Sacramento, Calif., June 1, 2016 – Wilke Fleury’s health care law team has assisted its client to obtain a restricted Knox-Keene license, creating one of California’s only full service health plans formed and entirely owned by a single physician.
Imperial Health Plan of California, Inc., was formed by Paveljit S. Bindra, MD, MBA, MSc, FACC to expand health care options for individuals residing in California. It seeks to improve access to quality care. Its services include all aspects of medical coverage ranging from preventive care to acute care and chronic care through a network of primary care physicians, hospitals, urgent care centers, ancillary service practitioners, imaging centers and pharmacies.
“Rarely has a single physician contemplated and achieved a vision of creating a Knox-Keene health plan,” said Michael G. Polis, partner, Wilke Fleury. “Assisting Dr. Bindra with the financial, legal and regulatory aspects of this transaction and the Knox-Keene Application resulted in one of the fastest restricted licenses being issued by the Department of Managed Care. Imperial is eager to collaborate with other health plans to meet the health care needs of all Californians.”
Dr. Paveljit Bindra has extensive health care experience in population health, health maintenance and health care administration. He is Board Certified in Internal Medicine, Cardiology and Cardiac Electrophysiology. He has served as Chief Medical Officer and Chief Information Officer of a three-hospital, 625+ bed acute care health system with an affiliated home health and hospice system. Leading the executive team responsible for a financial turnaround of $28 million, he was recognized as one of the “2012 Up & Comers” by Modern Healthcare magazine.
Before that, he was a partner in a large cardiology practice in Southern California and practiced Cardiology and Cardiac Electrophysiology. Dr. Bindra has also served as the CEO and founder of an investment firm, and earned his MBA from the Wharton School of the University of Pennsylvania, an MD from Harvard Medical School and an AB from Harvard College. He was a Fulbright Scholar at Magdalen College, University of Oxford, and received an MSc in Comparative Social Research.
As the Affordable Care Act continues to reward enterprises such as Accountable Care Organizations that (i) improve the health experience of patients, and (ii) operate efficiently by reducing costs, a health care practitioner should not lose sight on schemes that could run afoul of prohibited self-referral or anti-kickback laws. Since 1972, Congress prohibited practitioners from entering into “kickback” arrangements if such arrangements involved a paid referral that related to the Medicare Program. As enforcement of the anti-kickback law has expanded to include self-referrals as a prohibited activity, the anti-kickback and self-referral laws now cover the Medicaid and Tricare Programs . In fact, 2016 is expected to be a busy year with respect to enforcement of Stark and Anti-kickback violations.
As the year continues to unfold, it is important to be reminded generally what (i) anti-kickback and (ii) self-referral means in the ever changing economics of providing health care. In general, the anti-kickback prohibition or specifically Section 1320a-7b of Title 42 of the United States Code prohibits any person from:
(i) knowingly and willfully
(ii) soliciting, receiving, offering to pay, or paying any
(iii) remuneration (including any kickback, bribe, or rebate) in return for
(a) referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made under a federal health care program, or
(b) purchasing, leasing, ordering, arranging any good, facility, service, or item for which payment may be made under a federal health care program. (42 U.S.C.A. §1320a-7b(b).)
The anti-kickback statute has been interpreted to cover and prohibit any arrangement where one purpose of the remuneration is to obtain money for the referral of services or to induce further referrals even if there are many other legitimate purposes of the remuneration. (United States v. Kats, (9th Cir. 1989) 871 F.2d 105.)
The self-referral (i.e. Stark) or Section 1395nn of the United States Code prohibits a “physician” from making referrals for certain “designated health services” to an entity with which the physician has a “financial relationship” unless an exception applies. (See 42 U.S.C.A. §1395nn(a)(1).) The term “physician” includes a doctor of dental surgery or of dental medicine who is legally authorized to practice dentistry in the state in which he or she performs such function. (42 U.S.C.A. § 1395x.) A “financial relationship” includes an ownership or an investment interest in an entity or a compensation arrangement between the physician or dentist and the entity. (42 U.S.C.A. §1395nn(a)(2).)
