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As U.S. consumer outrage grows over prescription drug prices, state authorities and patient advocates in Maryland are preparing to enforce the nation’s first law designed to punish drugmaker price-gouging.

The state Attorney General’s office said it will field complaints and investigate "unconscionable increases" in essential generic medicines when the closely watched law takes effect Oct. 1.

Drugmakers fear the Maryland law will embolden other states and are seeking a court injunction. Both sides made their arguments on Thursday before a U.S. District Court judge in Baltimore, who could decide on an injunction in the coming days.

According to the Report in Reuters Health, anticipating the law will survive the legal challenge, the Attorney General’s office said it is working with health economists at Johns Hopkins University to identify price spikes, which are not made public by drugmakers. Patient advocacy groups are urging consumers to report increased costs for their medicines. Maryland Citizens’ Health Initiative will add an option to report price gouging to its website.

Pharmaceutical companies have so far dodged stricter federal oversight despite growing outrage over price hikes. Valeant Pharmaceuticals International Inc raised the price of heart medications Isuprel by about 720 percent and Nitropress by 310 percent, after acquiring them in 2015. Mylan NV raised the price of its life-saving EpiPen six-fold between 2008 and 2016.

But states, struggling to cover rising healthcare costs, are taking up the fight. At least 176 bills on pharmaceutical pricing and payment have been introduced this year in 36 states, according to the National Conference of State Legislatures.

Maryland’s law is the most aggressive legislation to be passed so far, and allows the state to levy fines and order a reversal of price increases.

The Association for Accessible Medicines, a generic industry trade group that filed the lawsuit, argues that the law is unconstitutional because it does not define price-gouging and amounts to intervention by an individual state in interstate commerce.

"The issue of drug pricing is a national issue ... not something that should be handled piecemeal in 50 different ways," said Jeff Francer, general counsel for the trade group which represents companies like Teva Pharmaceutical Industries Ltd and Novartis AG’s Sandoz unit.

Maryland Attorney General Brian Frosh said that states have a well-defined role to play in policing "unconscionable" business activity against consumers, especially when they have no other recourse. He cited consumer contracts for telephone service, which are non-negotiable.

Several states have passed laws requiring drugmakers to disclose price increases, but the Maryland law is one of a few drawing the most attention from the drug industry.

Nevada has been sued by two industry trade groups after passing in June a law requiring diabetes drugmakers to justify price increases above a certain amount.

Ohio voters next year will decide on a ballot measure requiring drugmakers to offer state groups the same discounts given to the federal Department of Veterans Affairs. A similar measure failed in California last year, but the state’s legislature this week approved a drug pricing bill requiring drugmakers to justify price increases over 16 percent in a two-year period. It now goes to the state’s governor for a final decision ...
/ 2017 News, Daily News
A new study on the California workers’ compensation independent medical review (IMR) process established by state lawmakers to resolve medical disputes finds that in the first half of this year, more than 91% of all utilization review (UR) physicians’ modifications or denials of treatment that were reviewed by an IMR physician were upheld, and after increasing steadily since 2013, IMR volume appears to be leveling off.

California law requires workers’ comp claims administrators to have a Utilization Review (UR) program to assure that care provided to injured workers is backed by clinical evidence outlined in medical guidelines adopted by the state. Most treatment requests are approved by UR, but in 2012 state lawmakers adopted IMR to give injured workers a chance to get an independent medical opinion on treatment requests that UR physicians deny or modify.

Use of IMR has grown sharply since 2013, but in its new study, the California Workers’ Compensation Institute (CWCI) tallied 86,066 IMR decision letters issued in the first half of this year in response to applications submitted to the state after a UR physician modified or denied a medical service request. At that rate, the volume of IMR letters in 2017 will decline 2.2% from the 2016 level, while the number of individual treatment requests decided in those letters will be down 0.6 percent - the first time IMR volume has not increased since the process took effect in 2013.

CWCI’s analysis of the 2017 IMR decisions found that after reviewing the patient’s records and other information provided to support the request, IMR physicians upheld the UR doctor’s modification or denial of the service 91.3% of the time, which was virtually identical to the 91.2% uphold rate in 2016.

As in prior years, pharmaceutical requests accounted for almost half of the 2017 IMR decisions, led by opioids, which represented 28.8% of all 2017 prescription drug IMRs, even though IMR doctors have consistently upheld the UR decision in 90% of the opioid requests.

Requests for physical therapy; injections, durable medical equipment; and MRIs, CTs and PET scans together comprised another 29% of the 2017 IMRs, but no other medical service category accounted for more than 4% of the disputed requests. Among the various service categories, uphold rates in 2017 ranged from 80.4% for evaluation/management services (primarily consultations) to 94.6% for chiropractic manipulation.

The Institute study also confirmed that a relatively small number of physicians continue to account for most of the disputed medical services that go through IMR. A breakdown of IMR volume among high-volume physicians showed that the top 10% of physicians who were named in IMR decision letters issued between July 2016 and June 2017 (1,114 doctors) accounted for 85% of the disputed service requests during that period, while the top 1% (111 providers) accounted for 45% of the disputed services.

Additional details and graphics from the study are available in a CWCI Spotlight Report, "Independent Medical Review Decisions: January 2014 Through June 2017." ...
/ 2017 News, Daily News
Digital devices and mobile applications are breathing new life into traditional workers’ compensation services. According to the report in the Claims Journal - this was a key takeaway from the session, "Ridesharing Technology: Transforming Transportation in Workers’ Compensation," presented at the 2017 California Workers’ Compensation & Risk Conference in Dana Point, California.

"Until recently, the workers’ compensation industry relied on an antiquated approach to coordinating transportation, which required a lot of manual oversight," said Joseph McCullough, senior vice president of product at One Call Care Management. "Not surprisingly, this model resulted in a significant number of missed medical appointments, which can delay and even derail an injured worker’s progress toward recovery with significant and costly consequences."

