The Physician says: “Save the Patient!” Will the federal government listen?

Monday, June 20, 2016

Dear Mr. Slavitt and Esteemed MACRA Rules Team,

In 1965, President Lyndon Johnson signed the Social Security Act Amendments into law creating Medicare and Medicaid with the promise that the Federal government would not interfere in any way with the practice of medicine whatsoever including compensation, administration or operation of any institution, agency, or person.

In spite of the federal government’s pledge not to interfere with the practice of medicine, the law has been continuously amended such that it is now in complete violation of Title XVIII SEC. 1801- our profession, the heart and the art of medicine, commandeered, if not lost.

MACRA is the absolute antithesis of what government promised with Medicare. It massively increases government control over patients, physicians, and the practice of medicine, proving once again, a government pledge is fleeting and begs the questions: What is in the MACRA proposed rules? How must the rules be modified to achieve what is best for patients? And what do the rules portend for the next 50 years of medicine in the US?

Tragically, medicine has been politicized. One side says, everyone’s stupid, and no one can be trusted, so promulgate more laws with voluminous rules, and take everything over fast. The other side says, it’s a failure, so don’t try to fix it, let it fail under its own weight and start over.

The physician says, save the patient.

I’m here for the patients, to dissent to flaws in the MACRA rule and to offer solutions for the patients. I’m here to advise you that the code of ethics embraced by the majority of US physicians and our allegiance to our patients and the patient-physician relationship has been vastly underestimated.

I have read MACRA and the MIPS/APM rule word for word. I have read and reported on the Affordable Care Act in its entirety, as well as the HITECH ACT contained in the American Reinvestment and Recovery Act of 2009 and the aspects of the law pertaining to the investment in data infrastructure for comparative effectiveness research (CER).

I have practiced medicine for over twenty years, from academic medicine and resident education to the front lines of patient care in private practice, having transitioned from a participating Medicare provider with in-network agreements with virtually all commercial insurers, to Medicare non-participating with select commercial agreements, to Medicare Opted-Out/private contracted with no in-network agreements whatsoever as of 10/01/2015.

Burgeoning coercive federal healthcare law and increasing 3rd party intrusion into the patient-physician relationship collided head on with my life of service and commitment to my patients, our confidential relationship, the Hippocratic Oath, and medical ethics. I asked myself, if I’ll do this, what won’t I do?

Our specialty and professional societies like the AMA no longer represent the will of the physicians and patients. Once prestigious, revered organizations like the ABIM, under the ABMS, have come under scrutiny for unscrupulous financial activities including a professional testing for profit and MOC scheme that undermines the trust of all physicians across the country. Sky-rocketing costs of premiums, deductibles, copays, and cost-sharing with Obamacare exchange plans and all commercial insurance accompanied by restrictive networks of physicians, poor patient access to care, emergence of 4th party entities like pharmacy benefits management companies requiring prior authorizations, step edits, and quantity limits, denying prescriptions, and exploding drug costs, and routine prior-authorization delays and insurer denials for operations, subjecting patients to prolonged pain and suffering, have become the norm. According to the 2015 National Health Interview Survey published by the CDC, the same number of people remain uninsured now as 10 years ago, but more patients are on Medicaid (government welfare) and fewer on commercial insurance. Medicaid and Medicare are in abysmal financial condition putting the US and its individual states at risk of economic collapse in the not too distant future. Enabling such a dysfunctional system is unethical, if not inhumane.

I seek a better way and work toward that end for my patients.

MACRA was passed with massive bipartisan support as the SGR repeal. In reality, it was a replace bill that we must ensure is an improvement, not a Trojan horse. It sets forth the Merit-Based Incentive Payment System, Alternative Payment Models, and the Composite Performance Score, whereby physicians are scored and incentivized or penalized based on their performance on a complex, experimental government rubric.

A false premise of epic proportion is that a government rubric is necessary to drive physicians toward quality performance. This implies that physicians are not providing high quality, high value care. The truth is we physicians spend our lives training and serving our patients to the very best of our abilities; we do not need a government rubric. We will repudiate the composite performance score.

