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PEOTUS Takes Aim at Big PhRMA

President-elect Donald Trump said last week that pharmaceutical companies are “getting away with murder” in what they charge the government for medicines, and promised that would change, sending drugs stock prices sharply lower.

The benchmark S&P 500 index .SPX slipped into negative territory after his remarks at a news conference spooked investors. The iShares Nasdaq Biotech ETF (IBB.O) dropped 4 percent at its session low and ended down 3 percent, its largest daily percentage drop in three months.

“When the president-elect says we’re going to negotiate drug pricing, you have to take that seriously, but at the same this is a complicated issue because there’s not going to be clarity on drug pricing reform anytime soon,” said Brad Loncar, manager of the Loncar Cancer Immunotherapy ETF (CNCR.O). “When somebody that high profile says something that negative, people do not want to invest in it.”

After his promise to bring down drug spending, the ARCA pharmaceutical index gave up as much as 2.6 percent and ended the day down 1.7 percent.

The drug industry has been on edge for two years about the potential for more government pressure on pricing after sharp increases in the costs of some life-saving drugs drew scrutiny in the press and among lawmakers. The government is investigating Medicaid and Medicare overspending on Mylan NV’s (MYL.O) allergy treatment EpiPen, for instance.

David Katz, chief investment officer at Matrix Asset Advisors in New York, said negative comments on drug pricing trigger selling both from algorithms and investors who suffered from share drops when Democrat Hillary Clinton campaigned against healthcare cost increases.

Trump’s campaign platform included allowing the Medicare healthcare program to negotiate with pharmaceutical companies, which the law currently prohibits. He has also discussed making it easier to import drugs at cheaper prices.

“We are going to start bidding. We are going to save billions of dollars over time,” Trump said.

Medicare, which covers more than 55 million elderly or disabled Americans, spent $325 billion on medicines in 2015.

Industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA President Stephen Ubl said “Medicines are purchased in a competitive marketplace where large, sophisticated purchasers aggressively negotiate lower prices.”

He said the industry is “committed to working with President-elect Trump and Congress to improve American competitiveness and protect American jobs.”

But Speaker of the House, Paul Ryan did not quite seem to be on board with the Trump agenda. He said that he wants to “have more conversations about” Trump’s efforts to crack down on Big Pharma corruption before the president-elect – soon to be president- does so. “I believe that the current premium support system with Part D works extremely well,” Ryan said. “I think there’s some real success stories – and I think we need to tell that story.”

Yet Democrats seem to be urging Trump to move forward. Sens. Sherrod Brown and Al Franken are leading a letter to President-Elect Donald Trump last month, urging him to prioritize prescription drug price reform and saying that Senate Democrats are standing by to partner with his administration.

“During your campaign, you promised to address the high prescription drug prices that the vast majority of Republicans and Democrats expressed as a top concern in the election,” Brown, Franken and 17 other Democrats write. “In this letter, we have listed tangible ways your Administration can lead bipartisan work on this issue.”

Researchers Draw 100 Conclusions About Marijuana

Twenty-eight states and the District of Columbia have legalized marijuana for a variety of medical uses, and eight of those states plus the district have also legalized it for recreational use.

Now, a new report from the National Academies of Sciences, Engineering, and Medicine offers a rigorous review of scientific research published since 1999 about what is known about the health impacts of cannabis and cannabis-derived products – such as marijuana and active chemical compounds known as cannabinoids – ranging from their therapeutic effects to their risks for causing certain cancers, diseases, mental health disorders, and injuries.

The committee that carried out the study and wrote the report considered more than 10,000 scientific abstracts to reach its nearly 100 conclusions. The committee also proposed ways to expand and improve the quality of cannabis research efforts, enhance data collection efforts to support the advancement of research, and address the current barriers to cannabis research.

The committee found evidence to support that patients who were treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms. For adults with multiple sclerosis-related muscle spasms, there was substantial evidence that short-term use of certain “oral cannabinoids” – man-made, cannabinoid-based medications that are orally ingested – improved their reported symptoms. Furthermore, in adults with chemotherapy-induced nausea and vomiting, there was conclusive evidence that certain oral cannabinoids were effective in preventing and treating those ailments.

