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Drugmaker Settles Illegal Kickback Case for $15 Million

Last week biopharmaceutical company Amgen Inc. paid the United States more than $15 million to resolve allegations that the Ventura County company provided illegal financial incentives to physicians and physician groups to induce them to prescribe the cancer drug Xgeva. Amgen, which is headquartered in Thousand Oaks, paid the money today pursuant to a settlement agreement with the United States to resolve allegations that it violated the Medicare Anti-Kickback Statute and the federal False Claims Act. The Medicare Anti-Kickback Statute prohibits anyone from offering, paying, soliciting or receiving anything of value to generate referrals for items or services payable by any federal health care program.

Xgeva, which is the brand name of the drug denosumab, was approved by the Food and Drug Administration in late 2010 for use with certain cancer patients undergoing chemotherapy. It is most commonly prescribed for patients with metastatic bone disease in order to prevent skeletal-related adverse events.

In order to increase sales of Xgeva, Amgen used data purchase agreements – which the company called the “Deep Dive” contracts – to provide financial incentives to oncologists and urologists to prescribe Xgeva. The original plan for the Deep Dive contracts called for Amgen to pay doctors to fill out a short survey on the Internet on how they were treating patients with bone cancer, including which drugs were used – whether or not Xgeva was prescribed. However, Amgen altered the original Deep Dive program design by increasing the amount of money it would pay doctors, and by offering such payments only to doctors who prescribed Xgeva for their patients. Amgen’s Xgeva marketing team also was not supposed to know the identities of the doctors who received Deep Dive contracts, but team members had access to that information. Additionally, in a further effort to influence doctors to prescribe Xgeva, Amgen provided cash payments characterized as honoraria to oncologists and urologists for participating in audience response sessions, data market research surveys, and “treatment trends” advisory board programs which touted the benefits of Xgeva.

This settlement resolves a lawsuit filed under the qui tam, or “whistleblower,” provisions of the False Claims Act, which allow private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. The case, which was filed last year in federal court in Los Angeles by two Amgen employees – United States ex rel. Davis et al. v. Amgen Inc., et al., CV12-00570-R (MRWx) – was unsealed last week after the United States elected to take over part of the case and negotiated the settlement with Amgen. The two men who originally filed the lawsuit, William Davis and Spencer Miller, will collectively receive $2.75 million as part of the settlement.

The United States Attorney’s Office for the Central District of California, and the Justice Department’s Civil Division, handled the civil settlement. This matter was investigated by the U.S. Department of Health and Human Services, Office of Inspector General.

WCAB Extends Deadline for Comments on Proposed Rules Until August 9

On July 9, 2013, the Workers’ Compensation Appeals Board announced its intent to modify the text of proposed amendments to its Rules of Practice and Procedure that had been the subject of a public hearing on April 16. The announcement stated that written comments regarding the proposed modifications would have to be received by the WCAB by 5 p.m. on July 25.

Following this announcement, some members of the workers’ compensation community requested the WCAB to extend the time for submitting written comments. The WCAB agreed that a limited extension of time was reasonable. Therefore, the WCAB extended the time for submitting written comments by an additional 15 days to Friday, August 9 by 5 p.m. The WCAB will consider only comments it has received by that time.

As previously announced, the proposed modifications to the initially proposed Rules and related documents are posted on the WCAB’s website. The originally proposed new and amended Rules and related documents may also be found at this site.

Additionally, to facilitate further public comments, the WCAB is presently in the process of adding to its website all public comments it has received regarding the proposed Rules amendments. The documents to be posted will include the written comments the WCAB received on or before April 16, a transcript of the April 16, public hearing, and the written comments the WCAB has received in conjunction with the July 9 announcement. The posting of these written comments will be periodically updated until the August 9 closure of the written comment period.

The address for submission of comments by e-mail is WCABRules@dir.ca.gov. The address for submission of comments by mail is: Neil P. Sullivan, Assistant Secretary and Deputy Commissioner, Workers’ Compensation Appeals Board, P.O. Box 429459, San Francisco, CA 94142-9459. The address for submission of comments by delivery service or personal delivery is: Neil P. Sullivan, Assistant Secretary and Deputy Commissioner, Workers’ Compensation Appeals Board, 455 Golden Gate Avenue, Ninth Floor, San Francisco, CA 94102.

