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TD and PD Awarded For UR/IMR Denied Treatment

Belinda Go sustained industrial injury to her neck while working for Sutter Solano Medical Center as a registered nurse in 2013.

On May 7, 2015, one of her treating physicians, Christopher Neuberger, M.D. submitted a request for authorization (RFA) for cervical spine surgery and related treatment and services. The RFA was submitted by defendant to its UR provider, which denied authorization. Applicant obtained IMR pursuant to Labor Code section 4610.5, but the UR denial was upheld in a July 22, 2015 IMR determination.

On September 11, 2015, her condition was found to be permanent and stationary following the UR denial by her primary treating physician. A consulting physician said that her neck disability caused 5% whole person impairment (WPI), which rated 7% permanent disability after apportionment of 20% to nonindustrial factors.

Belinda Go returned to work for a period of time until March 22, 2016, and experienced increased symptoms during that time. On March 28, 2016, she followed Dr. Nueberger’s recommendation for cervical spine surgery and self-procured it from Jason Huffman, M.D.

On August 1, 2016, applicant was evaluated by PQME Dr. Zwerin, who found that applicant’s condition became permanent and stationary on July 28, 2016, four months after the surgery. Dr. Zwerin further determined that as a result of the unauthorized surgery, applicant’s neck disability caused 17% WPI and that 20% of the permanent disability is properly apportioned to nonindustrial factors.

Defendant disputed the determination of Dr. Zwerin and argued that because authorization for the cervical spine surgery was denied through the UR and IMR processes that it has no liability for permanent or temporary disability that the surgery caused. Defendant further contends that the pre-surgery reporting of Dr. Cohen should be followed to award 7% permanent disability.

The WCJ found that applicant was entitled to temporary disability indemnity for a period of time following the cervical spine surgery, and finding that the industrial injury caused 23% permanent disability after apportionment, as opined by PQME Dr. Zwerin. The defendant’s petition for reconsideration was denied in the panel decision of Go v Sutter Solano Medial Center.

After reviewing several conflicting panel decisions on this issue, this panel concluded that “An employee is entitled to unapportioned compensation for permanent disability caused by reasonable medical treatment of the industrial injury. (See, Hikida v. Workers’ Comp. Appeals Bd. (2017) 12 Cal.App.5th 1249 [82 Cal.Comp.Cases 679] [2017 Cal. App. LEXIS 572].) In that the UR and IMR statutes are silent on the question of temporary disability indemnity, an employee is not precluded from claiming it even if the disability results from reasonable medical treatment that is self-procured pursuant to section 4605.”

Glendale Physician Sentenced to 37 Months in Fraud Case

Federal prosecutors announced that the owner-operator of a Burbank medical clinic was sentenced to 37 months in federal prison on federal healthcare fraud charges for participating in a scheme to defraud Medicare by prescribing unnecessary services and equipment, which often were not even provided.

Knarik Vardumyan, 53, of Burbank, who formerly owned and operated the medical clinic, was sentenced by United States District Judge Dale S. Fischer who also ordered Vardumyan to pay $1,711,789 in restitution to the Centers for Medicare & Medicaid Services.

Vardumyan pleaded guilty in April to two counts of federal healthcare fraud.

According to court documents, Vardumyan admitted that she knowingly and unlawfully participated in a scheme to defraud Medicare by billing Medicare for “medically unnecessary office visits and diagnostic tests,” and by arranging “for the issuance of . . . prescriptions and orders for medically unnecessary durable medical equipment” and “home health services.”

Vardumyan further admitted, “many, if not all” of the people who visited her clinic “were brought . . . by co-schemers known as ‘marketers,’ who offered promises of free, medically unnecessary [equipment] or food” to those Medicare beneficiaries who were willing to attend Vardumyan’s clinic.

In documents filed in relation to thesentence, the government noted that Medicare paid $1,711,789 as a result of this fraudulent scheme, and that a 37-month term of imprisonment appropriately reflects the nature and circumstances of the offense, as well as the need for the sentence to “promote respect for the law and afford adequate deterrence against this kind of serious fraud against our healthcare system and the public fisc.”

The case against Vardumyan was investigated by the Federal Bureau of Investigation and Assistant United States Attorneys Kristen Williams, Cathy J. Ostiller, and Julian André of the Major Frauds Section and prosecuted by Assistant United States Attorney Adam P. Schleifer.