The MIPS, APMs, and CPS rubric are untested, unproven metastases of underlying medical economic problems born of Medicare, Medicaid, Obamacare, and commercial health insurance. The rules further aggravate the problems by creating layers of new intermediaries with billions of dollars of new expenses, changing the intent of the law, and violating people’s rights. The money does not exist, and the people will resist.

While we approach solutions from different perspectives, we share our common goal. We seek what’s best for the patients.

While it is said, that sadly, people will be hurt in times of change. We cannot settle in haste for a suboptimal rule when the very lives of the American people are at stake. There can be no casualties of change with MACRA.

Thank you for the opportunity to engage in serious discussion at this level. Our time together is brief, but I pray this is the beginning of ongoing dialogue producing meaningful results. I appreciated the opportunity to speak with Jean Moody-Williams prior to the meeting and submit this outline in advance having seen how little time 30 minutes is for such crucial conversation.

I have gone through both the 962 page and 625 versions of the rules. These comments will refer to the 625 page version downloaded from The Federal Register. Here are my dissents and proposed solutions:

1.The entire concept of a MIPS/APMs/CPS, whereby government designs a perpetual rubric for scoring and accordingly incentivizing or penalizing physicians financially in order to drive behavior, is ill-conceived. The US federal government does not possess the authority to drive individual physician behavior by paying out more money or financially penalizing them. This is better called enticement and extortion. The premise that this is needed is false. The composite score must be eliminated.

The core of good medicine is the simple and sacred patient-physician relationship based on mutual trust and communication. As physicians we spend our lives acquiring the knowledge, skills, judgment, wisdom, courage, and moral code to do what we do. We are not selected for acceptance to medical school unless we exhibit flawless character and requisite traits worthy of the position. We do not complete our intense training, best called a rite of passage, until we are 30 years old or beyond. The patient-physician relationship is like no other, from the physician perspective. In fact, it often supersedes one’s relationship with family, including spouse and child in times of greatest need. When on call, in the O.R., when there is a crisis, complication, or emergency, we attend to the patients. Our families know this. This can’t be put in a rubric or IT analytics. It’s about commitment, compassion, trust, responsibility, ownership, and a professional code that cannot be coded by government.

Those of us in the smallest practices have this down to a tee. Our patients have our cell numbers. We live and work in the same communities. Our staffs are well-trained, cross-trained, fully employed, and loyal. We have trimmed our budgets, negotiated lower fees, cut waste, paid off equipment, and make things easy and accessible for our patients. Your rubric is an intrusion, an insult, and a sign of lack of insight into that which you seek to control. I invite you and your staff to visit my office, my staff, and my patients in San Antonio. I would love to show you, first hand, a real life model of quality/value medicine provided with greatest access at a fraction of the cost- and how top down intrusion from government is making it more difficult and more expensive for my patients and me.

2.The MACRA rule will harm small practices and patients and put us out of business in short order. Are we to presume this is the intent of MACRA? Is this the intent of your rule? I think not, but let’s look at your numbers.

Table 64 (on pages 378 and 379/625) projects that 87% of Eligible Clinicians who are solo practitioners will sustain a negative payment adjustment, as will 70% of those in practices of 2 to 9, and 60% of those in practices of 10 to 24. 73% of physicians in practices less than 25 will receive a negative adjustment. 60% of all eligible physicians practice in groups less than 100. Loss of these practices would shatter patient care.

My question is, what are the ramifications of this for each individual state?

According to the best information I could find out from the Texas Medical Association, over 60% of Texas physicians, who engage in patient care, practice in groups of 1-3. Under MIPS, 87% of such practices will be forced out of business. In an economically diverse and geographically vast state such as Texas this law will be devastating to patients. They will lose their doctors and access to care. Lives will be lost.

A July 2015 article from the AMA reveals the majority of America’s physicians still work in small practices- “These data show that the majority 60.7 percent) of physicians were in small practices of 10 or fewer physicians, and that practice size changed very little between 2012 and 2014 in the face of profound structural reforms to health care delivery,” said AMA President-elect Andrew W. Gurman, M.D.

