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Drug Pricing to Follow “International Pricing Index”

President Trump proposed changes to a segment of Medicare drug pricing that the White House believes would save Americans $17.2 billion over five years and cut down on “global freeloading.”

The president plans to change the pricing model for Medicare Part B drugs administered in doctors’ offices to keep costs aligned with the lower prices similar countries pay for the same medicines. Total payment for such drugs could drop by 30 percent over time, the White House says.

“We will no longer accept the inflated prices charged to our seniors,” Trump said.

The new “international pricing index” for Medicare Part B would set a target price for physician-administered drugs at 126 percent of the average price other countries pay. It would include a larger add-on fee for doctors and hospitals that would be independent of the drug’s price.

That’s a change from the current system that sets pricing based on the average sales price only in the US, plus a price-based add-on fee. The new model would end the incentive for doctors to prescribe the most expensive drugs to obtain the higher fees.

The Medicare Part B model would be phased in over a five-year period and initially apply to 50 percent of the country, with the opportunity to scale up afterward.

Trump on Thursday railed against a “rigged” drug system that allows other countries to benefit at America’s expense, calling it “wrong and unfair.”

“We’re taking aim at the global freeloading that forces American consumers to subsidize lower prices in foreign countries through higher prices in our country,” Trump said.

Earlier Thursday, Health and Human Services Secretary Alex Azar tweeted out an HHS report that highlights the disparities that the Trump administration seeks to end.

The report compared prices for 27 different Medicare Part B drugs that are administered by physicians – not those dispensed by the pharmacies. The report found that prices charged to the US are 1.8 times higher on average than 16 other countries with similar economic conditions. The US was paying the highest price for 19 of the 27 drugs.

The pricing disparities meant that Medicare Part B and its beneficiaries spent an additional $8.1 billion (or 47 percent more) on the 27 common drugs than it would if the payments were determined by an international pricing index, Azar said.

The new pricing aims to tackle the smaller market of non-retail drugs. Pharmacy-dispensed drugs account for about 72 percent of total prescription drug spending in the United States.

Outcomes Not Tied to Hospital Accreditation

A group of researchers claim that hospital accreditation is not necessarily tied to better outcomes for U.S. patients.

Based on records for more than 4.2 million patients over age 65 covered by Medicare, the study team found no difference between accredited and unaccredited hospitals in patient death rates, and only a slightly lower rate of patient readmissions at accredited hospitals, according to the report published in The British Medical Journal.

To be reimbursed for care provided to Medicare patients, hospitals either need to be accredited by an independent organization approved by the Centers for Medicare and Medicaid Services, or they must have passed a review by a state survey agency.

To see if accredited hospitals offer better quality care, researchers analyzed data from 4,400 U.S. hospitals, including 3,337 accredited facilities and 1,063 that passed state-based review in 2014-2017. They linked this data with Medicare files and with results of government-sponsored patient satisfaction surveys for all the hospitals.

Overall, they found that patients treated at accredited hospitals had slightly lower 30-day mortality than those at hospitals reviewed by a state agency (10.2 percent versus 10.6 percent), although the difference was too small to rule out the possibility it was due to chance.

The research team also found identical mortality rates (2.4 percent) and nearly identical readmission rates (15.9 percent versus 15.6 percent) for six types of major surgery at accredited and state-reviewed hospitals.

For the medical conditions, readmissions were lower at accredited hospitals, at 22.4 percent versus 23.2 percent, a statistically meaningful difference.

Patient experience scores were slightly higher at state-survey hospitals than at accredited hospitals.

In addition, the research team found no differences in mortality, readmission rates or patient experience scores between the hospitals accredited by The Joint Commission, considered the “gold standard” for accreditation, or other independent organizations, the study team notes.

Future studies should look at what type of accreditation and by which organization seem most helpful for better patient outcomes. For instance, hospitals designated as stroke centers or rehabilitation centers may have better outcomes for particular medical conditions, said Laura Wagner of the University of California, San Francisco, who wasn’t involved in the study.

“The bottom line is that accreditation does matter, and it provides a framework for both patients and healthcare providers around quality,” One of the authors said. “It can improve quality in some cases, and we need to improve that framework to provide care.”

