Re: Comments on Final rule with comment period,
Docket No. CMS-5517-FC, RIN 0938-AS69,
Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models,
Federal Register, Volume Vol. 81, No. 214, Part II (Friday, November 4, 2016)
The Association of American Physicians and Surgeons (AAPS) is a national organization of physicians in all specialties, founded in 1943 to protect the patient-physician relationship. Volunteer physician members have each read and summarized 100 pages of the 2200-page Final Rule. After reviewing their summaries, we submit the following comments:
CMS should withdraw this Rule in its entirety and inform Congress that MACRA is not enforceable in any equitable, reasonable, non-arbitrary, or non-harmful way, or in any way that does not force physicians into an unethical conflict of interest with their patients. Thus, it should be repealed.
Even if Congress decides to continue MACRA for physicians who elect to try an alternate payment methodology, CMS needs to revise the Rule to make explicit Congress’s intention that participation in this system is voluntary. The alternative is to accept a 4% pay cut (“adjustment”) in 2017, later increasing to 9%. This appears to happen automatically if the physician does not submit data, according to the CMS website https://qpp.cms.gov/. The Final Rule, however, states that “MIPS eligible clinicians and groups must submit measures, objectives, and activities for the quality, improvement activities, and advancing care information performance categories” [emphasis added]. 81 FR 77008, 77094.
“Eligible” to participate does not mean required to participate. The prospect of earning a boost in Medicare payment, in competition with other “eligible clinicians,” forces physicians to become a risk-bearing entity, like an insurance company, without the financial reserves. The only method physicians have to reduce the risk of their own bankruptcy is to ration care and practice strictly in accord with bureaucratic directives rather than their own judgment of what is best for patients. For CMS to dictate this radical change in medical ethics is contrary to the statute. Legislation that did require this would be unconstitutional.
Congress feared an exodus from Medicare if it ever allowed the SGR fee cuts to proceed, and hence delayed them every year. This exodus is indeed likely, especially when the MACRA penalty reaches 9%. The cost of compliance with this Rule will probably make independent medical practice impossible even for those in the 50% who might see payments increase.
If Congress wished to preserve access to care, it could allow physicians who decline to implement MACRA to implement patient-valued payment through balance billing, and remove penalties for providing charitable discounted or free care in case of need (as determined by patient and physician). The values rewarded by compliance with this Rule are submission to bureaucratic directives and reductions in services rendered. Even if patients have access to some type of “clinician” (not necessarily a physician), they will not have access to the care of their choice according to their own values.
A Zero-Sum Game with Minimal Impact on Program Spending
It is estimated that, if 90 percent of eligible clinicians of all practice sizes participate in the program, MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($199 million) and positive MIPS payment adjustments ($199 million) to MIPS eligible clinicians, to ensure budget neutrality. Positive MIPS payment adjustments will also include an additional $500 million for exceptional performance payments to MIPS eligible clinicians whose performance meets or exceeds a threshold final score of 70. This initial MIPS payment adjustment represents less than 0.2 percent of Medicare expenditures for physician and clinical services, which is too little savings to justify the immense burdens imposed by the rule. The cost/benefit ratio of this rule is simply irrational.
Burden on Small Practices
The positive adjustments will probably go overwhelmingly to large corporate practices that can afford the infrastructure needed exploit the system. Small practices are disproportionately burdened, if they can comply at all.
One reviewer noted that self-nominated QCDRs must have 25 or more providers. In other words, small or solo group practices CANNOT be their own QCDR and submit the required data for MIPS. They will have to either group up with other physicians/practices in order to meet the 25 threshold, or hire an entity that is QCDR as third party to submit their MIPS Data. This imposes disproportionate costs on practices that can least afford it.
CMS unjustifiably holds Physicians liable for any mistakes in the data submission by a 3rd Party/IT vendor. After notice of errors, vendors have only 14 days in which to remedy these. CMS, however, states on paqe 1351 that it needs a longer time to evaluate and calculate the MIPS scores! CMS needs more time but won’t give time sufficient to third parties to correct their mistakes, which is arbitrary, irrational, and unfair.
The MIPS data required will be constantly changing as well over the years, which means EHR companies will have to constantly upgrade their programs annually at a minimum. This means increased costs to physicians, which CMS has no intention of reimbursing.