But the report dismisses most of the drug’s other supposedly ‘medical benefits’ as unproven. Crucially, the researchers concluded there is not enough research to say whether marijuana effectively treats epilepsy – one of the most widely-recognized reasons for cannabis prescriptions.

The report also casts doubt on using cannabis to treat cancers, irritable bowel syndrome, or certain symptoms of Parkinson’s disease, or helping people beat addictions.

Turning to potential harms, the committee concluded:

1) Strong evidence links marijuana use to the risk of developing schizophrenia and other causes of psychosis, with the highest risk among the most frequent users.
2) Some evidence suggests a small increased risk for developing depressive disorders, but there’s no evidence either way on whether it affects the course or symptoms of such disorders, or the risk of developing post-traumatic stress disorder.
3) There’s strong evidence that using marijuana increases the risk of a traffic accident, but no clear indication that it promotes workplace accidents or injuries, or death from a marijuana overdose.
4) There’s only weak evidence for the idea that it hurts school achievement, raises unemployment rates or harms social functioning.
5) For pregnant women who smoke pot, there’s strong evidence of reduced birth weight but only weak evidence of any effect on pregnancy complications for the mother, or an infant’s need for admission to intensive care. There’s not enough evidence to show whether it affects the child later, like sudden infant death syndrome or substance use.
6) Some evidence suggests there’s no link to lung cancer in marijuana smokers. But there’s no evidence, or insufficient evidence, to support or rebut any link to developing cancers of the prostate, cervix, bladder, or esophagus.
7) Substantial evidence links pot smoking to worse respiratory symptoms and more frequent episodes of chronic bronchitis.
8) There’s weak evidence that suggests smoking marijuana can trigger a heart attack, especially for people at high risk of heart disease. But there’s no evidence either way on whether chronic use affects a person’s risk of a heart attack.
8) Some evidence suggests a link between using marijuana and developing a dependence on or abuse of other substances, including alcohol, tobacco and illicit drugs.

Currently, cannabis is the most popular illicit drug in the United States, in terms of past-month users. Based on a recent nationwide survey, 22.2 million Americans ages 12 and older reported using cannabis in the past 30 days. This survey also reports that 90 percent of adult cannabis users in the United States said their primary use was recreational, with about 10 percent reporting use solely for medical purposes. Around 36 percent reported mixed medical and recreational use. In addition, between 2002 and 2015, the percentage of past-month cannabis users in the U.S. population ages 12 and older has increased steadily from 6.2 percent to 8.3 percent.

San Bernardino Comp Task Force to Review Terror Attack Aftermath

After survivors of the December 2, 2015 San Bernardino terrorist attack brought their problems with receiving timely medical treatment to the Board of Supervisors, county leaders pointed to workers’ compensation. Now, the county has formed a task force, it says, set on mending issues with the statewide system beyond just those experienced by the attack survivors.

In conjunction with San Bernardino County’s employee associations and unions, the county will “work with them to identify issues they’re experiencing, their members are experiencing and see about suggestions for addressing those issues,” county CEO Greg Devereaux said Tuesday.

The Victorville Daily Press reports that the task force is the latest effort by the county to deal with criticism levied by public health workers in November over delayed treatment received following the terrorist attack at the Inland Regional Center on Dec. 2, 2015, where 14 died and 22 more were injured.

As of late November, 18 employees in the county’s Department of Public Health had filed for workers’ compensation and officials had anticipated 36 more cases at that time. Public records showed the cases reflected physical, emotional and/or mental distress.

Last month, Supervisors hired a firm to provide enhanced nurse case management and system navigation services to county employees injured in the attack.

The county said it had found many of the issues raised by employees stemmed from the county not receiving supporting documentation from their treatment providers.

Supervisors Josie Gonzales and Janice Rutherford suggested that the task force, and the Dec. 2 attack generally, could springboard efforts to address the workers’ compensation system as a whole. Gonzales added that “we have found that, in fact, the system works very much against the very solution and benefit that, again, originally was intended or that is needed.”

“… I find this a great opportunity for us to take a leadership role to a great deal of frustrations that I’m sure other agencies, other boards, groups and employees have found challenging,” she said, “but did not have the catalyst behind them to actually throw the doors open of this situation and say, ‘hey, let’s take a good and closer look.'”

