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At a time when bacteria are growing more resistant to common antibiotics, many companies that are developing new versions of the drugs are hemorrhaging money and going out of business, gravely undermining efforts to contain the spread of deadly, drug-resistant bacteria.

Melinta Therapeutics, founded in 2000 as Rib-X Pharmaceuticals, is an American publicly traded biopharmaceutical firm that focuses on the design and development of novel broad-spectrum antibiotics for the treatment of antibiotic-resistant infections in hospital and community settings.

On December 27, Melinta filed for bankruptcy protection, becoming the latest casualty of a persistent cash burn in the antibiotic industry. The drugmaker, which has four antibiotics on the market, warned that it was running out of cash last month.

Melinta has entered into a Restructuring Support Agreement with the lenders. Under the Agreement, the Supporting Lenders would acquire the Company as a going concern by exchanging $140 million of secured claims arising under its senior credit facility for 100 percent of the equity to be issued by the reorganized Company pursuant to a pre-negotiated chapter 11 plan of reorganization.

The Company’s Agreement with the Supporting Lenders positions the Company to emerge from Chapter 11 on an expedited basis under new ownership and continue operating as a going concern on sound financial footing. At the same time, the Supporting Lenders’ proposal to acquire the Company remains subject to a Court-supervised competitive process, which could result in higher and better offers.

The Agreement will be filed with the Securities and Exchange Commission in a current report on Form 8-K.

Global health officials have repeatedly warned about the rise of bacteria and other microbes that are resistant to most drugs due to their overuse, prompting health agencies to push for newer versions of antibiotics.

However, antibiotics are relatively cheap and are more effective the less they are used, making profitability hard to achieve.

Most of Big Pharma shuns the antibiotic space. Larger drugmakers, including AstraZeneca Plc, Novartis and Sanofi SA, have stopped developing antibiotics.

While smaller players such as Achaogen Inc have already failed and filed for bankruptcy. Bankrupt and running out of cash after going $186 million in the red last year, Achaogen has sold off the global rights to Zemdri (plazomicin for multidrug-resistant, gram-negative pathogens) along with its lab equipment for just $16 million.

The California biotech Aradigm filed for bankruptcy after a major knockback from the FDA for its lead inhaled antibiotic product and protracted efforts to try to resurrect the program.

"This is a crisis that should alarm everyone," said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center ...
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/ 2019 News, Daily News
Improper disposal of prescription medications results in pollution, antibiotic resistance, childhood poisoning, and intentional misuse. Pharmacies are in an ideal position to provide disposal information, but evidence is limited regarding the accuracy of the information they provide.

But a new study published in the Annals of Internal Medicine found that only 1 in 10 California pharmacies have programs to take back unused prescription opioids and just one in five give consumers accurate disposal information. The study suggests that drugstores could do more to help combat substance abuse.

For the "secret shopper"-style study, researchers called 898 pharmacies in California to inquire about the availability of take-back programs for leftover opioids and antibiotics, and find out how to safely dispose of these medicines at home. All of the secret shoppers in the study posed as parents of children who recently had surgery.

Callers asked pharmacies what to do with two leftover medications: the antibiotic Bactrim (sulfamethoxazole-trimethoprim), and liquid Hycet (hydrocodone-acetaminophen), a pain reliever containing an opioid compound.

"The danger of unused and unwanted prescription medication is substantial - from accidental childhood poisoning to pollution to intentional misuse," said senior study author Dr. Hillary Copp of the University of California, San Francisco.

"The FDA recommends dropping off medications at a take-back site as the best option for disposal," Copp said by email. "However, there are specific recommendations for medication disposal at home if the consumer does not have access to a take-back site."

Just 19% of pharmacies correctly told callers they should bring unused opioids back to a drugstore or flush unused opioids down the toilet, the study found. Only 11% of pharmacies offered to take back unused opioids at their location.

With antibiotics, 47% of pharmacies correctly advised callers to return leftovers to a drugstore or to mix unused medicines with unpalatable substances like coffee grounds or kitty litter and place in a sealed container before tossing the drugs in the trash. Only 19% of pharmacies offered to take back unused antibiotics.

Tossing leftover antibiotics in the trash helps prevent people from taking them in the future for illnesses they can’t cure, which contributes to the rise of antibiotic-resistant superbugs that can’t be treated with available medicines, Copp said. Flushing antibiotics might get them into the water supply, also contributing to antibiotic resistance.

Flushing opioids, however, prevents them falling into the wrong hands and contributing to substance misuse, addiction and overdoses. Addicts might still take opioids they find in the trash, even mixed with dirt or kitty litter or other substances, Copp said.

The study results suggest that many pharmacies may be falling short as educators and as places for safe disposal, said Dr. Chana Sacks of Massachusetts General Hospital and Harvard Medical School in Boston ...
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/ 2019 News, Daily News
The California Attorney General announced the terms of a settlement agreement reached with Sutter Health, the largest hospital system in Northern California. The Sutter network consists of some 24 acute care hospitals, 36 ambulatory surgery centers, and 16 cardiac and cancer centers. It also includes some 12,000 physicians and over 53,000 employees. In addition, Sutter negotiates contracts on behalf of the Palo Alto Medical Foundation and many affiliated physician groups.

The settlement resolves allegations by the Attorney General, the United Food and Commercial Workers International Union and Employers Benefit Trust, and class action plaintiffs, that Sutter’s anticompetitive practices led to higher healthcare costs for patients in Northern California compared to other places in the state.

As a result of the settlement, Sutter will pay $575 million in compensation and make significant changes in its operations and practices to restore competition in Northern California’s healthcare market.