One physician wrote: “I can’t uphold the MACRA standards listed on pages 1900-2000 because it takes an army of personnel that I can’t afford and they won’t pay for. To them, there doesn’t seem to be an acute care visit where someone can come in with an ear ache or sprained ankle and get out in time to go back to work. All complaints that reporting requirements were burdensome were dismissed out of hand with some variation of ‘CMS believes this measure is clinically relevant.’”
It is acknowledged that the program will worsen those dreaded “disparities” for underserved areas.
Meaningless Exemption for Small Practices
Very few practices will fall under the new, slightly relaxed threshold. Exceeding it by $1 results in huge expenses to try to comply—doctors will need experts and more websites just to understand the definitions.
Destruction of Privacy for All Patients
CMS writes: “We disagree with commenters who maintained that the disclosure of PHI to ONC or an ONC-ACB could be inconsistent with reasonable privacy or other organizational policies or would otherwise be an unjustified invasion of privacy or any other interest. As noted, the disclosure of this information would be authorized by law on the basis that it is a disclosure to a health oversight agency (ONC) for the purpose of determining compliance.” 81 FR 77008, 77024.
CMS insists on having ALL of the information and requires attestation that information is not being blocked. To be a meaningful EHR user, an eligible provider must “demonstrate 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 certified EHR technology.” Id. at 77028.
The record retention requirement of 10 years is unreasonable. The standard has always been 7 years for patient records. This means increased cost and increased liability exposure, with no evidence or rationale to support it.
No Meaningful Physician Input
CMS more or less told all of the commenters that CMS appreciated their opinions and recommendations, but wouldn’t change anything. One physician writes: “So far in the pages I’ve reviewed, not a single request or recommendation has been granted.”
No Justification for CMS Scoring Physicians
CMS is creating the equivalent of Angie’s List although patients already do their own ratings by choice of physician, and various ratings are available on the internet. The federal government does not presume to score any other professionals.
It Is Impossible to Be Certain of Compliance
It is stated that thresholds and metrics will “evolve.” 81 FR 77008, 77009.
One physician writes: “If anything is apparent it is that there is no such thing as final rules, and in fact everything in the section I read was prefaced with disclaimers. I would like to entitle my section as ‘The Destruction of Medicare and Those Practices That Attempt to Comply.’”
One physician writes: “This publication of the Final Rule is almost of zero value to any physician or any patient, and in fact is a gobbly-gook of acronyms that hardly make sense and make the reading of the rules almost impossible without constant reference to their senseless definitions.” Another called the rule “virtually incomprehensible.” Physicians are among the most highly educated people in the country. What is the justification for a rule that even they cannot understand?
One physician advises that doctors should just “take the fines.” He adds: “If compliance becomes mandatory because too few physicians will participate in their payment scheme, doctors will have to drop out because compliance is a fool’s errand, and a bankrupting one at that.”
Physicians expect and deserve (and need) to get paid for their work, not to “successfully take part in the CMS Quality Payment” system, which takes more than a thousand pages to define. 81 FR 77008, 77009. Furthermore, clearly 50% of physicians will not be “successful.” For every physician rewarded, another physician gets a deduction.
CMS states: “We believe the proposed definition of Medicaid Medical Home Model provides states with significant flexibility…. However, we retain the authority to determine whether any payment model under Title XIX meets our criteria.” 81 FR 77008, 77464. A physician’s translation: “The Rule is flexible; you just can’t see it. And if you do figure it out, we reserve the right to change the rules on you midstream.”
CMS admits that the Rule is intended to be “challenging.” 81 FR 77008, 77094; id. at 77124.
One physician’s overall reaction is that “this is another example of setting up a maze of laws so dizzyingly complicated that in order to follow one law, you might be breaking another, and then pointing the hapless citizen in multiple different directions for any hope of relief which, if it ever comes, will have exhausted said citizen to the point that it would have been better to go to jail.”
Physicians have no idea how they are doing under the system. Quality measures are reported quarterly and physician/institution payment can take up to one year. The payment can then be revoked at any time in the future if the records are reviewed and determined to be inadequate. This revocation can occur whether the physician remains employed at the initial monitoring institution or has been gone for up to 10 years. (“I suggest,” writes a physician hypothetically in order to illustrate how arbitrary and irrational the proposed very long retention requirement is, “that if and when you leave, that you do not keep a forwarding address.”)
Methods Are Not Validated
CMS admits that the proposed rules for cost performance category have never been used for payment purposes, and CMS may choose to specify a subset of these measures. Since doctors prescribe drugs, CMS thinks they are the drivers of drug costs, so drug prescription costs will be included in each doctor’s cost coefficients.
