The California Board of Pharmacy (the “Board”) is a member of the National Association of Boards of Pharmacy (the “NABP”), and as a member of the NABP the Board has certain reporting requirements to the NABP. This article sheds light on why you should care about the Board reporting to the NABP.
● What is the NABP Clearinghouse?
The NABP Clearinghouse “is a national database of disciplinary and administrative information from NABP’s member states and jurisdictions. It houses information reported by the member boards of pharmacy on actions taken against wholesale distributors, pharmacies, pharmacy owners, pharmacists, pharmacy technicians, and interns. That information is used to:
 Determine the acceptability and qualifications of pharmacists who request the transfer of examination scores and licenses into other states or jurisdictions; and
 Screen applicants for [NABP’s] Drug Distributor, Digital Pharmacy, and DMEPOS Pharmacy Accreditation programs.”
● When is the Board required to report a licensee to the NABP?
Therefore, if you are currently licensed in multiple states or may want to become licensed in multiple states in the future, the NABP reports are vital to the licensure process as reports may affect your license eligibility in other jurisdictions. Furthermore, understanding the Board’s reporting requirements and the impact of that reporting to other boards of pharmacy is critical in determining whether to pursue an appeal.
If you find yourself needing help, you may wish to contact an experienced healthcare attorney to help navigate this difficult terrain.
Selling a California pharmacy is significantly more complicated than the sale of other businesses. In addition to all of the typical business sale considerations, pharmacy sales require approval from the California Board of Pharmacy (the “Board”) of any transfer of 50% or more of the beneficial interest in that license prior to the closing. Additionally, due to the highly regulated nature of pharmacies, both on a state and federal basis, the pool of prospective buyers is dramatically smaller than with other businesses. Below are a few of the most important areas to be considered by pharmacy owners before moving forward with selling their business:
It is critical for sellers to leave themselves a long runway to complete their transaction. Licenses are not transferable to new owners. Therefore, buyers must seek a new license before the close of a transaction. The Board requires approval of changes in ownership before the change occurs. Additionally, change of ownership applications must be filed with the Board at least 30 days prior to closing. If a change of ownership application is not approved by the Board pre-closing, the Board may impose fines and issue citations to the parties. A temporary license should be considered where closing timelines are compressed and may be issued at the discretion of the Board based on the specific facts of the transaction.
The sale of a pharmacy corporation can be structured as either an asset sale or a stock sale. An asset sale is where certain business assets are acquired by the buyer and the seller maintains ownership over the corporation and the remaining assets. In a stock sale the buyer acquires all of the shares of the corporation and takes over complete ownership of the business. In general, a stock sale is preferrable to a seller because the buyer takes over responsibility for the entire business. Conversely, buyers generally favor asset sales because they can pick and choose the assets they want and the seller remains responsible for any skeletons in the closet. In either a stock or an asset sale, the parties will need to work together to clarify who is responsible for what after the sale.
It is important for sellers to understand that they remain on the hook for any pre-closing licensing issues with the Board. For example, if a seller had failed to satisfy a required notification requirement to the Board and this failure comes to light post-closing, the Board may impose a fine on the seller. Therefore, a careful review of any potential license issues is critical prior to any sale.
● Tax and Legal Advisors
Sellers can find themselves with a surprise tax bill where taxes are not a primary focus of the transaction. Experienced tax advisors can be invaluable when sellers evaluate potential deal structures. Tax advisors should be brought into the mix early so that sellers can make fully informed decisions relative to the tax impact of the sale of their business. Additionally, sellers should retain their own, independent legal advisors to guide them through the complex selling process. Too often sellers rely solely upon the buyer’s advisors for crucial legal advice. It is a mistake to assume that buyer-paid attorneys, no matter how well-meaning, can fairly, and aggressively, represent sellers’ interests as well.