FDA Adds “Drug Prices” to Approval Policies

The U.S. Food and Drug Administration just announced a series of measures designed to speed to market generic versions of complex drugs in an effort to address the rising cost of pharmaceuticals.

The measures, announced in a blog post by Commissioner Scott Gottlieb, stray into an area that has not previously been the FDA’s purview: drug prices. The agency has typically made its decisions based on safety and efficacy without regard to cost.

Gottlieb said the measures are designed to increase competition in the market by enabling generic competition to complex drugs, something he has long argued for.

Earlier this year, he announced the Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market. The goal was to improve access consumers have to the medicines that they need. Access to medicine is a matter of public health. “If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address, within the scope of its mandate and authorities.”

The plan has a number of different domains. Among them is a compilation of efforts to improve the efficiency of the generic drug approval process; and another is a group of policies aimed at closing loopholes that allow branded drug companies to game FDA rules in ways that forestall the generic competition that Congress intended.

One important group of policies is aimed at making it easier to bring generic competition to a category of branded drugs known as complex drugs. Thus the FDA announced a major new set of policies to advance these goals.

Complex drugs comprise high cost medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs. These medicines generally have at least one feature that makes them harder to “genericize” under traditional approaches. As a consequence, these drugs can face less competition. In some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition.

The new policies just announced are aimed at ensuring that the FDA provides as much scientific and regulatory clarity as possible with respect to complex generic drugs. The new guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review cycle meetings with FDA. These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways.

The FDA commissioner says it will soon release other important policies aimed at spurring competition to complex drugs.

New Osteoarthritis Medication Reduces Bone Damage

A daily pill which halts the disabling bone loss caused by osteoarthritis is being hailed as a new dawn in the treatment of the disease. The new drug has excited scientists after trials showed that after just six months it reduced bone damage around knee joints and also maintained cartilage thickness. It is the first time a drug has been shown to tackle underlying bone structure changes in diseased joints. Current treatments have aimed only at helping patients manage pain symptoms.

The pan-European study was carried out over six months with 244 patients aged between 40 and 80 with osteoarthritis in the knee. “This drug heralds a new dawn in the treatment of this disease as it is the first evidence we have of a drug which can have a significant benefit on the structure of the bone.”

Professor Conaghan, previously chairman of the National Institute for Health and Care Excellence group on the management of osteoarthritis, added: “We now need larger studies to replicate these findings, the results of which we hope will open up a new class of drug.”

The treatment, known as M1V-711, is based on a molecule involved in the turnover of bone and cartilage in the joints. It works by interfering with the process that leads to joint breakdown. It was tested against patients given a placebo and after six months those receiving the treatment showed a 65 per cent reduction in bone loss.

Those on the dummy pills showed slight increases in bone loss. The drug, which was shown to have relatively few side effects, also halted cartilage loss, with those on low doses experiencing a 70 per cent reduction in cartilage thickness and those on higher doses showing a slight increase in cartilage thickness.

Experts hope over a longer period the results may be greater, and could have an impact on significantly reducing pain from the condition. The results of the trial are likely to be revealed next month at a conference in San Diego.

The news comes as experts call for an end to the widespread long-term use of painkillers such as paracetamol and antiinflammatories such as ibuprofen for osteo arthritis, following research showing they may be doing more harm than good.

Current guidance from Nice still recommends paracetamol and anti-infl ammatories as treatments for this disabling condition. However, in one large US study people who regularly took paracetamol over 12 years had a 35 per cent increased risk of a stroke or fatal heart attack. Other recent studies have linked long term use of anti-inflammatory drugs to an increased risk of stomach ulcers and kidney failure.

One of the UK’s leading experts on arthritis, Dr Rod Hughes, former president of rheumatology at The Royal Society of Medicine, said: “There are numerous side effects linked with anti-infl ammatory drugs and we need to look at safer longterm alternatives for those living with joint pain.”

Disgruntled QMEs Sue DWC to Renew Certifications

Former QMEs Dr. Timothy C. Howard, Dr. Meera Jani and Dr. Benjamin Simon have filed a lawsuit in the Los Angeles Superior Court against the California Department of Industrial Relations, its Director Christine Baker and other officials seeking a writ of mandate ordering their reinstatement and reappointment as a QME.