One physician writes that everything upon which CMS is basing its assumptions is in actuality based on Medicare claims forms and their mostly failed “Accountable Care Organization” pilot projects to gather “episode of care” data. “The truth is they cannot judge quality or performance, only cost. This is deceitful propaganda.”
As CMS admits, “We do not currently have the optimal capability to validate data completeness for all data.” 81 FR 77008, 77124.
CMS states: “We appreciate the widespread desire to make as many Other Payer Advanced APMs available as possible.” Id. at 77462 But, “The statute requires us to use the three criteria discussed” and “We believe our proposed and final policies adhere to the statutes.” Id. A physician’s translation: “The Social Security Act forces us to intentionally force these criteria on you—never mind that only 25% of APMs have figured out how to do it.”
Quality Metrics Are Harmful to Medical Practice
One physician writes: “There is nothing remotely suggestive of the actual practice of medicine. For example, CMS regards radiologists and pathologists as ‘non-patient facing MIPS eligible physicians.’ One is struck with every rule and condition with the obvious question: how many bureaucrats at what expense would be required to track, collate, evaluate, and determine payment on over 800,000 physicians with this unwieldy payment system disguised as ‘quality not quantity’ rewards?”
A number of critiques were clinically based. The proposed quality measures were not consistent with current practice guidelines, or not consistent with the needs of all patients. These critiques were met with “we decline” (see id. at 77023) or that CMS does not own the quality measure and cannot change it. CMS never provided detailed, scientifically based justifications of its proposed measures in response to critiques based on science and clinical experience. About 65 requests for changes in measures were turned down. (85 measures received no comment, so they were not modified; 52 measures were supported by commenters and CMS thanked them for their support.)
One physician observed that MACRA will further diminish the practice of medicine, with its many uncertainties and gray areas, in favor of the “Application of Healthcare Directives,” which is black and white and determined by CMS and insurance companies. It imposes expansive controls over the entire system and very lives of all Americans.
In fact, CMS may in effect be practicing medicine by requiring monitoring on how patients are actually treated. Are the diabetics on an angiotensin converting enzyme (ACE) inhibitor? Are children with an upper respiratory infection given an antibiotic (naughty naughty)? Are sore throats checked for Strep and verified by Rapid Strep? And if they are positive, were they treated with an appropriate antibiotic? Are patients with congestive heart failure treated with an ACE inhibitor or angiotensin receptor blocker? Are rheumatoid arthritis patients tested for tuberculosis before starting a disease-modifying antirheumatic drug? The list seemed endless and seemed to touch on every medical specialty although primary care physicians carried the brunt of it.
MACRA Is a Rationing Mechanism
It is blatantly absurd to suggest that a physician take financial risk for treating diseases that are often unpredictable and, if treated properly, frequently cost unpredictable amounts of money. This is just another way of saying that medical care will be further rationed.
As CMS states, “We are finalizing the policy that full capitation arrangements would meet the Advanced APM financial risk criterion. All other payment arrangements would be assessed against the applicable nominal amount standards set forth in this final rule.” 81 FR 77008, 77431.
A physician observed that, “at this point ‘beneficiaries’ of government healthcare are so confused by the difference between what is medically possible and what the government will pay for that they have no idea how to even evaluate their medical care. The only person they know to complain to is their doctor. There is no way a patient would know whether a treatment was being withheld due to some ‘Advanced APM agreement’ or because the treatment really wasn’t medically indicated. ”
In view of these serious flaws that are inherent in the concept that the federal government should be dictating the practice of medicine and its financing mechanism, AAPS believes that the Rule should be withdrawn, and that physicians should withdraw from participation in activities that require attempts to comply. Such attempts are costly, potentially bankrupting, unlikely to succeed, and unethical because of violating patient privacy and compromising physician judgment. Principle #4 in the AAPS Principles of Medical Ethics is: “The physician should not dispose of his services under terms or conditions which tend to interfere with or impair the free and complete exercise of his medical judgment and skill or tend to cause a deterioration of the quality of medical care.”
The full unedited text of comments by our volunteer physician readers is found at: https://docs.google.com/document/d/1QbWHfLVWnxZ2OucssFJdSlF7k6xBE-WV6cahGhUDi5o/edit.
Jane M. Orient, MD