Devereaux said the task force had already endorsed the wider review of the system.

“That’s really the focus, it’s the whole system for all employees,” he said. “Dec. 2 and the impacts on those employees is what brought it to our attention, but it really is, we are looking at it more broadly.”

He said the task force will regularly report back to the board. Supervisor Curt Hagman said he appreciated a turn toward proactiveness.

Former Ventura Neurosurgeon to Serve 20 Years

A former Ventura County neurosurgeon has been sentenced to nearly twenty years in prison for his role in a $2.8 million health care fraud scheme in which he caused serious bodily harm to patients by performing unnecessary invasive spinal surgeries.

Aria O. Sabit M.D., 43, has a significant criminal history, dating back to 2010, while practicing at Ventura based Community Memorial Hospital. At the time Sabit was a licensed neurosurgeon in California.

Sabit admitted that, in approximately February 2010, while he was on the staff of a California Community Memorial Hospital, he became involved with Apex Medical Technologies LLC (Apex), which was owned by another neurosurgeon and three non-physicians. In exchange for the opportunity to invest in Apex and share in its profits, Sabit agreed to convince his hospital to buy spinal implant devices from Apex and to use a substantial number Apex spinal implant devices in his surgical procedures. Sabit further admitted that he and Apex’s co-owners concealed Sabit’s involvement in Apex from the hospitals and surgical centers.

As a result of these unnecessary surgeries, about 30 of Dr. Sabit’s patients sued him for malpractice. Community Memorial Hospital cut ties with Dr. Sabit in December 2010 to protect patients.

With his California career in the rearview mirror, Sabit took his practice to Detroit. His fraudulent ways were far from over, however. He convinced patients in Detroit to receive spinal fusions with metal instrumentation, but “subsequent diagnostic imaging revealed that he never installed the hardware, just bone dowels, and never achieved fusion,”.

On Nov. 24, 2014, authorities arrested Dr. Sabit. By May 2015, he pleaded guilty to four counts of health care fraud, one count of conspiracy to commit health care fraud and one count of unlawful distribution of a controlled substance, resulting in losses to Medicare, Medicaid and various private insurance companies.

In connection with his guilty plea, Sabit admitted that he derived significant profits by convincing patients to undergo spinal fusion surgeries with “instrumentation” (medical devices designed to stabilize and strengthen the spine) that he never performed and billed public and private healthcare benefit programs for those fraudulent services.

Sabit further admitted that, in some instances, he operated on patients and dictated in his operative reports – which he knew would later be used to support fraudulent insurance claims – that he had performed spinal fusion with instrumentation, when he had not. Specifically, Sabit fraudulently billed public and private health care programs for instrumentation when, in fact, he used cortical bone dowels made of tissue. Sabit failed to render services in relation to lumbar and thoracic fusion surgeries, including in certain instances, billing for implants that were not provided.

In connection with his guilty plea, Sabit admitted that the financial incentives provided to him by Apex and his co-conspirators caused him to use more spinal implant devices than were medically necessary to treat his patients in order to generate more sales revenue for Apex, which resulted in serious bodily injury to his patients. Sabit also admitted that, on a few occasions, the money he made from using Apex spinal implant devices motivated him either to refer patients for unnecessary spine surgeries or for more complex procedures that they did not need.

Sabit also is a defendant in two civil False Claims Act cases brought by the Justice Department in the Central District of California. These cases remain pending.

Cal/OSHA Responds to Tree-Trimming Fatalities

Following four recent tree-trimming workplace fatalities, Cal/OSHA is reminding workers and employers in this high-risk industry to take precautions to avoid accidents.

Cal/OSHA is investigating the four deaths, which occurred over the last six weeks, and has launched a statewide safety awareness campaign for tree service companies, landscapers and other businesses.

The four tree-trimming deaths under investigation include:

1) a worker in Mariposa County who was struck by a branch on December 1
2) a worker in San Bernardino County who suffocated when dry palm fronds collapsed and trapped him on December 4
3) a worker in Los Angeles County who fell approximately 60 feet when the branch he was tethered to broke on January 6
4) a worker in Siskiyou County who was struck by the tree he was cutting to clear power lines on January 9

“Cal/OSHA’s safety awareness campaign aims to protect the lives of tree service workers,” said Cal/OSHA Chief Juliann Sum. “Employers in this high-risk industry need to be aware of, and take steps to minimize, the hazards to their workers. We will cite employers that are not in compliance with safety requirements.”

