BB&T Washington Editor and Staff Reports

As many are aware, local carriers – not the Centers for Medicare & Medicaid Services – make most of the calls for Medicare reimbursement, and CMS announced in May that it may punt to local carriers regarding whether to pay for follow-up scans using FDG-PET for solid tumors and myeloma.

According to the proposed decision memo, posted on the CMS web site May 6, the agency concluded “that the current absolute restriction is not supported by the available evidence“ and that local carriers “will have discretion to cover (or not cover) . . . any additional FDG-PET scan for . . . therapeutic purposes.“ The agency indicates it will issue a final decision memo by Aug. 4.

CMS removed the evidence development requirement from initial coverage of this procedure for solid tumors early last year. At the time of the April 2009 announcement, CMS had opted to cover FDG-PET for follow-up scans for cervical and ovarian cancers, but left solid tumors and myelomas off the list for coverage of follow-up scans. The decision effectively forbade reimbursement for follow-up scans.

A number of providers chimed in, including Renee Moadel, MD, of the Albert Einstein College of Medicine (New York), who asked in a Dec. 9, 2009 letter to CMS why, “after nearly a decade of approval by the FDA, that Centers for Medicare and Medicaid Services has not broadly approved PET and PET-CT technology for cancer patients?“

Moadel argued that CMS's reliance on the National Oncologic PET Registry to establish the validity of FDG-PET for tumor tracking is conspicuous given that other novel technologies were able to “slide through without microscopic attention.“ She also stated that repeated surgeries and treatments with radiation and chemotherapy carry their own morbidities and mortalities and asked whether “cancer patients [are] second class citizens,“ closing with the comment that this is “certainly the perception when it comes to CMS reimbursement for PET imaging.“

Taking a different tack was Carmella Bocchino, executive VP for clinical affairs and strategic planning for America's Health Insurance Plans (AHIP; Washington), who stated in a Dec. 9, 2009, letter to CMS that member firms are of the view that PET studies “are often associated with false positives and negatives, as well as potential harm of additional exposure to radiation, and therefore should be utilized only when there is demonstrated clinical need.“ Bocchino stated further that the association does not support coverage of additional scans “without sufficient evidence that a second test is necessary to make treatment decisions and that these decisions improve health outcomes.

Shawn Farley, director of public affairs for the American College of Radiology (ACR; Reston, Virginia), told BB&T's sister publication, BB&T in an e-mailed statement, “this is just a proposed determination, but the ACR believes this would be a positive development over the current situation.“ Farley said ACR “will be providing further comment to CMS.“

OIG okay with imaging pre-auth service

Fans of healthcare cost containment are no fans of the “pay-and-chase“ approach to control of inappropriate imaging exercised by the Centers for Medicare & Medicaid Services, but private Medicare payers can require preauthorization. The Office of Inspector General at the Department of Health and Human Services recently received a request suggesting that imaging providers are horning in on the radiology benefits management business.

In an April 30 decision memo, OIG states that it has no intent to interfere with a proposal by “several imaging providers to offer free insurance preauthorization services to patients and physicians.“ In this arrangement, a medical center operating two community hospitals and a not-for-profit clinic operation with free-standing outpatient imaging centers would offer pre-authorization services to a physician group practice alongside its own in-house pre-authorization work.

OIG states that it makes a distinction between “a provider that offers free items and services that are integrally related to that provider's services and those that are not,“ using the example of a diagnostic lab that lets a doctor's office use a computer that can be used only to print out the results of diagnostic tests. This is seen as less than problematic because this computer would offer no value to the physician practice “apart from the service being provided“ by the lab.

While OIG notes that a free pre-authorization service frees up resources for the physician practice and hence may provide savings, the arrangement described by the relators is such that the agency sees the arrangement offering “a low level of risk“ of influence of referrals.

One of the reasons OIG is disinclined to worry about the idea is that the arrangement “would not target a particular referring physician“ and another is that each referring physician is likely to bill more than one payer. Also, physicians are able to use the service regardless of the volume of usage.

The service would entail no payments to doctors as well, another reason OIG is disinclined to interfere, but the memo also notes that the imaging centers are the only entity that has a direct financial interest in the outcome of the pre-authorization, an imperative that is “wholly distinct from a scheme to curry favor with referral sources.“

Transparency draft would disclose PMAs, 510(k)s

FDA released in May a draft proposal for the public transparency initiative in a 67-page document that covers 21 recommendations, many of which would shine a brighter light on the interactions between the agency and device makers, but the task force takes the position that companies that keep their compliance up to par will benefit. However, the proposal to require disclosures of applications for PMAs and 510(k)s might make smaller device makers nervous for the same reason that provisional patent applications make small inventors nervous: it may serve as an opening for larger firms to swoop in and shove aside the smaller company.

