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SCOTUS Allows Generic Suboxone

British drugmaker Indivior Plc launched a copycat version of its blockbuster opioid addiction drug Suboxone in the United States, just one day after the U.S. Supreme Court cleared the way for its rivals to market generic versions.

Rejecting arguments from Indivior, Chief Justice John Roberts left in force a ruling, set to take effect Tuesday, that lets Dr. Reddy’s put the generic drug on market.

Indivior argued that Dr. Reddy’s should wait until the high court considers whether to hear an appeal in the case.

Indivior has spent over two years fighting multiple legal battles and patent disputes in the United States with companies including Dr. Reddy’s, Teva and Mylan to block them from launching generics.

The drugmaker has said it faces potentially severe losses in market share to copycats in the immediate future.

Suboxone accounted for almost all of the company’s $1 billion in sales last year, and the company said on Feb. 14 that it’s unable to provide financial guidance for 2019 “given uncertainties surrounding how the U.S. market for both Suboxone Film and generic alternatives will ultimately develop.”

The United States accounts for 80 percent of Indivior’s revenue. Indivior ended 2018 with a 53 percent share of the Suboxone film market in the United States, compared to 56 percent in 2017 and 61 percent in 2016.

The appeals court case is Indivior Inc. v. Dr. Reddy’s Laboratories SA 18-2167, U.S. Court of Appeals for the Federal Circuit (Washington).

The company’s authorized generic is being marketed and distributed by Sandoz Inc.

CWCI Reports: “NSAIDs Overtake Opioids”

A new California Workers’ Compensation Institute (CWCI) study finds that non-steroidal anti-inflammatories (NSAIDs) have supplanted opioids as the most common therapeutic drug group prescribed to injured workers in California, while payment data show that both dermatological medications and anticonvulsants now rank ahead of opioids in terms of total reimbursements.

Using data from 5.75 million prescriptions dispensed to California injured workers from 2009 to June 2018, CWCI analysts examined changes in the prescription and payment distributions among therapeutic drug groups, identified trends in the use of generics, and determined average amounts paid for drugs within each drug group over the past decade.

The results show that efforts to curb inappropriate use of opioids – tighter scrutiny via utilization review and independent medical review; restrictions by payers, medical provider networks, pharmacy benefit managers and in the Medical Treatment Utilization Schedule (MTUS) formulary; and growing awareness of opioid risks – are continuing to have an effect, as opioids fell to 18.0% of the prescriptions filled in the first half of 2018, down from 20.2% in 2017, and down from 30.5% a decade ago.

Conversely, NSAIDs, often prescribed as non-opioid alternatives to treat pain, surpassed opioids as the top drug group in California workers’ compensation in 2016, and since then, their share of the prescriptions has continued to grow, climbing to a record 31.7% of the drugs dispensed to injured workers in the first half of 2018. Anticonvulsants’ share of the prescriptions also has increased, more than doubling from 4.1% in 2009 to 9.7% in the first half of 2018, likely due to their growing use as a non-opioid alternative to treat neuropathic pain.

The 2018 data show anticonvulsants were the third most prescribed drug group, moving ahead of muscle relaxants, which under the MTUS formulary that took effect on January 1, 2018, are not exempt from utilization review, with the exception of limited special fill or perioperative allowances that restrict the quantity of the drug that can be dispensed.

Until a few years ago, growth in dermatological payments was largely driven by high-cost “custom” pharmacy compounded drugs, but with legislative changes that took effect in 2012 (AB 378), high-profile indictments involving compounded drug kickbacks, and more public awareness, custom compounds have become less prevalent, though the study notes two other factors now underlie the continued growth in dermatologlical payments:

– – the increased prevalence of high-cost, mass-produced private label topicals containing one or more active ingredients (e.g., capsaicin, lidocaine, menthol, or methyl salicylate) commonly found in over-the-counter topical analgesics, which are marketed to physicians for in-office or mail order dispensing; and
– – increased payments for topicals containing a prescription NSAID (e.g., diclofenac) which are available in a number of formulations and strengths, some of which are exempt from utilization review under the formulary.