Howard has been licensed as an orthopedist since 1971, and has performed 400 to 500 total knee and hip surgeries, and 200 to 300 spinal surgeries. He was first appointed as a QME in 2005, and has prepared approximately 1,500 QME reports. Jani has been licensed as a chiropractor since 2000, and was first appointed as a QME in 2001. Simon has practiced medicine as a cardiologist for 30 years during which time he has performed thousands of interventional procedures. He has been a QME since 2015 and has prepared approximately 150 QME reports.

Prior to the DWC’s actions described below, none of them claim to have received any billing or other complaints from the DWC.

They allege that in addition to these three plaintiffs, so far approximately 400 QMEs have now “unlawfully” been denied reappointment out of a total DWC panel of only 3,000 QMEs, or approximately 1 3 .3% of all QMEs in California.

The 134 page complaint cites a variety of reasons for issuance of the relief they request. They assert that the DWC has “engaged in a scorched earth policy to deny reappointment licenses to qualified medical evaluators without due process of law – including without a hearing to challenge Respondents’ mere accusations – through Respondents’ imposition of new and different criteria governing such reappointments and the medical-legal fee schedule applicable to QMEs in California.”

The “new policy” they claim is the product of “underground regulations.” They allege that the DIR has “without notice, intentionally adopted underground regulations regarding the medical-legal fee schedule used as prima facie evidence of the reasonable fees paid for QME medical-legal evaluations of injured workers under California’s workers’ compensation system. These underground regulations are being utilized by Respondents to impose new and different criteria that effectively eliminate hourly billing code 104, a goal sought by the workers’ compensation insurers and other payors of the workers’ compensation benefits, which is contrary to the interests of the injured workers that workers’ compensation laws, for over 100 years, are designed to protect.”

Plaintiffs further say that respondents “are required by California law to provide QMEs with a hearing that protects QME rights to due process of law and procedural safeguards, before suspending, terminating or otherwise disciplining a QME for crimes, fraud, and all other violations of law, save for a few specifically enumerated circumstances that are irrelevant herein. However, through its use of underground regulations, Respondents have improperly extended the “no due process hearing” exception to apply specifically to the reappointment process for QMEs, thereby illegally denying reappointment based solely on mere accusations, and thus achieving an end-run around the QMEs’ rights to a due process hearing.”

The three allege they have requested hearings to contest the denial of their reappointment, and that the DIR refuses to allow them any type of hearing to present their case.

Petitioners allege that “a disproportionate number of QMES who have been denied reappointment without a due process hearing based on Respondents’ mere accusations of violations of the medical-legal fee schedule, reside in Los Angeles County.”

FDA Orders 74 Opioid Drugmakers to Train Doctors

The Food and Drug Administration Commissioner said on Thursday that makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives.

FDA Commissioner Scott Gottlieb announced that “This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy (REMS). The REMS requires that training be made available to health care providers who prescribe IR opioids, including training on safe prescribing practices and consideration of non-opioid alternatives.”

The medications, which include Vicodin and Percocet, often combine oxycodone or hydrocodone with less powerful painkillers like acetaminophen. They account for 90 percent of all opioid painkillers prescribed.

Manufacturers of long-acting opioids such as OxyContin, which release their doses over 12 hours or more, have been subject to the requirements since 2012.

Gottlieb called the immediate-release versions a “potential gateway to addiction” in a blog post Thursday.

Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing and an advocate for opioid reform, said the details of the trainings will be important in determining whether they have the potential to make a difference, but said Gottlieb’s choice of words is significant.

“To have the head of the FDA talk about addiction caused by medical treatment really suggests a change in what we hear about opioids,” Kolodny said.

The prescriber training, which could take a year to organize and implement, must include consideration of non-opioid alternatives.

Gottlieb wrote in the blog post that the agency’s new opioid policy steering committee is considering “whether there are circumstances when FDA should require some form of mandatory education for health care professionals, and how the agency would pursue such a goal.”

Feds Accuse Tenet Healthcare of $400 Million Fraud

According to an indictment made public on Wednesday, the U.S. Justice Department has brought new charges over a scheme that it says enabled Tenet Healthcare Corp to fraudulently bill state Medicaid for $400 million.