Like many businesses, a successful pharmacy is the result of years of work and relationships that the business owners and their teams have cultivated over time. Because of this, the hand-off period can be critical to the ongoing success of the business. The parties should work closely to clearly determine the post-closing role, if any, of the seller. Moreover, considerations should be made on whether there will be a change to the Pharmacist-in-Charge (“PIC”) position post-closing. California law requires that the Board be notified within 30 days of when a PIC ceases to act as the pharmacist-in-charge, and a replacement PIC must be approved by the Board. Additionally, consideration should be made as to whether the buyer will continue operating at the same location, or if a change of location will occur. Under California law, a change of location must also be approved by the Board prior to any change. Therefore, it is important to have these discussions early as the ultimate decision may be based on a third-party landlord.
Who will buy your pharmacy? Current employees and business partners can make attractive prospective buyers as they already are up to speed on running the business. Marketing to employees and partners is generally permissible. Alternatively, you may consider selling to a large pharmacy chain. Business brokers can be helpful in identifying additional buyers outside of a seller’s network.
If you are considering selling your pharmacy, you are not alone. Contact an experienced healthcare attorney to help navigate you through the sale of your business.
Some impacted healthcare entities, tasked with complying with myriad state and federal rules pertaining to privacy, may be aware that certain HIPAA privacy regulations have been relaxed due to the COVID-19 outbreak. Despite this, these entities should be aware that enforcement of certain HIPAA obligations continues.
The Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, to protect the privacy and security of protected health information, namely the HIPAA Privacy, Security and Breach Notification Rules (the “HIPAA Rules”). On March 15, 2020, the U.S. Secretary of HHS, Alex Azar, issued a limited waiver of certain provisions of the HIPAA Privacy Rule in order to address additional challenges placed on healthcare providers during the national emergency. Secretary Azar exercised the authority to waive sanctions and penalties against a covered hospital that fails to comply with limited provisions of HIPAA. The provisions that were waived include but are not limited to the following:
the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patients care (45 CFR § 164.510(b));
the requirements to honor a request to opt out of the facility directory (45 CFR § 164.510(a));
the requirement to distribute a notice of privacy practices (45 CFR § 164.520);
the patient’s right to request privacy restrictions (45 CFR § 164.522(a)); and
the patient’s right to request confidential communications (45 CFR § 164.522(b)).
HHS has also specified that OCR will utilize its enforcement discretion by not imposing penalties for noncompliance with the HIPAA rules requiring covered providers in connection with the good faith provision of telehealth during the COVID-19 pandemic, in an effort to bolster telehealth utilization.
However, healthcare providers, plans, and others are still required to follow all other HIPAA requirements, including the Minimum Necessary Rule (45 CFR § 164.502(b), 164.514(d)). Under the Minimum Necessary Rule, covered entities are required to limit unnecessary or inappropriate access to and disclosure of protected health information. This requirement applies today, despite the burden this may place on healthcare providers and other healthcare entities during the current national emergency.
Heather Claus and Aaron Claxton are healthcare attorneys at Wilke Fleury. Their practices include assistance with health care service plans, insurance regulatory matters and healthcare litigation.
“Cannabis and Industrial Hemp: Still a Sticky Wicket” was first featured in The Publication of the California Veterinary Medical Association Newsletter: Volume 74 – Number 2
By: Dan Baxter
If you have been closely following the legal landscape attending to the use and discussion of cannabis in a veterinary application, you are familiar with the fact that 2019 provided little clarity on what veterinarians can and cannot do. As practitioners muddled through 2019 with almost no direction as to what was permissible, the hope was that the Veterinary Medical Board’s end-of-year guidelines would clarify matters, and take us into 2020 with a clear—or at least clearer—roadmap regarding veterinary rights and obligations. While the VMB produced those guidelines in advance of their required publication date, and providedcontent that draws important distinctions between cannabis and industrial hemp(discussed below), it also left many questions unanswered.
What Happened in 2019?
On January 1, 2019, Assembly Bill 2215 went into effect. That bill, among other things, placed
Business and Professions Code section 4884 onto the books. Section 4884 provides as follows:
(a) A licensee shall not dispense or administer cannabis or cannabis products to an animal patient.
(b) Notwithstanding any other law and absent negligence or incompetence, a veterinarian licensed under this chapter shall not be disciplined by the board or have his or her license denied, revoked, or suspended solely for discussing the use of cannabis on an animal for medicinal purposes.
