinical data registries) and ONC-ACBs (Office of the National Coordinator for Health Information Technology-Authorized Certification Bodies). They will insert government’s untested practice guidelines. It is worse than ever imagined.
This paragraph, verbatim from the MACRA proposed rules, is chilling, “In addition, we note that ONC has clarified, in consultation with the Office for 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 (45 CFR 164.501), 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 during the limited time necessary for the ONC-ACB to perform the required on-site surveillance of the certified EHR technology (45 CFR 164.512(d)(1)(iii)) (80 FR 62716).” Read that again, slowly and thoughtfully, in the context of the current administration that crafted the rules. In the ultimate irony, the Office for Civil Rights authorizes the violation of “the right of the people to be secure in their persons, houses, papers, and effects against unreasonable searches and seizures…”, otherwise known as Amendment IV. of the Constitution of the United States. Perhaps, this is just part of the friendly “rebranding key terminology” initiative?
The rules are Stalinist at best. By what authority do they do these things?
This is why I opted out of Medicare and all commercial insurance and work solely for my patients creating a system whereby we can practice ethical, Hippocratic medicine that preserves the patient-physician relationship- a paradigm-shifting alternate universe-an underground railroad of medicine of sorts.
All physicians must stand up and refuse to enable the fundamental transformation and demise of American medicine via the MACRA proposed rules. There must be massive resistance and massive public outcry and comment to the rules.
Read and comment now. Please, go to this website, read this letter, share with all physicians and patients, and make comments on the CMS site regarding the intolerable MACRA proposed rules. Act now! http://www.npchcp.org/
Time is of the essence,
Kris Held, M.D.
Posted on May 23, 2016Sunday, May 22, 2016
Dear CMS Acting Administrator Andy Slavitt,
Thank you for the opportunity to voice my dissent regarding the proposed rule spawned from MACRA by the Center for Medicare and Medicaid Services and published in The Federal Register on 05/09/2016. I have read the ACA, MACRA, and MACRA proposed rule. Because the rule is extensive, my dissent is accordingly substantial. To be complete, my comments will be submitted in a series of submissions, my daily dissent, over the course of the next month prior to the deadline of 5 p.m. on June 27, 2016. To clarify, the initial document I downloaded from HHS/CMS and read was 962 pages, but my comments will refer to the document as published in The Federal Register on 05/09/2016 corresponding to numbers indicated in the right lower corner of each of 625 pages. The Table of Contents alone spans 12 pages. The rule does not reflect the stated intent of MACRA and represents brazen overreach by an Executive Branch agency including expansion of powers, changing the intent of the law, and violation of Constitutional rights of the people.
Your Executive Summary’s Purpose states on page 18 that you “rebranded key terminology.” Such Orwellian attempts at crafting current day Newspeak do not distract the people of the United States from recognizing inherent hazards of your goals of collecting the most intimate, private, personal details of our medical histories without our knowledge, consent, or authorization and forcing physicians under threat of penalty to disclose our patients’ protected health information to you in violation of our code of professional ethics using untested, unproven, unsecured, interoperable, bidirectional electronic health IT for surveillance, data collection, and use by the Secretary of Health and Human Services and her agents for whatever purposes she deems appropriate including selling the data to intermediary bodies of her own approval. The change of the name of this deplorable practice from “Meaningful-Use Electronic Health Records” to “Advancing Care Information” does not change the reality that this constitutes a violation of “the right of the people to be secure in their persons…papers, and effects against unreasonable searches and seizures…,” otherwise known as Amendment IV of The Constitution of the United States, and puts us at risk of targeting by agents of the Federal government in the fashion of the Internal Revenue Service under the direction of Lois Lerner, former director of the Tax Exempt Division at the IRS a few short years ago. Such illegal search and seizure of our private medical e-papers and effects and targeting of patients and physicians based on their medical data and disclosure thereof has the potential to result in loss of life and liberty in time as the government arrogation of medicine becomes the politicization and ultimately the weaponization of medicine.
The rule’s intentionally confusing terminology, methodology, and criteria for the “All-Payer Combination Option, based on the Medicare Option, as well as eligible clinician’s participation in Other Payer Advanced APMs” (Alternative Payment Models)- which includes commercial insurance- is not convoluted enough to hide the truth from the astute and vigilant American people that this rule sets forth the codification of single-payer, government run socialized medicine in the United States of America. No, we will not be fooled again by such games in the fashion of MIT economist Jonathan Gruber and his intentional misleading and mocking what he calls “the stupidity of the American voter” as he strategically crafted the ACA to “exploit the lack of economic knowledge” of the American people.