Within the past few years, ridesharing has become widely accepted with rapid adoption in healthcare and workers’ compensation. "Integrating ridesharing with a secure digital platform and proper credentialing has been the key to making this model safe and appropriate for the workers’ compensation market. With these critical components in place, One Call has experienced a 50 percent increase in daily ridesharing trips over the last seven months," noted McCullough.

Digitization of non-emergency medical transportation, as well as other additional services, is a radical shift for the industry. As a forward-thinking player in this space, One Call has leveraged technology and formed strategic partnerships to meet the evolving needs of payers and injured workers. Today, transportation network companies (TNCs), like Lyft, use ridesharing to provide full digital capabilities, complete transparency into ride coordination and an overall streamlined process.

"Going from passive to active ride management is a transformative experience for everyone involved, and the industry will reap significant benefits including a reduction in failed and late pick-ups, as well as minimizing the need to reschedule medical appointments and transportation. Clinical, claims and return-to-work outcomes improve as patients attend appointments with greater consistency and reliability," said McCullough.

As with any industry disruption, there have been fears over exposure and liability. Some initially considered ridesharing to be risky because of a misconception, largely perpetuated by traditional vendors like taxi companies, that the industry was not being properly regulated. In truth, 48 states have passed TNC-related regulations for driver and vehicle safety, licensing, background checks and liability insurance and these regulations are often stricter and more onerous than those regulating traditional taxi companies.

"This demonstrates that safety standards and regulations do exist," said McCullough. "Beyond these requirements, patient experience is also enhanced. Injured workers have improved visibility into the details of their rides, and they can rate their satisfaction with drivers and their ride experience."

Clients also want deeper and broader insights into their ancillary services. "We strive to provide prescriptive as well as actionable intelligence," added McCullough. "We’ve made strategic investments in our technology platform and tools, which have advanced our analytic capabilities. We’re well positioned to do more with data - in a secure environment. Our clients can draw powerful conclusions from various data points, especially as they begin to develop and integrate their own mobile apps."

Using this same type of modern digital platform, it’s possible to streamline the delivery of other accompanying services, such as web-based video translation services. "Similar to transportation, interpretation and language services are vital to communicating and facilitating the treatment plan with injured workers. Our goal is to eliminate any barriers so they receive the care they need to recover and return to work," concluded McCullough ...
/ 2017 News, Daily News
Arizona’s provider of workers’ compensation insurance since 1925, announced a definitive agreement to acquire Pacific Compensation Insurance Company (PacificComp), a California-based workers’ compensation carrier, from Alleghany Insurance Holdings LLC, a wholly-owned subsidiary of Alleghany Corporation (NYSE: Y), for $150 million in cash. The combined book of underwriting business for the two companies will represent approximately $400 million in premium and a combined asset base of nearly $4.1 billion, with $1.5 billion in policyholder surplus.

CopperPoint was founded in 1925 and is headquartered at CopperPoint Tower in Phoenix and has a presence statewide. Today it provides workers’ compensation insurance to more than 12,000 businesses, as well as offers other business insurance products, including property and casualty coverage. It holds $1.35 billion in surplus and more than $3.4 billion in assets with no debt. The family of CopperPoint Insurance Companies and its subsidiaries are rated A- Excellent XII by A.M. Best.

CopperPoint was privatized and converted to a mutual insurance company in 2013 with a vision of geographic expansion and product diversification. In 2016, Marc Schmittlein, a 30-year veteran of The Travelers, was brought on by the board of directors as CopperPoint CEO to help the company take the next step in its journey to become a regional mutual commercial lines company.

Pacific Compensation Insurance Company provides workers’ compensation insurance coverage exclusively through independent insurance brokers for California companies. The company was formerly known as Employers Direct Insurance Company and changed its name to Pacific Compensation Insurance Company in April 2010. The company was incorporated in 2002 and is based in Westlake Village, California with an additional address in Agoura Hills, California. Pacific Compensation Insurance Company operates as a subsidiary of Alleghany Insurance Holdings LLC.

The acquisition of PacificComp represents a significant milestone in CopperPoint’s geographic expansion and diversification initiatives. PacificComp brings a proven track record, strong underwriting discipline and focused approach to serving businesses in the California market. The two companies share complementary strengths, including expertise in workers’ compensation and a commitment to providing the highest quality customer experience through select independent agents.

"We are creating a family of insurance companies built on strong business relationships and best-in-class service," said Marc Schmittlein, President & CEO of CopperPoint. "PacificComp brings experienced professionals with deep California market expertise and a solid book of business that will undoubtedly provide us with a sound platform for growth."

"In joining CopperPoint, we have found an ideal strategic and cultural fit for our employees, broker partners and policyholders that will allow us to continue our service to the market without interruption and provide us with the ability to expand the products and services we offer," said Jan Frank, CEO of PacificComp. "Our companies share a strategic vision for the continued expansion of the business and an approach to the marketplace that makes me and the PacificComp management team excited to become part of the CopperPoint family of companies."

Schmittlein added, "A key tenet of our value proposition comes from our proximity to customers, their business, their markets and their communities. Acquiring PacificComp builds on that core strength and is a natural fit for our policyholders growing West, particularly into California."

Upon closing, PacificComp will continue to operate under its current name as part of the broader CopperPoint family of companies. Terms of the agreement include the purchase of adverse development reinsurance cover on PacificComp’s pre-acquisition claims. The transaction is expected to close at the end of the year subject to customary closing conditions and regulatory review and approvals.
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/ 2017 News, Daily News
California Insurance Commissioner Dave Jones on Tuesday issued a decision regarding the Workers’ Compensation Insurance Rating Bureau’s Jan. 1, 2018 regulatory filing, which was submitted to the California Department of Insurance on June 27.

Jones approved the following:

- The WCIRB’s proposed changes to the California Workers’ Compensation Uniform Statistical Reporting Plan - 1995;

- Miscellaneous Regulations for the Recording and Reporting of Data - 1995;

- California Workers’ Compensation Experience Rating Plan -1995.