This litigation against Sutter began in 2014 when the United Food and Commercial Workers International Union and Employers Benefit Trust and numerous individual plaintiffs - later consolidated into a class action - filed their lawsuit challenging Sutter’s practices in rendering services and setting prices.

They sought compensation for what they alleged were unlawful, anticompetitive business practices, which caused them to pay more than necessary for healthcare services and products.

In March of 2018, the California Attorney General filed a similar lawsuit against Sutter on behalf of the people of California principally seeking injunctive relief to compel Sutter to correct its anticompetitive business practices moving forward. The separate lawsuits were combined by the court into one case.

In October of 2019, on the eve of trial, the parties reached an agreement to settle the lawsuits. The settlement must be approved by the court. The court has set a hearing on the settlement for February 25, 2020.

Under the terms of the 122 page settlement agreement, Sutter will be required to pay $575 million to compensate employers, unions, and others covered under the class action and to cover costs and fees associated with the legal efforts. And limit what it charges patients for out-of-network services, helping ensure that patients visiting an out-of-network hospital do not face outsized, surprise medical bills. And increase transparency by permitting insurers, employers and self-funded payers to provide plan members with access to pricing, quality, and cost information, which helps patients make better care decisions.

Sutter has also agreed to cease anticompetitive bundling of services and products which forced insurers, employers, and self-funded payers to purchase for their plan offerings more services or products from Sutter than were needed. Sutter must now offer a stand-alone price that must be lower than any bundled package price to give insurers, employers, and self-funded payers more choice ...
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/ 2019 News, Daily News
The U.S. Food and Drug Administration is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.

These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.

Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome. The FDA evaluation of respiratory depression with the gabapentinoids provides some evidence contrary to the widely held belief that gabapentinoids lack drug interactions and have wide therapeutic indices. Published studies demonstrate these drugs can behave in an additive way to potentiate central nervous system (CNS) and respiratory depression.

The FDA evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse.

Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone.

Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system (CNS) depressant such as a benzodiazepine. Patients with underlying respiratory disease and elderly patients are also at increased risk and should be managed similarly.

Shifting treatment from one CNS depressant to another may pose similar risks. Be aware of the potential additive effects of all these CNS depressants and plan accordingly, by starting with low doses, titrating carefully, and informing patients of the potential for CNS and respiratory depression and their symptoms.

Incorporating one or more medications with non-drug therapies is the prevailing approach for optimizing analgesia. However, pairing an opioid with any CNS depressant - a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product - will increase the risk of respiratory depression.

The gabapentinoid prescribing information already includes guidance for health care professionals to caution patients about dizziness, somnolence, and the potential for impaired ability to operate a car or complex machinery.

The FDA will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs ...
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/ 2019 News, Daily News
San Diego chiropractor, George Reese was indicted in 2014 for referring patients to a Los Angeles area medical service provider. Foremost Shockwave Solutions in return for bribes. The bribes were $100 per patient and paid through an intermediary. After taking a cut amounting to $25 per patient, the intermediary would pay the remaining $75 per patient to Reese.

Foremost Shockwave Solutions was allegedly controlled by attorney Lee Mathis and Fernando Valdes its president. Both were also indicted. Although disguised as "office rent" payments, the illegal bribes were allegedly paid in cash during clandestine exchanges in restaurants and parking lots.

According to the indictment, Reese and his codefendants generated and submitted bills to insurers totaling in the tens of millions of dollars. Most of these treatments involved the providing of "Shockwave therapy," which uses low energy sound waves to initiate tissue repair. Proceeds from the insurance claims generated through this scheme were paid to Mathis and Valdes.

Reese pleaded guilty in June 2016. and began serving a one year one day sentence. His plea agreement remains sealed. Valdez entered into a plea agreement in July 2017. His plea agreement also remains sealed.

In 2018 attorneys claimed that Mathis has been interviewed and administered standardized psychological and neuropsychological, memory, malingering and motivation and he has been interviewed regarding competency factors for a total of 16 hours between February and July 2018. Dr Veronica Thomas concluded Mathis was unable to assist counsel at trial.

The Government engaged Dr. Matthew Carroll to evaluate Mr. Mathis’ competency to stand trial. In his interviews with Dr. Carroll, Mr. Mathis was able to provide a detailed personal and professional history. They discussed the pending charges and Mr. Mathis provided a summary of the Workers’ Compensation system, his role in the system and he discussed the Government’s case. Mr. Mathis demonstrated a reasonable appreciation of the charges against him. He described "his side of the story in a coherent and logical manner."

It was Dr. Carroll’s opinion that Mathis understands the nature and consequences of the proceedings against him and can assist properly in his defense and testify on his own behalf. Thus, in March 2019 Mathis was found competent to stand trial.

Mathis subsequently pleaded guilty on September 12, 2019 to count two of the nine count indictment, Honest Services Mail Fraud. He was sentenced to 14 month is federal prison and is scheduled to surrender on January 21, 2020. He will be on 3 years supervised release thereafter ...
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/ 2019 News, Daily News
Many of Canada’s drug suppliers cannot, or will not, agree to ship cheaper prescription medicines into the United States, a new challenge to the Trump administration’s push to reduce drug prices, companies and industry officials told Reuters.

The administration on Wednesday proposed new regulations that would allow states to import prescription drugs from Canada. They would require a state such as Florida to partner with a wholesaler licensed by Health Canada, which regulates drugs.

Florida and other states have said they are eager to start importation programs, and the proposal took the federal government one step closer to approving that plan. But there are practical barriers to actually bringing in drugs.

Two drug distributors and two Canadian industry groups that between them represent all of the potential suppliers named in a proposal published by Florida in August said they are not interested in participating.