WCAB En Banc Provides Guidance on QME Process

Sandab Duon filed three claims for injury while employed as a machine operator by California Dairies. Robert Weber, M.D., acted as the internal medicine panel QME and evaluated applicant on August 3, 2015. Robindra Paul, M.D., was the psychiatric panel QME.

On April 19, 2016, the Hartford representative sent a letter to the internal QME Dr. Weber enclosing a copy of Dr. Paul’s March 16, 2016 report in response to Dr. Weber’s request to see the psychiatric report during his deposition. The letter lists applicant’s attorney, Mr. Bryan Leiser, as one of the copied parties, but only states his name, not his address. No proof of service of the letter is in evidence.

Dr. Weber issued a report dated August 31, 2016 reflecting his receipt and review of Dr. Paul’s report. However, Dr. Weber’s opinion remained “as expressed” in his previous report.

The matter ultimately proceeded to trial. One of the issues was whether Dr. Weber as the internal medicine QME has been tainted based upon the provision of Dr. Paul’s reporting to him during the period of time that this issue was being disputed, and if so, is it sufficient to entitle the applicant to a new internal medicine panel.

The WCJ found that The Hartford, provided medical information to the internal medicine panel qualified medical evaluator (QME) without first serving applicant and engaged in ex parte communication with the QME in violation of Labor Code sections 4062.3(b) and 4062.3(e). (Lab. Code, § 4062.3(b) & (e).) and ordered the parties to obtain a new QME panel in internal medicine or agree to an internal medicine agreed medical evaluator (AME).

A co-defendant, Insurance Company of the West petitioned for reconsideration.The WCAB issued an en banc decision in the case of Sandab Suon v California Dairies; Insurance Company of The West; The Hartford; Starr Indemnity and Liability Insurance Company, interpreting Labor Code section 4062.3.

Section 4062.3(b) requires that “information” proposed to be provided to the QME “shall be served on the opposing party 20 days before the information is provided to the evaluator.” Section 4062.3(e) separately requires that “communications with a [QME] before a medical evaluation” must be served on the opposing party “20 days in advance of the evaluation.”

However, section 4062.3(e) further provides that “[a]ny subsequent communication with the medical evaluator “shall be served on the opposing party when sent to the medical evaluator.” The preliminary question is whether the documents or materials sent to the QME are “information” or “communication” as those terms are used in the Labor Code.

Whether a party properly served a written communication with the QME to the opposing party is a question of fact the determination of which must be supported by substantial evidence. In this matter, the evidence in the record is unclear whether Mr. Paul’s letter to the QME Dr. Weber was properly served and received by Mr. Leiser, and the matter will be returned to the WCJ to further address that issue pursuant to the discussion herein. If a communication was not ex parte, the trier of fact must decide if the documents or materials sent to the QME nonetheless constitute “information” subject to section 4062.3(b).

As a general rule, the WCAB determined that the following rules apply to a QME evaluation.

(1) Disputes over what information to provide to the QME are to be presented to the WCAB if the parties cannot informally resolve the dispute. The “meet and confer” provisions in the Civil Discovery Act are useful
(2) Although section 4062.3(b) does not give a specific timeline for the opposing party to object to the QME’s consideration of medical records, the opposing party must object to the provision of medical records to the QME within a reasonable time in order to preserve the objection.
(3) If the aggrieved party elects to terminate the evaluation and seek a new evaluation due to an ex parte communication, the aggrieved party must do so within a reasonable time following discovery of the prohibited communication.
(4) The trier of fact has wide discretion to determine the appropriate remedy for a violation of section 4062.3(b).
(5) Removal is the appropriate procedural avenue to challenge a decision regarding disputes over what information to provide to the QME and ex parte communication with the QME

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DWC Publishes 2017 Audit Report

Pursuant to Labor Code section 129(e), the Administrative Director of the Division of Workers’ Compensation submitted its twenty-seventh annual workers’ compensation report summarizing the results of 2017 audits conducted by the DWC Audit and Enforcement Unit.

The Audit Unit annual report provides information on how claims administrators audited by the DWC performed and includes the Administrative Director’s ranking report for audits conducted in calendar year 2016.

