12:30 p.m.: Called same number again and spoke to Kelly, the pharmacy claims coordinator, who informed me that the drug would be approved if I sent in a note indicating that the patient had received clinical benefit from the drug in the past;
2:05 p.m.: Called the same number. This time, spoke to Jennifer. I reviewed the language of my documentation with her, which stated that the patient had responded to treatment and that continued therapy was appropriate. She agreed that this documentation was adequate.
3:30 p.m.: My office received a call from Carrie, a nurse, who informed me that she needed additional documentation to initiate the appeal. I called back three times to discuss, but reached voicemail all three times;
4:25 p.m.: Spoke to Carrie. She recommended that I list all of the medications the patient had failed in the past, even though the drug had been previously approved. She noted that she was just one of three people who would be reviewing the appeal, and she could not predict what they might be looking for.
I will not bore you with the rest of the chronology, because you may not know the lyrics, but you certainly know the tune. The peer-to-peer review is an interesting concept; it implies that your insurance company is ready to serve as the guardian of sensible prescribing practices, defending the patient from the wanton prescribing practices of the rheumatologist. I have not yet met the Evil Rheumatologist who lives for the sadistic pleasure of starting patients on nonsensical drug regimens, but perhaps he or she lurks among us. For most of us, however, the risks associated with these medications are enough to keep our prescribing practices in check.
Physicians Respond
Stmool / SHUTTERSTOCK.COM
We’ve all been there: You glance at your clinic schedule and see a name that gives you a feeling of dread, because you know you are failing the patient. Generally, these patients fall into one of two categories: Maintaining the patient’s remission requires an unconscionable amount of steroids, or the patient continues to relapse despite your best efforts. You know what you need to try next, but you are equally certain that it will be a battle, because the drug you have in mind is too new, too expensive or both. What do we do now?
Sometimes, we lie. I know this because in 1999, Daniel Sulmasy conducted a study in which he contacted 471 randomly selected physicians and presented them with a number of hypothetical scenarios.1 With each scenario, participating physicians were asked if they would be willing to use incorrect or ambiguous documentation to ensure the patient would be able to obtain a procedure that he or she needed. Of the 169 physicians who responded to the survey, approximately half thought that some form of deception was justifiable if the patient required coronary bypass surgery, arterial revascularization or intravenous pain medications.
We lie, but we feel guilty about lying. In Sulmasy’s study, a quarter of respondents indicated that deception was never justifiable. Of the physicians who thought that deception could be justified, many wrote long, free-text comments justifying that deception. One interesting theme emerged: physicians who worked in areas with high penetration of managed care markets were more likely to condone bending the truth. “This finding is consistent with the hypothesis,” Sulmasy writes, “that, as managed care brings more restrictions to a market, physicians practicing in that market become more willing to support deception as a means of circumventing these restrictions.”
The more things change, the more they remain the same. In 2013, the ACR’s Committee on Ethics surveyed members to identify ethical issues that affected rheumatologists. Not surprisingly, many of the respondents identified “embellishing coding … as a way to obtain medications who would otherwise not be covered by their insurance” as an important ethical issue.2 In fact, over half of respondents noted that “the high cost of treatment for patients” was the most common ethical issue that they encountered.
Ethics aside, the legal term for bending the truth to obtain a drug or a service for your patient is fraud. It also shouldn’t be necessary. Will Harvey, MD, MSc, member-at-large of the ACR’s Board of Directors, went to Washington on Feb. 7, 2018, to explain this to the U.S. Senate Special Committee on Aging.3 In his testimony, he explained truths that, to us, are self-evident:
“If a provider wishes to prescribe a medication that is not preferred … the provider must go through an escalating appeals process that may involve talking to a clerk, a pharmacist, a nurse, a ‘peer review’ (another MD, but typically not a rheumatologist), a same specialty review, and in the case of Medicare, an Administrative Law Judge. Each of these steps may take 10–30 minutes, during which time the provider is taken away from caring for other patients. … Policies requiring that a provider try therapies in a specific order are referred to as step therapy or fail first protocols. [T]hese are primarily based on cost rather than efficacy.” 4
ACR President David Daikh, MD, PhD, carried the same message to the Department of Health and Human Services, in response to its request for “identification of actions that states or the federal government could take to support the development and operations of a health care system that provides high-quality care at affordable prices for the American people.”5
In his statement, Dr. Daikh made the following recommendations to the Centers for Medicare and Medicaid Services:6
- Ensure that peer-to-peer reviews are conducted with a physician in the same subspecialty as the prescribing physician;
- Restrict prior authorization to physicians whose prescribing practices differ significantly from their peers;
- Publicly disclose all drugs that are subject to restrictions, and provide this information through electronic medical records.