Some of these changes are effective Jan. 1, 2018, and others are effective Jan. 1, 2019.

The WCIRB will begin calculating January 2018 experience modifications within the next several days.

The Decision pertains only to the WCIRB’s Regulatory Filing and does not include amendments to advisory pure premium rates.

Changes to advisory pure premium rates were proposed in the WCIRB’s Jan. 1, 2018 pure premium rate filing, which was submitted to the CDI on Aug. 18 and amended on September 8 ...
/ 2017 News, Daily News
The Division of Workers’ Compensation (DWC) has posted an order adjusting the Official Medical Fee Schedule (OMFS) to conform to changes in the Medicare payment system as required by Labor Code section 5307.1.

The Physician and Non-Physician Practitioner Fee Schedule update Order adopts the following Medicare changes:

1) Centers for Medicare and Medicaid Services (CMS) Medicare National Physician Fee Schedule Relative Value File RVU17D October 1, 2017 quarterly update

2) National Correct Coding Initiative Physician/Practitioner Services CCI Edits October 1, 2017 quarterly update

3) National Correct Coding Initiative Medically Unlikely Edits October 1, 2017 quarterly update

The order adopting the OMFS adjustments is effective for services rendered on or after October 1, 2017 and can be found on the DWC website ...
/ 2017 News, Daily News
The intrusion of claims for "medical" marijuana as treatment for an industrial injury is an insidious process. It proceeds in a state-by-state push headed toward a tipping point that may lead to an avalanche. Another state high court will soon rule on a case that may add, or subtract from the push.

The Maine Supreme Judicial Court will decide if state law requires Workers’ Compensation Insurance to pay for a millworker’s medical marijuana or if the insurer could be charged as an accessory in a drug deal under federal law.

The Bangor Daily News reports that Justices are set to hear arguments in the case at the Capital Judicial Center in Augusta, which will be the first time the state’s highest court has considered the question of insurance reimbursement for the cost of medical marijuana.

The case pits a former Madawaska mill employee, injured on the job, against the company that administers the mill’s insurance for injured workers.

Gaetan Bourgoin, now 58, of Madawaska, in 2015 sought reimbursement for medical marijuana prescribed for pain due to a back injury suffered in 1989 when he was 29 and working at what is now Twin Rivers Paper Co.

Bourgoin tried a variety of opioid-based painkillers over the years without relief, according to briefs filed in Portland.

In 2015, the Maine Workers’ Compensation Board ordered that Sedgwick Claims Management Services of Memphis, the third party that administers Two Rivers’ insurance plan, to reimburse Bourgoin for his medical marijuana.

The cost of the drug runs between $350 and $400 a month compared to the more than $2,000 a month it had cost for Bourgoin’s opioid-based prescription painkillers, Bourgoin’s attorney, Norman Trask of Presque Isle, said in his brief to the state’s high court.

Attorneys for the mill and Sedgwick appealed the decision, arguing that an insurer can’t be ordered to pay for marijuana since it is illegal under federal law, which trumps state law. The U.S. Department of Justice could prosecute insurance companies for reimbursing people for purchasing illegal drugs, they argued.

In addition to the conflict between state and federal marijuana laws, requiring reimbursement for medical marijuana violates the Maine statute that legalized the drug for medicinal use, Bangor attorneys Anne-Marie Storey and John Hamer, who represent the mill and its insurer, said in their brief.

The Maine Medical Use of Marijuana Act states that it may not "require a government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana," Shorey and Hamer argued.

Trask countered that the state’s workers’ compensation law states that employees injured on the job are "entitled to reasonable and proper medical, surgical and hospital services, nursing, medicines, and mechanical, surgical aids, as needed, paid for by the employer." Marijuana, in this case, would fall under "medicines," Bourgoin’s attorney argued.

New Mexico’s appellate court appears to be the only state appellate court in the country that has ruled on reimbursement by insurers for medical marijuana. In three different cases since 2014, New Mexico justices have ruled that state law requires insurance companies pay for medical marijuana ...
/ 2017 News, Daily News
Entrepreneurs have always had an eye on the benefits of doing business within the Sovereign Immunity protection of recognized American Indian Tribes. Generally, recognized tribes are exempt from most state and federal law. A recent California example was attempts to form "staffing" companies that claimed to be a tribal enterprise that acted as an employer claiming to be exempt from the costly California workers compensation insurance requirements.

Now, there is a new twist to an old idea.

Reuters Health reports that a groundbreaking deal between Allergan Plc and a Native American tribe to shield the company’s patents in administrative proceedings could also be used be to protect them from challenges in federal court, legal experts said, potentially dealing a blow to generic competition.

Allergan said it had transferred patents on its blockbuster dry eye medicine Restasis to the St. Regis Mohawk Tribe, which will exclusively license the patents back to the company in exchange for ongoing payments. The deal takes advantage of the fact that the tribe is treated as a sovereign nation immune to civil lawsuits.

In announcing the deal, Allergan said it believed the Restasis patents would no longer be subject to review by the U.S. Patent Trial and Appeal Board, an administrative court empowered to cancel patents through a process called inter partes review. The company said it would not claim immunity in an ongoing lawsuit in federal court by generic manufacturers seeking to revoke the same patents.

"This was directed at and only affects the flawed IPR process," Allergan Chief Executive Brenton Saunders said in an interview.

But judges across the country have found tribal immunity applies to litigation in federal court. That means other brand-name drug companies could be motivated to follow Allergan’s lead and transfer their patents to tribes, severely limiting generic manufacturers’ ability to challenge those patents.

Drugs made by brand-name manufacturers like Allergan, Pfizer Inc and Merck & Co are usually protected by patents for up to 20 years after they are introduced. But generic companies can bring their versions to market earlier if they can successfully sue to have those patents invalidated. The price of a drug drops dramatically once generic versions enter the market. Restasis sales were $1.4 billion last year.