Under the Stark law, “designated health services” or “DHS” is defined to include clinical laboratory services; physical therapy services; occupational therapy services; radiology services; radiation therapy services and supplies; durable medical equipment and supplies; parenteral and enteral nutrients, equipment, and supplies; prosthetic, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drug; inpatient and outpatient hospital services; and outpatient speech-language pathology services. (42 U.S.C.A. § 1395nn(h)(6).)
In essence, Stark and anti-kickback are intended to eliminate financial influences that could result when a physician has some economic interest in transactions that involve her patients and the care that is provided. Since health care practitioners are entrusted with the health of their patients, referrals must not be influenced by possible economic gain for simply making the referral. To do so, would increase health care costs, cause unnecessary treatment and an over utilization of health care services to the patient’s and the taxpayer’s detriment.
Some of the most common employment-related legal issues faced by veterinarians include discrimination, harassment, whistle blower claims and leave laws. A more detailed discussion of each of these issues is included below.
Discrimination refers to the disparate treatment of employees or job candidates based on certain protected characteristics, such as age, gender, disability, religion or sexual orientation. As a veterinarian, accusations of discrimination may arise when you hire employees, terminate employees, assign duties to various employees or select employees for promotion. In all of these situations, you must be careful to consider how your actions will affect members of protected classes.
Despite education and increased public awareness, sexual harassment claims persist. Sexual harassment claims can arise when employers, clients or coworkers are accused of harassing an employee. As an employer, it is your responsibility to maintain a safe, harassment-free environment for your employees.
Whistle Blower Claims
The law provides protection for employees who report unsafe working conditions or fraudulent activity to the appropriate authorities. Be aware that, regardless of whether a claim is accurate, you cannot retaliate against an employee who makes a report against your practice in good faith.
When an employee is absent, leave laws govern your actions. In many cases, you won’t know the reason for the absence, and you may not know how long it will last. However, privacy laws prevent you from asking specific questions about the employee’s medical condition. Depending on the nature of the absence, the employee may be covered by the Family Medical Leave Act and/or California Family Rights Act, which allow up to 12 workweeks of leave per year for certain covered medical needs. The Americans with Disabilities Act may also cover some leaves.
Regardless of how many precautions you take, you may still face accusations of negligence or malpractice during your veterinary career. Any time an incident that may result in a claim occurs, be sure to:
1. Contact your insurance agent.
If you are made aware of an incident that may lead to a lawsuit or VMB complaint, contact your insurance agent immediately to find out whether you need to file a report with your insurance carrier. Your insurance agent will also be able to help you build your defense against any claims or proceedings you face as a result of the incident. Furthermore, since many policies require timely notification, informing your insurance agent of the incident immediately will ensure that you don’t lose any benefits.
2. Call a qualified lawyer who has experience working with veterinarians.
Some veterinarians are tempted to handle legal matters on their own, especially in the case of VMB complaints. However, attempting to deal with complaints in an uninformed vacuum can lead to unanticipated problems and put you in a compromised position. You may even risk losing your practice if you try to fight these issues on your own. Consult a lawyer when faced with a challenging complaint or potential lawsuit. Even if the plaintiff offers what seems to be a satisfactory settlement, a qualified lawyer should review the deal and make sure your interests are adequately protected.
Discrimination in the workplace occurs when an employer treats a prospective or current employee differently because he or she is the member of a “class” protected by California state or federal law.
In the past, discrimination laws typically pertained to disparate treatment based on an individual’s nationality, race, color, age, religion or sex. However, these laws have now expanded to include ancestry, disability, medical condition, genetic information, ethnicity, marital status, sexual orientation, military or veteran status, political office, gender identity and gender expression.
The laws that prohibit employment discrimination are enforced by various federal and California state agencies, including the Equal Employment Opportunity Commission, Department of Labor, Department of Industrial Relations and Department of Fair Employment and Housing. These agencies can bring actions on behalf of employees, so employees are able to file grievances against your practice with minimal investment or effort.
As an employer, remember that your duty to avoid discrimination begins as soon as the hiring process starts. In some cases, discrimination may be unintentional. For example, you may be tempted to choose a male applicant over a female because you believe that the male will have an easier time handling large animals. However, eliminating an applicant solely based on the applicant’s sex is considered discrimination.
