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DWC Updates SJDB Voucher Form

The Division of Workers’ Compensation (DWC) has posted a revised Supplemental Job Displacement Benefit voucher form on its website. The voucher form has been updated to conform to Title 8, California Code of Regulations, section 17303.

The Return-to-Work Supplement Program makes supplemental payments to workers whose permanent disability benefits are disproportionately low in comparison to their earnings losses. To be eligible for the fund, an applicant must have a date of injury on or after January 1, 2013 and have received a Supplemental Job Displacement Benefit voucher.

The following notice has been added to the first page of the voucher: “Because you have received this Voucher and are unable to return to your usual employment, you may be eligible for a Return-to-Work Supplement. You must apply within one year from the date this Voucher was served on you. You should make a copy of the Voucher which you will need to apply for the Return-to-Work Supplement. Details about the Return-to-Work supplement program are available from the Department of Industrial Relations website, or by calling 510-286-0787.”

Claims administrators must use the updated form and no longer need to attach a cover sheet with the above notice to the vouchers when they are issued to injured workers.

Philip Sobol M.D. Pleads Guilty and Agrees to Pay $5.2 Million Restitution

Philip A. Sobol M.D. has signed and filed a Plea Agreement in the United States District Court for the Central District of California. He agreed to plead guilty to a two-count information which charges him with Conspiracy, in violation of 18 U.S.C. § 371, and Interstate Travel in Aid of a Racketeering Enterprise, in violation of 18 U.S.C. § 1952.

In paragraph 3 of the Agreement, he agrees to make payment of half of the agreed-upon forfeited amounts and/or restitution totaling $5.2 million no later than 180 days of the entry of his guilty plea, and the remainder no later than 30 days before his sentencing.

Sobol further agreed to cooperate fully with the United States Attorneys Office, the Federal Bureau of Investigation, the United States Postal Inspection Service – Office of the Inspector General, the Internal Revenue Service, and, as directed by the USAO, any other federal, state, local, or foreign prosecuting, enforcement, administrative, or regulatory authority. This cooperation requires him to respond truthfully and completely to all questions that may be put to him, whether in interviews, before a grand jury, or at any trial or other court proceeding.

In exchange, prosecutors agreed to recommend a reduction in the applicable Sentencing Guidelines.

Sobol specifically admitted in this document that “Beginning in or around 2005, and continuing to in or around April 2013, there was an agreement between two or more persons to commit Mail Fraud and Honest Services Mail Fraud, in violation of Title 18, United States Code, Sections 1341 and 1346 and Interstate Travel in Aid of a Racketeering Enterprise, in violation of Title 18, United States Code, Section 1952(a) (3)” He further agreed that he understands that the total maximum sentence for all offenses to which defendant is pleading guilty is 10 years imprisonment; a 3-year period of supervised release; a fine of $500,000 or twice the gross gain or gross loss resulting from the offenses, whichever is greatest; and a mandatory special assessment of $200.

He agreed that he is “in fact guilty to the offenses” and agreed to a statement of facts stating that he agreed to exchange monetary kickbacks in return for the referral of patients to Pacific Hospital for surgical services paid for primarily through the California Workers’ Compensation System (“CWCS”). In paying the kickbacks and submitting the resulting claims for the surgical services, the conspirators acted with the intent to defraud workers’ compensation insurance carriers and to deprive the patients of their right of honest services. Drobot and other co-conspirators offered to pay kickbacks to doctors and chiropractors in return for their referring workers’ compensation patients to Pacific Hospital for spinal surgeries, other types of surgeries, magnetic resonance imaging, toxicology, durable medical equipment, and other services.

Sobol either performed surgeries on the patients at Pacific Hospital himself, or – particularly in the case of spine surgeries – admitted he referred them to other surgeons, with specific instructions to those surgeons that they were to perform the surgeries only at Pacific Hospital, if possible, as a condition of receiving the referrals.

WCAB Panel Limits Use of MPN Second/Third Opinion Process

Edward Bautista injured his ribs, pulmonary system, lumbar spine and right ankle in the course of his employment as a machine operator for Arlon Graphics on April 6, 2014, and he also claimed industrial injury to his psyche and sleep disorder.

He selected orthopedist Dr. Peter Borden as his primary treating physician from within the employer’s MPN. According to the WCJ, the applicant “credibly testified” to symptoms of anxiety which he has verbalized to Dr. Borden who failed to diagnose anxiety or refer applicant for an opinion on the issue of psychological treatment.