In addition to the increasing share of the workers’ compensation prescription dollars going toward dermatologicals, the study also found that anticonvulsants’ share of the drug spend tripled from 4.8% in 2009 to 15.2% in the first half of 2018, so anticonvulsants now rank ahead of opioids as the second most costly drug group.

The data show that most of the growth in anticonvulsant’s share of the payments occurred over the past four years, coinciding with the decline in opioid use, suggesting the use of certain anticonvulsants in place of opioids. Notably, anticonvulsant prescriptions used in California workers’ comp are heavily concentrated in just two drugs, one of which is only available as a brand drug, and that drug accounted for nearly three quarters of the anticonvulsant dollars paid in the first half of 2018.

CMS Actuaries Project Unending Increases in Health Spending

National health expenditure growth is expected to average 5.5 percent annually from 2018-2027, reaching nearly $6.0 trillion by 2027, according to a report published by the independent Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS).

Growth in national health spending is projected to be faster than projected growth in Gross Domestic Product (GDP) by 0.8 percentage points over the same period.  As a result, the report projects the health share of GDP to rise from 17.9 percent in 2017 to 19.4 percent by 2027.

Similar to the findings in last year’s report, the report found that by 2027, federal, state and local governments are projected to finance 47 percent of national health spending, an increase of 2 percentage points from 45 percent in 2017.

Medicare: Medicare spending growth is projected to average 7.4 percent over 2018-2027, the fastest rate among the major payers.  Underlying the strong average annual Medicare spending growth are projected sustained strong enrollment growth as the baby-boomers continue to age into the program and growth in the use and intensity of covered services that is consistent with the rates observed during Medicare’s long-term history.

Medicaid: Average annual growth of 5.5 percent is projected for Medicaid spending for 2018-2027.  Medicaid expansions during 2019 in Idaho, Maine, Nebraska, Utah, and Virginia are expected to result in the first acceleration in growth in spending for the program since 2014 (from 2.2 percent in 2018 to 4.8 percent in 2019).  Medicaid spending growth is then projected to average 6.0 percent for 2020 through 2027 as the program’s spending patterns reflect an enrollment mix more heavily influenced by comparatively more expensive aged and disabled enrollees.

Private Health Insurance and Out-of-Pocket:: For 2018-2027, private health insurance spending growth is projected to average 4.8 percent, slowest among the major payers, which is partly due to slow enrollment growth related to the baby-boomers transitioning from private coverage into Medicare.  Out-of-pocket expenditures are also projected to grow at an average rate of 4.8 percent over 2018-2027 and to represent 9.8 percent of total spending by 2027 (down from 10.5 percent in 2017).

Prescription Drugs:  Spending growth for prescription drugs is projected to generally accelerate over 2018-2027 (and average 5.6 percent) mostly as a result of faster utilization growth.  Underlying faster growth in the utilization of prescription drugs, particularly over 2020-2027, are a number of factors including efforts on the part of employers and insurers to encourage better medication adherence among those with chronic conditions, changing pharmacotherapy guidelines, faster projected private health insurance spending growth in lagged response to higher income growth, and an expected influx of new and expensive innovative drugs into the market towards the latter stage of the period.

Hospital:  Hospital spending growth is projected to average 5.6 percent for 2018-2027. This includes a projected acceleration in 2019, to 5.1 percent from 4.4 percent in 2018, reflecting the net result of faster expected growth in both Medicare (higher payment updates) and Medicaid (as a result of expansion in five states), but slower projected growth in private health insurance as enrollment declines slightly due to the repeal of the individual mandate.

Physician and Clinical Services: Physician and clinical services spending is projected to grow an average of 5.4 percent per year over 2018-2027.  This includes faster growth in prices over 2020-2027 for physician and clinical services due to anticipated rising wage growth related to increased demand from the aging population.

Ohio Comp Sues PBM for Being “Hosed”

As Medicaid officials investigate whether pharmacy middlemen are ripping off taxpayers by manipulating drug prices in the insurance program covering 3 million poor Ohioans, the Ohio Dispatch reports that another state agency recently found it overpaid millions under a similar arrangement.