William Moore, the ex-chief executive of Atlanta Medical Center Inc, which had been operated by Tenet; and Edmundo Cota, the ex-head of a clinic operator that provided prenatal care to Hispanic women, were charged in an indictment filed in Atlanta federal court. They were added as defendants in a case the Justice Department brought in February against John Holland, a former Tenet senior vice president. The trio faces multiple charges including conspiracy and wire fraud, according to the indictment.

The charges came after Dallas-based Tenet and two of its Atlanta-area units in October 2016 reached a deal with the Justice Department and agreed to pay more than $513 million to resolve criminal charges and civil claims in a related case.

Brian McEvoy, a lawyer for Moore at the law firm Polsinelli PC, said in a statement he was “extremely disappointed” with the agency’s action. “Mr. Moore is not guilty and we look forward to presenting this case to a jury at trial,” McEvoy said.

A lawyer for Cota, the former CEO of medical clinic operator Clinica de la Mama, could not be immediately identified. A Justice Department spokesman declined to comment.

The indictment said that from 2000 to 2013, Holland, Moore Cota engaged in a scheme to cause Tenet to pay over $12 million in bribes and other illegal inducements to Clinica, which operated clinics in Georgia and South Carolina. In exchange, the owners and operators of Clinica referred patients to Tenet hospitals and arrange for medical services for Clinica patients related to child birth at the hospitals.

To justify the $12 million, Holland, Moore, Cota and others created pre-textual contracts between Tenet’s hospitals and Clinica, which provided services mostly to undocumented Hispanic women, the indictment said.

In order to steer patients to Tenet hospitals in Georgia and South Carolina, Cota and others blocked doctors from seeing patients at Clinica unless the physicians agreed to deliver their babies at Tenet hospitals, the indictment said.

Prosecutors said the scheme enabled Tenet hospitals to fraudulently bill the Georgia and South Carolina Medicaid programs for over $400 million, and allowed Tenet to receive at least $127 million on those claims.

The case is U.S. v. Holland, et al, U.S. District Court, Northern District of Atlanta, No. 17-cr-234.

DWC Adjusts DMEPOS Section of OMFS

The Division of Workers’ Compensation (DWC) has posted an order adjusting the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) section of the Official Medical Fee Schedule to conform to the fourth quarter 2017 changes in the Medicare payment system as required by Labor Code section 5307.1.

The order effective for services rendered on or after October 1, 2017 adopts the Medicare DMEPOS Quarter 4, 2017, DME17-D ZIP file.

The 2017 Parenteral and Enteral Nutrition Fee Schedule File from DME17-A (Updated 01/06/17) ZIP file was not updated for the fourth quarter, and remains in effect for services on or after October 1, 2017.

The order adopting the adjustment can be found on the DWC website.

Governor Signs AB 1422 – Lien Fraud Clean Up Bill

Governor Brown signed AB 1422 into law on Tuesday. According to the Governor’s signing memo he said “I am signing AB 1422 which is clean-up legislation to last year’s workers’ compensation anti-fraud bills, AB 1244 and SB 1160. Those measures established new requirements and authority to help prevent and reduce fraud in the workers’ compensation system. Specifically, they require the suspension of medical providers who have been convicted of crimes involving fraud or abuse. They also require placing a stay on any liens filed by providers charged with such crimes (pending disposition of the charges).”

“AB 1422 confirms that the Workers’ Compensation Appeals Board retains jurisdiction to resolve disputes about the applicability of the automatic stay provision to specific liens. This bill is declaratory of existing law which provides for the resolution of these disputes through the Board’s current practices and procedures. Nothing in last year’s legislation creating the stay was intended, or operated, to divest the Board from jurisdiction over these issues.”

The Administrative Director of the Workers’ Compensation System would be authorized to adopt regulations to implement these provisions.

The original fraud law was ambiguous in terms of the status of liens filed by companies who were not themselves part of a criminal prosecution. Under the revised law, the stay provisions will apply not only to a person who is being prosecuted, but to a “controlled entity” as well. An entity is controlled by an individual if the individual is an officer or a director of the entity, or a shareholder with a 10 percent or greater interest in the entity.

In addition, the amendments address some other complications that have arisen. For example, in criminal law, a conviction is not entered until judgment is imposed, which usually means at the time of sentencing. With respect to addressing liens, that time frame does not work in cases where a provider pleads guilty, agrees to cooperate with prosecutors, and delays sentencing for an extended period. Other clarifications, such as the right to refuse to pay a bill of a convicted provider, simply fill in some gaps in the drafting of last year’s bills.