"We have not been contacted and we are not planning to participate," said Loblaw Companies Ltd (L.TO), which owns Canada’s largest pharmacy chain Shoppers Drug Mart. "Canadian patients currently face product and drug shortages and we are concerned this initiative may exacerbate what is already a critical issue."

Daniel Chiasson, president of the Canadian Association for Pharmacy Distribution Management (CAPDM), said none of its members would participate because their first priority was ensuring a safe and stable supply of medication for Canadians.

Mary Mayhew, secretary of the Florida Agency for Health Care Administration, said she was "excited and enthusiastic" about Wednesday’s announcement. "We are optimistic that Canadian suppliers will be interested, as the rule is understood, as there is more dialogue around this new and historic federal action," she said.

Chiasson said agreements between manufacturers and distributors prevent the export of products made for the Canadian market, creating a commercial risk and deterrent to exporting.

"These are issues we continue to consider and are committed to exploring how we might overcome any challenges and issues as we advance the proposed rule," U.S. Food and Drug Administration spokesman Michael Felberbaum said in a statement.

Some of Canada’s major distributors are subsidiaries of U.S. companies, who are unlikely to participate in a program to lower prices, since their revenue reflects a cut of the value of the drugs they provide to pharmacies in the much larger U.S. market.

AmerisourceBergen said that protecting bottom lines was not the issue, because importation implied that distributors could buy low-cost drugs and sell them in high-cost markets. "The reality is that legal and contractual barriers, as well as significant threat to the integrity of the supply chain, all stand in the way of importation being a viable solution," it said in a statement ...
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/ 2019 News, Daily News
The Department of Justice announced that Nassir Medical Corp. and its owner, Dr. Youram Nassir, have agreed to pay the United States and California $3,356,565 to settle False Claims Act allegations that they defrauded public health care programs by billing for oncology drugs and services that were not actually provided to patients.

Nassir Medical Corp., which does business as Cancer Care Institute, is a hematology and oncology practice based in in the Mid-Wilshire area of the City of Los Angeles. This medical office specializes in treating cancer patients and such treatment often requires physicians to prescribe, dispense, infuse, and administer a variety of oncology drugs. Medicare and Medi-Cal reimburse physicians both for the cost of drugs themselves and for the cost of infusing and administering those drugs to patients.

Between January 2010 and December 2013, Nassir Medical Corp. and Nassir allegedly violated the False Claims Act by submitting bogus claims to Medicare and Medi-Cal, according to this case’s settlement agreement. The defendants allegedly billed public health programs for drugs that were not actually purchased, dispensed, or administered, and for infusion services that were not actually provided.

The defendants have agreed to pay $2,377,675.51 to the United States and $978,907.49 to California. Nassir Medical Corp. and Nassir also have entered into an integrity agreement with the United States Department of Health and Human Services, Office of Inspector General.

This settlement resolves allegations originally brought in a lawsuit filed in 2016 by Kenneth Bryan, a retired health care consultant and administrator, under the qui tam, or whistleblower, provisions of the False Claims Act. These provisions permit private parties to sue on behalf of the government for false claims for government funds and to share in any recovery. Mr. Bryan will receive more than $475,000 from the federal government as his share of the settlement amount.

Assistant United States Attorney Ross M. Cuff of the Civil Fraud Section represented the United States in this matter, which was investigated by agents from the United States Department of Health and Human Services, Office of Inspector General.

The lawsuit is captioned United States, et al., ex rel. Bryan v. Nassir Medical Corp., et al., 16-cv-2289-JAK (C.D. Cal.). The claims resolved by the settlement are allegations only. There has been no determination of liability ...
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/ 2019 News, Daily News
James Wilson, 56, was sentenced by United States District Judge Terry J. Hatter Jr. At the conclusion of a bench trial in March, Judge Hatter found Wilson guilty of two counts of illegally distributing oxycodone.

The evidence presented at trial showed that Wilson, during two different transactions in early 2016, sold a total of four prescriptions to an undercover operative working with the Drug Enforcement Administration. Each of the four prescriptions were for 120 30-milligram oxycodone pills, which is the maximum strength of the opioid sold through pharmacies.

Wilson, who is neither a doctor nor a pharmacist, owned and operated what prosecutors called a "sham medical clinic." The illegal prescription sales took place in the parking lot of Wilson’s clinic, where he charged $200 for each of the illegal prescriptions.

Wilson was arrested in this case in August 2017, at which time investigators found 160 blank prescriptions in his vehicle.

Wilson’s "scheme involved the diversion of oxycodone, a powerful and deadly opioid at the center of the nation’s opioid crisis," prosecutors wrote in a sentencing memorandum.

This case was investigated by the DEA and was conducted with the support of the Organized Crime Drug Enforcement Task Force (OCDETF). This matter was prosecuted by Assistant United States Attorneys Marina A. Torres and Brittney M. Harris of the International Narcotics, Money Laundering, and Racketeering Section ...
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/ 2019 News, Daily News
The American Society of Journalists and Authors (ASJA) is the nation's largest professional organization of independent nonfiction writers. Its membership consists of freelance writers of magazine articles, trade books, and many other forms of nonfiction writing. The ASJA was founded in 1948 as the Society of Magazine Writers. Its membership consists of more than 1,100 freelance writers.

The National Press Photographers Association (NPPA) is an American professional association made up of still photographers, television videographers, editors, and students in the journalism field. It was founded in 1946. As of 2017, NPPA had total membership at just over 6,000.

Both the American Society of Journalists and Authors, Inc., and National Press Photographers Association as plaintiffs have just filed a lawsuit federal court against California, over the state’s controversial Assembly Bill 5 (AB 5), saying the law forces their independent contractors to "become employees of their clients," whether or not this is preferable or even feasible.

