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Drugmakers Battle PBMs Over Copay Manipulation

In the escalating battle over U.S. prescription drug prices, Reuters Health reports that major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs.

In recent years, insurers have tried to guide patients toward less expensive treatments by making them pay a higher portion of a drug’s costs. Drugmakers responded by dramatically raising the financial aid they offer, in the form of “copay assistance” cards – similar to a debit card – that reduce what consumers need to pay when they place their pharmacy order.

Express Scripts Holding Co and CVS Health, which manage prescription drug coverage for large U.S. employers, say these payments shield consumers from drug costs, making it easier for manufacturers to raise those prices. Insurers have to make up the difference.

This year, Express Scripts and others introduced a new “copay accumulator” approach for its corporate customers. The programs prevent copay card funds from counting toward a patient’s required out-of-pocket spending before insurance kicks in on expensive specialty drugs, such as arthritis and HIV treatments.

As an example, a patient whose medicine costs $1,000 per month might be required to pay that amount until they reach a deductible of $2,000 set by their insurer. A copay card from the drugmaker would cover most, or all, of those costs for the patient and it would count towards the deductible.  When the deductible is reached, the insurance begins to pay.

But if the insurance plan is using an accumulator, the patient could still have to pay the $2,000 out of pocket when their copay card expires or runs out of money. Some more aggressive accumulator programs will also draw more money than a drugmaker expected to pay off a copay card when the card is detected.

These tactics could force the drugmaker to keep paying the out of pocket costs. Otherwise the patient could move to an equivalent drug if one is available or abandon their prescription because it is too expensive.

Drugmakers are working on ways to counter copay accumulator programs, fearing that more employer health plans will adopt them in 2019.  

They include new payment options to evade detection by the pharmacy benefits managers (PBMs) so that a patient still benefits from the financial aid, said Matthew Turner, who is working with drugmakers as director of patient affordability at TrialCard, which operates copay cards for companies. He would not provide details of how those arrangements work.

Drugmakers are also taking a tougher stance when negotiating prices or new discounts for payers, according to insurance industry executives and pharmaceutical consultants.

They have reason for concern. A survey by the National Business Group on Health (NBGH), which represents large corporate employers, showed that 17 percent of respondents said they were currently using a copay accumulator program. Another 18 percent of respondents are considering using one next year or in 2020.

Savings can be substantial for employers when accumulators coax patients to switch to a drug for which they receive the highest rebate. For instance, rebates to PBMs for Humira and Enbrel can differ by as much as $1,000 per prescription, according to Michael Rea, CEO of Rx Savings Solutions.

AI Defeats Physician In Diagnostic Competition

An artificial intelligence (AI) system scored 2:0 against elite human physicians in two rounds of competitions in diagnosing brain tumors and predicting hematoma expansion.

The BioMind AI system, developed by the Artificial Intelligence Research Centre for Neurological Disorders at the Beijing Tiantan Hospital and a research team from the Capital Medical University, made correct diagnoses in 87 percent of 225 cases in about 15 minutes, while a team of 15 senior doctors only achieved 66-percent accuracy.

The AI also gave correct predictions in 83 percent of brain hematoma expansion cases, outperforming the 63-percent accuracy among a group of physicians from renowned hospitals across the country.

The outcomes for human physicians were quite normal and even better than the average accuracy in ordinary hospitals, said Gao Peiyi, head of the radiology department at Tiantan Hospital, a leading institution on neurology and neurosurgery.

To train the AI, developers fed it tens of thousands of images of nervous system-related diseases that the Tiantan Hospital has archived over the past 10 years, making it capable of diagnosing common neurological diseases such as meningioma and glioma with an accuracy rate of over 90 percent, comparable to that of a senior doctor.

All the cases were real and contributed by the hospital, but never used as training material for the AI, according to the organizer.

AI will not only reduce the workload but also push doctors to keep learning and improve their skills, said Lin.