The Patent Trial and Appeal Board, which Congress created in 2011 to make it easier and cheaper to challenge patents, has been embraced by generic drug companies. Earlier this year, the board invalidated some of the patents held by Abbvie Inc on its $16 billion immunosuppressant Humira, raising the possibility of low-cost competition for the country’s best-selling drug.

Challenging patents in federal court is slower and more expensive, though generic companies certainly do it. Teva Pharmaceuticals Inc and other generic drug companies are suing Allergan in federal court seeking a ruling that the latter’s Restasis patents should not have been granted in the first place because they cover obvious concepts.

Michael Carrier, a professor at Rutgers Law School, said drug companies may fear a public outcry if they use tribal immunity to remove their patents from scrutiny by both the board and federal court. A spike in drug prices, for example, could lead Congress to pass a law limiting the scope of that immunity in such cases ...
/ 2017 News, Daily News
The WCRC, the entity which reviews Workers’ Compensation Medicare Set-Asides (WCMSAs) for the Centers for Medicare & Medicaid Services (CMS) has issued the award to Capitol Bridge LLC, a government services firm with its headquarters in Arlington, Virginia. The award notice is as of September 1, 2017.

The purpose of the Workers' Compensation Review Contractor contract is to independently price the future Medicare-covered medical services costs related to WC injury, illness, and disease, and to price the future Medicare covered prescription drug expenses

Over the past several years, requirements for Workers’ Compensation Medicare Set-Asides (WCMSAs) have been somewhat well-established. The Centers for Medicare and Medicaid Services (CMS) now routinely update their WCMSA Reference Guide, providing detailed information on how to handle payment for Medicare-eligible expenses on behalf of beneficiaries who have received settlements in workers’ compensation cases.

For liability cases, however, CMS has been far less clear, making it difficult for claimants and their attorneys to ensure that Medicare won’t seek reimbursement down the road. However, it appears as though some major changes are imminent.

CMS recently issued a notification directing Medicare Administrative and Recovery Contractors (MACs) to create a set-aside process for Liability Medicare Set-Asides (LMSAs), as well as for No-Fault Medicare Set-Asides (NFMSA). The new process is scheduled to go into effect as of October 1, 2017.

The Medicare Secondary Payer (MSP) provision outlined in 42 U.S.C. §1395y(b)(2) and §1862(b)(2)(A)(ii) of the Social Security Act do specifically reference "an automobile or liability insurance policy or plan (including a self-insured plan) or no-fault insurance," under the umbrella of primary payers for claims related to settlements, judgments, awards, or other payments. The direction given to the MACs should now provide some framework for claimants involved in non-workers’ compensation cases.

Noteworthy of the award is that it is for approximately $60 million dollars, which is safe to say that CMS expects the WCRC to engage in a large number of MSA reviews. According to the Request for Proposal (RFP) for this award the WCRC will also potentially begin reviewing Liability Medicare Set-Asides (LMSAs) and No-Fault Medicare Set-Asides (NFMSAs) as early as July 1, 2018 which is likely the reason for the large award amount, in addition to an increased volume of WCMSAs over the years.

Since 2011, Provider Resources, Inc. has been the contractor reviewing WCMSAs. There have seen good turnaround times from Provider Resources and it is likely that Capitol Bridge LLC will continue to provide MSA approvals expeditiously.

It will be interesting to keep an eye on how Capitol Bridge reviews MSAs and also adopts updated guidance in the new WCMSA Reference Guide. Since the issuance of the Reference Guide, the industry has seen a shift in some of the WCRC’s approval policies.

The current WCRC is now requiring a court order to approve a zero allocation based upon denial of the claim. Further, with California MSAs in which the employer/carrier has relied upon a binding Utilization Review (UR), WCRC is now requiring an Independent Medical Review (IMR) decision or a court order to support the UR.

...
/ 2017 News, Daily News
Trinity County is the state’s fourth-smallest, and ended last year with an estimated population of 13,628 people.

Its residents also filled prescriptions for oxycodone, hydrocodone and other opioids 18,439 times, the highest per capita rate in California.

Places like West Virginia, Ohio and rural New England have become synonymous with prescription painkiller abuse, a scourge blamed for more than 183,000 deaths from 1999 through 2015.

California, though, is far from a bystander to the crisis. There were 1,925 opioid-linked overdose deaths in California last year, according to recently updated state data, and thousands of emergency room visits.

The story in the Sacramento Bee reports that problem also has a decidedly geographic dimension in California. In rural and semi-rural parts of the state, where the demographics resemble Appalachia more than Anaheim, prescription drug use and death rates vastly exceed the state average, state data show.

Besides Trinity, other counties with more prescriptions than people include Lake, Shasta, Tuolumne and Del Norte counties. In the Sacramento region, El Dorado, Placer and Sacramento counties had prescription rates above the statewide average, with Yolo County slightly below the state average.

A county’s prescription total represents all opioids dispensed via prescriptions filled at a pharmacy and tracked by the state. Statewide, 15 percent of Californians were prescribed opioids in 2016, ranging from 7.3 percent of residents in tiny Alpine County to almost 27 percent in Lake County.

"The following characteristics were associated with higher amounts of opioids prescribed: a larger percentage of non-Hispanic whites; higher rates of uninsured and Medicaid enrollment; lower educational attainment; higher rates of unemployment; (small-town) status; more dentists and physicians per capita; a higher prevalence of diagnosed diabetes, arthritis, and disability; and higher suicide rates," concluded the authors of a Centers for Disease Control and Prevention study released in July.

The National Institute on Drug Abuse last month awarded nine grants to address the opioid crisis in rural places. Oregon doctor Todd Korthuis, an expert on opioid abuse in the state, is the only grant recipient west of the Mississippi River. "What you’re seeing in California is what you’re seeing in many parts of the country, including Oregon," Korthuis said. "There are still a lot of rural counties around the U.S. that are awash in prescription opioids."