"We have no choice but to go to court to protect the rights of independent writers and freelance journalists as a whole," said Milton C. Toby, JD, president of ASJA. "The stakes are too high, and we cannot stand by as our members and our colleagues face ill-conceived and potentially career-ending legislation."

"Under the law, a freelancer like me can write 200-plus press releases in a year for a marketing firm, and it’s no problem. But if a newspaper wants me to write a weekly column about local politics, it must put me on staff - a very unlikely prospect - or violate the law. Otherwise I am silenced," said San Diego freelance writer Randy Dotinga, a board member and former president of ASJA.

The lawsuit asserts that the law violates the U.S. Constitution because it penalizes some freelancers while allowing other visual artists (including marketing photographers, fine artists, and graphic artists) to continue to perform as independent contractors, unencumbered by limits on the number of assignments they do.

Additionally, AB5 forbids any freelancing by visual journalists who shoot video, a provision that is challenged in the lawsuit as a content-based restriction on speech. For still photojournalists, the bill imposes a limit of 35 "submissions" or assignments per year for any single client, another content-based First Amendment violation. Similar limits are imposed on freelance writers, editors, and newspaper cartoonists.

And and an article in Forbes just announced that Vox Media, a large digital media company with an array of niche sites, abruptly terminated hundreds of freelance writers in the state of California. The company will cancel its agreements with about 200 contractors to comply with a new law that goes into effect on January 1, 2020.

The cuts target writers for the SB Nation blog, which covers sports in California. Vox intends to replace the freelance writers with roughly 20 new part-time and full-time staffers ...
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/ 2019 News, Daily News
WCIRB insurer experience summaries are released approximately three to five months after the end of the quarter. These reports contain information such as written premium, average cost of a claim, accident year combined loss and expense ratios, etc. It has just published its Quarterly Experience Report as of September 30, 2019. Here are some of the highlights.

Written premium for the first 9 months of 2019 is 7% below the same period for 2018, suggesting that premium decreases are escalating in 2019. Written premium for 2018 is 4% below that for 2017 and 6% below that for 2016. The decreases since 2016 are primarily driven by decreases in insurer charged rates more than offsetting increases in employer payroll.

The Average charged rate for the first 9 months of 2019 is 11% below that for 2018 and 32% below the peak in 2014. The January 1, 2020 approved advisory pure premium rates are on average 47% below those for January 1, 2015.

The projected loss ratio for 2018 is 3 points above that for 2017, driven by higher severities for 2018 and lower premium rates. These ultimate projections as of September 30, 2019 are generally consistent with those as of June 30, 2019 and March 31, 2019 as recent trends in downward loss development are moderating.

The projected combined ratio for 2018 is 5 points higher than 2017 as premium levels have lowered while average claim severities increased moderately. Despite the recent increase, combined ratios for the last six years remain below 100% and are the lowest since the 2003 through 2007 period.

Indemnity claims have settled quicker over the last several years, largely driven by SB 863 and SB 1160 reforms. The ratio for 2019 is only modestly higher than 2018, which is driven by more recent accident years, suggesting claim settlement rates may be plateauing.

Claim frequency increased by 11% from 2009 to 2014, but has decreased by 6% from 2014 through the first 9 months of 2019. The recent declining frequency is more consistent with patterns in other states though more modest compared to decreases in other states as well as the long-term trend in California.

Cumulative trauma (CT) claim rates continue to increase in 2017 and the ratio of CT claims to all indemnity claims has increased by over 80% since 2005. The sharp increase in CT claims since 2012 is in the Los Angeles and San Diego areas, as CT claims in other regions of CA have generally decreased.

Projected claim severity for 2018 is 5% higher than that for 2017, following several years of modest declines in claim severities. 2018 is projected from claims valued at 21 months and while the growth may still moderate as the year matures, the growth rate as of September 30, 2019 is consistent with that of the prior quarterly evaluation.

Pharmaceutical costs per claim decreased more than 80% from 2012 through the first half of 2019. These reductions have been driven by SB 863’s IMR & IBR, reduced utilization of opioids, changes to Medi-Cal reimbursement rates, efforts to combat fraud, and the new drug formulary. Pharmaceutical utilization continued to decrease significantly in 2018 and 2019, the first periods in which the new drug formulary is in effect.

The number of liens filed in the first three quarters of 2019 are more than 60% below pre-SB 1160 and AB 1244 levels ...
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/ 2019 News, Daily News
ABC contracted with the landowners to use a gas station/food mart and car wash for two days to film an episode of a television show. The contract gave ABC "the right to use both the real and personal property . . . together with access to and egress from the Property with its personnel and equipment."

The property sits on the corner of Foothill Boulevard and Terra Bella Street in Sylmar, California and is surrounded by an eight-foot high metal fence. ABC planned to close the property to the public during filming and needed access through three gates to the interior food mart and the parking areas.

On the side of the property along Terra Bella Street was a parking lot, a wall, and a metal rolling gate weighing approximately 900 pounds. The gate slid along a track that ran through containment towers to keep it upright. Cal-OSHA standards require that "[a]ll horizontal sliding gates . . . be equipped with positive stops or devices that limit the gate travel to the designed fully open and closed positions." Without stops, the gates are unsafe. The Terra Bella gate lacked stops.

ABC’s location scout, Gary Watt, visited the premises multiple times but did not inspect the gates. During his visits, Watt looked for clearly observable problems, "what they call bear traps, anything that could be a safety hazard or anything that might present a danger to cast, crew, [or] the public." Watt did not note that the gate was in any particular state of disrepair.

ABC hired Executive Assurance to provide security for the property during filming. On the day of filming, Reina Castro, a licensed security guard employed by Executive Assurance attempted to stop the Terra Bella gate from striking a truck that was backing out. The gate fell on her causing a broken leg, multiple fractures to her left shoulder, and torn ligaments and degenerative arthritis in her knee.