“We thought we had a solid contract that kept us from being taken advantage of (but) discovered we were being hosed,” said John Hanna, former pharmacy program manager for the Ohio Bureau of Workers’ Compensation.

“I’ve been a pharmacist since 1977 and I was stunned when I saw the level of manipulation that went on that I didn’t know about,” said Hanna, who retired last September after eight years.

After nearly a year of investigating, Ohio is taking its first steps to recover money from pharmacy middlemen who do billions of dollars worth of business with state agencies. The bureau spent about $86 million last year on pharmacy claims for about 41,000 injured workers.

Attorney General Dave Yost announced Tuesday that he is seeking repayment of nearly $16 million paid to pharmacy-benefit manager OptumRx by the Bureau of Workers’ Compensation. Yost intends to take OptumRx to nonbinding mediation, saying the company has overcharged the bureau since 2015. Such mediation is required under the contract between the bureau and OptumRx. If it fails, the dispute presumably will be taken to court.

“The state of Ohio and the BWC consider these matters of public significance and have calculated the following overcharges attributable to OptumRx’s failure to adhere to agreed discounts on generic drugs. …” says a copy of Yost’s Feb. 11 letter to OptumRx that was obtained by The Dispatch.

The firm that conducted the analysis, Healthplan Data Solutions, determined that OptumRx overcharged BWC by $5.7 million in 2017. That’s 6.5 percent of the $86 million in total agency spending on prescription drugs that year. The bureau fired OptumRx as a consequence of the analysis.

The bureau’s analysis, conducted by the Columbus-based Healthplan Data Solutions, found the private company hired by the bureau to run its pharmacy program overcharged the agency $5.6 million in 2017.

As described by Hanna, workers’ comp was paying pharmacists less to fill prescriptions than they were charging the state, allowing them to pocket millions.

In industry jargon, the practice is known as “spread pricing.” Serious questions about are being raised about it in Iowa, Kentucky, Arkansas and nationally

Hanna said “PBMs started in ’80s to process prescriptions and they slowly grew in the marketplace and realized they had the ability to control pricing and reimbursements. That’s where the concept of the spread came in – you’re my client and I tell you I will process prescriptions for you for your prescription drug plan for X dollars, and then I go to the pharmacies and tell them I will pay you X minus $9 and that’s my spread.”

“The client has no idea what the pharmacy is being paid unless they have a transparent contract.”.

High Group Deductibles Cause Higher Comp Claims

Workers who are injured on the job may or may not file for workers’ compensation, but among the factors that influence that decision – and tip it toward filing a comp claim – is the level of the deductible in their employer-provided health plan.

That finding comes from a new report from the Workers Compensation Research Institute, which finds that as deductibles rise, employees are more likely to turn to comp claims rather than their own coverage.

“In years past, workers may have chosen to have a work injury covered within their group health plan,” says John Ruser, WCRI’s president and CEO. “But the increasing cost of deductibles may cause them to consider having the injury covered – where it potentially belongs – in the workers’ compensation system, where there are no deductibles or copayments for the medical care they receive.”

According to the report, workers who have a higher deductible from their group health plan when they’re injured are not only more likely to file under workers’ compensation than under group health insurance, workers who have sustained soft-tissue injuries are even more likely to turn to workers’ comp rather than their own health coverage when deductibles are higher for the latter.

When injured workers have an average remaining deductible of $550 on their own health coverage, the report adds, they’re approximately 1.4 percentage points more likely to tip the scales in favor of filing a workers’ compensation claim than if their own coverage deductible is zero. And that results in an increase of 5.3 percent in workers’ compensation claim volume.

States in which workers can choose their initial provider are the ones seeing the most concentration in the rise in filing workers’ compensation claims. That could possibly be due to the ability within workers’ compensation of workers to stay with their group health doctor in these states.

The study also estimated the increase in workers’ compensation volume from the growth in high-deductible group health policies, and found that “the increase partially offsets the overall decline in workers’ compensation claims seen over the past decade.”

SCOTUS Rejects Maryland’s Drug Pricing Law Case

The U.S. Supreme Court rejected Maryland’s bid to revive a law aimed at preventing price gouging by pharmaceutical companies, dealing a setback to the power of states to rein in prescription drug costs.