The DWC Audit & Enforcement Unit completed 47 profile audit reviews (PARs), which were all routinely selected; there were 0 target audits, which would have been conducted based upon the failure of a prior audit. The PAR subjects consisted of 7 insurance companies, 14 self-administered/self-insured employers, 22 third-party administrators (TPA), and 4 insurance companies/third-party administrators’ combined claims-adjusting locations.

The performance of any insurer, self-insurer, or third-party administrator is rated for action in specific areas of benefit provision. Of foremost importance is the payment of all indemnities owed to an injured worker for an industrial injury. The timeliness of all initial and subsequent indemnity payments and compliance with the regulations of the Administrative Director for the provision of notice for a qualified or agreed medical evaluation are also measurable performance factors.

Forty-three audit subjects (91%) met or exceeded the PAR 2016 performance standard and therefore had no penalty citations assessed in accordance with LC section 129.5(c) and CCR, Title 8, section 10107.1(c)(4). However, these audit subjects were ordered to pay all unpaid compensation.
– Four audit subjects (9%) failed to meet or exceed the PAR standard, and their audits were expanded to a full compliance audit of indemnity claims (FCA stage
1) Two of these audit subjects (50% of those that failed to meet or exceed the PAR standard) met or exceeded the FCA 2016 performance standard and therefore had penalty citations assessed for unpaid and late payment of indemnities in accordance with LC section 129.5(c)(2) and CCR, Title 8, sections 10107.1(d).
2) The remaining two of the four audit subjects (50% of those that failed to meet or exceed the PAR standard) failed to meet or exceed the FCA 2016 performance standard and their audits expanded into full compliance audit of indemnity claims (FCA stage 2) and added a sample of denied claims to be audited. These audit subjects were assessed administrative penalties for all penalty citations in accordance with LC section 129.5(c) and CCR, Title 8, Section 10107.1(d) and 10107.1(e).

The audit regulations are currently being amended to address the statutory changes brought about by the adoption of Senate Bill (SB) 863. As of January 1, 2013, the amended Labor Code section 4650(b)(2) came into effect and now provides that, under specific circumstances set by statute, permanent disability (PD) indemnity will not be payable to an injured employee until it is awarded by the Workers’ Compensation Appeals Board.

FDA Approves Smartphone Urine Testing

Siemens Healthineers, the medical arm of the German engineering and technology conglomerate, has teamed up with Israeli start-up Healthy.io to allow patients to test their urine at home by using a smartphone camera that scans a dipstick and sends the results to their doctor.

Healthy.io’s founder and CEO Yonatan Adiri was selected as one of the 50 most influential people in healthcare by TIME magazine.

The alliance is the latest partnership between medtech firms and technology companies aimed at helping patients monitor their own health, as well as lowering the costs of managing chronic diseases.

Urine testing is the world’s second-most frequently conducted diagnostic test. Regular testing is needed to monitor kidney function in patients with chronic kidney disease, as well as to detect potential signs of diabetes.

Last summer. the Food and Drug Administration granted Class 2 approval to Healthy.io’s Dip.io, a urinalysis kit that includes an mHealth app and dipstick. Through a smartphone camera, the app’s AI software can detect 10 different healthcare conditions, including certain infections, pregnancy issues and chronic conditions, and instantly stores that data in the cloud for care providers.

Class II approval is granted to devices that have direct health implications and require a medium level of supervision. This is one of the first devices reportedly approved by the FDA that is designed for use with optical equipment designed by a third party.

Under the new global partnership Healthy.io will use urinalysis tests from Siemens Healthineers in dipkits that are sent to patients at home. Patients urinate on the dipstick and scan it using their smartphone camera, which uses computer vision and machine learning to ensure the results can be read. The results are then sent via an app to the patient’s medical record for a doctor to assess.

“This alliance expands our capabilities to improve patient experience by conducting testing in their home,” said Christoph Pedain from Siemens Healthineers’ Point of Care Diagnostics business.

Yonatan Adiri, founder and chief executive officer of Healthy.io said the technology was like a “medical selfie” that would improve patient outcomes through more frequent testing.

The mobile health platform is currently being tested at Pennsylvania’s Geisinger health system in a partnership with the National Kidney Foundation.

A number of technology companies including Apple, Samsung Electronics and Google are working on health-related applications for wearable devices and smartphones. Last month, Apple said its new watch can take an electrocardiogram and detect heart problems.