That the rule (page 23) aims to redistribute $833 million between 687,000 and 746,000 eligible clinicians in the MIPS system and between $146 million to $429 million to between 30,658 and 90,000 eligible clinicians in APMs in 2019 alone in order to “drive” government –directed changes (termed quality improvement) in provision of “care to Medicare beneficiaries and to all patients in the health care system” amounts to extortion of physicians and conscription of patients via expansion of MACRA rules from Medicare beneficiaries only to include “all patients” by the government in an unauthorized massive grab of power, money, and the lives of the American people.
MACRA was passed as a bipartisan bill and was sold as a repeal of the dreaded unworkable SGR, which it sunsets in Section 101, but this rule does vastly much more to expand the power of CMS and other Executive Branch Agencies and their control over all physicians (not just Medicare enrolled) and all patients (not just Medicare beneficiaries). The use of IT to achieve this end as proposed in this rule is chilling. My comments pertaining to this will follow in my next Daily Dissent.
Posted on May 23, 2016
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.
Posted on May 24, 2016
Tuesday, May 24, 2016
Dear CMS Acting Administrator Andy Slavitt,
The MACRA proposed rule requires extensive comment; therefore, I submit my daily dissent part three, focused on Pages 35-37. Section C (2)(b), Support for Health Information Exchange and the Prevention of Information Blocking, amends MACRA and requires that to be a meaningful use EHR user, an EP (Eligible Professional) must demonstrate to your agency that that he or she has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of your certified EHR technology. Your rules make corresponding amendments to MACRA applying this to hospitals and critical access hospitals as well. Your rules require us to make a three-part attestation:
- That we did not limit compatibility or interoperability of your certified EHR (AKA that we did not block you from getting into our system to steal our data or put yours in.)
- That we did implement technologies, standards, policies, practices, and agreements calculated to ensure that the certified EHR was at all relevant times connected (AKA whenever you want it) in accordance with applicable law, compliant with all standards applicable to the exchange of information, … and implemented in a manner that allowed for timely, secure, and trusted bi-directional exchange of electronic health information with patients, other health care providers, including unaffiliated providers, and with disparate certified EHR technology and vendors.
- That we respond in a timely manner to requests to retrieve or exchange electronic health information, including from patients, …and other persons, regardless of the requestor’s affiliation or technology vendor.
In other words, a doctor like me must sign documents promising to and then prove that I will grant interoperable, bidirectional exchange of my patients’ private data with any person, regardless of affiliation or technology vendor, to whom your agency says I must give the data. I must transmit this data quickly and must leave my system connected “at all relevant times”, in other words, whenever your agency wants access to the data.
First and foremost, I am a physician engaged in on-going, valid patient-physician relationships founded on the Hippocratic Oath of medical ethics and grounded in mutual trust. My duty is to my patients, not you and your overreaching executive branch agency. I have sworn an oath to keep my patients’ most private, intimate, sacred medical history confidential. My pledge is to keep my patients’ information from you not transmit it to you.
Through your rules, you are asking me to disavow my professional code of ethics and Hippocratic oath, betray my patients, and instead attest to you that I will give you and anyone of your choosing unfettered access to my patients private, protected health information health whenever you want it. Is this a joke? Why would I do this? For a bonus from you? To avoid a penalty from you? To avoid public humiliation when you give me a 0 for not complying with your rule and then you post my failing Composite Performance Score on your public CMS website?
Sorry to inform you, but not bribery, not threat of financial ruin, and not oppressive public humiliation will cause me to violate my professional ethics and lifelong commitment to my patients. You have grossly underestimated the integrity, heart, and soul of America’s physicians. What we and our patients share is beyond anything you and your agents of government have ever experienced nor can fathom. You should try it sometime. What is more troubling than the data you plan to extract and sell is the cookbook guidelines you plan to insert and require me to follow in the care of my patients. This rule is deplorable, outside the intent of the law, and a violation of humanity. Strike it out. More dissent to come tomorrow.
