Full Service Law Firm in Mt. Laurel Township, NJ | Capehart Scatchard
image 5

Healthcare Law Blog

This blog is published by the attorneys in Capehart Scatchard’s Healthcare Group. It focuses on cases impacting the healthcare industry, as well as recently-passed or pending legislation impacting doctors, dentists, practitioners, and employers.

As part of its increased enforcement efforts, the Office of Civil Rights of the US Department of Health and Human Services (OCR) recently entered into a $400,000 settlement with a Rhode Island hospital for failure to update its business associate agreement as required under the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).  This settlement brings the total of HIPAA security and privacy violation fines/settlements to more than $20 million this year, a dramatic increase from $6.2 million in all of 2015.

In short, in late 2012 the hospital alerted federal authorities that it lost unencrypted backup tapes containing ultrasounds for over 14,000 women, which included patient names, social security numbers, and dates of birth.

The hospital’s information technology and information security services were conducted by its parent company.  The parent company and the hospital, a subsidiary, were utilizing a business associate agreement effective March 15, 2005. This agreement was not updated until August 28, 2015, and thus did not include revisions mandated under the HIPAA Omnibus Final Rule.

Specifically, the $400,000 settlement, effectively a fine, was due to the hospital’s failure to “obtain satisfactory assurances as required under HIPAA,” in the form of a written business associate agreement that the parent company would safeguard the hospital’s PHI.  An additional $150,000 was paid to the Massachusetts Attorney General’s Office in response to a state investigation relating to the underlying data breach.

“This case illustrates the vital importance of reviewing and updating as necessary business associate agreements, especially in light of required revisions under the Omnibus Final Rule,” said OCR Director Jocelyn Samuels. “The Omnibus Final Rule outlined necessary changes to established business associate agreements and new requirements which include provisions for reporting.”

With the significant increase in data theft, it is clear that the OCR is ramping up its enforcement efforts and accompanying fines. This is to ensure that covered entities and business associates not only employ the appropriate physical and digital safeguards to properly protect patients’ PHI, but that they also keep abreast of changing HIPAA requirements. This guarantees that their written agreements reflect current regulation.  As such, covered entities must be vigilant and regularly reassess their business associate agreements, and other agreements, with vendors, subcontractors, and others that may qualify as business associates, to ensure compliance with changes to HIPAA.

 

Questions regarding this article may be sent to Publications@Capehart.com.

The national opioid addiction epidemic is one of the largest public health crises of our time. The U.S. Department of Health and Human Services reports that more people died from drug overdoses in 2014 than in any year on record, with the majority of drug overdose deaths (more than six out of ten) involving an opioid. In fact, drug overdoses are now responsible for more deaths in the U.S. than motor vehicle accidents and firearms. Legislators have been working together in an effort to address this public health issue.

On July 22, 2016, President Obama signed the Comprehensive Addiction and Recovery Act (CARA) of 2016 into law. The Act garnered overwhelming bipartisan support and was passed by a vote of 92 to 2 in the Senate and a vote of 407 to 5 in the House. The Act expands prevention and educational efforts aimed at adolescents and expands naloxone (used to treat overdoses) availability for law enforcement and first responders. The Act in part also expands disposal sites for unused medications and encourages the use of state prescription drug monitoring programs.

Health care providers are keenly aware of the prevalent prescription drug addiction problem and, as a result, many physicians are implementing policies to combat drug abuse, including requiring opioid patients sign pain treatment agreements. Such agreements are meant to prevent medication misuse while ensuring patients understand their treatment responsibilities and the responsibilities of the provider. However, the Centers for Disease Control reports that many providers still do not consistently use practices that are intended to decrease the risk for misuse, such as prescription drug monitoring programs, urine drug testing, and opioid treatment agreements. Given the tremendous increase in opioid addiction and the intense legislative and regulatory efforts to mitigate the same, practitioners are well advised to reconsider how they assist in preventing opioid addiction, as well as explore practices intended to minimize misuse when prescribing opioids.

 

Questions regarding this article may be sent to Publications@Capehart.com.

The buzzword “wellness” has permeated the healthcare industry for the better part of a decade, with everyone from insurance companies, to hospital systems, to acupuncturists, to even cellular phone manufactures promoting “wellness.”  Given the ambiguous meaning of “wellness,” the Food and Drug Administration (FDA) recently jumped into the ring and issued non-binding guidance that it will not regulate “general wellness products” as “devices” under the Food, Drug, and Cosmetic Act (FDCA).[1]

While this is not a new position for the FDA, the guidance seeks to more clearly define what the agency considers to be “low risk products that promote a healthy lifestyle.”

The FDA staff of the Center for Devices and Radiological Health defines general wellness products as “products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), when consistent with the two factors above.”

The FDA guidance further defines a general wellness products as having “(1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”

As one of several examples offered by the FDA guidance, general wellness products may make “claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.”  However, such a general wellness product may not make “a claim that a product will treat or diagnose obesity.”

Moreover the FDA’s guidance applies only to general wellness products that are “low risk.”  In determining whether a product is low risk, the FDA recommends, among other things, determining if the product is invasive, implanted, involves an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure, or whether the FDA actively regulates products of the same type as the product in question.