The WCAB will consider all written comments regarding the proposed Rules modifications it receives by Friday, August 9 at 5 p.m. It encourages all interested members of the workers’ compensation community to participate in this important process.

New Study Shows Cell Therapy Benefits for Disc Pain

Scientists have developed a new method of stopping or reversing disability and pain caused by degenerative disc disease in the spine using cell therapies, according to a proof-of-concept study published in the journal Biomaterials and summarized by Medical News Today. Researchers from the Duke Pratt School of Engineering at Duke University in Durham, North Carolina, have developed new biomaterials capable of delivering a booster shot of reparative cells to the nucleus pulposus (NP), effectively stopping pain caused by degenerative disc disease. The NP is the “jelly-like” cushioning found between the spinal discs. According to the researchers, the NP tissue distributes pressure and provides spine mobility, helping to soothe back pain.

Previous laboratory research has proven that re-implanting NP cells can delay disc degeneration, the researchers say. But Aubrey Francisco of the Department of Biomedical Engineering at Duke says that although many companies offer cell delivery strategies in a attempt to stop disc degeneration, the methods are poor, ineffective and “allow cells to quickly migrate out of and away from the injection site.”

Lori Setton of the Department of Biomedical Engineering and the Department of Orthopaedic Surgery at Duke, says: “Our primary goal was to create a material that would be liquid at the start, gel after injection in the disc space, and keep the cells in the location where they’re needed. Our second goal was to create a material that would provide the delivered cells with the environmental cues to promote their persistence and biosynthesis.”

The way the new biomaterials work are by keeping the cells in place and triggering a process which mimics laminin, a protein found in native NP tissue. Laminin is usually found in juvenile but not degenerated discs. The protein allows injected cells to attach and remain in place with the delivered biomaterial. Laminin could also enable the cells to survive for a longer period, as well as producing more of the “appropriate extracellular matrix or structural underpinning of the discs that help stop degeneration.” With this in mind, the scientists developed a “gel mix” designed to reintroduce NP cells to the intervertebral disc (IVD) area.

The gel is made up of three components; protein laminin-111 – which has been chemically modified – and two polyethylene glycol (PEG) hydrogels which can attach to the modified laminin. Once injected, the gel holds the cells in place. This gel was injected into rats’ tails, the same way the cells would be delivered to a patient. The needle was held in place in the thin outer layer of the tails for one minute while the gel entered the rat’s IVD area.

Results show that the gel began to solidify after 5 minutes, and by 20 minutes it was set. Using a luciferase biomarker to monitor the progress of the biomaterials, the researchers were able to see that more cells remained in place 14 days after the injection when conducted with the new biomaterial carrier, compared to cells delivered via methods requiring a liquid suspension, in which cells usually remain in place for 3 to 4 days. The preliminary results from this study could have a positive impact on the future of cell therapy.

WCAB Reverses Firefighter’s “Ogilvie” Based Award

Ronald Gerton incurred cumulative industrial injury to his low back while working as a firefighter for the City of Pleasanton. The parties’ AME Dr. Post used the range of motion method to rate applicant’s back impairment under the AMA Guides to the Evaluation of Permanent Impairment, Fifth Edition (AMA Guides) in accordance with the 2005 PDRS, and the physician opined that applicant has a 21% whole person impairment using that rating. With regard to apportionment, Dr. Post noted that applicant obtained a prior award of 3% permanent disability for a January 11, 2004 specific injury to the back, which was rated using subjective factors under the earlier 1997 PDRS.

However, the WCJ rejected this rating, and explained that the Diminished Future Earning Capacity (DFEC) adjustment factor contained in the 2005 Permanent Disability Rating Schedule (2005 PDRS) was rebutted at trial by the testimony and reporting of applicant’s vocational expert Eugene Van de Bittner, Ph.D., who opined that applicant’s work preclusions resulted in a 65% DFEC, and the WCJ used that 65% figure to find applicant’s 62% permanent disability after applying apportionment pursuant to the opinion of the parties’ Agreed Medical Examiner (AME) Michael Post, M.D.