Cal/OSHA investigated nearly 70 accidents involving tree work, including trimming or removal services, in the two-year period between October 1, 2014 and September 30, 2016. Nearly three out of four of these accidents (74%) resulted in a worker hospitalization, and 12 of the accidents involved the death of a worker.

As part of the Tree Work Safety Emphasis Program, Cal/OSHA inspectors throughout the state who observe unsafe tree trimming or tree removal operations will investigate possible violations. Inspectors will also respond to reports of unsafe operations.

The major causes of tree trimming injuries and fatalities include falls, electrical shock, being struck by a tree branch, chainsaw lacerations, palm tree skirt collapses and ladder accidents. For example, on December 30, 2015, a Wright Tree Service worker in Humboldt County accidently cut the lanyard used to secure himself to a tree and fell 54 feet to his death. The investigation revealed the employer failed to ensure the worker was using a required second point of attachment in his security system while he was operating a chain saw in a tree.

Cal/OSHA has resources available to help employees and employers prevent accidents like these, including a Tree Work Safety Guide, fact sheet and checklist.

Feds Wrap Up Fraud Case Against So. Cal Rehab Clinics

Simon Hong (who is also known as Seong Wook Hong), 55, a Brea man, who operated rehabilitation clinics in Walnut, Torrance and Los Angeles and defrauded Medicare out of approximately $3 million by billing for unneeded or unnecessary services has been sentenced to 121 months in federal prison.

Hong was found guilty in October of eight counts of healthcare fraud, nine counts of illegal kickbacks related to healthcare referrals and two counts of aggravated identity theft.

Hong owned physical therapy clinics operated by companies called Hong’s Medical Management, Inc., CMH Practice Solution, and HK Practice and Solution, Inc. As part of the scheme, Hong recruited Medicare beneficiaries and provided uncovered services like massage and acupuncture for them. Even though the beneficiaries did not receive actual physical therapy, Hong’s co-conspirators billed Medicare for physical therapy, and then funneled 56 percent of the reimbursement funds back to Hong.

Through this scheme Hong and his co-conspirators billed Medicare from the spring of 2009 until November 2013 and received approximately $2,929,775 in reimbursements, of which Hong received approximately $1,640,674. Hong was ordered to pay $2,929,775 in restitution.

Hong is one of 10 defendants who were charged in 2015 and early 2016 for healthcare fraud related to physical therapy. Eight others have pled guilty, and one, David Y. Kim, 54, of Los Angeles, remains a fugitive. Those previously convicted in the investigation are:

1) Joseff Sales, 39, of Buena Park, a co-owner and operator of Rehab Dynamics, who pleaded guilty to one count of healthcare fraud and one count of illegal kickbacks, and was sentenced last year to 51 months in prison;

2) Danniel Goyena, 39, of Buena Park, a co-owner and operator of Rehab Dynamics, who pleaded guilty to two counts of healthcare fraud and was sentenced last year to 51 months in prison;

3) Marlon Sonco, 39, of Sylmar, who pleaded guilty in June 2015 to conspiracy and is scheduled to be sentenced on January 23;

4) Eddieson Legaspi, 40, of Lomita, an employee of Rehab Dynamics, pleaded guilty to conspiracy to commit healthcare fraud and also was sentenced yesterday to 15 months;

5) Ohun Kwon, 50, of Fullerton, the owner/operator of E.K. Medical Management, which referred patients to Rehab Dynamics, pleaded guilty to conspiracy to commit healthcare fraud and was sentenced last year to 27 months in federal prison;

6) Leovigildo Sayat, 39, of Torrance, an employee of RSG Rehab, pleaded guilty to conspiracy to commit health care fraud and was sentenced last year to two years in prison;

7) Byong Chun “David” Min, 68, of Irvine, co-owner/operator of Glory Rehab Team, which operated as Dream Hospital in Orange County, who pleaded guilty to healthcare fraud and illegal kickbacks, also was sentenced yesterday to 45 months in prison; and

8) Jason S. Min, 35, of Irvine, David Min’s son, who was the other owner/operator of Glory Rehab, pleaded guilty last year to obstruction of justice and is scheduled to be sentenced on February 6.