The state data also compiles prescriptions by ZIP code. In Sacramento County, for example, ZIP codes with the highest rates of prescription opioids include Galt’s 95632, Del Paso Heights’ 95838, and Rio Linda’s 95673.

The country’s opioid abuse epidemic tracks a quadrupling of prescription drug sales from 1999 to 2014. Once prescribed mainly for short-term pain relief, prescription painkillers increasingly are taken for chronic pain.

Young people are among the biggest abusers. Although overall teen drug use has declined nationally, prescription drugs are second only to marijuana in teen drug abuse. One in five teens has abused a prescription pain medication, according to the Partnership for Drug-Free Kids.

In California, residents aged 15 to 29 got 1.7 million prescriptions in 2016, representing 7.2 percent of the state total. That’s down from the 1.9 million prescriptions in 2015, which represented about 7.8 percent of the state total. The age range that featured the largest prescription rate increase were 70- to74-year-olds, whose prescriptions grew from almost 1,354 per 1,000 people in 2015 to 1,394 per 1,000 people in 2016.

The worsening crisis has prompted state legislation, although few bills on the subject seem likely to pass this year. A measure by Assemblywoman Marie Waldron, R-Escondido, to require California to create a public-awareness campaign about opioid abuse passed the Assembly without a dissenting vote. It was held last week in the Senate Appropriations Committee because of the cost. And a bill by Assemblyman Kevin McCarty, D-Sacramento, to levy a new fee on opioid manufacturers would have generated an estimated $88.1 million to pay for treatment and prevention efforts. It did not advance.

One of the few prescription painkiller bills still moving would require the state Department of Public Health to convene a working group to craft guidelines for the prescribing of opioid pain relievers. It has had no opposition ...
/ 2017 News, Daily News
"Pile on" is a phrase used in football which describes the action of one or more players jumping on top of a player or group of players after a tackle has been made. The phrase may now be an accurate description of what states are doing to opioid drugmakers.

New Mexico seems to have joined a drugmaker pile on as it sued eight opioid manufacturers and wholesale distributors this month, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic.

Reuters Health reports that New Mexico Attorney General Hector Balderas accused Purdue Pharma LP, Johnson & Johnson, Allergan Plc, Endo International Plc and Teva Pharmaceuticals Industries Ltd of pushing addictive painkillers through deceptive marketing. The lawsuit also accused wholesale distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp of breaching their legal duties to monitor, detect and report suspicious orders of prescription opioids.

"New Mexico continues to endure the most catastrophic effects of the opioid crisis, all while major out of state corporations make billions in profits at the expense of our families and communities," Balderas said in a statement.

The lawsuit followed a wave of cases against drugmakers by Oklahoma, Mississippi, Ohio, Missouri, New Hampshire and South Carolina, as well as several cities and counties in states including California, Illinois and New York. The drug wholesalers have likewise faced litigation, particularly in West Virginia, where several county commissions and cities have the three main ones, following lawsuits filed by the state’s attorney general.

New Mexico’s lawsuit, filed in the First Judicial District Court in Santa Fe County, contended that the drugmakers downplayed the risks of addiction to prescription opioids and falsely touted the benefits of their long-term use. It also accused the wholesale distributors of violating their duties by selling large amounts of painkillers that were then diverted for illicit uses, helping to contribute to the opioid epidemic. The lawsuit seeks damages, including for the costs New Mexico has incurred responding to the epidemic.

The companies have in similar cases denied wrongdoing. The drugmakers have said they acted responsibly in connection with marketing the drugs, which carry U.S. Food and Drug Administration-approved labels warning about their risks.

"While we vigorously deny the allegations, we share public officials’ concerns about the opioid crisis and we are committed to working collaboratively to find solutions," Purdue, the maker of OxyContin, said in a statement.

Cardinal Health in a statement called the lawsuit "misguided," saying it was "launched in haste and without any factual investigation to support it." ...
/ 2017 News, Daily News
The Department of Industrial Relations’ Division of Workers’ Compensation has issued modified proposed regulations to adopt the Medical Treatment Utilization Schedule (MTUS) Drug Formulary. The proposed rulemaking implements Assembly Bill 1124 (Statutes 2015, Chapter 525), which mandates adoption of an evidence-based drug formulary.

DWC has reviewed comments received during the first 15-day comment period and has modified the proposed regulations to provide additional detail and clarity. The second 15-day public comment period will end September 22, 2017. Members of the public may submit written comments on the proposed regulations until 5 p.m. that day.

Some of the changes proposed in the revised regulations include:

- Added language clarifying that a compounded drug is subject to the compounded drug regulation even if it includes an active ingredient listed as "Exempt" on the MTUS Drug List. This modification improves the clarity; it is expected to avert the possibility that someone could argue that a compounded drug using one of the listed drugs is "Exempt."

- Removed a provision relating to repackaged drugs. The current structure of the MTUS Drug List does not require identification of a drug’s status as repackaged. In the future, after further evaluation, the Division may address repackaged drugs, and may determine whether particular provisions of the Formulary and MTUS Drug List are needed to address issues raised by use of repackaged drugs.

- Updated MTUS Drug List header text to match the regulatory language on the Perioperative period definition. It now states that the perioperative fill period begins 4 days, rather than 2 days, before surgery. This conforms the perioperative period to a modification in the text of section 9792.27.13, subdivision (b), that was made in the 1st 15-day comment period, but mistakenly overlooked on the drug list introductory language. This change appears to be the result of public comments made by Denise Algire with Albertson's companies according to the transcript of her comments on page 6.

The notice of modification of text of proposed regulation and related rulemaking documents are posted on the DWC rulemaking web page. More information about the rulemaking process is posted on the Office of Administrative Law’s website ...
/ 2017 News, Daily News
In the United States, the Centers for Disease Control and Prevention estimated roughly 1.7 million hospital-associated infections, from all types of microorganisms, including bacteria and fungi combined, cause or contribute to 99,000 deaths each year. And a hospital-associated infection of an injured worker being treated for an industrial injury may give rise to an additional claim for benefits as a compensable consequence injury.