(c) On or before January 1, 2020, the board shall adopt guidelines for veterinarians to follow when discussing cannabis within the veterinarian-client-patient relationship. These guidelines shall be posted on the Board’s Internet Web Site.
Pending the VMB’s adoption of the “guidelines” directed in subdivision (c), veterinarians were generally writing on a blank slate for purposes of determining the permissible parameters of the “discussion” authorized in subdivision (b). For instance, if the statutory authorization to “discuss the use of cannabis on an animal for medical purposes” did not include the ability to make recommendations regarding that use (for or against), the “discussion” authorization was effectively meaningless. All practitioners really knew was that said authorization did not permit a veterinarian to “dispense or administer cannabis or cannabis products,” as that conduct is affirmatively prohibited by subdivision (a).
Also newsworthy in 2019 was the introduction of Senate Bill 627 (Galgiani). That bill would repeal the provision prohibiting veterinarians from dispensing or administering cannabis or cannabis products to an animal patient, and would authorize veterinarians to discuss the use of, and issue a recommendation for the use of, cannabis for conditions in which it would provide relief. The bill would also allow a primary animal caregiver—on a veterinarian’s recommendation—to purchase cannabis products for use on an animal that the caregiver owns. Although the bill was unsuccessful in 2019, it is operating on a two-year time horizon, and will thus be again up for consideration in 2020.
In December, the VMB issued the aforementioned “guidelines” required under Business and Professions Code section 4884(c). (www.vmb.ca.gov/forms_pubs/cannabis_discussion.pdf) Those guidelines are closely modeled on those previously issued by the California Medical Board, and contain content drawn from existing statutes and regulations, including content relating to the formation of the veterinarian-client-patient relationship (VCPR), recordkeeping requirements, conflicts of interest, and advertising. The recordkeeping-related guidelines stress the importance of providing “advice about potential medical risks of the medical use of cannabis,” and urge clinicians to “remind the client that cannabis is not being recommended or prescribed by the veterinarian.” Hence, under the VMB’s guidelines, the bottom line as to cannabis is that as a veterinarian, you can talk about it, but you cannot recommend it, and whatever you talk about, you had better document.
Industrial Hemp and CBD Oil
The above synopsizes the current state of play relative to the ability of veterinarians to discuss cannabis with clients. However, what is meant by “cannabis” in this context? California’s definition of “cannabis” is set forth in Health & Safety Code section 11018, and does not include “industrial hemp.” “Industrial hemp,” in turn, is defined in Section 11018.5, and “means a crop that is limited to types of the plant Cannabis sativa L. having no more than three-tenths of 1 percent (0.3%) tetrahydrocannabinol (THC) contained in the dried flowering tops, whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin produced therefrom.” These provisions, as well as similar federal laws, make clear that industrial hemp—unlike cannabis—is not a controlled substance, and is thus regulated by the state and federal agricultural departments, as well as the FDA, rather than the DEA.
Why does this matter? The answer is simple: Popular products such as cannabidiol (CBD) oil are generally derived from industrial hemp, as defined above, rather than cannabis. As to industrial hemp, the VMB’s guidelines—after listing the relevant regulating entities—read as follows:
[I]f a veterinarian administers, dispenses, furnishes, recommends, or discusses the use of industrial hemp in an animal patient, the veterinarian would not be subject to the statutory provisions regarding cannabis but would be subject to the provisions of the Veterinary Medicine Practice Act applicable to diagnosing, prescribing, or administering a drug, medicine, appliance, application, or treatment of whatever nature for the prevention, cure, or relief of a wound, fracture, bodily injury, or disease of animals. (Bus. & Prof. Code § 4826 (b),(c).) In addition, a veterinarian who manufactures, markets, or sells drugs not approved by the FDA is in violation of federal law. Industrial hemp is not tested or regulated in the same manner as cannabis, so the veterinarian should use caution when administering, dispensing, furnishing, recommending, or discussing industrial hemp and ensure the product to be used is industrial hemp and not cannabis and should only do so after the industrial hemp product has been approved by the FDA for use in animals.