These individuals should be precluded from recovery of any bills or liens that may be pending in California Workers’ Compensation cases as a result of new law that took effect this year.

In a separate case, Hong pleaded guilty last month to conspiracy to commit health care fraud in another scheme involving occupational and physical therapy services that were never provided to Medicare beneficiaries. Medicare suffered losses of approximately $2.4 million in relation to this scheme. Hong is scheduled to be sentenced in this case in Los Angeles federal court by United States District Judge George Wu on March 6.

Details Emerge on Prescription Drug Black Market Supply Chain

The U.S. Department of Justice announced that 56 year old Randy Crowell plead guilty to fraudulently distributing more than $100 million worth of prescription drugs obtained on a nationwide black market. Crowell used a Utah-based wholesale distribution company to sell illicitly procured drugs to pharmacies, which in turn dispensed them to unsuspecting customers.

Crowell, purchased more than $100 million worth of prescription medications from a sinister black market chain at a fraction of the legitimate prices for these drugs, before selling the same as new, legitimate bottles of medication to legitimate licensed pharmacies all over the country.  To maximize profits, Crowell and his co-conspirators focused on some of the most expensive medications on the market, including those used to treat HIV/AIDS.

Scheme participants targeted the cheapest possible source of supply for these drugs – Medicaid patients and other individuals who received these prescription drugs on a monthly basis for little or no cost, and who were then willing to sell their medicines rather than taking them as prescribed.

These Insurance Beneficiaries had prescriptions filled for medications each month at pharmacies across the country. And then sold their medications to low-level participants (“Collectors”) in the scheme who worked on street corners and bodegas and would pay cash – typically as little as $40 or $50 per bottle.

Because the ultimate goal of the scheme was to resell these medications as new at full price, Collectors and other scheme participants used lighter fluid and other potentially hazardous chemicals to remove the patient labels affixed when the bottles were initially dispensed to the Insurance Beneficiaries. This process, referred to as “cleaning” the bottles, was dangerous, as these hazardous chemicals could infiltrate the bottles, rendering the medication unfit for human consumption.

Collectors then sold these second-hand drugs to higher-level scheme participants (“Aggregators”) who bought dozens, and sometimes hundreds, of bottles at a time from multiple collectors before selling them to higher-level scheme participants with direct access to legitimate distribution channels, including corrupt wholesale companies like Crowell’s accomplices.

The corrupt wholesale companies then resold the bottles as new, at full price, to pharmacies, including potentially the very same pharmacies that initially dispensed these medications.

Crowell and others acting at his direction created false and fraudulent documents known as “pedigrees” for these medications, which purported to document the legitimate movement of these medications bought and sold by them.

Crowell pled guilty to one count of conspiracy to commit health care fraud, which carries a maximum term of 10 years in prison. As a part of the plea, Crowell also consented to the forfeiture of more than $13 million in scheme proceeds, including the full contents of his primary operating account.

Crowell will be sentenced on May 11, 2017, at 12:30.

L.A. Must Borrow Millions to Pay Unprecedented Claims

Los Angeles budget officials warned, in a January 6 memo, that the City needs to immediately borrow tens of millions of dollars to avoid dipping into its emergency reserve fund after several high-profile lawsuit payouts.

The City Administrative Office recommended that the city borrow $50 million to $70 million to address cases that are part of a “new trend of increased liability payouts.”

The City typically budgets $60 million a year for its legal liability fund, but has already paid out $135 million since July 1, when the current fiscal year began.

Recent significant payouts include a $200-million settlement by the Los Angeles City Council over a housing-related lawsuit brought by disabled groups and an $8-million settlement to end lawsuits related to the fatal Los Angeles Police Department shootings of three unarmed men in separate incidents. The $200 million will be paid out over 10 years.

The report recommends issuing Judgment Obligation Bonds to fund these settlements, and warns against dipping into the city’s reserve fund, which is for financial emergencies.

As of November, the reserve fund stood at about $295 million, which the report said is “only precariously above” the minimum amount required under city policy – 5% of the General Fund budget. The recommendation comes after the city paid out $100 million in legal cases last fiscal year, said Assistant City Administrative Officer Ben Ceja. He said the rising expenditures “could be the new normal in terms of paying out cases.”

