“Milliman made me do it.”
That’s what an increasing number of spine surgeons say they are hearing from insurance reviewers who are denying coverage for fusion procedures the surgeons deem necessary for their patients.
It has the feeling of the immovable object of guidelines meeting the irresistible force of medical judgment.
Milliman Care Guidelines
Who and what is Milliman?
Milliman Care Guidelines LLC, is a Milliman Company that independently develops and produces “evidence-based clinical guidelines used by more than 1, 800 clients, including more than 1, 000 hospitals and 7 of the 8 largest U.S. health plans, ” including, reportedly, CMS.
The Milliman Care Guidelines are updated annually and products include: Ambulatory Care, Inpatient and Surgical Care, General Recovery Guidelines, Recovery Facility Care, Home Care, Chronic Care Guidelines, and Behavioral Health Guidelines. These products support, according to the company, “the healthcare management of a majority of Americans.”
Milliman is among the world’s largest independent actuarial and consulting firms. Founded in Seattle in 1947 as Milliman & Robertson, the firm has more than 50 offices worldwide, and employs more than 2, 400 people in healthcare, employee benefits, property and casualty insurance, life insurance, and financial services consulting practices.
Managing Risk
Insurance companies are in the risk management business. Milliman helps them manage their risk by providing guidelines which are often more conservative than standards of care developed by medical societies, according to device industry insiders.
One surgeon told us that in his experience, reviewing physicians “hide behind the Milliman criteria, stating they are not withholding care, but merely outlining what is covered as a benefit based on Milliman. Reviewers insist they are not defining standards of care, only covered benefits. The patient is free to have the surgery for out-of-pocket payment.”
Some device industry insiders tell us insurers are using the guidelines to deny care for patients to save money.
One Milliman employee told us that if insurers are using the guidelines to deny coverage, the insurer is misusing the guidelines. One industry attorney told us the guidelines are just that, guidelines, not rules. Ultimately the insurer makes the decision about coverage and reimbursement based on the contractual obligations of the patient’s insurance policy.
Guideline Development
Tim Muth is Milliman’s outside counsel. He told us that there is a misperception that because Milliman is an actuarial company, the guidelines are developed by actuaries. In fact, the guidelines are developed by medical professionals hired by Milliman.
According to the company, a team of doctors, nurses, and other clinicians have reviewed more than 100, 000 abstracts, articles, and other sources of evidence and chosen more than 14, 000 unique citations. The company says it uses the findings to “build evidence-based authorization criteria, care pathways, and other care management tools. These decision-support resources enable payors, care providers, and facilities to efficiently and consistently make care decisions grounded in rigorous, up-to-date research. They also assist clients in evaluating current practices and finding opportunities to improve both quality of care and care management.”
Medical Societies
Medical societies we spoke with are not engaged with Milliman in the development of their care guidelines. Some surgeons told us that the company rebuffs society input.
“They (Milliman) are one voice in advising payers, ” said Eric Muehlbauer, Executive Director of NASS, the North American Spine Society. Muehlbauer says that if the Society has an issue with an insurer’s care guidelines, the Society goes directly to the insurer. We were told the same thing by AAOS, the American Academy of Orthopaedic Surgeons.
AAOS sent us a statement that said, “Although management guidelines can lead to better patient outcomes and controlled costs, uniform standards of care can often be overly restrictive and cause harm to patients who don’t fit the mold. The AAOS remains constantly vigilant of insurer misuse of management guidelines and encourage insurers to establish coverage policies that protect the doctor-patient relationship and provide appropriate coverage for those patients who stand to benefit from alternative treatment options.”
Device Manufacturers “Rebuffed”
We heard from some medical device manufacturers that the guidelines feel as if they are created in a “black hole.” Milliman also rebuffs dialog with manufacturers, according to our sources. They point out that the physician editors of the guidelines are not orthopedic or neurosurgeons and covering a wide range of medical procedures can lead to narrow and inadequate research.
One device manufacturer told us that of the 200 healthcare consultants employed by Milliman, only a small handful were physicians – specifically one family practitioner, two internal medicine and one internal medicine/pulmonary medicine physician. James Schnibanoff, M.D., is the editor-in-chief of Milliman Care Guidelines.
Schnibanoff is board-certified in internal medicine and pulmonary medicine. He served as chief medical officer of a San Diego healthcare system and served for three years as chief executive officer of two San Diego hospitals with a combined budget of $250 million.
For an example of the immovable guideline meeting the irresistible medical judgment force, we looked at the Milliman Care Guideline’s 14th Edition specifically for Lumbar Fusion. Here are the major headings for the lumbar fusion section:
Care Planning – Inpatient Admission and Alternatives
- Clinical Indications for Procedures
- Alternatives to Procedures
- Operative Status Criteria
- Preoperative Care Planning
Hospitalization
- Optimal Recovery Course
- Goal Length of Stay
- Extended Stay
- Hospital Care Planning
Discharge
- Discharge Planning
- Discharge Destination
Usual
Alternate
Guidelines v Standard of Care
Chris Bono, M.D.Chris Bono, M.D., was one of the co-authors of the united surgeon society’s response to BlueCross BlueShield of North Carolina’s proposed change to their lumbar fusion policy.
