Tag: 2024 News

The former president and CEO of a Whittier medical clinic was sentenced today to 124 months in federal prison for submitting fraudulent billings to a Medi-Cal health care program that provides family planning services to low-income Californians who lack health insurance.

Vincenzo Rubino, 59, of Valencia, was sentenced by United States District Judge Otis D. Wright II, who also ordered him to pay $3,815,478 in restitution and entered a money judgment of $2,308,028.

Rubino pleaded guilty in August 2023 to nine counts of health care fraud and two counts of aggravated identity theft. Rubino pleaded guilty mid-trial when the prosecution had nearly finished presenting its case to the jury.

Rubino founded, owned and operated Santa Maria’s Children and Family Center, a Whittier-based medical clinic based registered as a non-profit public benefit corporation and enrolled as a Family Planning, Access, Care and Treatment (Family PACT) provider run through Medi-Cal.

From November 2014 to August 2017, the center submitted fraudulent claims totaling nearly $5 million to the Family PACT program for family planning services that were never provided, often using the information of patients who were recruited at off-site locations with offers of free diabetes testing.

To submit many of these claims, Rubino used the names of two medical providers who were not employed at Santa Maria’s. The patients did not see these providers – a physician’s assistant and an elderly doctor who was himself a patient in a skilled nursing facility during much of the scheme.

The Medi-Cal program paid more than $2.3 million dollars on the fraudulent claims, as well as an additional approximately $1.5 million to a pharmacy and laboratory for claims stemming from referrals from Santa Maria based on the same services that were never delivered.

“This defendant took advantage of health-care services intended for people in need,” said United States Attorney Martin Estrada. “Instead of allowing that money to go where it was intended, Rubino stole millions of dollars through sham claims to Medi-Cal for family planning services that either were unnecessary or unprovided. Today’s sentence highlights my office’s resolve to protect the most vulnerable in our community.”

The United States Department of Health and Human Services Office of Inspector General and the California Department of Justice investigated this matter.

Assistant United States Attorneys Kristen A. Williams of the Major Frauds Section and David H. Chao of the General Crimes Section prosecuted this case. Assistant United States Attorney Tara B. Vavere of the Asset Forfeiture and Recovery Section is handling the asset forfeiture portion of this case.

Many studies have documented US health care’s high administrative costs, with several studies pointing to complex billing processes as drivers of those costs. Several analyses have compared US administrative costs or staffing with those in other nations,but none have examined Veterans Health Administration (VHA) facilities.

A new study published in the journal JAMA Network Open, by researchers at Hunter College of the City University of New York, Harvard Medical School, the Veterans Health Administration, and the University of Washington, points fingers at profit-driven private facilities and insurers, where a whopping 30% of staff are stuck in the tangled web of paperwork, while the VHA shines with a lean 22.5% administrative staff.

That means nearly 900,000 fewer paper pushers would be needed if private hospitals, clinics, and insurers took a page from the VHA’s playbook. And most of the bloat comes because profit-seeking insurers try to avoid paying for care by imposing complex rules and documentation requirements.

The VHA’s leaner administrative staffing likely reflects the agency’s simpler financing scheme. High administrative costs in the private sector have been attributed to the complexity of collecting revenues. Health care institutions bill for individual patients and services and interact with insurers that have varying fee schedules, deductibles, prior-approval requirements, formularies, and referral networks.

Even capitation payment schemes generally entail risk-adjustment calculations requiring detailed tracking of each patient’s service use, diagnoses, and costs. In this context, investments in administration may make financial sense, for example, increasing revenue by documenting more diagnoses.

Financial success is key to private sector institution growth and even survival, and executive compensation is often linked to financial metrics. This could incentivize efforts to improve efficiency but could also encourage revenue-enhancing administrative activities that add little clinical value (eg, marketing and upcoding).

In contrast, VHA hospitals and clinics are funded mostly through lump-sum budgets. The VHA does not bill Medicare or Medicaid and collects only 2.7% of its revenues from private insurers and 0.3% from patients,minimizing the need to attribute costs and charges to individual patients. In the VHA, all facilities are in network, 1 formulary applies to all patients, and few services require prior authorization. While managers must adhere to budgetary constraints and provide a volume of clinical services commensurate with their budgets, incentives based on financial metrics are minimal for hospital leaders and their institutions.

“Our profit-oriented system rewards providers for devoting more resources to gaming the payment system,” said lead author Dr. Steffie Woolhandler.