Orthopaedics company Zimmer Biomet is also testing a new app with Apple which would allow patients due to have hip or knee replacements to funnel basic health data from their Apple watches to their surgeons.

Exclusive Remedy No Protection for Uninsured Employer

Fiona Bulanadi filed a lawsuit against Permanente Medical Group, and several entities involved in the administration of her workers’ compensation claim, a claims adjuster, Sedgwick Claims Management Services, Inc., and Sedgwick’s employee, Fia Kyono.

She alleged that the Permanente Medical Group induced her to accept employment with the company and to remain employed there by repeatedly assuring her it would pay her workers’ compensation benefits, if and when it became necessary. Allegedly representatives of Permanente Medical Group assured Fiona, orally and “in paperwork that was provided to her,” that “if she was injured on the job that she could count on the prompt provision of worker[s’] compensation benefits.”

On February 7, 2014 a car hit Fiona while she was walking on a footpath at a Kaiser facility. Fiona was on the footpath because Permanente Medical Group required its employees to “take walks and engage in invigorating activities during lunches and breaks.”

Fiona filed a workers’ compensation claim. Permanente Medical Group gave the claim to Kaiser Foundation Health Plan, which in turn assigned it to Sedgwick. Sedgwick sent Fiona a letter allegedly falsely identifying Kaiser Foundation Health Plan as her employer, purporting to deny her workers’ compensation claim, but suggesting the claim was “still open.” According to Fiona, the defendants investigated her workers’ compensation claim in bad faith, looked for ways to avoid paying her benefits, and denied the claim for patently false reasons.

Fiona sued Permanente Medical Group for “damages for being willfully uninsured or not permissibly self-insured,” breach of her employment contract, and unfair business practices. She sued all of the defendants for fraud, negligent misrepresentation, and intentional infliction of emotional distress. She sued Sedgwick, Kyono, and Kaiser for interference with contract, and she sued Kaiser for premises liability negligence.

The court sustained defendants demurrer to all of the Bulanadis’ causes of action on the ground they were barred by the exclusive remedy provision of the Workers’ Compensation Act. The court of appeal reversed in the unpublished case of Bulandi v. Southern California Permanente Medical Group.

Fiona alleged Permanente Medical Group was willfully uninsured or not permissibly self-insured. If that allegation is true, her employer is not protected by workers’ compensation exclusivity, and Fiona may bring a civil action for damages for her work-related injuries. If that allegation is not true, at least some of Fiona’s causes of action may be barred by the Workers’ Compensation Act.

The trial court ruled on demurrer that Permanente Medical Group was self-insured by taking judicial notice of two documents: (1) a DIR certificate of consent to self-insure issued to Permanente Medical Group in 1965 and (2) a document in portable document format posted on the DIR website listing Permanente Medical Group, among others, as a self-insured employer. Because these documents did not indisputably establish Permanente Medical Group was self-insured, however, the trial court erred.

EquityComp Arbitration Agreement is Unenforceable.

Respondents Low Desert Empire Pizza, Inc., Hi Desert Empire Pizza, Inc., Ten Cap, Inc., and Capten, Inc. sued several related insurance entities – Applied Underwriters, Inc. (Applied), Applied Underwriters Captive Risk Assurance Company, Inc. (AUCRA, and together with Applied, appellants) and California Insurance Company (CIC) (together with appellants, defendants).

Desert Pizza challenged the legality of defendants’ EquityComp workers’ compensation insurance program, which consists of an insurance policy and two related side agreements.

Applied and AUCRA moved to compel arbitration based on arbitration provisions in the side agreements, and Desert Pizza countered that the provisions were unenforceable because defendants failed to file them with California’s Insurance Commissioner for approval, as required in Insurance Code section 11658 (Section 11658).

The trial court agreed and denied the motions to compel arbitration. The Court of Appeal affirmed the denial in the unpublished case of Low Desert Empire Pizza, Inc. v. Applied Underwriters, Inc.

This case involves the intersection of California’s workers’ compensation insurance laws and the Federal Arbitration Act (FAA).