Defendant petitioned for reconsideration contending that Dr. Van de Bittner’s reporting was not substantial evidence in support of the WCJ’s finding of 62% permanent disability. The WCAB granted reconsideration, rescinded the aware and remanded the case of Ronald Gerton v City of Pleasanton for further proceedings.

One of the problems with the award was that the vocational expert excluded the Applicant’s actual post-injury earnings in his calculations of diminished future earning capacity. Starting in 6/10, applicant performed some work as a type of construction supervisor for his older brother and younger brothers. His first assignment was to live at a multimillion dollar home in Carmel, California during a remodel project conducted by his older brother. Mr. Gerton supervised the work of construction workers at this home. He worked for about 6 weeks at the rate of about 40 hours per week. Since then he has assisted his younger brothers in apartment remodeling projects. Apartments are gutted and remodeled when tenants vacate the premises. In exchange for his services, his brothers will perform construction work at his home in Livermore and at his cabin. Since his retirement, he has continued to work 20 to 40 hours per week as a jobsite supervisor for his brother’s construction company. He works as much as he wants to work. He is paid $45 per hour for his time

The WCJ found that those earnings were artificially high because the work was being done for a close relative, applicant’s brother. Dr. Van de Bittner found that this work lies outside what applicant could expect to compete for in the open labor market and said it was essentially sheltered employment. “The charity of Applicant’s family should not be used to create a false impression of Applicant’s true capacity for earnings.”

The WCAB disagreed. It concluded “We find no evidence in the record that supports the WCJ’s conclusion that applicant was performing “sheltered work” or that his post-injury earnings are “charity” provided by his family as stated in the Report. Instead, the expected duties of a construction supervisor, the continuing availability of that work to applicant and the $45 per hour pay he receives for it indicates otherwise, as does applicant’s expressed interest in performing that same kind of work as a volunteer overseeing the remodeling of homes. Upon return to the trial level the record should be further developed on the issue of applicant’s post-injury earnings and whether his actual earning history should be utilized to evaluate his DFEC and permanent disability.”

Pricing Survey Shows Workers’ Comp Increasing

Commercial insurance prices in aggregate increased by almost 7% during the fourth quarter of 2012, according to Towers Watson’s most recent Commercial Lines Insurance Pricing Survey (CLIPS). The survey compared prices charged on policies underwritten during the fourth quarter of 2012 to those charged for the same coverage during the same quarter in 2011.

Pricing data reported by carriers for the fourth quarter of 2012 indicated a pause in the upward industry price acceleration observed since the start of 2011. Price-change indications in total and by line of business were generally consistent with price increases in the third quarter of 2012, but with some upward movement in specialty lines.

The largest price increases were in workers compensation and employment practices liability. Increases for most lines fell in the mid- to upper-single digits. No line of business had an overall price increase of less than 3%.

Price increases were observed across all account sizes for standard commercial lines, with larger increases observed in mid-market and large accounts than in small accounts. Specialty lines prices continue to increase, but still lag the results observed in standard lines.

Historical loss cost information reported by participating carriers points to an improvement of almost 4% in loss ratios in accident-year 2012 relative to 2011, as earned price increases more than offset reported claim cost inflation. The report notes that CLIPS results are intended to exclude catastrophes. This indication is a reversal from the estimated 3% deterioration between 2010 and 2011. This improvement comes from both earned price increases and reduced estimates of claim cost inflation. Carrier estimates of claim cost inflation come in at 1% for 2012.

Total Disability Award Reversed by Court of Appeal

Michael Borman sustained continuous trauma injury to his ears (hearing loss), bilateral upper extremities, neck and head during the year prior to his last day at work for Acme Steel as a steelworker. AME Dr. David Schindler apportioned hearing loss based on both non-industrial, degenerative causes and prior injury, opining that Borman’s 100 percent “binaural neurosensory hearing loss” was 60 percent due to “occupational factors, specifically noise induced hearing loss. Approximately 40 percent of Mr. Borman’s hearing loss is the result of non-occupational factors, particularly cochlear degeneration.”