“In the VHA, caring for our patients – not money – is at the center of our mission,” said Dr. Andrew Wilper, chief of staff at the Boise, Idaho, VHA and associate professor of medicine at the University of Washington. “We strive to care for those who have served in our nation’s military and for their families, caregivers, and survivors.”

A 2014 Congressional Budget Office review found suggestive but not conclusive evidence that VHA care was cheaper than private sector care. A 2022 quasi-experimental study of patients with myocardial infarction who had both Medicare and VHA coverage found 21% lower costs and lower mortality in the VHA. This finding was consonant with an analysis that found fewer complications among patients who underwent knee replacement in the VHA. A 2023 comprehensive review concluded that VHA care was generally of equal or better quality compared with the private sector.

On January 18, 2024, the Centers for Medicare & Medicaid Services (CMS) announced the Innovation in Behavioral Health (IBH) Model.  This model is intended to prepare practices for more advanced alternative payment models and accountable care arrangements in the future.

IBH is focused on improving quality of care and behavioral and physical health outcomes for Medicaid and Medicare populations with moderate to severe mental health conditions and substance use disorder (SUD). Medicare and Medicaid populations experience disproportionately high rates of mental health conditions and/or substance use disorders (SUD), and as a result are more likely to experience poor health outcomes and experiences, like frequent visits to the emergency department and hospitalizations, or premature death.

The IBH Model seeks to bridge the gap between behavioral and physical health; practice participants under the IBH Model will screen and assess patients for select health conditions, as well as mental health conditions and/or SUD, in community-based behavioral health practices. IBH is a state-based model, led by state Medicaid Agencies, with a goal of aligning payment between Medicaid and Medicare for integrated services.

The model works to improve care through four key program pillars:

– – Care Integration: Behavioral health practice participants will screen, assess, refer, and treat patients, as needed, for the services they require.
– – Care Management: An inter-professional care team, led by the behavioral health practice participant, will identify, and as appropriate address, the multi-faceted needs of patients and provide ongoing care management.
– – Health Equity: Behavioral health practice participants will conduct screenings for HRSNs and refer patients to appropriate community-based services. Participating practices will be required to develop a health equity plan (HEP). The HEP should stipulate how the practice participant will address disparities that impact their service populations.
– – Health Information Technology: Expansion of health IT capacity through targeted investments in inter-operability and tools (including electronic health records) will allow participants to improve quality reporting and data sharing.

CMS will release a Notice of Funding Opportunity (NOFO) in Spring 2024, and up to eight states will be selected to participate. The model will launch in Fall 2024 and run for eight years.

The Innovation in Behavioral Health (IBH) Model is designed to deliver person-centered, integrated care to Medicaid and Medicare populations with moderate to severe mental health conditions and/or substance use disorder (SUD). The practice participants in the IBH Model will be community-based behavioral health organizations and providers, including Community Mental Health Centers, opioid treatment programs, safety net providers, and public or private practices, where individuals can receive outpatient mental health and/or SUD services. These practice participants may include safety net providers who ensure that vulnerable populations are able to access care.

Practice participants will lead an inter-professional care team and be responsible for coordinating with other members of the care team to comprehensively address a patient’s care to include behavioral and physical health, and health-related social needs (HRSN) such as housing, food, and transportation.

The practice participants will conduct an initial screening and assessment, offer treatment or referrals to other care specialists and community-based resources, and monitor ongoing behavioral and physical health conditions and HRSNs. In this value-based care approach, the practice participants will be compensated based on the quality of care provided and improved patient outcomes.

IBH is a state-based model focused on community-based behavioral health practices that treat Medicaid and Medicare beneficiaries and includes both Medicaid and Medicare-aligned payment models. CMS will first issue awards to Medicaid agencies in up to eight states to implement the model. Practice participants within selected states may volunteer to participate in the Medicare payment model. The selected states will partner with their state’s agencies for mental health and/or SUD to ensure alignment in clinical policies, as well as work with at least one partnering Medicaid Managed Care Organization (MCO) or another intermediary partner, where applicable, to develop and implement the IBH Model in their state.

IBH supports behavioral health practices in delivering integrated care in outpatient settings. This person-centered approach to addressing whole-person health represents a “no wrong door” approach that prioritizes close collaboration with primary care and other physical health providers to support all aspects of a patient’s care.