Too Much Transparency?
Dr. Daikh’s and Dr. Harvey’s recommendations speak to the importance of transparency to make healthcare coverage work. With the system we have now, it is almost as if we are all learning to play chess without the benefit of knowing the rules. We learn the rules on the fly, by watching as our pieces are taken from the board and resolving not to make the same mistake twice. We learn to overdocument and undertreat, using regimens that we know are doomed to failure, because we must demonstrate that failure to gain access to the drugs that might actually help our patients.
This implies, of course, that there are rules. This commonly held assumption may require reexamination. This reexamination was initiated by a young man named Gillen Washington, a 24-year-old college student who happens to have common variable immunodeficiency and requires routine treatment with intravenous immunoglobulin.7 His treatments were approved, until suddenly, they were not. Mr. Washington’s appeals had fallen on deaf ears.
It turns out that Mr. Washington’s appeals had fallen far short of the ears in question, which belonged to Jay Ken Iinuma, MD, who was the medical director for Aetna for Southern California at the time. Dr. Iinuma was charged with reviewing and, ultimately, denying Mr. Washington’s appeal for intravenous immunoglobulin. Indeed, Dr. Iinuma’s signature appears at the bottom of the denial for preauthorization that Mr. Washington had received.
The trouble is that Dr. Iinuma denied Mr. Washington’s appeal without having reviewed it. Mr. Washington sued Aetna for “reckless withholding of benefits,” and as part of the lawsuit, Dr. Iinuma was deposed. During the deposition, Dr. Iinuma admitted that he had never reviewed Mr. Washington’s records. He knew this because during his time as the medical director for Aetna, he had not reviewed any patient’s medical records. We apparently should not find this concerning, because he also admitted that he did not know anything about common variable immunodeficiency and did not know the consequences of stopping therapy.
With the system we have now, … [w]e learn to overdocument & undertreat, using regimens that we know are doomed to failure, because we must demonstrate that failure to gain access to the drugs that might actually help our patients.
The mind reels. We have all complained—privately and not so—about implacable insurance companies making arbitrary or ill-reasoned decisions, but I wonder how many of us suspected that these decisions were not reasoned at all. And yet, this seems like a natural extension of what we already knew to be true. Of all the times I have received a rejection of preapproval from an insurance company, I wonder how many times the undersigned recognized (or could even spell) granulomatosis with polyangiitis. Treating rheumatic diseases is challenging even for rheumatologists; it is difficult to imagine that every medical director of every insurance company is actually a peer.
Even if Dr. Iinuma had reviewed every page of Mr. Washington’s medical record, it seems doubtful that it would have changed his decision. That possibility was precluded by Dr. Iinuma’s lack of understanding of the patient’s illness and lack of interest in learning about the condition before rejecting a therapy that, by his own admission, he knew nothing about. Dr. Iinuma cannot be the first medical director to sign off on a decision that he was not qualified to make; he was just the first to be caught.
Aetna is now under investigation by California Insurance Commissioner Dave Jones, who told CNN, “If the health insurer is making decisions to deny coverage without a physician actually ever reviewing medical records, that’s of significant concern to me as insurance commissioner in California—and potentially a violation of law.”8
The Way Forward
Mr. Washington had the right idea. If a patient’s insurer makes a decision that seems to lack foundation, it may be time to call for an external referee. Instead of taking the insurance company to court, you may want to start by involving your state’s insurance commission. Truly egregious cases can be referred to your state’s attorney general. Either might help encourage the insurer to do the right thing. Longer term, however, we need more than better enforcement of existing laws; we need better laws.
In a time during which Congress seems increasingly paralyzed by complexity, it will likely be the states that will lead the way. With the recent revelations regarding Aetna’s preapproval review/nonreview practices, patients across the country are likely starting to wonder how carefully their records were scrutinized before their request for a biologic (or another inconveniently expensive intervention) was rejected. Colorado, Washington and Connecticut have already initiated their own reviews of Aetna’s practices, and other states are bound to follow suit.8
Over the next several months, we are likely to get a crash course in how insurance companies actually make the decisions that impact so many of our patient’s lives.
Biosimilars were supposed to have rendered most of these issues moot. Alternatives to brand-name biologics creates competition, and competition lowers prices. Lower prices remove the profit motive for the preapproval process, and insurance companies would move on to bigger game. Quod erat demonstrandum.