Posted on May 26, 2016
Wednesday, May 25, 2016
Dear Mr. Andy Slavitt Acting Administrator of CMS,
Thank you for the opportunity to comment on the MACRA proposed rules, which are unworkable and unacceptable. The Secretary of HHS’s Qualified Clinical Data Registries (QCDRs) are of particular concern prompting my dissent. (Refer to pages 224-250). MACRA intended for the QCDRs’ to submit Quality metrics. The rule proposes to expand QCDRs’ capabilities allowing them to submit data on measures, activities, or objectives from the Quality, Clinical Improvement Activities, and Advancing care information categories. Such authoritarian granting of expanded power to agents of your choosing is beyond your scope of power and changes the intent of the law. CMS already has access to data for the resource use performance category since such measures are claims-based. The QCDRs’ are CMS-approved entities that collect medical and/or clinical data for patient and disease tracking. Of concern is that QCDRs will provide you quality measure specifications including data elements for non-MIPS quality measures intended for reporting from certified EHR technology. Thus, this entity can collect any data the Secretary of HHS wants by collecting it as a non-MIPS measure. The QCDR must risk-adjust the non-MIPS measures and list them on their websites. Further, (page 228) QCDRs must submit to you “data on measures, activities, and objectives for all patients, not just Medicare patients.” By whose authority does CMS, the Center for Medicare and Medicaid Services, collect data on all patients in the USA? This not only changes the intent of the law and epitomizes executive overreach but violates individual Constitutional rights.
To make matters worse, on page 228, your rules “require QCDRs must comply with any request by us to review the data submitted.” Page 229, “QCDRS may request to report on up to 30 quality measures not on the annual list of MIPS quality measures.” This is a massive, intrusive data grab on All Patients by CMS entities that must allow you to review the data on any measure you desire at any time you request. When groups use a QCDR to submit their data to you, each individual eligible clinician does not need to grant individual permission to the QCDR to submit their patients’ data.
Next, the rule expands health IT vendors’ powers and allows and requires Health IT vendors to obtain data from MIPS eligible clinician’s certified EHR and submit to CMS in quality, Clinical Practice Improvement Activities, and advancing care information performance categories (page 233). The rule allows the HIT vendors to use intermediaries to submit data to CMS. Again CMS, an agency, is legislating, changing the law, and violating personal, individual privacy. This rule allows protected health information, which includes demographics and past, present, and future physical and mental individually identifiable information, to be passed through several levels of intermediaries vastly increasing, cost, bureaucratic waste, and risk of security breeches, if not data loss or transposition.
In continued unauthorized legislating on page 234, the rule defines “Qualified Registries” as a medical registry, a maintenance of certification (MOC) program operated by a specialty body of the American Board of Medical Specialties or other data intermediary and grants them power to submit data in the quality, clinical practice improvement, and advancing care information categories. One such specialty group, the ABIM, is under scrutiny for its unethical maintenance of certification practices including profiting hundreds of millions of dollars on the backs of physicians in an unethical testing/MOC industry shown by FOIA documents to include falsifying tax documents, transferring money to the ABIM foundation, and sending millions to the Cayman Islands. Such an organization and anything having to do with MOC cannot and will not be trusted by physicians for handling of privileged medical data.
Page 236 requires these intermediaries to do randomized audits of data including periodic examinations to compare patient record data with submitted data. The qualified registry must submit to CMS, quality measures and activities data on all patients, not just Medicare patients (p. 237) and “must comply with any request by us to review the data.” They must report on all payers, including Medicare part B FFS patients and non-Medicare patients.
Page 239 proposes yet another third party intermediary to transmit data, CMS-Approved Survey Vendors.
All of these CMS sanctioned third party entities “must retain all data submitted to CMS for MIPS for a minimum of 10 years.” (page 425) The potential for massive problems here is beyond the scope of these comments. This massive government intrusion into every American’s private medical data and demographics by multiple third party entities who must collect data on all patients, not just Medicare, and all payers, including commercial insurers not just Medicare, who will peruse it, gather it, adjust it, transmit it to CMS, and store it for 10 years makes the NSA look like Boy Scouts. This is unacceptable and will not be tolerated by the American people. This rule must go.
Kris Held, M.D.
Posted on May 27, 2016
Thursday, May 26, 2016
Dear Mr. Slavitt Acting CMS Administrator,
I dissent to the MACRA rule; it changes intent of the law, increases the scope and power of CMS, transfers power over taxpayer money and private patient data to CMS, and violates the 4th Amendment and individual rights.