Bautista then attempted to utilize the MPN second and third opinion process to obtain a second opinion from a psychologist. The WCJ found that use of the second and third opinion process was not appropriate and that Bautista was ordered to return for an appointment with Dr. Borden and ask Dr. Borden to specifically comment on the need for psychological medical treatment.

Bautista petitioned for Reconsideration/Removal contending that Labor Code section 4616.3 and Rule 9767.7 entitle him to obtain a second opinion from a psychologist he selected in defendant’s Medical Provider Network. Reconsideration/Removal was denied in a split panel decision of Bautista v Arlon Graphics.

The panel majority ruled that under section 4616.3(c) and AD Rule 9767.7, applicant has a right to obtain a second opinion physician in the MPN if he disputes either the diagnosis or the treatment prescribed by the treating physician. In this situation, it is necessary to first obtain a diagnosis from the treating physician regarding the issue in dispute before there can be a basis to exercise the section 46l6.3(h) right to obtain a second opinion. That has no occurred in this case, and the WCJ correctly determined that Dr. Borden should directly “address the issue of a diagnosis of anxiety and whether referral for psychological consult/treatment is reasonable and necessary.”

The dissenting opinion of Commissioner Sweeney disagreed stating “Under section 4616.3(c), applicant has an absolute right to obtain a second opinion from an MPN physician with the education, skills, training and experience to properly evaluate his psychiatric condition. The WCJ’s decision unnecessarily burdens applicant’s right to obtain a psychiatric evaluation by an MPN provider.”

ProPublica Persuades National Conference to Investigate Workers’ Comp Opt Out

In response to a ProPublica and NPR highly critical investigation, the National Conference of Insurance Legislators said it will look into an effort by some of the biggest names in corporate America to opt out of workers’ comp.  This year, a group founded by Walmart and several of the biggest employers in America has pushed a campaign to get laws passed in as many as a dozen states within the next decade. Tennessee and South Carolina are seriously considering such bills.

But now, a national association of state lawmakers has announced that it will investigate a burgeoning effort to let companies opt out of workers’ compensation insurance and write their own plans for how they’ll care for injured workers. The National Conference of Insurance Legislators, whose members serve on insurance committees and often act as gatekeepers for related bills in their states, said the decision was prompted by a ProPublica and NPR story last month that found that employers’ opt-out plans typically provide lower benefits for injured workers, more restrictions and little independent oversight. Texas and Oklahoma currently allow companies to opt out and other states are considering similar plans.

“The issues brought forward by the recent NPR/ProPublica study regarding the Texas and Oklahoma workers’ compensation programs are of significant concern to state legislators responsible for the protection of injured workers,” said North Dakota state Sen. Jerry Klein, a Republican who chairs the association’s workers’ comp committee.

Nearly every state requires employers to carry workers’ comp to provide medical care and lost wages if someone gets hurt on the job. In exchange, workers are barred from suing their employers. But Texas has allowed companies to have no insurance, sometimes forcing injured workers to go to court or arbitration to obtain benefits. And in 2013, Oklahoma passed a law allowing companies there to opt out – while still retaining their immunity from lawsuits – if they adopt an alternative benefit plan.

Proponents say the alternative plans save companies money by removing bureaucracy and providing better medical care.

But ProPublica and NPR analyzed the plans of 120 companies and found that the Texas programs typically cut off medical treatment after about two years, don’t compensate workers for most permanent disabilities and cap payouts for deaths and catastrophic injuries. Workers’ comp typically covers medical care for workplace injuries for life and death benefits for children until they graduate college.

In Oklahoma, companies that opt out must provide the same level of benefits as workers’ comp, but unlike workers’ comp, the benefits are subject to income and payroll taxes. In addition, in almost every plan, workers cannot choose their doctors and must report injuries within 24 hours or risk losing all benefits.

A show of support from the national association would make opt-out bills much easier to pass, while a negative assessment might cause lawmakers to try to block efforts in their states. The group also said it would hold discussions to counter any attempts by the federal government to intervene in state workers’ comp programs.

An earlier ProPublica/NPR investigation found many states have drastically scaled back workers’ comp benefits in recent years. In response, several prominent members of Congress have called for increased federal oversight to ensure states are properly caring for injured workers.

Newport Beach Paver Faces $5.6 Million Fraud Charges

A man was arraigned in Orange County Superior Court on charges of tax evasion and insurance fraud for failing to report over $5.6 million in payroll and failing to pay over $384,000 in taxes.