Bian Xiuwu, an academician with the Chinese Academy of Science and a member of the competition’s jury, said there has never been an absolute standard correct answer in diagnosing developing diseases, and the AI would only serve as an assistant to doctors in giving preliminary results.

Dr. Paul Parizel, former president of the European Society of Radiology and another member of the jury, also agreed that AI will not replace doctors, but will instead function similar to how GPS does for drivers.

Dr. Gauden Galea, representative of the World Health Organization in China, said AI is an exciting tool for healthcare but still in the primitive stages.

China has introduced a series of plans in developing AI applications in recent years.

In 2017, the State Council issued a development plan on the new generation of Artificial Intelligence and the Ministry of Industry and Information Technology also issued the “Three-Year Action Plan for Promoting the Development of a New Generation of Artificial Intelligence (2018-2020).”

The Action Plan proposed developing medical image-assisted diagnostic systems to support medicine in various fields.

Jones Targets Comp Carrier Profits and Tax “Savings”

Insurance Commissioner Jones announced he has issued an order that every insurer licensed to write workers’ compensation insurance in the State of California must report their federal income tax savings annually through a rate filing in light of the new tax law.

The recent revision to the Federal Tax Schedule for 2018 reduced the corporate tax rate from 35 percent to 21 percent. Jones says “That means that nationally insurers will now be able to retain even more of policyholder premiums as profit.”

He is referring to the “Tax Jobs and Cuts Act of 2017” signed into law by President Trump on December 22, 2017.

“Any savings to insurers should be passed along to California businesses,” said Commissioner Jones.

Thus, Jones’ order will require each insurer to submit a rate filing to report the dollar amount of their tax savings by December 31, 2018, and on a yearly basis through December 31, 2020.  Insurers will need to provide details about how those savings impact their rates.

The insurer must also provide a detailed explanation if they have determined that there is no rate impact, stating why the reduction in the federal corporate tax rate does not affect their rates.

The Order is broadly written to include tax savings from earnings having nothing to do with workers’ compensation lines of insurance in California. It pertains to profits from any line of insurance, or an business enterprise of an insurance company, as though that would pertain to setting a premium for workers’ compensation insurance risk in the California marketplace.

Nonetheless, Jones maintains that “This order will allow my department to examine workers’ compensation insurers’ savings and rates and provide transparency to the public. I urge insurers to pass these savings along to policyholders.”

Jones has no rate making authority over worker’s compensation insurance pricing in California. Thus it would seem that the outcome of this study would lead to no particular regulatory action other than “transparency” which is already available for most insurance companies that are publicly held. All publicly held corporations are required to file regular certified financial statements with the Securities and Exchange Commission that provide detailed financial and tax information. The Commissioner – and the public – can review this historical and current information at any time.

$647K in Penalties for Farm Labor Wage Theft

The Labor Commissioner’s Office has issued wage theft citations to a large farm labor contracting operation for failing to timely provide 1,374 seasonal farm workers their final pay.

Vista Santa Rosa Inc. did not pay discharged workers on the last day of work as required by law, and the company consistently issued final paychecks at least 72 hours late. Both client employers and their labor suppliers are accountable for workplace labor law violations in California.

An investigation was launched in August 2016 after workers reported violations of late pay to California Rural Legal Assistance, a nonprofit that provides free legal services. The investigation identified $646,875 in waiting time penalties, of which $323,729 is due to 867 affected workers in 2016, and $323,145 is due to 864 workers in 2017.

Vista Santa Rosa Inc. hires and provides farm workers to growers in the Coachella Valley region. In 2016, Vista was a sole-proprietorship owned and operated by Jose Luis Gomez Jr. In 2017 Gomez began doing business as Vista Santa Rosa Inc. Both Gomez and his successor company Vista share joint and several liability for the $646,875 in waiting time penalties.