Have you looked at the ramifications of MIPS on a state by state level? I would like to see these numbers.

So, you might say- there is assistance for small practices. Based on 2014, only 63% of small practices were participating in PQRS, and you might predict more will participate and do better participating in MIPS. I contend, fewer of us will participate in MIPS.

Of note from his inaugural address June 17, is that Andy Gurman, M.D., AMA’s new president who is an orthopedic hand surgeon in solo practice, said “I don’t have an EHR,” and he found it easier to forgo the enhanced payments he would get under the federal “meaningful Use” regulations for converting to electronic records. “I just take the penalties,” he said.

While you sell MIPS as less burdensome, in reality, it is intrusive, expensive, and fraught with unlimited potential for mistakes that could harm patients and the practice. Many of such practices are not going to adopt CEHRT. A recent publication showed 2-4% of physicians have had ransomware problems and even more have had data breaches. You are familiar with the arguments against CEHRT- that it is not specialty and practice specific, that it makes one less efficient and distracts from patient-focused care, and so on. I predict fewer will participate in MIPS, and a doctor shortage tsunami is incited under this plan.

If the intent is to drive physician behavior, in other words, if your intent is to end small private practices and drive physicians to large groups, you will fail, because we will not do it. Patients will be harmed. Many like me are not subject to such malevolent manipulation. We will find a way to care for our patients outside the constraints of this rule. (While not the intent, it may be inferred based on your numbers.)

So, you might say there is money and technological assistance to help us participate. We don’t want or need that. It serves no purpose. (From the rule-Technical assistance to MIPS EPs in small practices, rural areas, HPSA’s-practices less than 15 ECs (p 30). The SECRETARY is required to enter into contracts or agreements with appropriate entities (such as quality improvement organizations, regional extension centers, or regional health collaboratives) to offer guidance and assistance to practices of 15 or fewer -a separate guideline coming. Page 30 MIPS and APMs RFI published in Federal Register Oct 1,2015 (80 FR 59102, 59102-59113)

Where is that money coming from? It is better spent on patient care than expanding new classes of intermediaries to extend government reach into the physician’s office. This is a prime example of administrative waste.

You may say, well, the negative adjustment factor is only 4% instead of the 9% cut that was coming with SGR cuts. But that is a partial truth. First, the 4% cut will be imposed on the lowest quartile of compliers, while the best compliers will get an 8.7% positive adjustment and bonus for an overall disparity in pay of 12.7%. This is just for the first year, 2019, based on work done in 2017, just 6 months from now. Each year the penalty and resultant pay disparity will increase, and in a mere 3.5 years the penalty will be 9% compared to the incentive and bonus of 9.9% for a difference of 19%. MIPS will end small practices within the next few years if this rule goes forward as such. Many like me will opt out of Medicare and commercial insurance pursuing successful practice models outside MACRA, and patients will be harmed.

Doctors can care for patients without MACRA; MACRA can’t care for patients without doctors.

My suggestion is, let practices of less than 100 be permitted to choose not to participate in MIPS/APMs and settle for a 0% adjustment factor, in lieu of so much expense and interference. This will save money, resources, and error.

Who do you not trust? The medical schools and residencies that trained us? Physicians as a whole? I trust us, the physicians and patients at the small practice level, more than any other professional entity in the world. The need for MACRA is a false premise. Spend money on patient care not false premise.

Large practices and massive healthcare organizations with inherently more cogs, waste, and potential for problems, such as hospital systems and ACO’s, can remain subject to MACRA/APMs.

3.The ONC and its ONC-ACBs absolutely must not be granted unrestricted access to CEHRT individually identifiable protected health information without patients’ authorization under any circumstance (page 33/625). This constitutes unreasonable search and seizure of patients’ most intimate papers and effects- a violation of one’s most intimate, private information. Knowing a federal government agency has self-appointed itself with such authority makes it a violation of the physicians’ professional code of ethics to even engage in use of CEHRT. Our ethical duty is to keep our patients’ data from government, not transmit it to government. The potential for misuse of such information is unacceptable.