And now a new medical study says that the risk now includes untreatable hospital-associated infections that are deadly.

Chinese researchers say an outbreak of severe pneumonia at a Chinese hospital was caused by hypervirulent, highly drug-resistant, and highly transmissible strains of Klebsiella pneumoniae. Their findings were reported recently in the Lancet Infectious Diseases.

The ST11 carbapenem-resistant hypervirulent K pneumoniae strains were identified in five patients in the intensive care unit (ICU) of a hospital in Hangzhou, China. All five patients - who were admitted to the ICU between late February and April of 2016 - had undergone surgery for multiple trauma followed by ventilation and subsequently developed carbapenem-resistant K pneumoniae infections and severe pneumonia that responded poorly to all available antibiotics.

All five patients died of severe lung infection, multi-organ failure, or septic shock.

Analysis of the 21 carbapenem-resistant K pneumoniae strains recovered from the patients indicated that the strains had almost identical antibacterial susceptibility profiles and shared highly similar DNA fingerprints. Further genetic and phenotypic characterization of one representative carbapenem-resistant K pneumoniae isolate from each patient showed that all five belonged to the ST11 lineage, contained several resistance genes, and originated from a single clone.

"Due to acquisition of a virulence plasmid by classic ST11 carbapenem-resistant K pneumoniae strains, these new strains are simultaneously hypervirulent, multidrug resistant, and transmissible, and should therefore be regarded as a real superbug that could pose a serious threat to public health," the authors write.

In a commentary in the same journal issue, two experts from Rutgers University wrote that the study describes an alarming evolutionary event: plasmid-mediated convergence of multidrug-resistance and hypervirulence in an epidemic cabapenem-resistant K pneumoniae clone.

Though a similar event had been reported before, the new report on five fatal cases characterizes the virulence and resistance plasmids. The two wrote that the transfer of the virulence plasmids raises worries that the organisms might not only cause untreatable hospital infections, but also serious life-threatening ones in the community.

The new findings underscore the need for new effective antibiotics, and new strategies such as vaccines, phage therapy, and gene therapy for battling drug-resistant organisms offer optimism. "However, the reality is that we are now in a crisis," they wrote, adding the keys to curbing the new hypervirulent strains are early detection and containment with comprehensive infection control measures.

From a claims administration standpoint, one might question the track record of facilities that are used to treat injured workers, and steer clear of facilities with tenacious infection histories. Some of this information is publicly available, but not widely know.

The Healthcare-Associated Infections (HAI) Program is one of two programs in the Center for Health Care Quality of the California Department of Public Health. The Program was created by mandate to oversee the prevention, surveillance, and reporting of HAI in California's general acute care hospitals. Since 2010, the HAI Program has produced annual public reports of hospital HAI data to inform choices of healthcare consumers and prompt providers to take actions to prevent infections.

The latest 2015 report identifies 2894 infections and predicted an overall infection rate of 4744 which was then allocated to each of the medical facilities by name on the seven page table. Surprisingly, the Ronald Regan UCLA Medical Center had 149 observed infections, the highest of any facility on the list. It is likely that claims administrators can manage the risk of a compensable consequence injury caused by hospital-associated infections by periodic scrutiny of these reports and lists and strategies for the management of claims ...
/ 2017 News, Daily News
The WCIRB Governing Committee at it's September meeting voted to amend the WCIRB’s January 1, 2018 Pure Premium Rate Filing that was submitted to the Insurance Commissioner on August 18, 2017.

The vote to amend the filing was based on the Actuarial Committee’s review of recently available June 30, 2017 loss experience, which showed lower than anticipated loss development in the second quarter.

The WCIRB anticipates amending its filing to propose advisory pure premium rates that average $1.96 per $100 of payroll in lieu of pure premium rates which averaged $2.01 per $100 of payroll that were proposed in the August 18, 2017 filing.

These amended proposed pure premium rates are on average 2% less than the average approved July 1, 2017 advisory pure premium rate of $2.00 and 16.1% less than the industry average filed pure premium rate of $2.34 as of July 1, 2017.

The amended filing will be submitted to the Insurance Commissioner within the next week and will be posted on its website once it is available.

The California Department of Insurance has scheduled a public hearing on October 5, 2017 in San Francisco to consider the WCIRB’s filing ...
/ 2017 News, Daily News
Charles Taylor has agreed to acquire Metro Risk Management LLC (MRM) from Nautilus International Holding Corporation for an undisclosed amount.

MRM was founded in 1996 as a subsidiary of Metropolitan Stevedore Company (the original parent corporation), which was one of the earliest self-insured, self-administered companies in the State of California.

Nautilus and its subsidiaries - Metro Ports, Metro Cruise Services, Metro Shore Services and Metro Risk Management - are a suite of companies known internationally as leaders in stevedoring, terminal operations, logistics, risk management and more.

Charles Taylor is a leading international provider of professional services to clients in the global insurance market. It has been providing services to insurance clients since 1884 and today has over 1,800 staff in 71 offices, spread across 28 countries in the UK, the Americas, Asia Pacific, Europe,the Middle East and Africa.

The deal is part of Charles Taylor’s plans to extend its US workers’ compensation claims capabilities. Based in Southern California, MRM provides state and federal workers’ compensation claims administration services to self-insured clients and insurers.

Acquiring the third-party claims administrator will see the addition of 13 highly experienced workers’ compensation claims specialists to the Charles Taylor team - expanding the buyer’s presence in Long Beach in support of its TPA growth in the US.

James Callahan, Nautilus chairman, president, and chief executive, said the transaction will provide its staff with greater opportunities for career development and advancement.

"We have worked closely with Charles Taylor for many years, and know first-hand the insurance expertise and professionalism of the team. Charles Taylor provides MRM with the resources and expertise to expand its services to a wider range of clients," he noted.