The guidance states that FDA should immediately disclose when it receives an application for a device – or other healthcare product – upon receipt of the application because to do so would “ease some of the current frustration“ experience by patients who contact the agency about whether such products exist. The task force attributes the frustration to FDA's inability to disclose some such information to patients who are “awaiting a treatment for a particular disease.“ This would also apply to applications for expanded indications for a therapeutic product. However, labeling changes would not be subject to such disclosures under the task force's recommendations.

The task force recommends that FDA disclose the receipt of investigational applications as well, and conversely, the non-existence of applications for a particular drug, biologic, diagnostic or device. The justification for this kind of disclosure is that it would “reduce public confusion about the development of a particular product“ that is the subject of an investigational application, although the precise source of this purported confusion is not explained. However, the guidance notes that such disclosures might aid enrollment in those trials.

It may come as no surprise to industry that the task force recommends more rapid disclosure of adverse events reports, but industry might not have anticipated that the recommendation would include that such data would be posted in a searchable online database with software that can generate reports about the outcomes. The guidance also acknowledges that it could be misleading “to disclose the frequency of adverse events“ without providing some context as to the total numbers who received the drug or device, but states that FDA might not have such information on hand.

The task force also recommended that FDA enforcement reports disclose instances in which the Department of Justice is in pursuit of enforcement action against a firm that is regulated by FDA. The rationale here is that consumers are entitled to information dealing with public health and that such information “may have a deterrent effect“ on other companies.

Another suggestion is that the agency ought to disclose the inspectional status of device firms, along with firms making drugs and biologics as well as entities involved in clinical trials, although the task force recommended that such reports be handled “so as not to interfere with planned enforcement actions.“ Again, the incentive is to push firms to correct violations quickly and to provide an incentive for entities to keep their operations in compliance in the first place.

Janet Trunzo, executive VP for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington), told BB&T in an e-mailed statement, that the association's staff are “still reviewing the details of the draft transparency proposals and will be providing detailed comments on FDA's transparency recommendations“ at a later date.

Trunzo said that while AdvaMed “applaud[s] FDA's focus on transparency“ and that “improved transparency can reinforce public confidence in the agency,“ she nonetheless stated “that care must be taken to protect companies' proprietary information.“ This concern, she said, is raised by the task force's proposal to “disclose information on investigational device exemptions, 510(k) submissions, and premarket approval applications that are still under review.“

Survey: Lawsuit fears hinder new med-tech

Doctors are so afraid of being sued that many of them hesitate to try new approaches, and delay the adoption of new medical technology or drugs, according to a recent national survey on defensive medicine by Jackson Healthcare (Atlanta).

Bob Schlotman, VP of marketing at Jackson, told BB&T that the firm's survey revealed that physicians tend to hold off on adopting new devices, procedures, or drugs, because they don't want to be viewed as “learning on a patient.“ “Physicians are afraid of exposing themselves to a lawsuit,“ Schlotman said.

More than half (53%) of survey respondents said they had delayed adopting medical innovations such as new pharmaceuticals, procedures and medical devices due to fear of litigation, Jackson Healthcare reported. According to the survey, surgery subspecialists (66%) and OB/GYNs (63%) are most likely to delay the adoption of medical innovations, while pediatricians (27%) are least likely.

“I practice defensive medicine by avoiding the practice of those procedures which might benefit my patients, but are considered too risky by my malpractice insurer and would increase my premiums to a degree that is prohibitive,“ wrote one physician, who cited joint injections as an example. Another physician wrote, “anything 'new' exposes you to the accusation that you are 'learning' on this patient . . . “

In March, Jackson Healthcare conducted a web-based survey of 1,407 physicians. The firm reported a response rate of 1.13% from the 124,572 invitations distributed. The survey has an error range of ±1 .7%, at the 95% confidence level, Jackson Healthcare noted. “Delayed adoption of new medical advancements is another serious consequence of our culture of litigation, which is unique to the U.S.,“ said Richard Jackson, CEO/chairman of Jackson Healthcare. “As long as our physicians remain personally financially liable for mistakes, we will continue to feel the impacts of defensive medicine.“

Jackson said the adverse impacts of defensive medicine include unnecessary costs, limited access for certain patients, over- and under-treatment of life threatening illnesses and delayed adoption of medical advancements.

Schlotman stressed that Jackson Healthcare's role is to report the data, not to form an opinion on the data, however he did offer his personal thoughts on the survey results. “I think from a medical technology standpoint . . . [companies] have to give physicians, I think, a whole lot more comfort that the medical technology will work,“ he said.

The survey found that 83% of physicians ages 25 to 34 reported being taught in medical school or residency to avoid lawsuits, but the survey also revealed that patients most likely affected by defensive medicine are those requiring surgery, women, and those visiting emergency rooms. In a related finding, Jackson Healthcare noted that surgeons and OB/GYNs are most affected by lawsuits, and that 83% of OB/GYN respondents, 79% of surgeons and surgery sub-specialist respondents, and 68% of emergency room physician respondents have been named in a lawsuit.