The IBH Model is projected to run for eight years and includes a pre-implementation period (model years 1-3). During this period, states and practice participants will receive funding to develop and implement model activities and capacity building. During model year 1, states will conduct outreach and recruit behavioral health practice participants into the model. Practice participants will receive funding to support necessary upgrades to health IT and electronic health records, as well as practice transformation activities, and staffing to implement the model. Practice participants who elect to participate in the Medicare payment model may also be eligible for additional funding to support model activities.

Royalty Carpet Mills Inc., operated facilities located on Derian Avenue and the other on Dyer Road in Orange County. Jorge Luis Estrada worked at Derian.

Estrada filed a complaint against Royalty alleging various claims, including one asserting that Royalty violated Labor Code provisions requiring that it provide first and second meal periods, and one seeking PAGA penalties for various alleged Labor Code violations. Estrada and plaintiff Paulina Medina, a former Royalty employee who worked at Dyer, filed a second amended complaint that realleged Estrada’s individual claims as class claims and retained the PAGA claim from the original complaint.

Estrada, Medina, and 11 other plaintiffs then filed the operative third amended complaint. The third amended complaint alleged a total of seven class claims, one which was based on the failure to provide first and second meal periods, and one which sought PAGA penalties for various Labor Code violations, including those related to meal periods.

Several named plaintiffs moved for class certification in June 2017. The trial court certified a Dyer/Derian class composed of former nonexempt hourly workers who worked at the two facilities between December 13, 2009, and June 14, 2017. The court also certified three Dyer/Derian subclasses, including a meal period subclass to determine whether “class members were provided timely first meal periods and/or deprived of second meal periods.”

The trial court held a bench trial on plaintiffs’ claims. Plaintiffs presented “live testimony from 12 of the 13 named plaintiffs, deposition testimony from four different managers and officers of Royalty, live testimony from two of Royalty’s human resources employees, and live testimony from an expert witness.” In defense, Royalty presented testimony from two former employees and an expert witness.

After hearing this evidence, the trial court entered an order decertifying the two Dyer/Derian meal period subclasses alleging the first and second meal period violations, on the ground that there were too many individualized issues to support class treatment. In the same order, the trial court dismissed the PAGA claim seeking penalties for the alleged Dyer/Derian meal break-related violations with respect to persons other than the named plaintiffs as being unmanageable and subsequently entered judgment. Plaintiffs appealed from the decertification order and the judgment.

In the Court of Appeal, plaintiffs claimed that the trial court abused its discretion by decertifying the Dyer/Derian meal period subclasses and erred in dismissing the subclasses’ PAGA meal period claims on manageability grounds. The Court of Appeal agreed with plaintiffs on both issues.The Court of Appeal, in it’s published decision, directed the trial court to hold a new trial on both claims on remand, and added, “[a]s to both, we leave it in the court’s discretion to determine whether additional witnesses or other evidence will be allowed in light of the principles set forth in this opinion.” Estrada v. Royalty Carpet Mills, Inc. (2022) 76 Cal.App.5th 685).

The California Supreme Court granted Royalty’s petition for review to resolve the issue dividing the appellate courts: whether trial courts have inherent authority to strike a PAGA claim on manageability grounds. The Supreme Court affirmed the Court of Appeal and concluded that “trial courts lack inherent authority to strike PAGA claims on manageability grounds in the case of Estrada v. Royalty Carpet Mills, Inc. -S274340 (January 2024).

In 2003, the Legislature enacted PAGA to remedy “systemic underenforcement” of the Labor Code. Civil penalties recovered on a PAGA claim are split between the state and aggrieved employees. PAGA suits exhibit virtually none of the procedural characteristics of class actions.

The term “manageability” and its variants may be used more specifically to refer to a factor utilized in determining whether a class may be certified. This factor looks to whether issues pertaining to individual putative class members may be fairly and efficiently adjudicated.

Under federal law, manageability refers to the rule that a court consider “the likely difficulties in managing a class action” in determining whether the class action certification requirements of predominance and superiority are met.

Royalty and some amici curiae claim that trial courts have broad inherent authority to strike any type of claim, irrespective of its nature, to foster judicial economy.Contrary to Royalty’s contention “case law has recognized that the inherent authority of trial courts to dismiss claims is limited and operates in circumstances that are not present here.” The California Supreme Court explained the limits of a court’s “inherent discretionary power to dismiss claims with prejudice” in Lyons v. Wickhorst (1986) 42 Cal.3d 911,

In reaching this conclusion, the Supreme Courts emphasized that trial courts do not generally possess a broad inherent authority to dismiss claims. Nor is it appropriate for trial courts to strike PAGA claims by employing class action manageability requirements. And, while trial courts may use a vast variety of tools to efficiently manage PAGA claims, given the structure and purpose of PAGA, striking such claims due to manageability concerns – even if those claims are complex or time-intensive – is not among the tools trial courts possess.”