Darrin Shawn Wilson, 50, Newport Beach, is charged with 15 felony counts of misrepresenting facts to the State Compensation Insurance Fund (SCIF), five felony counts of misrepresenting facts to a workers’ compensation insurance company, 20 felony counts of failing to file a return with the intent to evade tax, 20 felony counts of willful failure to pay tax, and a sentencing enhancement for white collar crime and committing a theft exceeding $500,000 and a taking that exceeded $200,000. The defendant is out of custody on $500,000 bail and is scheduled for a pre-trial Feb. 9, 2016, at 8:30 a.m. in Department C-55, Central Justice Center, Santa Ana.

Wilson is the sole principal for American Blacktop Incorporated, dba Seal-It, an asphalt and paving company, and The Mavrick Company, a property management company.

Between Jan. 1, 2009, and July 31, 2012, Wilson is accused of obtaining a workers’ compensation policy of insurance for these companies and failing to report all of the payroll for his workers’ to SCIF in the amount of $4.3 million for the policy periods of 2009 to 2012. On Aug. 1, 2012, Wilson is accused of purchasing a workers’ compensation policy of insurance from the insurance company, AIG. He is accused of underreporting payroll for the AIG policy in an amount exceeding $1.3 million for the time period of Aug. 1, 2012, through Dec. 31, 2013.  From January 2009 through Dec. 31, 2013, Wilson is accused of failing to report to the EDD, accurate payroll in quarterly reports and failed to collect, account for, and pay over taxes required by law.

The insurance fraud came to light when a claim was submitted to SCIF from an injured worker who reported that he had fallen approximately 12 feet from a ladder while working for the Mavrick Company and suffered work-related injuries. Wilson is accused of disputing the claim, stating that the worker was employed by a painting company subcontractor at the time of the injury. SCIF in attempting to determine whether to accept or deny the claim learned that the painting company subcontractor was unlicensed and uninsured.

In construction, to be a subcontractor, one must hold a valid Contractor’s State License and must have a workers’ compensation insurance policy for its employees. Without a valid license and insurance, the subcontractors would be in fact employees of the employing company, thus in this case Mavrick Company. Wilson was required to disclose all payroll to the insurance companies in order to determine the premium for the policy, and he is accused of hiring numerous unlicensed and uninsured workers asserting they were subcontractors in an attempt to avoid paying premium.

Philip Sobol M.D. and Others Face Prison for Illegal Kickbacks

In a series of related cases the former chief financial officer of Pacific Hospital of Long Beach, two orthopedic surgeons and two others have been charged in long-running health care fraud schemes that allegedly referred thousands of patients for spinal surgeries and generated nearly $600 million in fraudulent billings over an eight-year period.

Two of the defendants have pleaded guilty and three others have agreed to plead guilty in the coming weeks. All five defendants have agreed to cooperate in the government’s ongoing investigation into kickbacks for patient referrals and fraudulent bills for spinal surgeries.

The schemes involved tens of millions of dollars in illegal kickbacks to dozens of doctors, chiropractors and others.As a result of the illegal payments, thousands of patients were referred to Pacific Hospital in Long Beach, where they underwent spinal surgeries that led to more than $580 million in bills being fraudulently submitted during the last eight years of the scheme alone. Many of the fraudulent claims were paid by the California worker’s compensation system and the federal government.

In a second, similar scheme that also involved spinal surgeries, doctors received illegal kickbacks for referrals to a Hawaiian Gardens hospital.

Federal prosecutors filed two cases related to the scheme, and earlier three other cases were unsealed by a federal judge. Those named in the cases are:

1) James L. Canedo, 63, of San Pedro, California, the former CFO of Pacific Hospital in Long Beach, who pleaded guilty on Sept. 4 to a criminal information charging him with participating in a conspiracy that engaged in mail fraud, honest services fraud, money laundering, paying or receiving kickbacks in connection with a federal health care program and violating the Travel Act, specifically, interstate travel in aid of a racketeering enterprise. The case against Canedo was unsealed a few days ago by U.S. District Judge Josephine L. Staton of the Central District of California, who is scheduled to sentence the defendant on June 17, 2016.
2) Philip Sobol, 61, of Studio City, California, an orthopedic surgeon who has agreed to plead guilty to conspiracy to commit mail fraud, honest services fraud and violations of the Travel Act; as well as a separate, substantive Travel Act violation. The information against Sobol and a related plea agreement were filed in U.S. District Court, where the Sobol is expected to be arraigned next month.
3) Alan Ivar, 55, of Las Vegas, a chiropractor who formerly resided in San Juan Capistrano, California, and owned several businesses based in Costa Mesa, California, was charged in a criminal information that alleges one count of conspiracy to commit mail fraud, honest services fraud, money laundering and violations of the Travel Act. In a plea agreement also filed at the same time, Ivar admitted that for well over a decade, he had an agreement with the owner of Pacific Hospital to refer patients in exchange for a monthly retainer. Ivar, who also agreed to plead guilty, is expected to be arraigned next month.
4) Paul Richard Randall, 56, of Orange, California, a health care marketer previously affiliated with Pacific Hospital and Tri-City Regional Medical Center in Hawaiian Gardens, pleaded guilty on April 16, 2012, before Judge Staton to conspiracy to commit mail fraud. Randall, who admitted recruiting chiropractors and doctors to refer patients to Tri-City in exchange for kickbacks, is scheduled to be sentenced on April 8, 2016.
5) Mitchell Cohen, 55, of Irvine, California, an orthopedic surgeon, was charged last week with filing a false tax return. Cohen admits in a plea agreement filed on Nov. 16 that he failed to report income received from kickback payments and is expected to be arraigned next month.

All five defendants have agreed to cooperate with the government’s ongoing investigation, dubbed “Operation Spinal Cap,” into the kickback schemes, which involved dozens of surgeons, orthopedic specialists, chiropractors, marketers and other medical professionals.

Under the terms of their plea agreements, Sobol faces a federal prison term of up to 10 years; Canedo, Ivar and Randall face up to five years in prison; and Cohen faces up to three years in prison on the tax charge. All of the defendants will be required to pay restitution to the victims of the scheme, which in Canedo’s case will be at least $20 million.

As part of the scheme, the conspirators typically paid a kickback of $15,000 for each lumbar fusion surgery and $10,000 for each cervical fusion surgery. Some of the patients lived hundreds of miles away from Pacific Hospital and closer to other qualified medical facilities. The patients were not informed that medical professionals had been offered kickbacks to induce them to refer the surgeries to Pacific Hospital. From 2005 through 2013, only part of the overall scheme, Pacific Hospital billed insurers more than $580 million for spinal surgeries on more than 4,400 patients. Insurers paid the hospital more than $226 million for the surgeries performed as a result of illegal kickbacks.

The conspirators in the Pacific Hospital scheme concealed the kickback payments by entering into bogus contracts to provide a “cover story” for the doctors, chiropractors and others who received illegal payments. For example, a number of doctors entered into agreements with a Pacific Specialty Physician Management (PSPM), a company owned by Drobot, under which the doctors received as much as $100,000 per month from PSPM in return for the right to purchase their medical practices – an option that was never exercised. PSPM paid some doctors inflated prices for the right to operate their practices and collect on their insurance claims. In still other cases, Pacific Hospital entered into contracts with doctors under which the doctors were to help the hospital collect on its surgery bills to insurance companies, but the hospital’s own collection staff, rather than the doctors, actually performed the collections work. Several doctors entered into lease agreements under which PSPM or Pacific Hospital paid rent for the use of office space, but rarely used the space. And other doctors had agreements to provide consulting services to Drobot’s companies, but did not actually provide the services. Still others, including marketers who introduced doctors to Pacific Hospital, had additional agreements with Drobot’s companies.

Sobol, Ivar and Cohen each received, respectively, $5.2 million, $1.24 million and $1.64 million in kickbacks.Together they referred more than 200 patients to Pacific Hospital.

Two other Drobot companies, California Pharmacy Management (CPM) and its successor, Industrial Pharmacy Management (IPM), were also important players in the scheme. Both companies set up and managed what were essentially mini-pharmacies within doctors’ offices. CPM and IPM bought and dispensed medication that the doctors prescribed to their patients, and these businesses received a portion of the money reimbursed by insurance companies for the medications. Drobot, along with others at CPM and IPM, often agreed to increase the doctors’ shares of the insurance claims in return for those doctors’ referral of patients to Pacific Hospital. In many cases, for doctors who made such referrals, the conspirators “advanced” payments from CPM and IPM before the companies had collected any money for the medications or even prescribed them, and often simply “wrote off” payments as losses when collections fell short.