This is one of several actions in this state and across the country challenging the legality of defendants’ EquityComp program based on their failure to seek and obtain regulatory approval of side agreements to the insurance policy. (E.g., Citizens of Humanity, LLC v. Applied Underwriters, Inc. (2017) 17 Cal.App.5th 806 (Citizens of Humanity); Minnieland Private Day Sch., Inc. v. Applied Underwriters Captive Risk Assur. Co. (4th Cir. 2017) 867 F.3d 449; Citizens of Humanity, LLC v. Applied Underwriters Captive Risk Assur. Co. (2018) 299 Neb. 545.)

California’s Insurance Commissioner recently issued an administrative decision concluding appellants’ failure to file a virtually identical EquityComp side agreement under Section 11658 rendered the arbitration provisions in that agreement void and unenforceable. (Matter of Shasta Linen Supply, Inc., Decision & Order, dated June 20, 2016, file No. AHB-WCA-14-31, at p. 43 (Shasta Linen).)

Even more recently, the Fourth Appellate District, Division One, reached the same conclusion. (Nielsen Contracting, Inc. v. Applied Underwriters, Inc. (2018) 22 Cal.App.5th 1096, 1118 (Nielsen), review den. Aug. 15, 2018.)

Thus, in this case, the Court of Appeal concluded that defendants’ violation of Section 11658 renders their arbitration provisions unenforceable, and affirmed the order denying the motions to compel arbitration.

Written Consent Required for Comp Attorney Referral Fee

Mark R. Leeds sued Reino & Iida, a Professional Corporation, and individual lawyers Donald Reino and Myles Iida, claiming that defendants breached an agreement to pay him 25 percent of attorney fees earned for workers’ compensation cases plaintiff referred to them. According to the complaint, plaintiff and his law firm separated from defendants in October 2010, and a controversy arose regarding plaintiff’s entitlement to fees for cases plaintiff had referred to defendants.

This is the second time this case has been before the Court of Appeal. In the first review, the trial court sustained defendants’ demurrer to the complaint. In 2013, the Court of Appeal reversed and remanded for further proceedings, concluding that plaintiff and his law firm should be given leave to amend their complaint to state a cause of action for breach of contract.

After remand, the trial court granted defendants’ motions for summary judgment, reasoning that the fee splitting agreement was illegal under Rules of Professional Conduct, rule 2-200 because the parties had not obtained written client consent. Leeds again appealed. Following a second review, the Court of Appeal affirmed the trial court in the unpublished case of Leeds v. Reino and Iida.

State Bar Rule 2-200, captioned “Financial Arrangements Among Lawyers,” provides that “[a] member shall not divide a fee for legal services with a lawyer who is not a partner of, associate of, or shareholder with the member unless: [¶] (1) The client has consented in writing thereto after a full disclosure has been made in writing that a division of fees will be made and the terms of such division; and [¶] (2) The total fee charged by all lawyers is not increased solely by reason of the provision for division of fees and is not unconscionable as that term is defined in rule 4-200.” (Rule 2-200(A).)

The Supreme Court has held that rule 2-200 unambiguously directs that a member of the State Bar ‘shall not divide a fee for legal services’ unless the rule’s written disclosure and consent requirements and its restrictions on the total fee are met. Rule 2-200 “encompass[es] any division of fees where the attorneys working for the client are not partners or associates of each other, or are not shareholders in the same law firm,’ and a lawyer’s failure to comply with rule 2-200 precludes him from sharing fees pursuant to a fee splitting agreement.”

It is undisputed that the parties have not obtained written client consent for the division of fees among them. Leeds contended that client consent was not required, because he performed all of the work on the cases under defendants’ control, and he did not merely refer the cases to defendants. Plaintiff argues that rule 2-200 was not intended to apply to this type of situation.

The Court of Appeal concluded that “no authority supports plaintiff’s contentions.”

Court of Appeal Denies Tristar Lien Law Challenge

Michael E. Barri, Tristar Medical Group, and Coalition for Sensible Workers’ Compensation Reform petitioned the court of appeals pursuant to Labor Code section 5955, seek orders directing the Workers’ Compensation Appeals Board to perform its duties and adjudicate Tristar’s lien claims and not enforce provisions contained in newly enacted anti-fraud legislation. (§§ 4615 & 139.21.) claiming certain provisions were unconstitutional.

The new anti-fraud scheme cast a very broad net to halt all proceedings relating to any workers’ compensation liens filed by criminally charged medical providers, as well as any entities “controlled” by the charged provider. The Legislature created this new scheme because existing laws permitted charged providers to collect on liens while defending their criminal cases, allowing continued funding of fraudulent practices.