Castro sued ABC Studios, Inc. to recover for for her personal injuries.The trial court granted ABC’s motion for nonsuit under Privette v. Superior Court (1993) 5 Cal.4th 689 and its progeny, ruling that Castro had presented no evidence that ABC controlled the manner or mode by which its independent contractor’s employees, such as Castro, performed their work.

The Court of Appeal agreed that the Privette doctrine applies to this case and that Castro failed to adduce evidence of an exception in the unpublished case of Castro v. ABC Studios.

Subject to certain exceptions, the Privette doctrine bars employees of independent contractors from recovering damages from the hirer of the contractor for workplace injuries.

The rationale is twofold. First, because workers’ compensation insurance generally provides the exclusive remedy for employees who are injured on the job, allowing the employee to recover from the contractor’s hirer, who did not cause the injury, would unfairly subject the hirer to greater liability than that faced by the contractor who was negligent.

Secondly, by hiring an independent contractor, the hirer implicitly delegates to the contractor any tort law duty it owes to the contractor’s employees to ensure the safety of the specific workplace that is the subject of the contract ...
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/ 2019 News, Daily News
The Division of Workers’ Compensation has issued an order updating the Medical Treatment Utilization Schedule (MTUS) Drug List effective January 15, 2020 pursuant to Labor Code section 5307.29.

The Administrative Director’s update order adopts changes to the MTUS Drug List, based on the American College of Occupational and Environmental Medicine (ACOEM) Practice Guidelines, including the new drug recommendations addressed in the Hip and Groin Disorder Guideline.

The MT US Drug List must be used in conjunction with 1) the MTUS Guidelines, which contain specific treatment recommendations based on condition and phase of treatment and 2) the drug formulary rules. (See 8 CCR §9792.20 - §9792.27.23.)

"Exempt" indicates drug may be prescribed/dispensed without seeking authorization through Prospective Review if in accordance with MTUS.

"Non-Exempt" or "Unlisted" drug requires authorization through Prospective Review prior to prescribing or dispensing. (See 8 CCR §9792.27.1 through §9792.27.23 for complete rules.)

Special Fill - Indicates the Non-Exempt drug may be prescribed/dispensed without Prospective Review: 1) Rx at initial visit within 7 days of injury, and 2) Supply not to exceed #days indicated, and 3) is a generic or single source brand, or brand where the physician substantiates medical necessity, and 4) if in accord with MTUS. (See 8 CCR § 9792.27.12.)

Perioperative Fill - Indicates the Non-Exempt drug may be prescribed/dispensed without Prospective Review: 1) Rx issued during the perioperative period (4 days before through 4 days after surgery), and 2) Supply not to exceed #days indicated, and 3) is a generic or single source brand, or brand where physician substantiates medical necessity, and 4) is in accord with MTUS. (See 8 CCR § 9792.27.13.)

The updated MTUS Drug List v.6 and the order can be accessed on the DWC MTUS drug formulary webpage ...
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/ 2019 News, Daily News
Ten former National Football League (NFL) players have been charged in the Eastern District of Kentucky for their alleged roles in a nationwide fraud on a health care benefit program for retired NFL players.

The alleged fraud targeted the Gene Upshaw NFL Player Health Reimbursement Account Plan (the Plan), which was established pursuant to the 2006 collective bargaining agreement and provided for tax-free reimbursement of out-of-pocket medical care expenses that were not covered by insurance and that were incurred by former players, their wives and their dependents - up to a maximum of $350,000 per player. According to the charging documents, over $3.9 million in false and fraudulent claims were submitted to the Plan, and the Plan paid out over $3.4 million on those claims between June 2017 and December 2018.

Two separate indictments filed in the Eastern District of Kentucky outline two alleged conspiracies involving different players related to the same scheme to defraud the Plan. Those charged in the indictments are the following:

-- Robert McCune, 40, of Riverdale, Georgia, is charged with one count of conspiracy to commit wire fraud and health care fraud, nine counts of wire fraud and nine counts of health care fraud.

-- John Eubanks, 36, of Cleveland, Mississippi; Tamarick Vanover, 45, of Tallahassee, Florida; and Carlos Rogers, 38, of Alpharetta, Georgia, are each charged with one count of conspiracy to commit wire fraud and health care fraud, two counts of wire fraud and two counts of health care fraud.

-- Clinton Portis, 38, of McLean, Virginia; Ceandris Brown, 36, of Fresno, Texas; James Butler, 37, of Atlanta, Georgia; and Fredrick Bennett, 35, of Port Wentworth, Georgia, are each charged with one count of conspiracy to commit wire fraud and health care fraud, one count of wire fraud and one count of health care fraud.

-- Correll Buckhalter, 41, of Colleyville, Texas, and Etric Pruitt, 38, of Theodore, Alabama, are charged with one count of conspiracy to commit wire fraud and health care fraud.

In addition, the government has filed notice that it intends to file criminal informations charging Joseph Horn, 47, of Columbia, South Carolina, and Donald "Reche" Caldwell, 40, of Tampa, Florida, with conspiracy to commit health care fraud in the Eastern District of Kentucky.

The indictments charge that the scheme to defraud involved the submission of false and fraudulent claims to the Plan for expensive medical equipment - typically between $40,000 and $50,000 for each claim - that was never purchased or received.

The expensive medical equipment described on the false and fraudulent claims included hyperbaric oxygen chambers, cryotherapy machines, ultrasound machines designed for use by a doctor’s office to conduct women’s health examinations and electromagnetic therapy devices designed for use on horses.