Also of interest, 75% of the doctors surveyed say that defensive medicine will impact the physician shortage by decreasing the number of U.S. doctors. This survey was the third in a series of national physician surveys Jackson Healthcare conducted between October 2009 and March 2010 in an effort to quantify and qualify physician attitudes, perceptions and recommendations regarding healthcare reform and defensive medicine practices.

According to Jackson Healthcare, physicians estimated that between $650 billion and $850 billion is spent each year on medically unnecessary tests and treatments in an effort to avoid lawsuits. In addition, significant consequences surfaced beyond wasted costs, consequences negatively impacting the physician/patient relationship, the firm noted.

“Our lawsuit-driven healthcare system allows personal injury lawyers to dictate how doctors treat patients. That's completely backwards,“ Jackson says. “We need real, comprehensive reforms that will end the lawsuit abuse lottery and remove the barriers that contaminate the physician-patient relationship.“

A solution to the problem, according to Jackson, is a three-step approach to ending lawsuit-driven medicine:

• Eliminate personal financial liability for physicians' unintended errors, so they can treat patients based on what is needed, not out of fear of a lawsuit;

• Create independent, expert medical review boards to review claims and determine if negligent treatment has been provided to the patient;

• Establish separate boards to award consistent, fair compensation to wrongfully injured patients.

“I believe this new approach would promote physician accountability and establish medical facts – not lawsuits – as the basis of our nation's approach to healthcare,“ Jackson wrote. “This approach will end the lawsuit lottery and outlandish judgments that go beyond reason and drive up costs for everyone.“

CREST shows similar results for stenting, surgery

Armed with data from the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), published in May in the New England Journal of Medicine, Abbott (Abbott Park, Illinois) says it plans to ask the FDA to expand the approved indication for its Acculink carotid stent system to treat patients with carotid artery disease who are considered standard risk for surgery.

In the trial, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women, Abbott noted. Adverse event rates of death, stroke and heart attack were also similar for both therapies. Abbott's Acculink carotid stent system and Accunet embolic protection system were used in the study, which was sponsored by the National Institute of Neurological Disorders and Stroke and funded partly by Abbott.

“Based on the strength of the CREST data, we plan to file an application in the U.S. by the end of this year seeking an expanded indication for the Acculink carotid stent system to treat patients with carotid artery disease who are at standard risk for surgery,“ Robert Hance, senior VP of vascular at Abbott, said in a company statement.

Jonathon Hamilton, a spokesman for Abbott, told BB&T that the reason CREST is such a landmark study is because it was done in patients who are at standard risk for surgery. Currently, all the FDA approved carotid stent systems are indicated only for patients who are considered to be at high risk for surgical treatment due to anatomical factors, age or other considerations, he noted. According to Abbott, the majority of patients with carotid artery disease are not part of this high-risk group, and therefore are not within the current FDA indications for carotid stenting.

The Society for Cardiovascular Angiography and Interventions (SCAI; Washington) released a statement emphasizing the importance of the CREST study, which found carotid artery stenting (CAS) is equally safe and as effective as carotid endarterectomy (CEA) for stroke prevention. According to the SCAI, the study is the largest and most rigorous randomized stroke prevention trial ever undertaken, and its findings are the strongest evidence to date for clinical equality and long-term durability (out to four years) of both therapies.

“CREST represents a landmark trial. The most important finding is that both strategies – CAS and CEA – produce excellent results in patients at risk for stroke, and carry similarly low procedural risk,“ said Kenneth Rosenfield, MD, an interventional cardiologist and section head for vascular medicine and intervention at Massachusetts General Hospital (Boston).

According to Abbott, CREST demonstrated results consistent with American Heart Association (Dallas) guidelines for outcomes in patients with a severe carotid stenosis. These guidelines state that rates of death and stroke for carotid artery surgery within 30 days of the procedure be less than 3% for asymptomatic patients and less than 6% for symptomatic patients. The study showed equivalent low rates of adverse events for either procedure in the 2,502 patients studied, with 6.8% of surgery patients and 7.2% of stenting patients experiencing a primary endpoint of death, stroke or heart attack event in the periprocedural period (during the procedure and within about 30 days thereafter) and ipsilateral strokes up to four years after the procedure (mean follow-up of 2.5 years).

In the periprocedural period, 5.2% of surgery patients and 4.5% of stenting patients experienced any of these adverse events, with a rate of stroke of 2.3% in the surgical patients and 4.1% in the stenting group, and a rate of heart attack of 2.3% in the surgical group and 1.1% in the stenting group. After the periprocedural period, the incidence of ipsilateral stroke was similar for stenting (2%) and surgery (2.4%).

The rate of cranial nerve palsy during the periprocedural period was 4.7% for the surgical group and 0.3% for the stenting group (representing crossover stenting patients who also underwent the surgical procedure). Cranial nerve palsy refers to a temporary injury of the nerves that run close to the carotid artery, potentially causing difficulty with speaking, swallowing and facial expressions. It is not a complication of stenting, Abbott noted.