Christopher Schaffer, USA CEO, Charles Taylor Insurance Support Services, commented: "We are excited to join forces with MRM, given the company’s history of providing quality services and proven expertise to long-term, deeply satisfied clients."

He said MRM broadens Charles Taylor’s claim services on the West Coast - adding to the core federal workers’ compensation, ports and terminals, marine, casualty, and cyber TPA business.

For Charles Taylor group chief executive David Marock, the acquisition reflects the firm’s continued commitment to growing its TPA business in the US and globally.

...
/ 2017 News, Daily News
A former California Highway Patrol officer who injured his back while on duty has pleaded no contest to felony workers’ compensation insurance fraud as a result of the Sacramento County District Attorney felony workers’ compensation insurance fraud and attempted perjury charges in June 2012.

Former officer Brian Christopher Hansen was a California Highway Patrol officer who sustained a back injury while on duty in November 2008.

The criminal complaint alleged that between Nov. 14, 2008 and Oct. 1, 2011, Hansen made numerous false statements to various doctors, investigators and in a sworn deposition regarding the extent of his physical disabilities caused by an on-duty injury to his back.

Hansen stated that because of pain from his back injury, he could only drive for short periods of time, could not sit for more than 30 minutes, could not pick up items weighing more than 10 pounds, and was so restricted in his physical abilities that he could not even perform limited office duties.

After being medically treated, he was placed on limited duty status in April 2009. Hansen worked one day watching training videos for four hours, but never returned stating it was too painful to sit for extended periods of time.

In July 2009, the CHP began an investigation. Hansen was observed performing tasks that were in conflict with what he reported his functional limitations were at the time, including driving non-stop for hours and participating in outdoor activities. Videotaped surveillance showed him driving for hours at a time, moving furniture when he changed residences, bending over and picking up items weighing more than 30 pounds, and engaging in everyday activities with no signs of any physical limitations, the DA’s office said.

Physicians who reviewed his medical reports and surveillance videos agreed Hansen did suffer an injury, but that he overstated his symptoms and understated his capabilities regarding his workers’ compensation claim.

Hansen entered the plea Aug. 29 and was sentenced by Sacramento Superior Court Judge Jaime Román to 180 days in Sacramento County Jail and five years formal probation, according to a Sacramento County District Attorney’s Office news release. He also is prohibited from ever seeking or accepting employment as a law enforcement officer.

Hansen graduated from the CHP Academy in 2007 and left the department in January 2012. The Redding native worked for the Shasta County Sheriff’s Office before joining the CHP.

This case was investigated by the California Highway Patrol Internal Affairs Division Workers Compensation Insurance Fraud Unit.
...
/ 2017 News, Daily News
Federal Judge George H. Wu was again scheduled to hear more arguments in his downtown Los Angeles Courtroom for and against imposing a preliminary injunction halting the implementation of newly adopted SB 1160. This new law provides for a stay on lien claims filed by indicted medical providers until after their case has been resolved.

Dr. Eduardo Anguizola is facing multiple counts of insurance fraud filed by Orange County prosecutors. His federal lawsuit claims that SB 1160 and Labor Code 4615, the anti-fraud law that took effect January 1, violates the 5th, 6th, and 14th amendments of the United States Constitution. His request for a preliminary injunction was originally scheduled for hearing on July 13, 2017 and the motion was continued to August 24 to allow additional briefing.

Plaintiffs argued that Labor Code 4615 violates the procedural component of the due process clause because it immediately stays all liens without notice or a hearing. The defendants responded that Section 4615 affords sufficient process because Plaintiffs still have the same rights afforded to them by the workers' compensation scheme generally. However in the Tentative Ruling Judge Wu pointed out that "Defendants do not explain how these pre-existing procedures would actually be used to challenge a stay imposed by Section 4615." He thus provided the parties additional time before the August 24 hearing to provide information about how due process might be afforded lien claimants under 4615.

The 18 page Tentative Ruling by Judge Wu in July focused the case on the narrow issue of a "facial" challenge to newly adopted Labor Code Section 4615 which implements SB 1160. He ruled that to succeed in a facial challenge to a statute a plaintiff must establish that a law is unconstitutional in all of its applications. Because facial constitutional challenges often rest on speculation, they are disfavored. Thus, the fact that a statute "might operate unconstitutionally under some circumstances is not enough to render it invalid against a facial challenge."

Between July 13 and August 24 many additional arguments and declarations were filed by both parties. The Defense filed a 117 page Declaration of Workers' Compensation Chief Judge Paige Levy that clearly articulated how lien claimants subject to 4615 have rights to due process under the new law, and indeed attached several illustrative cases on the stay law that have been decided by either Removal or Reconsideration by the WCAB. Essentially several panel decisions have held that any lien claimant who asserts they do not fall subject to the stay have the right to have their argument heard and decided upon filing a DOR on the issue. Any WCJ that had refused to do so was overturned. Judge Levy pointed out the statutory and regulatory provisions that allowed lien claimants to challenge the application of the "automatic stay" to their individual cases.

Plaintiffs responded to the Levy declaration by claiming "The State knows that the statute is unconstitutional on its face and that the statute provides no mechanism for due process to those affected by the statute. ... Because of the clear lack of due process - on its face - the State had no choice but to throw a 'Hail Mary.' Behold the declaration of Paige Levy." They asked for expedited discovery to depose Judge Levy.

The outcome of the August 24 hearing according to the minute order was "Court and counsel confer re scheduling. For reasons stated on the record, Plaintiffs’ motion is continued to September 25, 2017 at 8:30 a.m., with Plaintiffs’ supplemental declaration due by September 12, 2017. Defendants will respond by September 20, 2017." Thus the outcome of this case will not be known at least until the end of September ...
/ 2017 News, Daily News
The drug epidemic in America is increasingly fueled by synthetic opioids like fentanyl, which overtook heroin as the deadliest substance in the U.S. in 2016.