According to allegations in the indictments, McCune, Eubanks, Vanover, Buckhalter, Rogers and others recruited other players into the scheme by offering to submit or cause the submission of these false and fraudulent claims in exchange for kickbacks and bribes that ranged from a few thousand dollars to $10,000 or more per claim submitted. As part of the scheme, the defendants allegedly fabricated supporting documentation for the claims, including invoices, prescriptions and letters of medical necessity. After the claims were submitted, McCune and Buckhalter allegedly called the telephone number provided by the Plan and impersonated certain other players in order to check on the status of the false and fraudulent claims ...
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/ 2019 News, Daily News
Jose Ricardo Loza and Randy Lee Walker were charged in a criminal complaint with distributing fentanyl and heroin.

An affidavit filed in the case alleges that Loza sold blue counterfeit oxycodone pills that were laced with Fentanyl. According to the affidavit, Loza sold to a third party 50 Fentanyl-laced pills on August 22, 2019, when at the auto body shop where he works in Pittsburg, California.

Loza allegedly did not initially have enough pills to sell, so he texted Walker, who arrived with more Fentanyl-laced pills.

During the transaction, Loza warned the customer to be careful when taking these pills because he (Loza) gave the same pills to a mutual friend who overdosed and died. According to the affidavit, a laboratory test verified that a sample of the pills Loza sold contained fentanyl.

In addition, the affidavit alleges that on November 22, 2019, Loza sold 500 more counterfeit pills to an undercover officer and then told the officer that he had 10,000 more of the same pills for sale. Further, the affidavit alleges Loza sold two ounces of heroin on September 10, 2019.

Loza and Walker are charged with distribution of controlled substances, in violation of 21 U.S.C. §§ 841(a)(1) and (b)(1)(C).

Loza and Walker were arrested on December 12, 2019. At the time of Loza’s arrest, law enforcement agents found more than 2,000 counterfeit oxycodone pills hidden in hallowed out compartments of his furniture.

Both defendants currently are in custody. Walker’s next court appearance is scheduled for Monday, December 16, 2019, for appointment of counsel. Loza’s next court appearance is scheduled for Wednesday, December 18, 2019, for a hearing to address detention issues.

If convicted, the defendants face a maximum statutory penalty of up to 20 years in prison. A term of supervised release, fines, forfeitures, and restitution also may be ordered, however, any sentence following conviction would be imposed by the court only after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553 ...
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/ 2019 News, Daily News
The world has been told that the drug Tramadol, is safer than the OxyContins, the Vicodins, the fentanyls that have wreaked so much devastation. But now they are the root of what the United Nations named "the other opioid crisis" - an epidemic featured in fewer headlines than the American one, as it rages through the planet’s most vulnerable countries.

Mass abuse of the opioid tramadol spans continents, from India to Africa to the Middle East, creating international havoc some experts blame on a loophole in narcotics regulation and a miscalculation of the drug’s danger. The man-made opioid was touted as a way to relieve pain with little risk of abuse. Unlike other opioids, tramadol flowed freely around the world, unburdened by international controls that track most dangerous drugs.

But abuse is now so rampant that some countries are asking international authorities to intervene.

Grunenthal, the German company that originally made the drug, is campaigning for the status quo, arguing that it’s largely illicit counterfeit pills causing problems. International regulations make narcotics difficult to get in countries with disorganized health systems, the company says, and adding tramadol to the list would deprive suffering patients access to any opioid at all.

Tramadol has not been as deadly as other opioids, and the crisis isn’t killing with the ferocity of America’s struggle with the drugs. Still, individual governments from the U.S. to Egypt to Ukraine have realized the drug’s dangers are greater than was believed and have worked to rein in the tramadol trade. The north Indian state of Punjab, the center of India’s opioid epidemic, was the latest to crack down. The pills were everywhere, as legitimate medication sold in pharmacies, but also illicit counterfeits hawked by street vendors.

This year, authorities seized hundreds of thousands of tablets, banned most pharmacy sales and shut down pill factories, pushing the price from 35 cents for a 10-pack to $14. The government opened a network of treatment centers, fearing those who had become opioid addicted would resort to heroin out of desperation. Hordes of people rushed in, seeking help in managing excruciating withdrawal.

Jeffery Bawa, an officer with the United Nations Office on Drugs and Crime, realized what was happening in 2016, when he traveled to Mali in western Africa, one of the world’s poorest countries, gripped by civil war and terrorism. They asked people for their most pressing concerns. Most did not say hunger or violence. They said tramadol.

Most of it was coming from India. The country’s sprawling pharmaceutical industry is fueled by cheap generics. Pill factories produce knock-offs and ship them in bulk around the world, in doses far exceeding medical limits.

In 2017, law enforcement reported that $75 million worth of tramadol from India was confiscated en route to the Islamic State terror group. Authorities intercepted 600,000 tablets headed for Boko Haram. Another 3 million were found in a pickup truck in Niger, in boxes disguised with U.N. logos. The agency warned that tramadol was playing "a direct role in the destabilization of the region."

The United Kingdom and United States both regulated it in 2014. Tramadol was uncontrolled in Denmark until 2017, when journalists asked doctors to review studies submitted to regulators to support the claim that it has a low risk for addiction, said Dr. Karsten Juhl Jorgensen, acting director of the Nordic Cochrane Centre and one of the physicians who analyzed the materials. They all agreed that the documents did not prove it’s safer.
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/ 2019 News, Daily News
In mid-September the U.S. Food and Drug Administration received a 19-page document with some startling claims about a popular medicine. The online pharmacy Valisure, which tests prescription drugs before dispensing them, said it had found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac. As for the carcinogen, NDMA, the FDA knew it well: For more than a year the agency had been recalling batches of the blood pressure medication valsartan because they were contaminated with it.