After calling the financial crisis to the attention of City officials, a Second Financial Status Report reported “a potential $52 million expenditure deficit and highlighted risks to revenues totaling $138 million. Since that report, additional information has increased the reported expenditure deficit to up to $80 million, while a new identified shortfall increases the combined revenue risk to $165 million. Therefore, the combined potential deficit currently stands at $245 million.”

The Report goes on to state that the “options to resolve this deficit are extremely limited.” The deficit is “mostly driven by the liability claims account, human resource benefits account, and recent labor agreements reached with firefighters.”

“One significant source of expenditures includes pending resolutions to additional cases being handled by the City Attorney and Conflict Counsel. These payouts are above the $135.5 million identified in the FSR, which already exceeded the Adopted Budget by $67 million. As this Office stated at the time of the adoption of the 2016-17 Budget, potential liabilities above budgeted amounts posed a major risk in 2016-17 that had the potential to exceed the available reserves set aside in the Unappropriated Balance. The City must strive to increase the funding available for liabilities in the upcoming budget process.”

In order to borrow the money, the report requests that “the City Attorney to present an amendment to the Los Angeles Administrative Code (Section 11.27) to clarify and expand on the types of settlements that are eligible to be paid with Judgment Obligation Bonds in a manner more consistent with current legal practice, and to provide more procedural flexibility with respect to the timing of certain portions of the issuance process.”

CDI Says “Foreign Government” Hacked Insurance Company

The California Department of Insurance released the examination findings and regulatory settlement agreement concerning the cyber security breach of health insurance giant Anthem Inc., which compromised 78.8 million consumers’ records. CDI says this “was one of the largest cyber hacks of an insurance company’s customer data,”

Anthem agreed to make a number of enhancements to its information security systems, and also agreed to provide credit protection to all consumers whose information was compromised. Anthem is paying more than $260 million dollars for security improvements and remedial actions in response to this breach.

The CDI also said “In this case, our examination team concluded with a significant degree of confidence that the cyber attacker was acting on behalf of a foreign government.”

The cyber breach was first discovered by Anthem on January 27, 2015. In early February 2015, Anthem and its affiliates announced the company had suffered a major breach, which compromised 78.8 million consumer records, including records of at least 12 million minors.

An investigation by the insurance commissioners’ examination team and a separate internal investigation by Mandiant, an information security firm hired by Anthem, revealed the data breach began on February 18, 2014, when a user within one of Anthem’s subsidiaries opened a phishing email containing malicious content. Opening the email permitted the download of malicious files to the user’s computer and allowed hackers to gain remote access to that computer and at least 90 other systems within the Anthem enterprise, including Anthem’s data warehouse.

The lead insurance commissioners employed an examination team composed of the cybersecurity firm CrowdStrike and Alvarez & Marsal Insurance and Risk Advisory Services, LLC. The team focused its investigation on Anthem’s pre-breach response preparedness, the company’s response adequacy at the time of the breach, and their post-breach response and corrective actions.

The team found Anthem had taken reasonable measures prior to the data breach to protect its data and employed a remediation plan resulting in a rapid and effective response to the breach once it was discovered. The team noted Anthem’s exploitable vulnerabilities, worked with Anthem to develop a plan to address those vulnerabilities, and conducted a penetration test exercise to validate the strength of Anthem’s corrective measures. As a result, the team found Anthem’s improvements to its cybersecurity protocols and planned improvements were reasonable.

The team determined with a high degree of confidence the identity of the attacker and concluded with a medium degree of confidence that the attacker was acting on behalf of a foreign government. Notably, the exam team also advised that previous attacks associated with this foreign government have not resulted in personal information being transferred to non-state actors.

Within two weeks of discovering the breach and following discussions with the lead states, Anthem hired AllClear ID, a consumer credit protection company, to offer credit protection services to all breach-affected consumers for a two-year period. Additionally, as a result of this multi-state settlement, Anthem has agreed to offer a credit protection solution to all minors who were under age 18 when the security breach occurred. Consumers affected by the breach, including parents of affected minors, are encouraged to visit www.AnthemFacts.com to learn more about the credit monitoring and identity theft services that Anthem agreed to offer to individuals.