1.CMS is using the rule to expand its scope of power, applying the rule to ALL patients not just Medicare beneficiaries and to all insurers (including commercial) not just Medicare. The All-Payer Combination Option includes Medicare, Medicaid, commercial payers, and Medicare Advantage. The rule constitutes the codification of government run, single payer, socialized medicine, thus completing the fundamental transformation of the USA, which was not the intent of MACRA’s sponsor.
2.The rule “Rebrands key terminology”, classifying everyone from a physician to psychologist and dietician to speech pathologist as ECs (Eligible Clinicians) or EPs (Eligible Providers) making virtually anyone who contacts a patient subject to the rule.
3.The rule changes the scope of to whom MACRA applies. It would apply not only to Medicare patients but to ALL patients. It applies MACRA not only to CMS (the Medicare Payer) but to ALL payers-commercial, Medicaid, and Medicare Advantage. MACRA collects “MIPS” data on patients in order to grade, reward or penalize doctors; the rule allows data collection of non-MIPS data by CMS too.
4.The rule sets up MIPS (Merit Based Incentive System) and APMs (Alternative Payment Models), incentivizing physicians to report patients’ protected health information to CMS. Physicians and all EPs are then graded and either paid or penalized based on a “Composite Performance Score.” The rule applies this system to other payers via the ALL-Payer Option by 2021, based on 2019 data, just 2.5 years away.
5.The rule authorizes intermediary entities to collect data and compile data registries for which they must keep identifiable, even protected health information, on file for 10 years-should CMS want a targeted audit. If the targeted audit comes in year 10, the intermediary must keep the data for 10 more; that’s 20 years of patients’ data collected and stored for CMS and anyone who demands access. For special cases, CMS can request data for longer. The potential for problems here is huge. CMS can come into our offices and do targeted audits whenever desired.
6.As far as Quality Measures and Clinical Improvement activities, data intermediaries can collect up to 30 additional “non-MIPS” measures each (which means they can collect whatever data they or CMS wants to collect on patients-even though not MIPS approved). Then they must grant CMS access to non-MIPS measures AND post them on their websites.
7.Clinical practice improvement activities reward physicians/EPs for compiling registries of patients with, for example, mental health and behavioral problems, doing depression screening, and so on. CMS has access to this data. Potential for misuse of the data is mind-boggling.
8.The OCR (Office of Civil Rights) OK’d physicians to give ONC (Office of National Coordinator of Health IT) intermediaries called ONC-ACBs access to patients’ PHI (Protected Health Information) without the patients’ knowledge or authorization . PHI includes individually identifiable private medical data, demographics, physical and mental data, past, present, and future including diagnosis, medications, treatment and more. ONC-ACBs can do onsite surveillance to prove EP’s are providing interoperable, bidirectional, unblocked access to data “at all relevant times”, AKA whenever CMS wants it.
9.Advancing Care information is still Meaningful-use EHR, just “rebranded”, and you misled us saying it was going away. The MU-EHR incentive program started in 2011; your MACRA rule will expand it and increase its impact exponentially. You will publicly display an indictor to identify high performers and seek comment to indicate low performance. Those who refuse to betray our patients and violate the patient-physician relationship will get 0’s and public humiliation on the CMS website. This is oppressive if not abusive.
10.Composite Performance Score (CPS) -CMS has power to adjust the value of each of the four performance categories used in the rubric to calculate each physician’s/EPs CPS, so if wanted, CMS could grade and pay physicians according to your desired data collection/reporting preference; for example, who has the lowest resource use and reports the most data, disregarding Quality and Clinical Practice Improvement Activities altogether. Thus, you can put those of us who won’t comply out of business and reward those who you effectively bribe (extort) to do your bidding, building your army of minions.
11.The Pay to report/ Comply or die strategy is sick. Most physicians will not do what you ask, because we serve our patients. They’re smart; they know this. We trust one another and communicate, privately. The comment in the rules that only selected measures will be openly posted on Physician Compare, because “providing too much information can overwhelm consumers and lead to poor decision making,” proves that you and your agency staffers who wrote this rule think we, the American people, are stupid. We are not.
12.Your collaborating entities-OCR, ONC, TEP, PTAC, PFPM, Innovation Center, NQF, and every other Executive Branch Department and agency are to be feared, as they are your weapons as you assault the lives and liberty of the people. Your rule enables you to work with them against us. But we will not break.