Last year, Maryland became the first state in the country to give its attorney general the power to take legal action against drug companies that dramatically increase the price of off-patent or generic drugs.

The complicated law applied to generic or off-patent drug makers that manufacture a medicine at least three other firms also make. If those conditions applied, companies could not impose a significant price increase without justifying it to the attorney general, who could ask a judge to order that the price increase not take effect. Violating the law carried a $10,000 fine.

The Association for Accessible Medicines, a trade group representing generic drug manufacturers such as Teva Pharmaceutical Industries Ltd and Mylan NV, sued its Attorney General Brian E. Frosh and Dennis R. Schrader, who was the state’s acting health secretary, to block the measure.

The case worked it way to the U.S. Court of Appeals for the Fourth Circuit, which said in a 2-to-1 ruling that the 2017 law is unconstitutional because it violates the commerce clause of the U.S. Constitution.

“Although we sympathize with the consumers affected by the prescription drug manufacturers’ conduct and with Maryland’s efforts to curtail prescription drug price gouging, we are constrained to apply the dormant commerce clause to the Act,” Judge Stephanie D. Thacker wrote for the majority opinion. “We hold that the Act is unconstitutional under the dormant commerce clause because it directly regulates transactions that take place outside Maryland.”

Maryland argued that the 4th Circuit’s decision not only prevents Maryland and other states from reining in abusive prescription-drug prices that harm consumers and public health but that the ruling could call into question other state regulatory efforts. At issue was whether the measure violated Supreme Court precedents that constrain states from enacting laws that burden out-of-state competitors.

The U.S. Supreme Court just declined to take up Maryland’s appeal of the 2018 federal appeals court ruling, without comment, letting a lower court ruling against the law stand.

So far, California as had better results with S.B. 17. The California law requires all drug price hikes over 16% over a two-year span to be subject to transparency requirements, which would discourage double-digit price increases and better negotiations between drug companies and purchasers.

Last August, the U.S. District Court, Eastern District of California dismissed a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) to halt S.B. 17.

PhRMA filed this lawsuit alleging the law as unconstitutional and seeking a permanent injunction preventing its implementation. The U.S. District Court dismissed the suit as PhRMA did not produce enough facts to substantiate their claims or standing.

Physical Therapy Clinics Resolve Fraud Claims for $450K

Two San Diego physical therapy clinics and their owners have paid $450,000 to resolve allegations that they fraudulently billed TRICARE for medical services that were supposedly performed by qualified medical doctors, but were actually provided by unqualified and unauthorized employees.

South Bay Physical Medicine, Inc. and Direct Health Medical Center, Inc. d/b/a San Diego Spine and Rehabilitation were physical therapy clinics.  Brett Allan, Sr., Brett Allan, Jr. and Jeff Allan owned the clinics.

“The United States Attorney’s Office works hard to safeguard the integrity of the TRICARE program and the safety of our soldiers and their family members,” said U.S. Attorney Robert Brewer.  “Health care fraud hurts the entire health care system, from taxpayers down to honest providers and innocent patients. We are committed to using all available remedies, both civil and criminal, to combat health care fraud.”

The Government’s resolution of this matter illustrates its emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, and abuse can be reported at https://www.tricare.mil/ContactUs/ReportFraudAbuse.

This matter was handled by Assistant U.S. Attorney Dylan M. Aste of the U.S. Attorney’s Office for the Southern District of California, the Federal Bureau of Investigation, the Defense Criminal Investigative Service, and the Defense Health Agency Program Integrity Office.

Worker Must Prove Injury in Uninsured Employer Tort Claim

Evangelina Ruiz began work as a legal assistant with Carter and Carter, APLC in 2007 at their office in Corona. Christopher Carter specialized in mold and mold remediation cases.

In September 2011, Christopher Carter accepted a tort case involving black water and mold in a house. Ruiz was assigned to inspect documents in the case, which she alleged contained mold and mold spores.