The FDA issued an alert, one that seemed to downplay Valisure’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. In fact, Valisure had found high levels of NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself. In other words, if Valisure is correct, there is no safe version of ranitidine.

The muted quality of the FDA’s statement didn’t stop concern from going global. By mid-October, a month after the FDA’s alert, at least two dozen countries had pulled ranitidine from stores or halted its distribution. Numerous companies had acted on their own to slow or stop the supply of the drug. The FDA continued to conduct tests.

Finally, on Nov. 1, the agency announced that it had found higher-than-acceptable levels of NDMA in some ranitidine- though not nearly as high as Valisure detected. The FDA then deployed the strongest weapon available to it: The agency asked manufacturers to voluntarily recall some of the Zantac on the market.

At a time when a poorly policed global supply chain and demand for ever-cheaper generics have exposed drugs to new safety risks, an effective recall system is crucial. Spotting problems earlier is getting harder: From 2016 to 2018 the number of FDA inspections of drug manufacturers declined 10% overseas and 13% for domestic facilities, according to a recent report from the Government Accountability Office.

But the agency’s authority over this system is limited. It can only request a pullback - manufacturers can and do say no. It can’t contact patients directly; it relies on pharmacies for that. It doesn’t control how the recall is conducted or how its effectiveness is assessed.

Rosa DeLauro, in her role on the House committee that oversees the agency, has tried to give it more authority over recalls. She sponsored a bill that gave the FDA the power to order food recalls; it was signed into law by President Barack Obama in 2011. The agency also has recall power over manufacturers of vaccines, medical devices, infant formula, and tobacco products. As of last year, it can order a recall of opioids deemed dangerous. It can do all of that, but it can’t order a recall of any other prescription drug.

DeLauro tried to push a bill two years ago to change that. The bill went nowhere. At least one reason was opposition to it from the trade group representing drug manufacturers. Now, after two high-profile recalls of common drugs have exposed flaws in the system, DeLauro plans to try again to give the FDA more clout.

When the federal government couldn’t make progress, states tried. The first was California, which, because of its size, can establish de facto national standards for industries. In 2004, California passed a law requiring electronic tracking of drugs all the way to the patient by 2009. The drug industry pushed back, saying the changes were technologically impossible to make that quickly. The deadline was extended to 2014. Nothing happened.

Then, in 2013, the industry preempted the California statute and its deadline by winning passage of a federal drug tracking law. The law created a uniform national system for electronically tracing pharmaceuticals from the manufacturer to the pharmacy’s back door. The industry was given 10 years - until November 2023 - to fully comply. Other countries trying to create tracking systems aren’t moving any faster, says Eric Marshall, executive director of a new industry governance group for implementation of the law.

The legislation exempts pharmacies completely. Even after the law goes into full effect, pharmacies won’t have to track which lots they sell to which customers. Nor will they be required to put lot numbers on labels. Some pharmacies do that now, and others don’t. One concern is patient privacy. To further complicate matters, high-volume pharmacies, such as mail-­order companies, mix pills from different lots. Pharmacies can also subdivide packages ...
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/ 2019 News, Daily News
The American College of Occupational and Environmental Medicine (ACOEM), an international society of more than 4,000 occupational physicians and associated professionals, provides leadership to promote optimal health and safety of workers, workplaces, and environments. Occupational and environmental medicine is the medicine specialty devoted to prevention and management of occupational and environmental injury, illness and disability, and promotion of health and productivity of workers, their families, and communities.

ACOEM has taken the position that marijuana is an impairing substance and its legalization has huge public and workplace health implications. Before passing any legislation legalizing this substance, the U.S. Congress should proceed deliberately and consider workplace safety when dealing with this complex issue.

To date, 33 states and the District of Columbia have legalized the medical and/or recreational use of marijuana. With most Americans living and working in states that allow some form of legal marijuana use, it is critical that safety be at the forefront of any policy discussions regarding the use of cannabinoids outside of the standard Food and Drug Administration approval process.

The current patchwork of laws to address marijuana use and workplace safety is detrimental to employees, employers, and the general public, notes ACOEM in its statement on the Legalization of Marijuana - Implications for Workplace Safety which was sent to all members of Congress late last week.

ACOEM urges legislators to carefully consider the impact of any federal marijuana legislation on workplace safety. "While there is much not known about marijuana, what is known is that marijuana can cause impairment which will interfere with safe and acceptable performance in the workplace," said ACOEM president Stephen Frangos, MD. "Furthermore, this is particularly concerning for those individuals working in safety-sensitive positions where impairment can affect the health and safety of other workers, customers, the general public, or others."

ACOEM notes that employers have a legal responsibility under the Occupational Safety and Health Administration’s general duty clause to protect employees from workplace illness or injury, and an ethical responsibility to prevent impaired workers from exposing themselves, their co-workers, and/or the general public to risk of harm.

Therefore, regardless of marijuana’s legal status in a jurisdiction, ACOEM strongly supports legislative proposals that allow employers to prohibit those employed in safety-sensitive positions from working while under the influence of marijuana ...
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/ 2019 News, Daily News
"Healthcare is the biggest business in the world, and it is phenomenally broken," says Peter Diamandis, cofounder of the X-Prize, Singularity University, and Health Longevity Inc. "So, do I think Apple and Google and Amazon can do a better job? A thousandfold."

In his upcoming book, The Future Is Faster Than You Think, which will hit bookshelves in late January 2020, Diamandis makes the case for why he believes big tech companies are going to be running healthcare by 2030.

"We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers," he says, referring to smart speakers such as Google’s Assistant, Amazon’s Alexa, and Apple’s HomePod. While many of these home voice assistants started with simple tasks like restocking home pantries and surfacing cooking tutorials, they’re already starting to move into the business of managing family well-being.