We asked Dr. Bono to review the Milliman Care Guidelines for Lumbar Fusion and give us a hypothetical example where the guidelines are at odds with a standard of care.
“Mrs. X has bilateral leg pain associated with a grade II isthmic spondylolisthesis (less than 50% slip). She has had 10 years of symptoms and has failed many different attempts at nonoperative care. She is functionally limited, is not able to perform her activities of daily living, and is becoming increasingly sedentary. Under the Milliman criteria, she would not qualify for a lumbar fusion.”
David Polly, M.D. was more forceful.
David Polly, M.D.Polly said insurance guidelines are a step towards appropriate use criteria. “However it is not clear how these have been developed. They certainly have not all been done in a scientific, transparent fashion.” Polly says all payers have negative incentives to fund these procedures as they directly cost the insurance company’s money (or profits).
He told us that some insurers are doing a good job at finding appropriate use criteria. But he notes that perhaps the other extreme would be the Milliman criteria, which he understands were, “Developed by a for-profit entity with no transparency and without clear evidence of spine surgeon involvement. Similarly I have never seen any outcomes data as a result of the application of these guidelines/criteria. Are patients better off or worse off as a result? The only data seems to be how much the payers are paying for spine surgery. Is insurance company profitability the appropriate medical care metric? Certainly as a society we have a need for viability of these entities but the degree of their profitability to the detriment of their policy holders is a legitimate topic for detailed public discourse.”
Public Scrutiny
Milliman and the guidelines have rarely come under media scrutiny as we were able to find few references in our media search.
An August 2001 article entitled “Hospital Stay Guidelines: Just Plain Weird” in Medical Economics, pointed out the inaccuracies in the Milliman guidelines as it relates to the number of days a patient should stay in the hospital. The guidelines state that a patient with congestive heart failure should have a one day stay or less, the mean nationwide, at the time, was 5.5 days according to Solucient (a health care research company). Another example was a 1996 protest over Milliman guidelines of 24 hours in the hospital for mothers and newborns following normal vaginal delivery.
Milliman: “Never Replaces Clinical Judgment”
Milliman guidelines, according to the story, come with “warning labels” that states the physician has the last word. “Use of guidelines requires, and never replaces, clinical judgment.” The article also found that insurance companies interpret the guidelines differently and that even within one company it can be reviewer specific. The story notes that Milliman itself does not present the guidelines as clinical practice guidelines or a standard of care.
There is also little litigation involving the guidelines.
According to the article, there were three lawsuits involving Milliman guidelines up to 2001. The first, a class action suit against insurers such as Humana and Ætna accused insurers of using guidelines from Milliman and other companies to defraud patients and doctors. The second was a class action suit against Prudential where patients claimed the insurer wrongly relied on Milliman guidelines to deny them needed care. The third involved four Texas pediatricians who sued Milliman for listing them erroneously as contributors to Milliman pediatric guidelines that they call dangerous.
Milliman’s counsel told us that in none of those cases, from the last century, were the guidelines at issue and he remembers the cases being settled between the insurer and their policyholders.
Industry View
While device industry leaders are understandably reluctant to get into a public fight with insurers, two device leaders with companies deeply tied to the fusion market gave us their views about Milliman.
Alan Milinazzo, president and CEO of Orthofix, told us that it is incumbent on the industry, to collaborate with payers and technology assessment organizations to identify those patients who will benefit the most from our technology. “Having proactive and open dialogue about the data and the supporting evidence for prescribing the therapy is our main objective.”
Alex Lukianov, the chairman and CEO of NuVasive, was combative and told us that his concern about the “negative impact of the Milliman guidelines” is manifest in several ways.
First, access to appropriate care for patients is denied. Second, the guidelines inhibit spine surgeons to practice and provide the best care for their patients. And third, the guidelines “curtail industry from providing innovative products together with a loss of jobs.”
Said Lukianov: “The guidelines in my view are too far reaching and limiting. The vast majority of patients in need of fusion may not qualify for surgery. This is incredulous and appears to be linked solely to the best interests of payers to limit or even eliminate spine fusion as a viable option for patients.”
“The problem with the guidelines is they are being treated as Gospel by the payers and substituted for the judgment and training of a spine surgeon. Who do you want caring for your back? A guideline or the judgment of a skilled surgeon?”
“Overall the Milliman guidelines seem to have slowed down spine market growth by increasing the frequency and hurdles associated with denials…Right now there are too many patients being denied spine fusions.”
This recent focus on guidelines developed by insurance consultants may spur physician societies to push efforts to engage private consultants like Milliman who are involved in “the healthcare management of a majority of Americans.”