The VMB’s closing comment reflects the fact that FDA approval
is necessary before industrial hemp may be used in a clinical application. In that regard, under the Federal Food, Drug
and Cosmetic Act (FFDCA), any product used to diagnose, cure, mitigate, treat,
or prevent disease in animals is a drug that requires FDA approval.
As of this writing, industrial hemp has not yet received such FDA approval; indeed, the FDA has indicated that the sale of any CBD or hemp product in food as a (human) dietary supplement is not legal. Accordingly, it is unclear what the FDA’s final policy in this area will be and how that policy will look relative to a veterinary application. In the meantime, as noted in the CVMA’s recently-issued “Cannabis and Industrial Hemp FAQs” (September 12, 2019, available at cvma.net/wp-content/uploads/2019/09/Cannabis-and-Industrial-Hemp-FAQ_9-13-19.pdf), “veterinarians should exercise caution to understand the legal status of any hemp or CBD products utilized for therapeutic purposes.”
So What Can You Do?
To date, the VMB has not seemed eager to launch aggressive enforcement measures to prohibit veterinary use of cannabis and industrial hemp products. However, the VMB’s guidelines do place veterinarians on notice that the Board is by no means blessing the use of those products. While it is perhaps unlikely that the VMB would independently come after a practitioner for, as an example, displaying or recommending the use of CBD oil, it is not a remote possibility for a veterinarian to be cited for such conduct in the context of another VMB-related procedure, such as a complaint-driven investigation or even a site inspection. At this point, the VMB’s intentions regarding whether and how to enforce prohibitions on cannabis and industrial hemp are simply not clear. Short of the VMB’s issuance of a more detailed position statement, only time and experience will tell.
While we wait to see what happens with SB 627 in 2020, the current bottom line is that if a veterinarian is going to prescribe, furnish, or recommend any substance for use on an animal, including CBD oil, it should be FDA-approved for such use. Unless and until that occurs, veterinarians who engage in such conduct leave themselves open to VMB citation, including for “unprofessional conduct” under Business and Professions Code section 4883(g). Veterinarians should also be wary of industry representatives claiming that CBD oil and like products may permissibly be used, sold, displayed, et cetera, in a clinical setting.
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.
Sacramento, Calif., April 30, 2018 – Wilke Fleury’s health care law team has again assisted client Paveljit S. Bindra, MD, MBA, MSc, FACC to form a new health care entity. In 2016, the firm helped Dr. Bindra obtain a Knox‐Keene license to create Imperial Health Plan of California, Inc., one of California’s only full‐service health plans formed and entirely owned by a single physician.
With the firm’s help, on April 13, 2018, Dr. Bindra was issued a certificate of authority as an Accident and Health insurance company by the Texas Department of Insurance, allowing him to establish Imperial Insurance Company of Texas, Inc.
“Helping Dr. Bindra with the complex regulatory, financial and legal aspects of expanding access to quality care in both California and Texas has been immensely gratifying,” said Michael G. Polis, partner, Wilke Fleury, who worked with Associates Anna Eck and Aaron Claxton on the recent licensing in Texas.
Dr. Paveljit Bindra has extensive healthcare experience in population health, health maintenance, and healthcare administration. He is Board Certified in Internal Medicine, Cardiology and Cardiac Electrophysiology. He has served as a Chief Medical Officer and Chief Information Officer of an acute care health system, was a partner in a large cardiology practice in Southern California, and served as the CEO and founder of an investment firm. Dr. Bindra 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.
Wilke Fleury is a thriving mid‐sized general practice law firm located in California’s business and political epicenter, Sacramento. Our attorneys offer broad expertise, creativity, and strong ties to local businesses, families and individuals, making Wilke Fleury one of the region’s most respected and long‐standing law firms. Our support of local charitable organizations, universities, law schools, political interests and the community reveals the character of the firm and our sincere commitment to the Sacramento region.
Has your business ever encountered an unsatisfied customer? It’s likely the answer is – yes!
When a health care provider faces this situation, they often find themselves weighing a number of variables before taking a course of action that fits their situation best. Pediatric health care providers often face an additional factor that other business don’t encounter. When you are determining the best course of action, consider – cost of settlement, attorneys’ fees, litigation costs, and public opinion. Where the merits of the matter justify it, the cost of settling the dispute may be less than the risks and expenses of a prolonged legal battle.