California Labor Code section 2810.3 holds client employers – those that obtain or are provided workers from a subcontractor – responsible for their subcontractor’s workplace violations. Client employers also liable for Vista’s violations include:

— Brighton Distributing, Inc.
— Alexandra Dates, Inc.
— Coachella Valley Ranch Development, Inc.
— MICA, LLC
— The Wildwood Group, Inc.
— East-West Unlimited, LLC
— Anthony Vineyards, Inc.
— Sun World International, LLC

If a worker quits, final wages are due within 72 hours of the notice. Waiting time penalties are imposed when the employer intentionally fails to pay all wages due to the employee at the time of separation. This penalty is calculated by taking the employee’s daily rate of pay and multiplying it by the number of days the employee was not paid, up to a maximum of 30 days.

Enforcement investigations typically include a payroll audit of the previous three years to determine minimum wage, overtime and other labor law violations, and any payments owed and penalties due are calculated.

July 2, 2018 Edition


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: No Jurisdiction Over NFL Player’s Injuries – Affirmed, Illicit Opioid Sales Skyrocket on “Dark Net”, Uninsured Contractor Pleads Guilty, WCIRB Says 2017 Combined Loss Ratio Drops to 91%, WCIRB Considering Use of Blockchain Technology, Janitorial Companies Face July 1 PSWPA Registration Deadline, 2019 TTD Rates to Increase Nearly 3%, Robotic Doctor Passes Medical License Exam, Silicon Valley High Burn Out Rate Health Risks, FDA Approves First Cannabis Based Drug.

Daniel Capen M.D. – and Dozens More – Indicted

Federal officials are charging 601 people in the largest bust of health care fraud in U.S. history. Southern California criminal cases named a total of 33 defendants. Nine new defendants being charged as part of Operation “Spinal Cap.” The scheme was spearheaded by Michael Drobot, the former owner of Pacific Hospital in Long Beach.

In the cases announced in Operation Spinal Cap Daniel Capen, 68, of Manhattan Beach, an orthopedic surgeon, has agreed to plead guilty to conspiracy and illegal kickback charges. Capen accounted for approximately $142 million of Pacific Hospital’s claims to insurers, on which the hospital was paid approximately $56 million.

Timothy Hunt, 53, of Palos Verdes Estates, another orthopedic surgeon who referred spinal surgery patients to Capen and other doctors, has agreed to plead guilty to a conspiracy charge involving his receipt of illegal kickbacks stemming from various financial relationships with Pacific Hospital and related entities.

George William Hammer, 65, of Palm Desert, the former chief financial officer of the physician management arm of Pacific Hospital, has agreed to plead guilty to tax charges based on the fraudulent classification of illegal kickbacks in hospital-related corporate tax filings.

Lauren Papa, 52, of Tarzana, a chiropractor, has agreed to plead guilty to a conspiracy charge involving her receipt of illegal kickbacks to refer patients to a neurosurgeon with the understanding that the neurosurgeon would perform the surgeries at Pacific Hospital.

Tiffany Rogers, 53, of Palos Verdes Estates, an orthopedic surgeon, was named in an indictment unsealed Wednesday in connection with receiving illegal kickbacks to refer patients for spinal surgeries at Pacific Hospital.

Brian Carrico, 64, of Redondo Beach, a chiropractor – along with Performance Medical & Rehab Center, Inc., which was partially owned by Carrico; and One Accord Management, Inc., which Carrico wholly owned – were charged in connection with the receipt of illegal kickbacks to influence the referral of patients to Pacific Hospital. An indictment unsealed Wednesday alleges that these defendants and other co-conspirators were responsible for approximately $80 million in claims submitted to the federal workers’ compensation program and were paid approximately $56 million in connection with patients that Performance Medical referred to Pacific Hospital.

William Parker, 64, of Redondo Beach, was charged in a separate indictment unsealed on Wednesday in connection with the same kickback scheme involving Carrico and his companies.

In San Diego, the cases include Marco Antonio Chavez, a licensed medical doctor specializing in psychiatry, was charged with 30 counts of health care fraud in connection with over $928,000 in bills he submitted to TRICARE for services he never provided. He was also charged with five counts of aggravated identity theft and one count of obstruction of a federal audit..