CIGA Defeats CMS “Excessive Demands” – So Far

Last March, a federal judge in California granted the United States’ motion to dismiss portions of CIGA’s complaint regarding Medicare payments, holding that California’s insurance codes are preempted by federal law in the case of California Insurance Guarantee Association v. Sylvia Mathews Burwell, et al., No. 15-cv-1113, C.D. Calif..

CIGA is currently paying several claims in the Burwill case under various workers’ compensation policies issued by now-insolvent insurers. Some of these claimants also received payments from Medicare for items and services that were otherwise covered by these policies. Where Medicare pays benefits for a loss that is also covered by another insurer, the Medicare Secondary Payer statute, 42 U.S.C. § 1395y, designates Medicare as the “secondary payer” and generally requires those other insurance plans (called “primary plans”) to reimburse Medicare for all benefits it paid. Concluding that the workers’ compensation policies were “primary plans” within the meaning of the statute, the United States demanded that CIGA reimburse it for the Medicare benefits paid to these claimants. CIGA refused, prompting the United States to commence collection proceedings.

CIGA filed a declaratory and injunctive relief action against Defendants Sylvia Mathews Burwell, United States Department of Health and Human Services, and the Centers for Medicare and Medicaid Services contending that it was not required to reimburse the United States for Medicare benefits paid to individuals whose losses may also be covered by CIGA.

Ultimately, the California District Court for the Central District of California held last March that the McCarran-Ferguson Act did not subject the United States to California’s claims filing deadline because the Act was never intended to waive the federal government’s sovereign immunity. CIGA’s claims against the United States were dismissed to the extent that they were based on the United States’ failure to file timely proofs of claim under California’s Guarantee Act.

But the CIGA litigation in the case continued, and things change.

In the same case, CIGA alleged that CMS calculated its reimbursement liability in a manner that is contrary to the MSP and the implementing regulations, resulting in over-inclusive reimbursement demands. It sought a judicial declaration to that effect, as well as a permanent injunction barring CMS from reapplying the offending practice to future demands against CIGA.

Curiously, CIGA and CMS were ordered into mediation to resolve the dollar value of the CMS obligation and were unsuccessful. At the conclusion, CMS gave up and withdrew its demands in court altogether, hoping to just walk away from CIGA.  Ultimately CMS claimed that this rendered CIGA’s litigation “moot” and asked that the case be dismissed. CIGA responded that Defendants’ conduct does not make it “absolutely clear” that CMS will never again reopen these claims or reapply the offending practice, which means the case is not moot.

The federal judge agreed that the issue was not moot, and held CMS in the lawsuit to consider CIGA’s allegations. It said “Here, the government clearly has not met that burden. Defendants have not changed their practice with respect to reimbursement calculations; rather, they have simply withdrawn their reimbursement demands for the three particular claims at issue in this lawsuit.”

CIGA did not dispute that each charge for which CMS sought reimbursement contained at least one diagnosis code that is covered by CIGA’s policies, and CMS did not dispute that each charge also contained codes that were not covered by those policies. Thus, the parties’ arguments center on two main issues: (1) whether CIGA made a prima facie case to CMS that the reimbursement requests were erroneous; and (2) whether the MSP and the implementing regulations support Defendants’ position that CIGA must always fully reimburse CMS for a charge containing one covered code regardless of whatever uncovered codes are also present.

The Court concluded in a January 5 ruling “that if a single charge contains multiple diagnosis codes – some of which relate to a medical condition covered by CIGA’s policy and some of which do not – the presence of one covered code does not ipso facto make CIGA responsible for reimbursing the full amount of the charge. Instead, CMS must consider whether the charge can reasonably be apportioned between covered and uncovered codes or treatments. Upon such consideration, CMS might still conclude that apportioning the charge is unreasonable. In addition, even if the charge should be apportioned, the Court takes no position on how CMS should do so (e.g., pro-rata by covered codes versus uncovered codes, or some other method)”

This is a ruling at the federal district court trial level, and it may very well and likely will be appealed even to the U.S. Supreme Court.  However at this point in time, there is a well reasoned opinion in CIGA’s favor, and also inures to the benefit of all other California workers’ compensation carriers and self insureds.