Health care service plans licensed under the Knox-Keene Health Care Service Plan Act of 1975, as amended, (the “Knox-Keene Act”) are categorized as either full-service or specialized health care service plans. A full-service license is issued to an entity that provides, at minimum, six basic health care services (e.g., physician services, inpatient hospital services, home health services, etc.). Examples of full-service health care service plans include Kaiser and HealthNet. A specialized license is issued to an entity that provides health care services in a single area such as dental, vision, or mental health. One such example is Vision Service Plan (VSP)
Although, it isn’t clear from the Knox-Keene Act or the regulations issued by the Department of Managed Health Care (the “DMHC”), a subcategory exists: a restricted (full-service or specialized) Knox-Keene license. A restricted licensee is “restricted” to provider contracting, and is not permitted to contract directly with employer groups and individuals. This means that the licensee does not create its own products nor does it participate in marketing. Instead, the entity subcontracts with other health care service plans or contracts directly with government payors, such as Centers for Medicare & Medicaid Services or CMS, in which products have already been developed.
Naturally, certain supplemental information to the application (called an “exhibit”) does not apply to the restricted licensee and is not required in the licensee’s filing. This includes exhibits related to marketing and group and individual contracts. The exhibit requirements further deviate depending on the type of product offered: Medicare, Medi-Cal (Medicaid), or commercial.
Generally, the application process for a restricted license still requires a fairly thorough review of network adequacy, quality of care processes, grievance procedures, and so forth. This is the case for both Medi-Cal and commercial offerings because the regulation of Medi-Cal (Medicaid) and commercial products is widely left to the states. Since the regulation of Medicare is a function of the federal government (CMS), the DMHC is limited in its review of Medicare products. As a result, the DMHC will spend most of its time reviewing the applicant’s financial viability as opposed to a more encompassing review that would include network adequacy and quality of care processes.
Of course, to some degree, the exhibits that the DMHC would require in any given filing may change based on the current state of the law. To the extent that you may have any questions, feel free to contact myself or my colleague, Michael G. Polis.
The term “duty of care” refers to the way in which you must interact with your clients and patients in order to satisfy the requirements of the law. For California veterinarians, this amounts to:
Being a competent care provider.
Providing care that is consistent with the current veterinary practice standards.
Since “current” veterinary practice standards are continuously evolving, the duty of care evolves as well.
When a veterinarian fails to meet the required standard of care, he or she may be guilty of “negligence.” In order to establish veterinary negligence, a plaintiff must show that:
The veterinarian had a responsibility to care for the animal (duty of care).
The veterinarian didn’t act in accordance with the appropriate standard of care.
The veterinarian’s failure to provide adequate care was a proximate cause of injury, which means that the injury occurred as a direct result of the action and would not have occurred if the veterinarian had acted appropriately.
1. A client brings her cat Lucy in for her annual shots. An inappropriately high dosage is administered, and the animal dies as a result. In this case, the client can sue for negligence because the veterinarian:
Was responsible for providing care to the animal.
Did not act in accordance with pertinent standards of care.
Was the direct cause of the animal’s death.
2. A client brings his dog Fido in for a checkup. After collecting the necessary information and obtaining consent to treatment, the veterinarian administers an appropriate heartworm prevention medication at the correct dosage. The animal has a severe and highly unusual reaction to the medication. In this case, the veterinarian is not guilty of negligence. Even though the veterinarian’s actions were a cause of the animal’s injuries, he or she was acting in accordance with accepted standards of care, and most other veterinarians would have made the same choices.
The Veterinary Medical Board’s “Cite and Fine” Program was first implemented in 1990 to aid in the processing of complaints made against veterinarians. These guidelines are used to address violations of the law that are not serious enough to warrant criminal prosecution or the suspension or revocation of a veterinarian’s license to practice. In these cases, the VMB issues a citation, and the veterinarian must pay a fine.
Common “Cite and Fine” Issues
Examples of issues that may result in a citation and fine include:
Discipline of license in another state
Animal abuse or cruelty
Failure to keep premises and/or equipment clean and sanitary
Record keeping violations
Record confidentiality violations
Of these issues, one of the most common citations veterinarians encounter is inadequate recordkeeping. This issue can result in a citation on its own, or it can complicate other actions initiated against the practice. In general, the VMB holds to the belief that information not contained in the records cannot be taken as fact. Thus, this issue often acts as a jumping-off point for more extensive disciplinary actions.