Four defendants, including two chiropractors, a physical therapist and an acupuncturist, were charged with conspiracy to commit health care fraud and honest services fraud and to pay unlawful kickbacks stemming from their operation of R.I.S.E. Medical Center. According to the indictment, R.I.S.E. operated several “Wellness Centers” in San Diego County, including Bonita and Oceanside, and offering a range of services including physical therapy, diagnostic tests, massages, chiropractic treatments, and acupuncture..

Joserodel Zavala Candelario, a chiropractor and owner of R.I.S.E., imposed quotas for non-reimbursable services and treatments, allegedly telling staff that they were expected to provide a certain number of diagnostic tests, “no matter what”; to “grab patients in lobbies to put into provider schedules”; and to ply patients with complimentary treatments so R.I.S.E. could continue to fraudulently bill TRICARE and Medicare.  

In addition, Candelario was also charged with paying a patient recruiter over $18,000 to refer TRICARE patients to the R.I.S.E. clinic. The recruiter, Mariam Reyes, was charged separately with conspiring to solicit and receive kickbacks.

In a separate indictment, Candelario was charged with participating in a scheme to defraud California Workers’ Compensation insurers and R.I.S.E. patients by receiving illegal kickbacks and bribes to refer patients to certain providers. According to the indictment, Candelario paid kickbacks to his co-schemers through a front company in exchange for referrals of Workers’ Compensation patients, and then concealed these kickbacks through sham “marketing” agreements.

One of Candelario’s co-schemers, Boris Dadiomov, was charged separately for his role in the fraudulent conspiracy. As a result of their unlawful cross-referral kickback scheme, Candelario and the other schemers received over 500 illegal patient referrals and submitted over $6.6 million in false billings to insurance companies.

Gov Brown Appoints Non-Attorney to WCAB

Juan Pedro Gaffney, 80, of Sebastopol, has been appointed to the California Workers’ Compensation Appeals Board by Governor Brown.

Gaffney has been a member of the California Alcoholic Beverage Control Appeals Board since 2017 and director at Coro Hispano de San Francisco since 1975.

He was director of Hispanic liturgy at Mission Dolores from 1993 to 2008 and was the first artist-in-residence at the Yerba Buena Center for the Arts.

Gaffney was an associate professor of philosophy at St. Joseph’s College and a lecturer at Saint Mary’s College from 1972 to 1996.

Gaffney is a vice president of the Instituto Pro Música de California.

He has been researching, editing, teaching and performing the choral music of Latin America, Spain and Portugal for the past 35 years.

He received early choral training from local maestros Herbert Bergman, Leonard Fitzpatrick, Richard Irven Purvis, Sergei Konstantinov and Waldemar Jacobsen, later earning advanced degrees in music from the University of California at Berkeley and Stanford University.

His discovery of the classical and folk repertories of Latin America while working in Venezuela in the mid-60’s proved key in determining the path of his career.

In 1975 he founded the Coro Hispano de San Francisco and Conjunto Nuevo Mundo, and conjointly, the Instituto Pro Música’s Musicological Research Program, through which he has transcribed and/or edited more than 100 works by New World Renaissance and Baroque masters.

Maestro Gaffney also serves as Director of Hispanic Liturgy at the Basilica of Mission San Francisco de Asís.

He does not have any background in workers’ compensation. This position requires Senate confirmation and the compensation is $147,778. Gaffney is a Democrat.

No Jurisdiction Over NFL Player’s Injuries – Affirmed

Larry Tripplett was a professional football player who played defensive tackle for the Indianapolis Colts from 2002 to 2006, then played for the Buffalo Bills from 2006 to 2008, and played briefly for the Seattle Seahawks in 2008. In his six-year career, Triplett played approximately 110 games of professional football, but only played two games in California.

In 2009, Tripplett filed a claim for workers’ compensation benefits, alleging injury to multiple body parts throughout the course of his National Football League (NFL) career. Each of the defendant football teams and insurers denied his claim. Both Buffalo and Seattle disputed California jurisdiction. Trial proceeded on the jurisdiction issue.