In some respects, the amendments are intended to be more explicit about what the Legislature intended the language in last year’s enactments to mean – and these are designated as declaratory of existing law because it is clear that the new language is precisely what was intended by the Legislature in this bill and SB 1160.

The new law deletes language that terminates the stay on lien proceedings at the end of the criminal proceedings, and specifies that the stay remains in effect until the completion of the special administrative proceedings that apply to liens filed by providers convicted of workers’ compensation fraud.

With respect to the constitutional issue of “due process” over the automatic stay provisions, the new law added the following language to LC 4615 “(e) The automatic stay required by this section shall not preclude the appeals board from inquiring into and determining within a workers’ compensation proceeding whether a lien is stayed pursuant to subdivision (a) or whether a lien claimant is controlled by a physician, practitioner, or provider.”

The next hearing on the motion for preliminary injunction pending in federal court based upon this constitutional issue filed Dr. Eduardo Anguizola, who is facing multiple counts of insurance fraud filed by Orange County prosecutors, is set on this Thursday, September 28, 2017 at 8:30 am in courtroom 9D in downtown Los Angeles. AB 1422  should provide federal Judge Wu with ample authority to deny the request for an injunction now that there is clear language affording stayed lien claimants with “due process” of law.

Going and Coming Rule Precludes Employer Tort Liability

In 2012, Mr. Ong’s vehicle collided with a vehicle driven by Louis Deandre Gonzalez, Jr. A passenger in the Gonzalez vehicle, Marisol Morales, was killed in the collision.

Ong told the officer who investigated the accident that he was driving to his employer, Genentech in South San Francisco on his night off to collect resumes for “some upcoming interviews he had.” Ong said that he worked the night shift at Genentech. A few hours before the accident, Ong told his friend Dan Alvarez that he was going to Genentech to do something important for work.

Ong resided in Hayward, California and commuted to Genentech in his own vehicle. Genentech never owned, leased, or possessed Ong’s 1999 Range Rover or Land Rover, the vehicle he was driving at the time of the accident. Genentech did not require Ong to drive or own a vehicle, and did not compensate Ong for travel time or expenses.

During his deposition, Ong gave various reasons for his trip to Genentech that morning. Ong testified that he intended to stop at Genentech to retrieve old resumes he had left in his mailbox and some personal belongings from his locker on his way to visit his grandmother in hospice care in South San Francisco. He also said one purpose of the trip to Genentech was to pick up the resume of his unemployed friend, Dan Alvarez, who had asked Ong if he could recommend Alvarez for a job. Ong’s testimony with respect to Alvarez’s resume was impeached; Alvarez stated he does not have a resume and never gave one to Ong.

Plaintiffs filed a civil complaint in 2013 alleging Ong and Genentech were both liable for the accident that caused Marisol Morales’ death, asserting causes of action for motor vehicle negligence and general negligence, together with a survivorship action. Plaintiffs’ claim against Genentech was based on the doctrine of respondeat superior.

Genentech moved for summary judgment. The trial court entered judgment in favor of Genentech, dismissing it from the case and leaving Ong as the sole defendant. The court of appeal affirmed in the unpublished case of Morales-Simental v. Genentech.

Under the doctrine of respondeat superior, an employer is vicariously liable for the tortious conduct of its employees within the scope of their employment. The scope of employment has been interpreted broadly under the respondeat superior doctrine in California. Nevertheless, there are exceptions to the respondeat superior doctrine. Pursuant to the going and coming rule the employment relationship is ‘suspended’ from the time the employee leaves until he returns or that in commuting he is not rendering service to his employer.

An employee’s decision to take work home or to drive to work at an unusual time does not bring the trip within the scope of employment. Even accepting as true plaintiffs’ assertion that Ong took it upon himself to drive to Genentech on his day off to respond to a hiring crisis, an employee’s unilateral decision to commute to work after hours does not bring the trip within the special errand rule.

The court concluded by stating “we decline plaintiffs’ invitation to expand the special errand exception in the manner they suggest. What they propose is an invitation to self-serving pretense by anyone with a plausible claim to supervisorial authority.”