Borman told Dr. Schindler he filed a workers’ compensation claim following a December 1994 explosion at the factory that threw him 10 to 15 feet and knocked him out momentarily. He was rated at 22 percent disability due to hearing loss from the 1994 injury, and his hearing has gradually gotten worse since then. Borman was examined by Dr. David Manace in October 1994. Dr. Manace documented that the explosion experienced by Borman occurred in 1993, found Borman had “a 37.5 percent monaural loss in the right ear and a 37.5 percent monaural hearing loss in the left ear for a 37.5 percent binaural hearing loss at that time,” and concluded Borman had a bilateral high-frequency hearing loss consistent with accumulated noise exposure. Dr. Manace recommended Borman should be fitted with hearing aids.

Dr. Schindler reiterated his conclusion in a subsequent report that Borman had “a 100 percent hearing loss . . . apportioned . . . as 60 percent due to noise-induced hearing loss and 40 percent due to other factors. The noise-induced hearing loss . . . includes the explosion component that was found by Dr. Menace,” adding, “I did not apportion Dr. Menace’s portion of the hearing loss.”

In July 2012, the Workers’ Compensation Administrative Law Judge (WCALJ) issued a “Findings and Award” and “Opinion on Decision” following proceedings held in April 2012 at which Borman was the only witness. The WCALJ found Borman’s injury ratable under the post-2004 Permanent Disability Ratings Schedule. The WCALJ also found Borman a straight-forward and credible witness, noting that during testimony he “clearly had difficulty understanding questions and had to face his questioners directly in order to ‘lip read’ as well as listen. His cochlear implants have improved his hearing but his hearing . . . is quite limited[,] . . . particular[ly] . . . in crowded or noisy environments, and [he] cannot function effectively on the phone.” The WCALJ found Borman effectively rebutted any Diminished Future Earnings Capacity (DFEC) and showed 100 percent loss of earning capacity entitling him to permanent and total disability. The WCALJ based the latter finding on expert vocational testimony proffered by Borman showing there was no job in the open labor market that could accommodate Borman’s “difficulty with oral communications, limitations with use of the upper extremities, limited mobility, need for daily narcotic medication, rests and serious headaches.’ Additionally, the WCALJ found that “Labor Code section 4664 is not pertinent as prior to the instant cumulative trauma injury there was no earnings loss due to the prior award of permanent disability for hearing loss,” reasoning that “Borman continued to work [after] the prior award for prior hearing loss, [and his] hearing loss progressed to the point where he required implants, which . . . have severe limitations.”

The WCAB summarily denied Acme’s petition for reconsideration. The Court of Appeal reversed in the unpublished case of Acme Steel v WCAB (Borman), finding that the WCALJ erred “by failing to address the issue of apportionment.” The clear intent of the Legislature in enacting Senate Bill No. 899 was to charge employers only with that percentage of permanent disability directly caused by the current industrial injury. “Here, the WCAB ignored substantial medical evidence presented by Dr. Schindler, as summarized above, showing that Borman’s 100 percent loss of hearing could not be attributed solely to the current cumulative trauma. ” The matter was “remanded to the WCAB with directions to order the WCALJ to make an award consistent with this opinion.”

DWC Posts RAND Working Papers on Proposed RVRVS Fee Schedule

The Division of Workers’ Compensation (DWC) today posted three documents to provide the public with tools which assess proposed rulemaking on the Official Medical Fee Schedule.

The first document is a revised RAND working paper, providing a quality assurance review of the impact for a transition to a resource-based relative value scale (RBRVS) based physician fee schedule. The revised working paper includes updated impact tables, revised estimated transition conversion factors, and an explanation of the changes made.

The other documents include a detailed impact file intended for public use as well as a supporting document with a description of the data elements included. The impact file is a comprehensive data table which allows members of the public to focus on specific components of the proposed changes.

“I am pleased to provide this impact file so that stakeholders can better assess areas that are of specific interest to them. I believe providing this data file improves the opportunity for meaningful public participation in the rulemaking process,” said Christine Baker, Director of the Department of Industrial Relations (DIR). DWC is a division of DIR.

The revised RAND working paper and the public use data file can be found on the proposed regulations page.