At that trial, Tripplett testified about his hiring by Indianapolis, explaining that his agent David Dunn, who was located in Newport Beach, negotiated all of his contracts. Tripplett asserted he was living in Los Angeles when he signed his Indianapolis contract in his agent’s Newport Beach office. At the end of Tripplett’s cross-examination, he moved to “‘elect against the Indianapolis Colts. Since jurisdiction was not contested by the Colts even prior to this trial, over the objection of the Indianapolis Colts, the Court allowed the election.’”

The matter proceeded to a further trial against Indianapolis. However, after Tripplett was provided with a copy of that agreement, showing he and his agent, Joby Branion, had signed separate copies of the signature page, he acknowledged “I honestly don’t remember” where he signed the agreement. Tripplett also testified that although he “put a lot of trust in [his] agent” to negotiate his employment agreements, and “whatever he advised me to do, that’s what I signed,” it was Tripplett himself who “had the final say.”

The WCJ found that the WCAB had jurisdiction over the claim. The WCAB granted the petition for reconsideration and reversed the WCJ’s finding of jurisdiction based on Tripplett’s hiring in California. The Court of Appeal affirmed the dismissal in the unpublished case of Tripplett v. WCAB.

Tripplett relies on Labor Code section 3600.5(a), which specifies that “[i]f an employee who has been hired or is regularly [employed] in the state receives personal injury . . . arising out of . . . [such] employment outside of this state, he . . . shall be entitled to compensation according to the law of this state,” and 5305, which specifies the WCAB has “jurisdiction over all controversies arising out of injuries suffered outside the territorial limits of the state in those cases where . . . the contract of hire was made in this state.”

But when courts have grappled with the issue of determining the location at which an injured employee was hired for purposes of workers compensation law, they have done so by applying traditional principles of contract formation.

Here, Tripplett’s agent’s negotiation of terms to be included in a written employment contract was not sufficient to bind Tripplett to anything. And because those negotiations were the only contract-related activity that took place in California, there is no basis to conclude the contract was formed in this state.

Robotic Doctor Passes Medical License Exam

In the eastern Chinese city of Hangzhou, an ambulance speeds through traffic on a wave of green lights, helped along by an artificial intelligence (AI) system and big data. The system, which involves sending information to a centralized computer linked to the city’s transport networks, is part of a trial by Alibaba Group Holding Ltd. The Chinese tech giant is hoping to use its cloud and data systems to tackle issues hobbling China’s healthcare system like snarled city traffic, long patient queues and a lack of doctors.

According to the report published by Channel News Asia, Alibaba ‘s push into healthcare reflects a wider trend in China, where technology firms are racing to shake up a creaking state-run health sector and take a slice of spending that will hit US$1 trillion by 2020.

Tencent-backed WeDoctor, which offers online consultations and doctor appointments, raised US$500 million in May at a valuation of US $5.5 billion. Ping An Good Doctor, a similar platform backed by Ping An Insurance, raised US $1.1 billion in an IPO this year. “The opportunity is growing very fast,” said Min Wanli, the Hangzhou-based chief machine intelligence scientist at Alibaba’s cloud division.

Alibaba is working with a hospital in Shanghai using data to predict patient demand and allocate doctors. In Zhejiang province, the company is working on AI-assisted diagnosis tools to help analyze medical images such as CT scans and MRIs.

Chinese hospitals are increasingly using technology to bridge the gap between urban centers and remote parts of the country where doctors are in short supply. Using document-sharing systems and livestreaming video, specialists can direct more junior medical staff on-site doing patient diagnoses.

DXY, one of China’s biggest online networks of doctors, offers consultations on the WeChat social media platform for patients with chronic diseases such as diabetes, with a team of nurses and doctors providing medical advice.

China is pressing to reduce healthcare costs that are soaring as the population ages, putting huge strains on the state insurance system. China’s healthcare system has long grappled with a shortage of doctors, exacerbated by low wages and a dearth of local clinics and general practitioners. That means patients often crowd into large, specialist hospitals for even minor ailments.