Pursuant to these two new statutes, the Government gained authority to automatically stay liens filed by charged providers and noncharged entities, without considering if the liens were actually tainted by the alleged illegal misconduct. (§ 4615.) As a result, untainted liens may be stayed (and go unpaid) for a lengthy stretch of time because, in addition to the period required for completion of the criminal case, the statute provides for two post-conviction evidentiary hearings. In the first hearing, the administrative director decides whether to suspend the convicted provider from further participation in the workers’ compensation system. (§ 139.21, subd. (b).)

Following this hearing, the “special lien proceeding” attorney identifies and gathers liens to be adjudicated together by a workers compensation judge (WCJ) in a consolidated “special lien proceeding.” (§ 139.21, subd. (e)(2).) In this second hearing, the lienholder has the evidentiary burden to rebut the statutorily mandated presumption the consolidated liens are all tainted by the misconduct and should not be paid. (§ 139.21, subd. (g).)

In their petition, Barri, Tristar, and CSWCR maintain these statutory provisions go too far and are forcing many legitimate lien providers to stop treating injured workers because the process has become too onerous, expensive, and financially risky. They maintain the creation of a “significantly delayed post deprivation hearing,” the over-inclusive application to untainted liens, and the Government’s failure to provide adequate notice to noncharged entities, has effectively dismantled the safety net in place for injured workers. They suggest the true legislative purpose of the statutes goes beyond fraud prevention and serves the district attorney’s desire to financially cripple criminally charged lien claimants, hampering their ability to adequately defend themselves at trial.

The court of appeal took judicial notice of a number of related documents including the proceedings in federal court by other lien claimants -Vanguard Medical Management Billing, Inc. v. Baker, No. EDCV 17 CV 965 GW(DTBx). It found no merit to any of their claims and denied them the requested relief in the published case of Barri v WCAB.

WCIRB Reports Payments to Indicted Providers Declines

The California WCIRB recently released a new study in which its researchers examine the impact that increased efforts to identify and prosecute provider fraud may be having on the California workers’ compensation system.

As of April 7, 2018 (the time of this analysis), more than 450 medical providers have been indicted and/or suspended by the DIR from practicing in the California’s workers’ compensation system. Many of these providers previously billed and were paid significant amounts for workers’ compensation-related services. While many of the procedures billed by these providers may have been for legitimate services, the suspension of their practices in California’s workers’ compensation is likely a significant driver of reduced medical costs.

The Impact of Medical Fraud Enforcement on California Workers’ Compensation study uses data from the WCIRB’s medical transaction database to analyze the volume and type of medical services that were performed by providers who were subsequently indicted or suspended for fraud (“Indicted Providers”).

The Indicted Providers identified in the WCIRB’s medical transaction data included medical doctors, pharmacists/ pharmacies and other providers and entities such as chiropractors, suppliers of durable medical equipment and hospitals. As shown in Chart 1, approximately half of the Indicted Providers were medical doctors and about one third were pharmacists or pharmacies. Medical doctors accounted for 55% of total medical payments to Indicted Providers, while pharmacists or pharmacies totaled approximately 30% of the payments.

Almost half of the providers received less than $100,000 in payments for medical services in the California workers’ compensation system, and about 10% received more than $10 million in medical payments.

Notable findings of the study include:

– Within the California workers’ compensation system, the share of medical payments to Indicted Providers declined from 7.2% in the second half of 2012 to 1.9% in the second half of 2017. The share of paid transactions by Indicted Providers also fell from 4.4% to 1.4% over the same time period.
– The payments to Indicted Providers for different medical services varied over time. For example, for the second half of 2012, Indicted Providers accounted for 5% of payments for Physician Fee Schedule Services, while by the second half of 2017, Indicted Providers accounted for 1.2% for Physician Fee Schedule Services.
– The proportion of payments to Indicted Providers for Medical Liens showed a steady increase, from 18% for the second half of 2012 to 45% for the second half of 2017.
– The time between when the service was provided and when the payment was made was noticeably longer for Indicted Providers than for Other Providers, with the exception of medical lien payments.

The complete study is accessible in the Research section of the WCIRB website