Randall, who also facilitated the Pacific Hospital scheme by introducing doctors to Drobot and coordinating kickback arrangements, pleaded guilty to participating in a separate, similar scheme involving Tri-City Regional Medical Center. According to his plea agreement, Randall acted as a “marketer” for Tri-City and conspired with hospital executives to pay kickbacks to doctors and chiropractors to refer workers’ compensation patients Tri-City for spinal surgeries. As in the Pacific Hospital scheme, the surgeries at Tri-City involved use of spinal surgery hardware that Randall distributed to Tri-City at inflated prices through his company Summit Medical Group, knowing that the cost would be passed on to insurers. Using proceeds from the sale of the hardware, Randall paid a 5 percent kickback to Tri-City and kickbacks of up to $20,000 per surgery to the doctors and chiropractors who referred the patients. In addition, Randall paid kickbacks to doctors in return for referrals of patients for toxicology tests though a separate company, Platinum Medical. The scheme resulted in several million dollars in losses to insurers.

WCAB Panel Defines Housekeeping as “Medical Care”

In 2002, Heather Reese sustained industrial injury while employed by All Saints Healthcare to her lumbar spine, psychological system, central nervous system (in the form of a sleep disorder) and cardiovascular system (in the form of deep vein thrombophlebitis). Stipulations with Request for Award for 100% permanent disability were approved including an award for future medical care.

In 2013, her PTP, Philip A. Sobol, M.D., requested authorization for home care assistance at four hours per day, five days per week for one year on an indefinite basis to aid in food preparation, cooking and cleaning, laundry, sweeping, mopping, vacuuming, household chores and grocery shopping due to the patient’s permanent disability. The State Fund adjuster sent a letter to Sobol denying the request for home care assistance (and other requests) but did not send the letter to Reese’s attorney.

On March 19, 2014 the parties proceeded to an expedited hearing on the need for home health care services. The WCJ found that despite the fact that UR was untimely Reese was not entitled to further medical treatment in the form of home health care services. In his Opinion, he noted that applicant had the burden to show that the requested treatment was reasonable and necessary. He found that the request for assistance for food preparation, cooking and cleaning, laundry, sweeping, mopping, vacuuming, household chores and grocery shopping was not considered medical treatment based on Bishop v. Workers’ Comp. Appeals Bd. (2011) 76 Cal.Comp.Cases 1192 (writ den.) (Bishop). With respect to the request for assistance with dressing and bathing, he found that Dr. Sobol had not provided a sufficient rationale.

The WCAB reversed in the panel decision of Reese v All Saints Healthcare. It rejected the view in Bishop and relied instead on Smyers v. Workers’ Comp. Appeals Bd (1984) 157 Cal.App.3d 36 [49 Cal. Comp. Cases 454] (Smyers). The Court of Appeal stated that “Our holding in the instant case extends coverage to recipients of housekeeping services when there is a demonstrated medical need. …. We hold that the proper approach by the Board is to treat the question of reimbursement under section 4600 for housekeeping services as a factual question to be resolved in each case by lay and expert evidence. The test then is whether household services in the particular case before the Board are medically necessary and reasonable.” Thus, under Smyers, applicant’s request for housekeeping services was not precluded.

Further, on June 12, 2014, the WCAB issued Neri Hernandez v. Geneva Staffing, Inc. dba Workforce Outsourcing, Inc. (2014) 79 Cal.Comp.Cases 682 (Appeals Board en banc) concerning home health care services. In Hernandez, the WCAB summarized the impact of section 4600(h): “Section 4600(h) makes clear that home health care services are included in the definition of ‘medical treatment,’ but it also limits an employer’s duty to provide that treatment by imposing two additional conditions which are part of an injured worker’s burden of proof. The first condition requires that home health care services be prescribed by a physician, and an employer may become liable for home health care services provided 14 days prior to receipt of a prescription. The second condition requires that an employer’s liability for home health care services is subject to either section 5307.1 or section 5307.8. (Id. at pp. 688-689.)

Highlights of National Healthcare Anti-Fraud Association Annual Conference

San Diego became the destination for information about anti-health-care fraud efforts, courtesy of the National Healthcare Anti-Fraud Association’s annual training conference. According to the recap published in Bloomberg BNA attendees were treated to an inside look at how law enforcement is fighting the scourge of health-care fraud.

