Imagine you are a 62-year-old diabetic patient who’s been in a car accident and you are on the way to the hospital for emergency spine surgery.
The surgeon determines you need spinal instrumentation and fusion, but he’s worried about your ability to generate bone growth given your diabetes and other comorbidities. He determines that the risks of harvesting bone graft are too high and that, in his best medical judgment you are a good candidate for BMP (bone morphogenetic protein) to promote bone growth and fusion—but in your case such a use would be “off-label”.
In Minnesota, Blue Cross Blue Shield (BCBS) is threatening to deny your entire treatment from the car accident if your surgeon uses BMP off-label.
Off-Label Usage and Coverage
The FDA has approved two BMPs and associated carrier/delivery systems. One is osteogenic protein-1 (OP-1) consisting of rh-BMP-7 and bovine collagen, which is reconstituted with saline to form a paste. The addition of carboxymethylcellulose forms a putty. The other is the Infuse system which consists of rhBMP-2 on an absorbable collagen sponge carrier.
But because the BMP used in the emergency surgery was used off-label, the insurance carrier calls you soon after and says the spinal surgery you just had, and all the associated expenses will not be paid because your surgeon used the BMP off-label.
That’s what Blue Cross Blue Shield of Minnesota (BCBS MN) set in motion when the insurer issued a new coverage decision (policy number IV-85) effective on November 13, 2011. The policy stated the following:
“When BMP is used for indications that are considered investigative or not medically necessary, any procedures performed in conjunction with BMP will not be covered. This includes, but is not limited to, professional, facility, and anesthesia services as well as supplies.”
Surgeons Cry Foul
Surgeons from the Scoliosis Research Society (SRS) and International Society for the Advancement of Spine Surgery (ISASS) responded to say the insurer has crossed the line.
“They’re trying to force us to practice yesterday’s medicine tomorrow, to maximize insurer’s profits today, ” said SRS member and University of Minnesota spine chief David Polly, M.D.”
Polly told OTW that when a spine surgeon fixes a patient who has a complex problem, he or she uses a series of surgical approaches, various screws, rods and cages, and bone graft. “The use of BMP is only a very small part of the surgery and treatment process. Emerging data in complex cases suggests that it may help many people avoid the need for repeat surgeries if the bone does not heal. The use of BMP may constitute 5 minutes of a 10-hour surgery and a full-week hospital stay. The BCBS policy would deny payment for the entire hospitalization.”
Tom Errico, M.D.“They [BCBS MN] are directly interfering with the doctor/patient relationship here and are (de facto) attempting to practice medicine without a license, ” added Tom Errico, M.D. former president of both ISASS and the North American Spine Society (NASS). He’s currently heading the nascent International Advocates for Spine Patients (IASP) along with ISASS colleague, Gunnar Andersson, M.D. “This coverage policy is exactly why patients need their physicians standing up for them.”
OTW contacted the insurer on March 6 and asked if the surgeons were right and if the policy went too far?
Blue Cross Blue Shield Considers Revisions
We received this reply from Blue Cross Blue Shield of Minnesota on March 7:
“All medical policies are written with the goal of ensuring the safest and most effective care for our members. We are taking feedback on our BMP policy under advisement and will consider making immediate revisions if the current language has unintentionally created confusion about approvals for other covered services.”
Commenting on the BCBS MN response, Errico told OTW that surgeons have to remain vigilant and respond immediately and forcefully with the best interests of the patients at heart. “They [the insurers] will learn to go elsewhere to save money. Spine surgeons simply cannot continue to keep their heads buried in the sands of clinical work and not pay attention to the whirling winds around them.”
Nontransparent and Ill-Defined Process
In a joint letter, SRS and ISASS say their concerns with the new policy were twofold.
Their first concern involves the “lack of a transparent and clearly elucidated rationale for the decision to severely restrict access to BMP.” The societies write that a critical tenant of evidence-based decision making is that the methodology and process are available for review and discussion. “We strongly believe that this approach must be applied in a fair and uniform manner. It is unreasonable to hold physicians to a standard of transparency and academic rigor if [BCBS MN] is permitted to make payment decisions based upon a nontransparent and ill-defined process.”
Punishing Patients at Risk
Their second concern is over the policy itself, which they believe to be “completely unjustified and inappropriate.” They say the policy puts patients with severe and complex spine deformities for which BMP may be a necessary component of their treatment regimen at risk for inadequate medical care. “Whether or not [BCBS MN] of Minnesota finds it necessary to restrict payment for a device that it deems too costly, it is unconscionable to use that as a basis in denying payment for the underlying medically necessary procedure.”
David Polly, M.D.Polly doesn’t buy the reported rationale for this denial as being simply about off-label use. He told OTW that the FDA has specifically stated that the agency does not regulate physicians’ practice of medicine. The FDA only regulates how companies can advertise their products. Physicians are free to do what is best for their patients.
Off-label use can, sometimes, even be the standard of care. He noted that the initial use of aspirin to prevent heart attacks and strokes was off label but the standard of care. Oftentimes the use of medical devices, potentially even lifesaving use in children, is off label because there is not a business case to be made for the companies to do the studies in children since the companies will never get a return on their investment. He added that cancer chemotherapy for unusual or advanced cancers are often off label but may be the only hope for patients in these settings.
“BCBS [BCBS MN] could have taken a number of steps, ” says Polly, ” that would have been reasonable. They could have partnered with physicians to create a registry of off-label use and looked at the results. They could have created a category of coverage with evidence determination where the physician could use the product but have to report the outcomes back to BCBS [MN]. They could have chosen to say that they would pay for everything except the BMP and put the physicians and hospitals at the financial risk for the decision.”
“But instead they have chosen to fully deny coverage for the standard of care practice when there is only a very small variation in that care that physicians do to improve patient outcomes. Physicians do not get paid any extra money for the use of BMP; in fact they get paid less than if they harvested the patient’s own bone, a procedure which causes its own pain and morbidity. BCBS of MN did not ask for input from the professional medical associations on this decision. They have specifically refused to talk to key opinion leaders and academics on this topic.”
Profit Enhancing Strategy?
“So, ” concluded Polly, “one is left to draw the conclusion that BCBS [MN} did this as a pure profit enhancing strategy. Patients may think that when they pay for an insurance policy that this will cover the treatment that their doctor thinks is best for them, clearly this decision demonstrates otherwise. Insurance companies ARE regulating the practice of medicine right now!”
Interfering With Doctor/Patient Relationship
Errico is not a big fan or user of BMP. If anything, he says he’s biased against BMPs.
“But BCBS MN has crossed the line. This should be about the relationship between a patient and his doctor who is ethically and morally bound to do what’s in the best interest of the patient.”
“With this policy, ” said Errico, “the insurance company is punishing patients for using BMP. This policy is directly interfering with the doctor/patient relationship and is going down a very slippery slope and sets a dangerous precedent.”
Need for Structured Responses
Errico said surgeons respect the needs of insurers to spend money based on the “best practice of medicine”. He added, “Let’s all agree however that this is NOT best accomplished by unilateral, arbitrary, punitive insurance directives but by insurers collaborating with the medical professional societies to arrive at justifiable practice guidelines when confronted with clinical cost effectiveness dilemmas.”
Polly added this latest episode of coverage denial in one state is a good demonstration of the lack of a structured recourse mechanism for surgeons to be alerted to and respond to various private carriers across the country. He said the staffs of national surgeon societies don’t always focus on states. He pointed to the IPAB (Independent Payment Advisory Board) as another example of why societies need to develop such a structured mechanism to respond to payer challenges of physician-directed medical decisions.
Hopefully, the medical societies are listening.