The MACRA proposed rule bastardizes MACRA and must not stand. As bad as MACRA is and was from inception, this rule makes it worse. I would love to discuss alternatives with you.
Kris Held, M.D.
Posted on May 28, 2016
Saturday, May 28, 2016
Dear Mr.Slavitt, Acting Administrator CMS,
By now you should have received five prior dissents to the proposed MACRA rule from me, although I do not see them yet posted on your site. I will make this one shorter and focused solely on page 431/625 regarding the proposed 414.1460 Monitoring and Program Integrity section, which is beyond your capability. You might as well propose to establish a rural health clinic on Mars.
Specifically absurd is (c) Information submitted for All-Payer Combination Option. You state that information submitted to you by physicians and all reporting eligible clinicians and Advanced Alternative Payment Entities may be “subject to audit by CMS.” And further you state that we must maintain copies of any supporting data (which includes our patients’ private records including their protected health information) for at “at least 10 years.” Further you will recoup payment based on your audit.
Is this a threat to the nation’s physicians and providers of health services to the people? This would be laughable if it weren’t so potentially harmful to the very lives and liberty of the American people. You and your agency have NO RIGHT to our protected health information at your whim. When you say at least 10 years, would your corroborating agencies determine this to be lifetime access?
There is no limit to the potential for abuse and malfeasance by the Center for Medicare and Medicaid Services under the auspices of the Department of Health and Human Services under the administration of the President of the United States of individuals’ personally identifiable health information, which includes all demographics, past, present and future, physical and mental history, medications, treatment, and so forth. Similar Executive Branch agencies like the IRS under Lois Lerner and John Koskinen and the NSA with its assumed metadata powers, have taken on a life of their own expanding their scope and strength of powers to intolerable levels (and by whose authority?)
History has proven agencies such as yours cannot and should not be trusted with such vast amounts of medical data, that constitute the very lifeblood of the United States citizenry. This rule must be struck. CMS must be denied the power to audit the medical records of each individual American for what will be at least 10 years, and could be their entire lives.
While CMS was created to manage Medicare and Medicaid, MACRA and your proposed rule, through this preposterous “All -Payer Combination Option” (Newspeak for single-payer government-run socialized medicine), grants you access to ALL patients. I can imagine no American who would support a group of DC bureaucrats having lifetime access to all their records- particularly as you have proven time and again you cannot protect the security of this data.
The cost of undertaking such a ludicrous proposal is not conscionable, and pragmatically speaking, on a macro level, your programs are broke and are bankrupting the US economy. How do you expect doctors and all eligible clinicians to do this at the micro level?
This rule is an abomination the Constitution of the United States and an affront to her people. Strike it.
Kris Held, M.D.
Addendum for those who think I’m exaggerating see Page 432/625: And I quote-
(e) Maintenance of Records. An Advanced APM Entity or eligible clinician that submits information to CMS under 414.1445 for assessment under the All-Payer Combination Option must maintain such books, contracts, records, documents, and other evidence for a period of 10 years from the final date of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later, unless-
(1)CMS determines there is a special need to retain a special record or group of records for a longer period and notifies the Advanced Payment Entity of eligible clinician at least 30 days before the formal disposition date; or
(2) There has been a termination, dispute, or allegation of fraud or similar fault against the Advanced APM or eligible clinician, in which case the Advanced APM Entity or eligible clinician must retain records for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud, or similar fault.
Translation: CMS can retain targeted records for eternity with a 30 day notice per (1), 2o years minimum and going forward in 10 year chunks for eternity per (e), and 16 years per (2).
And remember, the Office of Civil rights said eligible clinicians can disclose protected health information to these agencies via ONC-ACBs (Office of the National Coordinator for Health Information Technology Authorized Certification Bodies). You tricky devils, you. So, much for our “civil right to privacy” and our “civil right” to the Fourth Amendment.
Posted on May 30, 2016
Monday, May 30, 2016
Dear Mr. Slavitt, Acting Administrator CMS,
As I await CMS posting my prior six dissents to the proposed MACRA rule, I submit this seventh dissent.