Beijing has enacted legislation over the last two years that has included strong support for internet-based basic healthcare services. Now, Beijing may be about approve the sale of some prescription drugs online, creating a major opportunity for local and global firms, according to companies in the sector.

Janssens of Merck KGaA said the company had “good indications” that policymakers were addressing the issue of pharmaceutical e-commerce “as we speak”.

In the United States, technology firms like Amazon, Google and Apple have made pushes into healthcare, with mixed results, often finding sprawling medical markets tougher to crack than entertainment or media. Technology firms in China also face major obstacles.

One is convincing patients to see doctors online or getting hospitals to spend extra money on high-tech tools that promise efficiency boosts or improvements for patients. And regulators still have concerns about drug sales online.

Wang Aihu, a cardiologist at Beijing Chaoyang Hospital, said medical centers were increasingly using online appointment and payment systems, and that he conducted internet consultations for patients in remote regions. He added that his hospital may eventually have “AI-powered medical imaging systems or robot doctors”, but these could not replace medical staff.

That hasn’t stopped one hospital in Beijing doing a “man vs machine” standoff this month to detect neurological disorders including brain tumors. A robot developed by the prestigious Tsinghua University and iFlytek, a local firm, has also taken and passed China’s medical exam for doctors.

WCIRB Says 2017 Combined Loss Ratio Drops to 91%

The Workers’ Compensation Insurance Rating Bureau (WCIRB) has prepared a new report containing estimated California workers’ compensation costs for 2017 based on insured employer experience. The report also reflects payments made by the California Insurance Guarantee Association (CIGA)

Key findings in the report include:

Total insurer combined losses and expenses incurred in 2017 were $16.2 billion, or 91% of calendar year premium, compared to $16.9 billion (or 94% of calendar year premium) in 2016.

Calendar year 2017 earned premium totaled $17.7 billion (as compared to the $18.0 billion of premium earned in 2016).

Medical losses paid in 2017 were $4.7 billion, or 56% of total loss payments. Of these payments, $1.3 billion were paid for physician services, $1.3 billion were payments made directly to injured workers, $0.7 billion were paid for inpatient or outpatient services, $0.2 billion were paid for pharmaceuticals, and $0.3 billion were paid for medical-legal evaluations.

Beginning with claims incurred on policies incepting on or after July 1, 2010, the cost of medical cost containment programs is required to be reported to the WCIRB as allocated loss adjustment expense rather than as medical loss.The total cost of medical cost containment programs in 2017 was $443 million compared to $468 million in 2016.

Indemnity benefits paid in 2017 were $3.7 billion, or 44% of total loss payments. Of this amount, temporary disability benefits paid totaled $1.8 billion and permanent partial disability benefits paid totaled $1.5 billion.

Medical-legal cost data for 2017 shows that orthopedic evaluations accounted for about 55% of the cost of all medical-legal evaluations. The exhibits also show that the average cost of a medical-legal evaluation was $1,496. Psychiatric evaluations were the most expensive, averaging $3,268.

Incurred loss adjustment expenses (allocated and unallocated) in 2017 were $3.3 billion, or 19% of earned premium. (This includes the full cost to insurers of administering, adjudicating and settling claims.) Incurred loss adjustment expenses include $894 million in defense attorney expenses incurred in 2017. (For comparison purposes, in 2016, incurred loss adjustment expenses were 16% of earned premium, including $827 million in defense expenses.)

In total, California insurers have incurred about $6.7 billion in expenses in 2017, or 38% of 2017 earned premium. (For comparison purposes, in 2016, total incurred expenses were 34% of earned premium.)

Although generally part of incurred indemnity losses rather than expenses, the amount paid in 2017 to applicant attorneys was derived from the WCIRB’s Annual Expense Call. In 2017, applicant attorneys were paid $413 million. (In 2016, applicant attorneys were paid $408 million.)