Health care providers typically negotiate disputes with the allegedly harmed individual themselves (pro per) or through their attorney. However, this is a little different with pediatric health care providers. They may find themselves in an unusual situation where they are not negotiating with the party that allegedly sustained harm – the patient who is a minor. Often the parent or parents of the minor will negotiate on their minor child’s behalf with the health care provider, provided that the minor’s parents have not retained counsel or are attorneys themselves. The problem with this is that while the parents could represent themselves without an attorney, they cannot represent their children. Moreover, if a minor signed a waiver and release of his or her own rights it would not be enforceable. Once the minor reached the age of 18, they could affirm the release at that time, but it is unlikely that would happen.
California Probate Code § 3500 provides a solution to this problem by allowing the parents of the minor to “compromise, or to execute a covenant not to sue on or a covenant not to enforce judgment on, the claim…only after it has been approved, upon the filing of a petition, by the superior court.” This means that the parents of the minor may enter a waiver and release of the child’s rights to their claim, provided that they file the required petition with the court and the petition is approved. After judicial approval of the petition, a health care provider would be assured that the parents of the minor have the authority to enter into a final settlement on their child’s behalf. Once the waiver is executed, the minor would be barred from bringing an action against the provider, based on the same alleged injury, at a later date.
However, the filing of a petition pursuant to California Probate Code § 3500 will undoubtedly increase the cost of any proposed settlement and may require that the minor’s parents retain counsel in order to assist with the drafting and filing of the petition. This additional expense represents the cost of finality of the dispute. Pediatric health care providers should be aware and cognizant of this provision in the California Probate Code and its use should be weighed in any settlement negotiation decision involving a minor.
The article, “Debunking the Myth Behind Insurance Coverage for Oncofertility Treatment,” features Shannon Smith-Crowley and co-author Catherine Gordon, MD and was originally published on the ACOG (The American Congress of Obstetricians and Gynecologists) members only website.
EyeMax Vision Plan, Inc. To Provide Comprehensive Vision Care To Individuals And Groups In California Sacramento
Sacramento, CA., July 26, 2017 – Wilke Fleury’s health care law team, led by Michael G. Polis, has assisted its client, EyeMax Vision Plan, Inc., in obtaining a Knox-Keene license, making the plan the State of California’s first new full-service vision plan in the state in 20 years.
EyeMax Vision Plan’s founder, president and CEO D.K. Kim previously founded one of the nation’s top 20 optical labs, CSC Labs, in 1967. The company grew to become the 2nd largest independently owned optical lab in the nation, servicing over 3,000 customers nationally and internationally.
Kim’s new company, EyeMax Vision Plan, has contracted with more than 1,000 board-certified optometrists and ophthalmologists, and prescription lens manufacturers to provide affordable, comprehensive prepaid vision care to individuals, employer groups, government agencies, and labor organizations.
“We are proud to support Mr. Kim’s desire for providing high-quality, affordable vision care options for Californians,” said Michael G. Polis. “Obtaining a Knox-Keene license requires satisfying very rigorous regulatory and financial requirements. Mr. Kim’s experience and professionalism made this exciting transaction possible.”
The U.S. eye care market is growing, according to Vision Watch. The industry generated nearly $40 billion in revenue in 2015, an increase of 5.8% over the previous year.
“EyeMax recognizes that the vision care market is shifting, with private pay patients declining and group plan patients becoming a larger share of market,” said D.K. Kim. “We are focused on tailoring flexible plans to meet the unique needs of employer groups, large and small.”
Wilke Fleury is a thriving mid-sized general practice law firm located in California’s business and political epicenter, Sacramento. Celebrating our 95th year, our attorneys offer broad expertise, creativity, and strong ties to local businesses, families and individuals, making Wilke Fleury one of the region’s most respected and long-standing law firms. Our support of local charitable organizations, universities, law schools, political interests and the community reveals the character of the firm and our sincere commitment to the Sacramento region.
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.
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