Page 398/625 (414.1340 Data completeness for the quality performance category.) states: “(a) MIPS eligible clinicians and groups submitting quality measures data using QDCR, qualified registry, or EHR submission mechanism must submit data on at least 90 percent of the MIPS eligible clinician or group’s patients that meet the measure’s denominator criteria, regardless of payer.”
Translation: Government will give doctors (and all healthcare providers) a grade called a Composite performance score (CPS). The grade will be used to pay doctors. The grade will be posted on a public website to humiliate doctors who won’t comply with government. The grade will be based on performance in 4 categories. A huge component of the grade is the Quality Performance Category. To qualify for government payment under this grading system, a physician must report data to CMS, a government agency in charge of Medicare and Medicaid, on 90% of ALL their patients including commercially insured, self pay, uninsured, charity… not just Medicare patients.
MACRA was written and passed as a fix for the unsustainable Sustainable Growth Rate Factor as it applied to Medicare payments. By what authority, does CMS (Center for Medicare and Medicaid Services) justify data collection of 90% of an individual physician’s or their group’s patients “regardless of payer?”
On what authority does, CMS, a government agency under the Department of Health and Human Services, rationalize data collection of all patients in the United States? Who gives you the right to private medical data from all patients’ charts “regardless of payer?” You have no such right or authority.
The contents of a patient’s medical record are confidential and constitute “protected health information” to which you have no right. This rule expands CMS authority over Medicare and Medicaid patients to include authority over all patients regardless of payer- including commercial or even self-paid. You have no right to this protected health data, much less to coerce physicians through your perverse Merit Based Incentive Payment System (MIPS) to turn this information over to you. That this rule proposes this is abominable.
By linking physician pay to reporting data on ALL patients, you confiscate the payment systems of all patients and effectively create a government run, socialized system of medicine. This is not the stated intent of the ACA or MACRA. Your rule changes the intent and scope of law. The rule increase your scope of power.
The ACA mandates purchase of qualified healthcare plans by all Americans. Then MACRA, as expanded by this proposed rule, incentivizes physicians, and all Merit Based Incentive Plan System eligible clinicians (which you define as the following: a physician, a practitioner per 1842(b)(18)(C) of the ACT, a physical or occupational therapist or a qualified speech-language pathologist, and a qualified audiologist) to give CMS access to their patients’ data in order to receive a better Composite Performance Score and thus a positive adjustment factor to what government pays out.
Eligible clinicians with the highest Composite Performance Scores receive up to a 10% incentive payment for reporting private patient data to CMS, a federal government agency. Is this bribery? How little you must think of a physician’s code of ethics, adherence to the Hippocratic oath, and commitment to the patient-physician relationship.
Those of us who refuse to disclose medical data to CMS on 90% of our patients will receive a 0 in the Quality performance Category of the Composite Performance Score by which you grade us. The non-reporters will receive a negative payment adjustment factor and get a 9% decrease in pay. This scoring mechanism constitutes punishment of our nation’s physicians by your agency for not reporting their patients’ confidential medical data to you. Or is this extortion of the very people who have devoted their lives to care for others by unauthorized, overreach of your agency? How seriously you must want to get rid of us.
Just think, eligible clinicians who comply with your data collection and reporting will be paid 19% more than those who do not comply. The compounded effects of this system applied annually are profound. Those who will not betray the patient will soon be out of business. Is this your strategy?
Under 1848(q)(5)(F), CMS claims authority to reweight performance category weights. So while, the Quality Performance Category may be weighted at 30% now and 50% in 2019, if CMS desires, it can change the weighting system to inflate the weight of this category to 100% of the Composite Performance Score. If so, CMS will pay physicians who report data to government on 90% of ALL of their patients 19% more than those who don’t report- who will then be forced out of business- and you will be left with a select group of physicians to care for the American patient- those who will do government bidding, whatever it may be, in order to be paid. From here, the fundamental transformation of the practice of medicine in the US will be complete.
MACRA and its proposed rule must go. The American people do not support a perverse system that pays its doctors to report their most sacred data to CMS. The people do not support a system that pays doctors to do CMS biding and puts them out of business if they don’t. The people do not support a rule whereby CMS (Medicare and Medicaid) suddenly anoints itself czar and empowers itself to collect all data on ALL patients regardless of payer. No, this must go. Your agency should be sanctioned for proposing it.
Kris Held, M.D.
Posted on May 30, 2016
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 Optionthat 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.