Amazon has put significant effort into making Alexa a health resource. In the United Kingdom, it has partnered with the National Health Service to answer basic health questions such as "What are the symptoms for shingles?" or "What do you do if you have a cold?" It has also made Alexa compliant with U.S. HIPAA laws and signed partnerships with major healthcare insurers and providers so patients can access or remit health information through the device. To date, there are nearly 2,000 health wellness skills on its platform.

Similarly, the Google Assistant uses search to serve up information about medications, symptoms, and diseases, as well as physicians and medical services. Both the Google Home and the Echo have a Mayo Clinic-developed skill called First Aid that helps people navigate minor injuries. Meanwhile, Apple’s HealthKit takes a slightly different approach to tackling personal health. The kit connects to Apple’s own products such as the HomePod, iPhone, and Apple Watch as well as a bevy of devices from other companies, such as scales and blood pressure cuffs. The HealthKit can also tap into electronic medical records and other apps connected to hospitals and doctors. Essentially, it becomes a single repository for all your precious health data.

Diamandis believes the involvement of home health devices has the potential to lower costs by shifting care away from hospitals, where expenses can be much higher. This is the general idea behind telemedicine, but Diamandis thinks that big consumer tech companies will play a big role in driving that vision. He also thinks that these companies, which have mastered using personal data to anticipate user behavior, can use personal health data to make predictions about a person’s long-term health prospects and advise them accordingly.

Diamandis posits that the more information is available about you - your genetic makeup, your health history, what you ate for breakfast, the bacteria in your bowel movement, how you slept last night, what kind of sound you’re exposed to every day - the better artificial intelligence will be at spotting your potential for illness and suggesting care before the problem becomes intractable. This approach might shift the medical establishment from a structure that treats disease once it’s wreaking havoc in your body to one that prevents the disease from striking in the first place. "It is literally hundreds if not thousands of times cheaper to do that," he says.

It is this cost savings that he believes will allow for new models of healthcare. Diamandis predicts Apple and Amazon will come up with a service where a person pays a company to keep them healthy, rather than to cover the cost of illness, based on their health history and daily activities ...
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/ 2019 News, Daily News
Sedgwick may have been established as a regional claims administrator in 1969, but it has since grown into a global provider of technology-enabled risk, benefits, and integrated business solutions, with 21,000 employees spread across 65 countries. The company’s solutions span from casualty risk to benefits, and property and loss adjusting to marine claims, alongside offering innovative technology platforms and global expertise in areas such as workers’ compensation, liability, property, disability, and absence management.

The Sedgwick Institute serves as an incubator for some of the best and brightest minds to advance the conversations that affect all the players in our industry, including injured and ill members of the workforce, insurance carriers, employers, property owners, third party claims administrators, brokers, lawmakers and medical providers.

The Sedgwick Institute has released a new book that takes a critical look at the workers’ compensation market and what the future holds for the industry.

Authored by Dr. Richard A. Victor of the Sedgwick Institute, "SCENARIOS FOR THE 2030s: Threats and Opportunities for Workers’ Compensation Systems" discusses the workers’ compensation-related challenges faced by US employers, as well as injured workers, lawmakers, and practitioners of occupational medicine. The book highlights the importance of workers’ comp and how such systems have remained despite social and economic changes.

Dr. Victor was appointed to the senior fellow position at Sedgwick Institute in 2016. He is the former founder and CEO of the Worker’s Compensation Research Institute.

One of the key topics discussed in Victor’s book is that workers’ compensation insurance costs could triple from 2016’s levels, while injured workers see no real change to their benefits. Victor observed in his studies that both employers and worker advocates have agreed that the systems could be "out of balance," despite attempts to file through legislation and regulatory reforms.

This book also explores some of today’s most perplexing questions:

-- Is there a plausible scenario where many state workers’ compensation systems remain in a dangerously unbalanced state?
-- And where the workers’ compensation reform process is unable to restore a reasonable balance: What might cause that imbalance? What are the threats? Where are the opportunities?
-- Why will the workers’ compensation reform process be unlikely to deliver effective solutions?
-- What might replace state workers’ compensation systems?

"I am very fortunate that the Sedgwick Institute supported this work. It provides an opportunity to provoke system stakeholders to think outside the box about upcoming challenges to be faced by a critical part of our nation’s social safety net," commented Victor.

"With more than 30 years of experience in insurance and large global corporate risk management, I am pleased to have the Sedgwick Institute stand behind a book that truly shines a light on the complexity and importance of the industry and the challenges that it faces," said Sedgwick Institute director and Sedgwick senior vice-president of strategic solutions Christopher E. Mandel ...
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/ 2019 News, Daily News
The owner of a temporary staffing company was sentenced to 180 hours of community service, three years formal probation and ordered to pay $944,718 in restitution after pleading no contest to insurance fraud for underreporting payroll by approximately $4.9 million that resulted in a $944,718 loss to his insurer.

Michael Zendejas, 47, of Turlock, as the owner and president of Trinity Personnel Inc., an employment agency that provides temporary workers, obtained a workers’ compensation policy from State Compensation Insurance Fund (SCIF) in September 2014 through December 2016.

SCIF performed an audit of the policy and found that Zendejas significantly underreported the company’s payroll by $4.9 million and number of employees in order to receive a lower workers’ compensation insurance premium.

The joint investigation with the California Department of Insurance and the Amador County Workers’ Compensation Fraud Unit found Zendejas provided SCIF with fraudulent Employment Development Department and payroll documents resulting in the $944,718 loss in insurance premiums to his insurer.

On November 22, 2019, Zendejas pleaded no contest to insurance fraud. The case was prosecuted by the Amador County District Attorney’s Office ...
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/ 2019 News, Daily News