First up on the docket was a presentation from Timothy Delaney, deputy assistant director of the Federal Bureau of Investigation’s criminal investigative division. According to Delaney, health-care fraud prison sentences have gotten increasingly longer, which has served as an effective deterrent. In addition, Delaney said the number of qui tam settlements and judgments has grown dramatically, from 43 in 1985, totaling around $2 billion, to 753 in 2014, totaling around $3 trillion.

Delaney said the major health-care fraud areas include mental health, durable medical equipment, labs and pharmaceuticals, and said there’s no lack of creativity behind some of the fraud schemes. For instance, Delaney said one doctor billed for wave therapy, which turned out to involve the doctor walking through a room full of patients and waving to them.

A presentation from the OIG that laid out the scope of existing pharmaceutical drug fraud. Shimon Richmond, the OIG’s special agent in charge of Miami, said that while the agency continues to have trouble with opiate drug fraud, non-controlled drug fraud is rising rapidly. Richmond said Medicare Part D spending has increased from $51 billion in 2006 to $121 billion in 2014, and out of the $121 billion, $113 billion was spent on non-controlled drugs.

Richmond was joined by the OIG’s Michael Cohen, who said the agency is concerned by the rise of high-dollar specialty drugs being approved by the FDA. Cohen said the high-priced drugs are too much of a temptation for fraudsters. For example, Cohen said the agency is keeping a close eye on the new Hepatitis C drugs that have recently hit the market, such as Solvadi and Harvoni.

Pfizer and Allergan Announce $160 Billion Merger

It what might be considered bad news for health insurers and consumers, pharmaceutical giants Pfizer Inc. and Allergan just announced a $160-billion merger that would create the world’s largest drugmaker with high-profile products such as Botox, Lipitor and Viagra, while increasing pressure on Washington policymakers to address corporate tax policy because the deal would shelter the new firm’s global earnings. Although New York-based Pfizer is the larger company, the deal is structured so that Allergan technically is the purchaser.

The Los Angeles Times reports that the move allows the new firm – which would take Pfizer’s name and be headed by its current chief executive, Ian Read – to be headquartered for tax purposes in Dublin, Ireland, where Allergan already is located, to take advantage of that nation’s lower corporate tax rate. The tactic, known as an inversion, would lead to an effective tax rate for the new company of about 17% to 18%, Pfizer and Allergan said Monday. Pfizer’s effective tax rate last year was about 27%. The new firm would have its global headquarters in New York, but its principal executive offices would be in Ireland, which has a 12.5% corporate tax rate. The U.S. has a 35% corporate tax rate, the highest of any developed economy.

Corporate mergers and acquisitions this year are on pace to break the record of $4.6 trillion set in 2007, according to Dealogic, which tracks the market. Healthcare, in particular, has seen a spree of takeovers as providers, insurers, pharmaceutical makers and drugstores reposition themselves for industry changes spawned by the federal Affordable Care Act.

But critics have raised concerns about the increased number of takeovers. In the case of healthcare, some have said that as the number of players in each sector shrinks, consumers will have fewer choices and prices will rise. The Pfizer-Allergan deal drew such criticism amid the ongoing debate about higher drug prices.

Serious Criticism Aimed at Nominee for Head of FDA

Dr. Robert Califf, President Obama’s recent nominee to head the Food and Drug Administration, has been the target of serious criticism in recent weeks over his close ties to the pharmaceutical industry. He has received hundreds of thousands of dollars from Big Pharma.

The New York Times reports that Dr. Califf, a cardiologist, is a renowned clinical researcher who has deep respect for the system in which he works, and no one who knows him thinks he wants to weaken the regulatory agency he has been chosen to lead. But he has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.

While the previous commissioner, Dr. Margaret A. Hamburg, a former top health official in New York City, came from the field of public health, Dr. Califf ran a multimillion-dollar clinical research center at Duke University that received more than 60 percent of its funding from industry.

His financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary, including Merck, Novartis and Eli Lilly. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.

“In a sense, he’s the ultimate industry insider,” said Daniel Carpenter, a Harvard political science professor who has written extensively about the F.D.A.

But , Dr. Califf’s supporters note that a résumé studded with industry funding is not unusual in academic medicine. Doctors are paid consulting fees all the time, and universities routinely conduct clinical trials on behalf of companies. Those contracts help support university researchers’ salaries, a standard practice. Many emphasize that it does not imply an inherent conflict. His supporters contend that Dr. Califf’s vast experience in the clinical science world could be a major asset in his new post.