The physician-patient conversation is a cornerstone of medicine, in which skilled and intentional communication drives diagnosis, management, empathy and trust. AI systems capable of such diagnostic dialogues could increase availability, accessibility, quality and consistency of care by being useful conversational partners to clinicians and patients alike. But approximating clinicians’ considerable expertise is a significant challenge.

Recent progress in large language models (LLMs) outside the medical domain has shown that they can plan, reason, and use relevant context to hold rich conversations. However, there are many aspects of good diagnostic dialogue that are unique to the medical domain. An effective clinician takes a complete “clinical history” and asks intelligent questions that help to derive a differential diagnosis. They wield considerable skill to foster an effective relationship, provide information clearly, make joint and informed decisions with the patient, respond empathically to their emotions, and support them in the next steps of care. While LLMs can accurately perform tasks such as medical summarization or answering medical questions, there has been little work specifically aimed towards developing these kinds of conversational diagnostic capabilities.

Inspired by this challenge, Google developed Articulate Medical Intelligence Explorer (AMIE), a research AI system based on a LLM and optimized for diagnostic reasoning and conversations. It trained and evaluated AMIE along many dimensions that reflect quality in real-world clinical consultations from the perspective of both clinicians and patients. To scale AMIE across a multitude of disease conditions, specialties and scenarios,  scientists developed a novel self-play based simulated diagnostic dialogue environment with automated feedback mechanisms to enrich and accelerate its learning process. We also introduced an inference time chain-of-reasoning strategy to improve AMIE’s diagnostic accuracy and conversation quality. Finally, then  tested AMIE prospectively in real examples of multi-turn dialogue by simulating consultations with trained actors.

Researchers designed a randomized, double-blind crossover study of text-based consultations with validated patient actors interacting either with board-certified primary care physicians (PCPs) or the AI system optimized for diagnostic dialogue.  They set up the consultations in the style of an objective structured clinical examination (OSCE), a practical assessment commonly used in the real world to examine clinicians’ skills and competencies in a standardized and objective way. They We then trained AMIE on real-world datasets comprising medical reasoning, medical summarization and real-world clinical conversations.

The performance was tested in consultations with simulated patients (played by trained actors), compared to those performed by 20 real PCPs using a randomized approach. AMIE and PCPs were assessed from the perspectives of both specialist attending physicians and our simulated patients in a randomized, blinded crossover study that included 149 case scenarios from OSCE providers in Canada, the UK and India in a diverse range of specialties and diseases.

The result showed AMIE had greater diagnostic accuracy and superior performance for 28 of 32 axes from the perspective of specialist physicians, and 24 of 26 axes from the perspective of patient actors. However the research has several limitations and should be interpreted with appropriate caution.

Twenty (20) generalist clinicians were then asked to evaluate 303 challenging, real-world medical cases sourced from the New England Journal of Medicine (NEJM) ClinicoPathologic Conferences (CPCs). Each case report was read by two clinicians randomized to one of two assistive conditions: either assistance from search engines and standard medical resources, or AMIE assistance in addition to these tools. All clinicians provided a baseline, unassisted DDx prior to using the respective assistive tools.

AMIE exhibited standalone performance that exceeded that of unassisted clinicians (top-10 accuracy 59.1% vs. 33.6%, p= 0.04). Comparing the two assisted study arms, the top-10 accuracy was higher for clinicians assisted by AMIE, compared to clinicians without AMIE assistance (24.6%, p<0.01) and clinicians with search (5.45%, p=0.02). Further, clinicians assisted by AMIE arrived at more comprehensive differential lists than those without AMIE assistance.

AMIE is Google’s exploration of the “art of the possible”, a research-only system for safely exploring a vision of the future where AI systems might be better aligned with attributes of the skilled clinicians entrusted with care. It is early experimental-only work, not a product, and has several limitations that we believe merit rigorous and extensive further scientific studies in order to envision a future in which conversational, empathic and diagnostic AI systems might become safe, helpful and accessible..