Further, systems do not operationally exist that can secure such information from ransomware insertion and hacking of patients’ demographic data as well as all details of their medical history past, present, and future. Patients’ medical records are not subject to government surveillance, particularly on site for in-the-field surveillance.

What is the annual operating budget of the ONC, and what is the estimated cost of the ongoing CEHRT surveillance and the ONC-ACBs? This must be struck.

Who will bear the ongoing cost of hardware, software, coding updates and upgrades? What is the projected cost of this to all parties? (For example, when will ICD-11 and so forth be implemented?) Who pays for this type of ongoing expense that takes resources from actual patient care?

4.What is the projected cost of the massive expansion of 3rd party intermediaries to collect, analyze, and report patient data including the self-nominated QCDR’s, Health IT vendors, qualified registries, and CMS-approved survey vendors? Who bears this cost burden? The money would be better spent on patient care.

The random CMS audits of such data, including patient medical records, are unacceptable. The last thing we need is layer upon layer of new administrative costs and potential data breeches. The fact that CMS wants the data kept for 10 years at minimum to eternity with 30 day notice is unacceptable. All the surveillance and auditing begs the question-who don’t you trust. Adding new layers of intermediaries adds new layers of mistrust.

5.With regard to the Other-payer and All-payer options- CMS is expanding its scope of power to incorporate commercially insured patients and their data under the agency’s control, not just Medicare. All patients and all insurers are not subject to CMS jurisdiction. This must be delayed.

6.The collection of MIPS and Non-MIPS data by 3rd party intermediaries like the QCDRs and Health IT vendors of All patients and all insurers is beyond overreach and must not be sanctioned. This must be debated at length and defined succinctly.

7.The definition of EC’s and EPs cannot continue to be modified. This changes the scope of power for many and results in overutilization of resources by midlevel clinicians and increased potential risk for patients.

8.The power of the Secretary to reweight categories is risky and should be limited and defined

.9.As far as capitation, if the HMOs failed, as have many of the co-ops and ACO’s, what evidence points toward successful APMs going forward?

10.The operational feasibility by January 1, 2017 is 0 to none. Delay.

11.The public reporting of physicians CPS’s is misleading and oppressive and must be eliminated.

12.According to P28, the Innovation Center works directly with CMS and has collaborated with these federal agencies: CDC, HRSA, AHRQ, ONC, ACL, HUD, ACF, SAMHSA, and “colleagues throughout the federal government” to test new models and execute mandated demonstrations. This is far too much federal agency intrusion and risk for data breech, individual targeting, and worse when considering the army of 90,000 IRS agents. These agencies must be restricted form interfering with the practice of medicine by agency proxy. Patients’ data must be protected from intrusion by so many potential data seekers.

In conclusion, MACRA and its rules create a whole new level of intermediaries with associated expense. The MACRA, MIPS, and CPS rubric are convoluted, subject to change on a whim, expensive, and unnecessary. Application of this theoretical, untested, system to all patients and all insurers to collect all data, MIPS and non-MIPS, using a new level of intermediaries overseen by ONC and CMS without patient or physician authorization is not an acceptable plan. This unnecessarily complicates and increases administrative cost and resource utilization instead of facilitating and improving patients’ care.

Exclude the multitude of federal agencies from interfering in healthcare. Simplify and consolidate government agencies. Encourage individual patient responsibility and transparency. Limit dependency on Medicaid. Medicare must be reformed, but this isn’t the way to success. Instead, uncouple PART A from Social Security, create voucher option for Part B, and allow patients to choose and purchase their own plans if so desired. Allow a voucher for Part B and allow out-of network billing per patient choice.

This MIPS/APMs MACRA rule is not ready for launch in 6 months. The last thing we need is a rerun of the failed launch of 2013. Do not go forward with MACRA, MIPS, or APMS now. Do not allow ONC-ACBs or other entities access to individually identifiable protected health data.

Thank you and I look forward to working together toward healthcare solutions. I have many specific examples from the trenches of real life practice that will save vast amounts of taxpayer money and more importantly, patients’ lives.

Respectfully Submitted,

Kris Held, M.D.















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