The National Center for Health Statistics, part of the Centers for Disease Control and Prevention, released the first preliminary federal report, giving an accounting of drug overdose deaths in 2016. The CDC estimates that drug deaths rose by more than 22 percent in 2016, killing 64,070 Americans. Opioid deaths rose from 33,000 in 2015 to nearly 50,000 in 2016, driven primarily by fentanyl, a painkiller roughly 50 to 100 times more powerful than morphine, reports The New York Times.

Synthetic opioids, including fentanyl and its analogs, claimed roughly 20,100 lives in 2016, up from 9,945. Heroin continues to be a major problem, killing an estimated 15,400 Americans. Fentanyl is also fueling an increase in cocaine deaths, as dealers are increasingly cutting the fatal painkiller into their cocaine supplies.

The Drug Enforcement Agency issued new guidance to police departments across the country in June on how to handle heroin and other narcotics due to the increasing prevalence of fentanyl. Deputy Attorney General Rod Rosenstein warned it only takes two milligrams of fentanyl, "the equivalent of a few grains of table salt," to cause a fatal overdose.

Dealers in the U.S. and Mexican cartels are turning to China in greater numbers for shipments of fentanyl at a fraction of the price of heroin. It is then used to create roughly 20 times more doses out of a heroin batch, providing dealers with huge profits. Officials estimate that more than 90 percent of heroin in the U.S. is flowing in from Mexico.

A bipartisan proposal in the Senate would give border agents the technology to screen for chemicals at U.S. entry points in an effort to target fentanyl shipments.

Democratic Sen. Ed Markey of Massachusetts and Republican Sen. Marco Rubio of Florida proposed the INTERDICT Act earlier this year and are renewing their call for support after recent data showed fentanyl deaths are rising.

Republican Sen. Rob Portman of Ohio is also leading a bipartisan effort to crack down on illegal shipments of synthetic opioids like fentanyl through the U.S. mail.

The STOP Act, co-sponsored by Rubio and Democratic Sen. Elizabeth Warren, aims to put packages shipped through the U.S. Postal Service under more intense security screenings to cut down on international trafficking.

Drug overdoses are now the leading cause of accidental death for Americans under 50.

A STAT analysis predicts the annual death toll from opioids will rise by roughly 35 percent between 2015 and 2027. Their research predicts that up to 500,000 people could die from opioids over the next decade. The experts agree, even in a best-case scenario, the crisis will not visibly start to subside until after 2020 ...
/ 2017 News, Daily News
A controversial genetic testing firm under federal investigation for healthcare fraud has been placed into court-ordered receivership - a form of bankruptcy - that could lead to the restructuring and sale of the company. The CEO and founder of Proove Biosciences has also left the company.

Proove Biosciences specializes in DNA testing that the company claims can improve the effectiveness of pain management treatment and determine whether a patient is at risk of opioid addiction.

In June, FBI agents raided the company’s headquarters in Irvine, California. Former and current employees who were interviewed said the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called "research fees."

In July, Pain News Network reported that Proove was linked to a Medicare fraud case in which three Indiana healthcare providers allegedly "caused Proove Bioscience" to falsely and fraudulently bill various health care programs for genetic tests administered to Physicians Primary Care patients that were not medically necessary and never interpreted."

Proove was not named as a defendant in the Indiana case. In an email to PNN, the company CEO said Proove had cooperated with investigators.

The CEO claimed "Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

The CEO also defended Proove research, published in the Journal of Addiction Research & Therapy, which claimed to show the effectiveness of its genetic tests.The publisher of the journal, OMICS International, has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

"Proove can only speak to its experience with this particular journal," the CEO said in an email to PNN. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'."

According to the FTC complaint filed last August, OMICS has created hundreds of "open access" online medical journals that publish articles with little or no peer review. Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

Proove has aggressively promoted its genetic tests with healthcare providers around the country. A pain clinic in Montana, for example, had a Proove "patient engagement representative" employed on site at the Benefis Pain Management Center.
...
/ 2017 News, Daily News
Inappropriate patient sexual behavior remains a common experience for physical therapists during their careers, according to a recent U.S. study reported by Reuters Health.

More than 80 percent of nearly 900 physical therapists surveyed said they have encountered sexual remarks, touches, indecent exposure and sexual assault. Almost half said they’ve experienced one of these situations in the past year - numbers that haven’t changed since the last major surveys in the 1990s.

"The numbers stand for themselves, and it’s quite alarming," said lead author Jill Boissonnault of the George Washington University School of Medicine and Health Sciences in Washington, D.C.

U.S. health care professionals have 16 times greater risk for non-fatal violence at work than other fields, the study authors write in the journal Physical Therapy.

"Many of us are not trained in how to deal with this behavior, which can lead to consequences for both the physical therapist and the patient, who may be discharged from care early when this happens," Boissonnault told Reuters Health by phone.

The most recent studies that focused specifically on patient sexual harassment and physical therapists were done in the United States, Canada and Australia in the late 1990s, the study team notes. At that time, nearly 80 percent of therapists said they had experienced sexual harassment, and one quarter of those reported psychological consequences such as anger, guilt, fear, anxiety and depression.

The research team surveyed 892 physical therapists and physical therapy students across the country, recruited through physical therapy academic programs and the American Physical Therapy Association. About 80 percent of the participants were women, and 60 percent reported working with patients who had dementia, delirium or brain injuries. Most said they treated an equal number of male and female patients.

Researchers found that 84 percent of survey participants had experienced inappropriate patient sexual behavior during their career, and 47 percent experienced it during the last year. Women reported significantly higher rates of harassment, especially staring, suggestive remarks, inappropriate touches, date requests, sexual gestures, requests for sexual activity and masturbation.

Several factors increased the risk of experiencing inappropriate behavior, such as routinely working with patients with brain impairments and having fewer than five years of direct patient experience. Harassment was most common between a female therapist and male patient. Treating mostly male patients increased the odds of harassment by almost 400 percent, and treating an equal mix of patients doubled the odds, as compared to those who mainly treated female patients ...
/ 2017 News, Daily News