DWC 2012 Claim Audits Finds 4690 Violations and $1.2 Million in Penalties

The Division of Workers’ Compensation has posted the 2013 DWC Audit Unit annual report on its website . The Audit Unit annual report provides information on how claims administrators audited by the DWC in 2012 performed and includes a ranking report. Labor Code sections 129 and 129.5 provide the framework for oversight and enforcement of the regulations of the Administrative Director for the prompt and accurate provision of workers’ compensation benefits. The performance of any insurer, self-insurer or third-party administrator is rated for action in specific areas of benefit provision. Of foremost importance is the payment of all indemnity owed to the injured worker for an industrial injury. The timeliness of all initial and subsequent indemnity payments and compliance with the regulations of the Administrative Director for provision of notice for a qualified or agreed medical evaluation are also measurable factors for performance.

In 2012, the DWC Audit Unit completed a total of 64 profile audit reviews (PAR audits). Of the PAR audits, 61 were routinely selected and three were target audits, which were conducted based upon failure of a prior audit. The total number of PAR audit subjects included 15 insurance companies, 14 self-administered / self-insured employers, 30 third party administrators (TPA), and five insurance company / third-party administrator combined claims adjusting locations.

At all audits, claim files were selected for review on a random basis, with the number of indemnity and denied cases being selected based on the numbers of claims reported in each of those populations for the audit subject in the three calendar years prior to audit commencement. In addition, if any complaints were received regarding possible violations of the Labor Code or regulations of the Administrative Director, each respective claim file related to a complaint may have been part of the audit.

Fifty-nine audit subjects (92.2%) met or exceeded the PAR 2012 performance standard thereby having all penalty citations waived. Five audit subjects (7.8%) failed to meet or exceed the PAR standard and the audit expanded into the full compliance audit of indemnity claims (FCA stage 1). Four of these audit subjects (6.3%) then met or exceeded the FCA-1 2012 standard. For these four audits, the Audit Unit issued notices of compensation due and assessed administrative penalties for late and unpaid indemnity. One of the 64 audit subjects (1.6%) that failed the PAR audit also failed to meet or exceed the FCA performance standard thereby demonstrating poor performance and this claims administrator will be subject to a return target audit within two years. The complete list of the performance ratings for the 64 audit subjects can be reviewed in order, from the best to worst performer. In 2012, two claims administrators disputed one or more penalties cited in the course of their respective audits. The disputes will be reviewed by the Workers’ Compensation Appeals Board.

As a result of PAR/FCA audits conducted during the calendar year 2012, the Audit Unit found and cited 4,690 violations against claims administrators with administrative penalties totaling $1,273,489. Not all administrative penalties are subject to collection. Under the Labor Code, no penalties are assessed on those “cited” violations unless the audit subject fails the audit at a specific level.

Study Says Post-Operative Checkups by Telephone is Safe and Saves Time and Money

In a preliminary study of patients who had simple surgeries, most did well and seemed satisfied with post-operative checkups by telephone instead of seeing their surgeon in a clinic visit. According to the article in Reuters Health, the phone follow-up saved doctors and patients the time and effort involved in clinic visits without compromising patient care, according to the study of California patients. “These clinic visits are usually five minutes or less, very brief, the doctor asks ‘how are you, do you feel well, are you going to the bathroom okay, that kind of thing,” said senior author Dr. Sherry Wren of the Stanford University School of Medicine. Those questions can easily be asked over the phone, and only patients with unusual symptoms need to come see a doctor in person, she told Reuters Health. The study included patients who had hernia repairs and gallbladder removals, both routine surgeries with very low post-op complication rates. But so-called telehealth follow-up would not be appropriate for all surgeries Wren said; for cancer patients, for example, follow-up doctors’ visits include discussions of continuing care and treatment plans.

For the new study, Wren and her colleagues identified patients of the Palo Alto Veterans Administration Health Care System who were scheduled for one of two surgeries. In total, 115 patients had hernia repairs and 26 had gallbladders removed. All were scheduled for a follow-up clinic visit three weeks after their surgeries. But two weeks post-surgery the patients were called by a physician assistant. The assistant asked scripted questions about the patient’s pain and activity levels, swelling, the look and feel of the incision, appetite and bowel movements. If patient responses indicated normal recovery, the patient’s scheduled follow-up clinic visit was canceled with the patient’s consent. If recovery seemed abnormal, the patient was encouraged to keep the clinic appointment. Any patients who wanted in-person follow-up were also allowed to keep their appointment. Calls went through to 110 of the patients; 63 hernia patients and 19 gallbladder patients agreed to have surgical follow up by phone only and canceled their clinic appointments.