Ruiz became ill. Ruiz filed a worker’s compensation claim but Carter advised Ruiz it did not carry worker’s compensation insurance during the time that she alleged to have been sickened by the documents.

Ruiz filed a lawsuit in the trial court and with the Worker’s Compensation Appeals Board (WCAB).

The second amended complaint filed in the trial court, which alleged one cause of action for premises liability. Carter brought a motion for summary judgment, which was granted by the trial court.

Ruiz appealed the grant of Carter’s Motion claiming that (1) because Carter was an illegal uninsured employer, she only had to prove worker’s compensation causation, which is a lower standard than the civil causation standard used by the trial court in granting the Motion; (2) pursuant to Labor Code section 3708, Carter had the burden to prove it was not negligent; and (3) the trial court erred by rejecting Ruiz’s argument when she filed the first amended complaint, that she could allege different theories of negligence

The court of appeal conclude the Motion was properly granted and affirm the judgment in the unpublished case of Ruiz v. Carter & Carter, APL.

LC 3706 states, “If any employer fails to secure the payment of compensation, any injured employee or his dependents may bring an action at law against such employer for damages, as if this division did not apply.” LC 3708 mandates a presumption not present in other tort actions that the injury to the employee “was a direct result and grew out of the negligence of the employer, and the burden of proof is upon the employer, to rebut the presumption of negligence.”

Here, Ruiz had the burden of proving by a preponderance of the evidence that she was injured in the Carter offices. Ruiz failed to provide any competent evidence with the SAC to support she was injured at Carter’s office.

The burden of proof did not shift to Carter under Labor Code section 3708 to prove that it was not negligent because Ruiz failed to present competent evidence that she had suffered an injury at work.

UK Funding AI to Detect Insurance Fraud

A project to develop breakthrough artificial intelligence technology for the anti-fraud sector is one of a number of new projects set to receive funding to enable the UK accountancy, insurance and legal services industries to transform how they operate.

The artificial intelligence software, being developed by Intelligent Voice Ltd, Strenuus Ltd. and the University of East London will combine AI and voice recognition technology to detect and interpret emotion and linguistics to assess the credibility of insurance claims.

The project is one of 40 backed by £13 million in Government investment to support collaborative industry and research projects to develop the next-generation of professional services.

Business Secretary Greg Clark said: “Artificial intelligence and data are transforming industries across the world.  We are combining our unique heritage in AI with our world beating professional services to put the UK at the forefront of these cutting-edge technologies and their application.

“We want to ensure businesses and consumers benefit from the application of AI – from providing quicker access to legal advice for customers, to tackling fraudulent insurance claims, these projects illustrate our modern Industrial Strategy in action. We’re investing record levels in research and development so that every part of the UK can benefit from the industries and high-skilled jobs of the future.”

The projects announced on February 15 back innovation in the accountancy, insurance and legal services and are part of the Next Generation Services Industrial Strategy Challenge Fund. This is a £20 million fund, administered by UK Research and Innovation (UKRI), to support the development and adoption of AI and Data technologies that will transform the UK’s services industries.

This announcement builds on reviews that BEIS has undertaken with the InsurTech (insurance technology) and LawTech (legal technology) emerging sectors, in partnership with Treasury and the Ministry of Justice.

The Industrial Strategy sets out Grand Challenges to put the UK at the forefront of the industries of the future, ensuring that the UK takes advantage of major global changes, improving people’s lives and the country’s productivity. Artificial intelligence and data is one of the four Grand Challenges which will see AI used across a variety of industries and put the UK at the forefront of the AI and data revolution.

February 11, 2019 News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: SCOTUS Affirms Employers Arbitration Rights, Carriers Sued for QME Sexual Misconduct, OCDA Recovers $1.6M for Unsafe Workplace, Bay Area Doctor Arrested for SDI Fraud Schemes, Congress Questions a Once Free Drug, Now $375k a Year, MTUS/ACOEM Guidelines Now Free and Online, TV Ads to Include Drug Price Transparency, Novartis and Eli Lily Support end to PBM Rebates, CorVel Reports on 10,000 Telehealth Visits, Study Shows No Value to Topical Compounded Pain Creams.