For example, assume a client brings action against your practice on the basis that you did not provide competent care to her pet. Even if the client’s story is misleading, embellished or completely inaccurate, you won’t have a leg to stand on if you don’t have detailed records to support your side of the story. The VMB won’t simply take your word as fact if you have no written documents to back up your position. Thus, you may find yourself facing unnecessary penalties simply because you failed to keep adequate records.
Medical care continues to evolve given the use of electronic media and communication, and a number of large health care practitioners are turning to telehealth as a method to provide medical care to a greater number of patients who reside in California’s rural communities. Before embarking on a telehealth practice, a practitioner must first be licensed by the Medical Board of California if the care provided involves California residents. If a physician is not licensed in California and provides care to a California resident, the physician has violated California law and could be subject to substantial fines and possible imprisonment.
Telehealth Advancement Act
In addition to the above requirement that the physician must be licensed in California, a telehealth practitioner is subject to the Telehealth Advancement Act, which became effective on September 18, 2004. The Act describes the mode of delivering health care in a system that provides “real-time” interaction via “communication technologies to facilitate the diagnosis, consultation, treatment, education, care management, and self-management of a patient’s health care.” Simply interacting via telephone and e-mail is insufficient to constitute providing “telehealth” medical care in accordance with California law.
Conduct an “Appropriate Prior Examination”
Moreover, to the extent that a patient is treated via “telehealth” medical services, a practitioner may prescribe a drug or device after conducting an “appropriate prior examination.” While various commentators have differing opinions of what constitutes “an appropriate prior examination,” it is commonly acknowledged that a physical examination is not the sole method of obtaining “an appropriate prior examination.” Thus, an interactive and sophisticated real-time communication system that has the capability of gathering current and detailed medical information — by way of a medical interview of a patient, allergies and medical history — could suffice as an “appropriate prior examination.” An exchange of random emails that are not detailed enough to constitute “an appropriate prior examination” would not permit a physician to prescribe pharmaceuticals, and could be deemed insufficient to justify providing health care via “telehealth.”
Consequences of Providing Telehealth Services Without an “Appropriate Prior Examination”
If a physician prescribes medication without “an appropriate prior examination,” the prescribing physician is subject to a $25,000 per occurrence fine. Thus, it is imperative that a physician who provides “telehealth”, and then prescribes medication as a result of his or her diagnosis of the patient, complete a thorough and detailed medical examination. While a physical examination is not required to constitute “an appropriate prior examination,” the medical examination that is provided must be detailed, which includes gathering his or her patient’s current medical condition, existing allergies and complete medical history of the patient.
Adherence of the California Medical Practices Act and Appropriate Regulations
Lastly, a telehealth provider must comply with the California Medical Practices Act and appropriate regulations regardless of where the provider is located. Consequently, a provider is required to file an application with the medical board if the provider desires to use a fictitious name. In addition to the physician being licensed in California, a professional medical corporation that provides telehealth services must be incorporated as a California corporation and is subject to California’s prohibition against the lay practice of medicine. Thus, the shareholders of the professional medical corporation are subject to scrutiny and must be designated health care professionals.
Navigating the requirements to become a telehealth provider and provide telehealth services can be challenging. A physician or medical group exploring or attempting to provide telehealth services should consult with an experienced healthcare attorney to ensure compliance with all state and federal regulations pertaining to telehealth services and providers.
In overturning a trial court decision made two years ago and ordering a new trial to establish damages, California’s Fifth District Court of Appeals has ruled that hospitals can no longer expect to seek reimbursement from health plans in amounts well in excess of the actual value of services rendered to plan members.
In issuing its decision in Children’s Hospital Central California v. Blue Cross of California, the appellate court shifted the state’s health care provider reimbursement landscape. Wilke Fleury’s Dan Baxter, a member of the legal team that tried the original case in 2012 on behalf of Blue Cross in Madera County Superior Court, explained the court’s ruling means the ‘charge master’ system—whereby providers sought, for example, $10.00 in reimbursement for the provision of two aspirin—will no longer stand as a legitimate, defining measure of expected compensation. The appellate court found the trial court erred in not allowing Blue Cross to present evidence of the reasonable value of the services rendered by Children’s Hospital Central California. The court ordered the case retried and awarded Blue Cross its appellate costs.