None of the gallbladder patients and three hernia patients had surgical complications up to 10 months after surgery, which is comparable to complication rates in the general population, according to the results published in the journal JAMA Surgery. The authors did not compare the outcomes of the telehealth group to a group going to traditional clinic visits.

Of the patients who said they wanted to visit the clinic, even after the phone checkup, most wanted to pick up a return-to-work form and thought they had to do so in person, whereas it can actually be mailed or faxed, Wren said. Most patients said they were very satisfied with the telehealth checkups and seemed grateful that they didn’t have to drive to the clinic, Wren said, Of the patients who accepted the telehealth follow-up, the average round-trip travel distance from their homes to the hospital was 141 miles, and the average driving time Wren’s team calculated would have been about two and a half hours. Though research supports the safety and efficacy of telehealth, it is only used in some pockets of healthcare, Wren said. Some physicians balk at leaving behind the “gold standard” of in-person visits, she said.

The current study indicates that even the relatively low-tech telephone call can be a reliable telehealth option, and it may be more appealing to people, she said. “Nothing about this was surprising, especially in this patient population and with what we would consider relatively routine procedures, especially if they travel great distances, we know people would like an alternative,” said Dr. Glenn Ault of the department of surgery at the University of Southern California in Los Angeles. Using telemedicine to make sure only surgical patients who need to be seen end up going to a clinic could help cut down on crowds and wait times, said Ault, who wrote a commentary to accompany the research. He already uses telemedicine in his practice in L.A. health system, and has also had patients send pictures of their wounds before coming in to the office. The next step will be to study telehealth options for other procedures, he said. “Healthcare as we view it will undergo some significant transformation in the years ahead, the status quo cannot continue,” he said. “We are going to have to look for different ways to safely and efficiently provide care,” and telehealth could play an important role, he said.

IRS To Review State Funds Tax Exempt Status

The nation’s 20 state-run workers compensation funds showed strong growth for the second straight year, according to a new A.M. Best report. The article in Property Casualty 360 says that state funds accounted for 44 percent of total net premiums written in 2012. Net premiums written increased 7.1 percent in 2011 and 13.5 percent in 2012, reaching $6.9 billion last year–the highest level since 2008. The report says the increases are an outgrowth of a hardening market as the economy returns to a growth mode. Rate increases accounted for some of the increase in NPW, but overall premium growth was only slightly higher than the 6.8 percent and 13.1 percent respective increases in the A.M. Best workers’ comp composite for 2012 and 2011. Premium income rose for state funds in both years despite a precipitous decline in the California state fund.

Excluding State Compensation Insurance Fund of California (SCIFCA) premiums, the premium increase of the 19 other competitive state funds rose a 18.3 percent in 2012, compared to 11.7 percent in 2011–an indication state funds may be fulfilling their role as residual market providers to a greater degree as workers’ comp markets harden.

The report notes one emerging concern: the Internal Revenue Service’s Exempt Orga­nizations division is reviewing the tax-exempt status afforded state funds. “While still in a preliminary and exploratory phase, any eventual IRS rulings in this regard could have significant impacts on affected state funds’ markets, business strategies and operations,” the report said.

One factor in premium growth is most of the funds predominately serve residual markets–small businesses, for example–while also competing with the private market. Typically during hardening markets, some businesses find it more difficult to afford or secure coverage in the voluntary market and turn to state funds. The report noted that each fund tends to develop its own, unique characteristics, largely depending on its business profile and growth initiatives.

The report said some state funds maintain a steadfast role in the residual market and often contend with political pressure that can affect surplus and rate levels. Others have undergone transformations toward becoming private, mutual insurers. Some funds have taken to writing business beyond their state borders, the report said.

The term “state funds” is used for the 20 U.S. competitive state compensation funds, the report said. It does not include the monopolistic funds operating in North Dakota, Ohio, Puerto Rico, Washington or Wyoming.