Posted on June 3, 2016
Friday, June 03, 2016
Daily Dissent 9
Dear Mr. Slavitt, Acting Administrator CMS,
I am pleased to see my comments finally posted on the CMS site. Although I have been submitting them daily for the last 13 days, they were held until yesterday and posted at once. A CMS employee was kind enough to call me at my office yesterday to inform me that my comments could not be posted, because they contained “proprietary information.” I was perplexed by her assertion having painstakingly read the law and rule and citing supporting information verbatim from the proposed rule. Turns out the banned “proprietary information” was simply the name of a government agency official who had targeted individuals based on political preference and the name of a government-contracted ACA economist who had taken advantage of what he called “the lack of economic understanding of the American people” in his economic design. Further, she wanted me to submit all comments in a single attachment and informed me I could get a confirmation email. I told her I believed she was suppressing my speech and that she could redact the “proprietary information” then publish my dissents individually as intended. I informed her I did not want my comments to show up obscurely as a single paper clip icon, but as 8 individual ready-to-read dissents. I further told her, not only do I know about the email confirmation option, but I have screen shot and photographed my 8 confirmation numbers- just to be safe. You see, I have spent countless hours reading the MACRA laws and rules, and I want truth to be told to my fellow Americans, who in recent history have been deceived by what you and your coworkers in the multitude of Executive Branch departments and agencies say is in the laws vs. what truly is in the laws. I would love to name names of government officials who told us things like, “we’ll have to pass the law to see what’s in it” and “if we like our doctors, we can keep our doctors” to factually back up my point, but then this dissent might be withheld from posting on the basis it contains “proprietary information” as well.
The proposed MACRA rule is an assault on the American people. Unless struck down and MACRA repealed, your agency, CMS, will have expanded its powers in unprecedented and unconstitutional fashion. The rule grants CMS access to any and all protected health information of ALL patients in the US without their authorization via a new class of intermediaries that must keep the data for CMS audit for 10 years minimum, if not a lifetime in targeted cases. My 8 prior dissents address this in detail.
The proposed rule defines its All-Payer-Option, which is single-payer, government-run medicine.
The proposed rule incentivizes physicians and hospitals to merge into huge groups, like failed HMO’s of the ‘90s, that must comply with your data reporting, including maintaining interoperable, bidirectional, unblocked certified electronic health records that must be available for surveillance during all relevant times, including on-site inspection.
Physicians will be graded and receive a Composite performance Score from 0-100 for following your top- down rubric in grade school fashion- except that the scores will be publicly posted to intimidate, oppress, and humiliate those of us who will not comply and to glorify those who best do your bidding. Those with the high scores will receive more money from you. Those with the low scores will be penalized monetarily and forced out of business in short order. An example of a Clinical Practice Improvement Activity Measure for which a physician will be rewarded with 20 points by CMS is creating or contributing patient mental health/ behavioral health data to a national, state, or local registry. The potential for malfeasance with government control over such data is chilling. The MACRA plan to bribe, extort, coerce, and punish physicians in order to drive their behavior is more suitable for the Mafia than the US government.
What MACRA and its proposed rule do is require physicians to violate their professional code of ethics, betray their patients, and turn everything over to your agency. And on whose authority do you do this? My allegiance is to my patients, and my job is to keep their private medical information from you not transmit it to you. I will treat them according to my time-honored professional standards not CMS’ global population-based government experimentation.
Finally, I have looked at the projected costs of this fiasco as outlined in your rule. Hundreds of billions of dollars that could be better spent on patients or kept by taxpayers will be squandered on a whole new bureaucratic wasteland of intermediaries leeching off IT and data marketing. Groups like the ONC-ACBs, QCDRs, and Health IT Vendors will siphon hundreds of billions from patient care. And if these bodies and registries are disqualified, the physicians and their groups are left holding the financial burden and assuming the financial risk. Your pet insurance and IT companies stand to make billions at minimal risk. I read one projection that an individual physician could be out $33,000 and a large group up to $6,500,000 per year if the ONC-ACB, QDCR, or other new bureaucratic intermediary they work with is suspended or disqualified. The lobbying efforts (money and power) and incestuous conflict of interest (money and power) at play here is beyond epic.
We really must talk. I will email you this weekend. You have my email and phone number as well. Time is of the essence as is the lifeblood of the USA and her patients. The MACRA rule must go and MACRA must be repealed.
Kris Held, M.D.