So what happened? For all their promises, biosimilars have had trouble establishing a foothold in the U.S. Of the 240 biosimilars in development, only nine have been approved by the U.S. Food and Drug Administration, and only three are now in use.9 It gets worse: I defy you to find a colleague who has deliberately switched a patient to a biosimilar.
Part of the problem is the birthing process associated with new statutes. Legislators may write the laws, but it is up to the courts to determine what the laws mean. There are now multiple lawsuits winding their way through the American court system, each designed to prevent biosimilars from seeing the light of day. These delays cost money. Add to this uncertainties regarding intellectual property, and the costs continue to mount. Thus, in the U.S., use of a biosimilar may save an insurance company only 15% of the costs associated with using the brand-name originator, a cost savings that is easily offset by the sweetheart discounts engineered by insurance companies for steering patients toward biologic X, rather than biologic Y.10 Ironically, patient assistance programs contribute to the problem by making it cheaper for many patients to continue to take brand-name biologics, rather than transition to a biosimilar.
Of the 240 biosimilars in development, only nine have been approved by the U.S. Food & Drug Administration, & only three are now in use. It gets worse: I defy you to find a colleague who has deliberately switched a patient to a biosimilar.
Eventually, statute will be turned into precedent, and once a clear pathway from development to market has been carved by the courts, the cost savings should start to emerge. In Sweden, for example, the availability of anti-TNF biosimilars has caused the price of drugs in this class to drop by 39%; prices in the U.S. will eventually follow suit.11 The Rand Corporation estimates that the use of biosimilars will lead to $54 billion in healthcare cost savings from 2017 to 2026.12 We can only hope.
Scratch that. We can do more than hope. We can also act, by supporting advocacy by direct action or through investment in RheumPAC. Unbeknownst to many of us, the Government Affairs Committee and the Committee on Rheumatologic Care have advocated on our behalf for legislation to deter step therapy, mandatory drug switching, onerous prior authorizations and tiering of medications. These efforts will eventually benefit all of us, patients and physicians alike.
Until then, we need to remind our patients to vote with their pocketbooks. Most of our patients are unaware of the uncounted minutes we spend to ensure they can receive the drugs they need. They don’t know because we do not tell them, because it seems unseemly to complain.
Many patients will have no choice in their insurance carrier, and for them, we will do what we must. Others may be able to speak to their employers about how their current options are failing them; I have had patients who have convinced their employers to drop or add carriers to address their need for medical insurance that will support patients who need more than just the occasional visit for the common cold. Otherwise, most patients who receive medical insurance through their employers will have an annual opportunity, typically during autumn, to change their carriers. We should remind our patients to take advantage of these opportunities to ensure that their coverage matches their needs.13 Their lives may depend on it.
Philip Seo, MD, MHS, is an associate professor of medicine at the Johns Hopkins University School of Medicine, Baltimore. He is director of both the Johns Hopkins Vasculitis Center and the Johns Hopkins Rheumatology Fellowship Program.
References
- Freeman VG, Rathore SS, Weinfurt KP, et al. Lying for patients: Physician deception of third-party payers. Arch Intern Med. 1999 Oct 25;159(19):2263–2270.
- MacKenzie CR, Meltzer M, Kitsis EA, Mancuso CA. Ethical challenges in rheumatology: A survey of the American College of Rheumatology membership. Arthritis Rheum. 2013 Oct;65(10):2524–2532.
- Patients have no more skin to give: Dr. William Harvey testifies on rheumatology issues before Senate Committee. The Rheumatologist. 2018 Feb 16.
- Harvey WF. Testimony before the Senate Special Committee on Aging. 2018 Feb 7.
- Department of Health and Human Services. Promoting healthcare choice and competition across the United States: Request for information. 2018 Jan.
- American College of Rheumatology. ASPE-Healthcare Choice RFI. 2018 Jan 25.
- Drash W. CNN exclusive: California launches investigation following stunning admission by Aetna medical director. CNN. 2018 Feb 11.
- Drash W. Aetna inquiry widens over ex-medical director’s comments. CNN. 2018 Feb 16.
- Nowogrodzki A. How can the U.S. catch up on biosimilars? MedCity News. 2018 Feb 16.
- Mortimer R, White A, Frois C. Will ‘biosimilar’ medications reduce the cost of biologic drugs? Not necessarily. Scientific American. 2017 Mar 9 .
- QuintilesIMS. The impact of biosimilar competition in Europe. European Commission. 2017 May.
- Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: Initial experience and future potential. Rand Corporation. 2018 Feb 19.
- Make sure you’re covered for your biologic medicine! Creaky Joints. [n.d.]