Among other examples, the FDA guidance suggests that a mobile application which plays music to soothe and relax an individual and to manage stress is low risk as is a portable product that is intended to monitor the pulse rate of users during exercise and hiking.

Given the multitude of mobile applications, technology startups, progress in handheld/mobile hardware technology and a general trend in healthcare towards “wellness,” the FDA guidance offers much-needed guidance as to what the FDA considers “general wellness products” not subject to the scrutiny of “devices” under the FDCA.  However, software developers, manufacturers, and those in the healthcare market must still be readily aware that products that even tangentially touch on health are still on the FDA’s radar, and as the FDA guidance is non-binding, is still subject to change.

[1] See U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff.

 

Questions regarding this article may be sent to Publications@Capehart.com.

On May 13, 2016, the Department of Health and Human Services (HHS) Office for Civil Rights issued a Final Rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities receiving federal financial assistance. Entities subject to the rule are: (1) entities operating a health program or activity, any part of which receives federal financial assistance; (2) entities established under Title I of the ACA (e.g. state-based marketplaces); and (3) health programs or activities conducted by HHS.

HHS notes that the Final Rule is the first federal civil rights law to broadly prohibit discrimination on the basis of sex in federally funded health programs. Sex discrimination includes discrimination based on pregnancy, gender identity, and sex stereotyping. Notably, the Final Rule requires covered entities to treat individuals consistent with their gender identity, including with regard to access to facilities. However, the Rule does not indicate whether discrimination based on sexual orientation is prohibited under Section 1557.

The Final Rule requires covered entities to take appropriate initial and continuing steps to notify beneficiaries, applicants, and members of the public that they are to provide language assistance services, including translated documents and oral interpretation, free of charge and in a timely manner, when such services are necessary to provide meaningful access to individuals with limited English proficiency (LEP). Covered entities may not require an LEP individual to provide her own interpreter and cannot rely on accompanying bilingual individuals to facilitate communication except in emergency situations.

Most of the requirements have a July 18, 2016 effective date with the exception of provisions affecting health insurance or group health plan benefit design, which will take effect on the first day of the first plan year beginning on or after January 1, 2017. HHS estimates that the regulations will affect roughly 900,000 physicians and 133,343 health care facilities. Facilities and practitioners in receipt of federal financial assistance should consult with a qualified regulatory attorney to ensure that they meet the Final Rule’s new requirements by the prescribed deadlines.

 

Questions regarding this article may be sent to Publications@Capehart.com.

On April 22, 2016, the New Jersey Appellate Division found that a hospital’s medical records processor could not enforce an arbitration clause, which was included in an invoice for fees charged in response to a request for medical records.[1]

A law firm, on behalf of and authorized by its client, requested Medical Records Online Inc. (MRO) to furnish the client’s medical records. In response to the request, MRO forwarded a $204.19 invoice, conditioning delivery of the records on payment of the fee. The invoice included the following arbitration clause:

By paying this invoice, you are representing that you have reviewed and approved the charges and have agreed to pay them. Any dispute relating to this invoice must be presented before paying this invoice. Any dispute not so presented is waived. All disputes must be resolved by arbitration under the Federal Arbitration Act through one or more neutral arbitrators before the American Arbitration Association. Class arbitrations are not permitted. Disputes must be brought only in the claimant’s individual capacity and not as a representative of a member or class. An arbitrator may not consolidate more than one person’s claims nor preside over any form of class proceeding.

The law firm paid the fee and received a CD-ROM containing the 271 pages of medical records, but thereafter filed a complaint in part alleging that MRO violated the New Jersey Consumer Fraud Act by overcharging for medical records that patients and their authorized representatives are legally entitled to. In response, MRO filed a motion to compel arbitration or, in the alternative, to dismiss the complaint.

The Appellate Division upheld the trial Court’s decision to deny MRO’s motion, reasoning that arbitration clauses are unenforceable without consideration. MRO had a statutory pre-existing duty to provide the client’s medical records. Fees charged in response to a request for medical records are only meant to cover the cost incurred in producing a copy of the records. In some instances, hospitals must accept less than a cost-based fee since New Jersey regulations set a $200 maximum charge for an entire record.[2] The Court further held that the waiver of disputes was likewise unenforceable due to the lack of consideration.

There are a number of regulations pertaining to fees which may and may not be charged for certain types of medical record requests. State and federal regulations set forth standards for fees that providers can charge for medical records and time frames within which records must be supplied. Be sure that your practice has an experienced regulatory attorney to navigate the web of restrictions and requirements pertaining to medical records.

[1] Bernetich, Hatzell & Pascu, LLC v. Medical Records Online, Inc., 2016 N.J. Super. LEXIS 56 (App.Div. Apr. 22, 2016).

[2] N.J.A.C. 8:43G-15.3(d).

 

 

Questions regarding this article may be sent to Publications@Capehart.com.

With the recent and continuing proliferation of ambulatory care facilities, drug treatment facilities, and diagnostic, therapeutic, and ancillary care services frequently under the same roof as medical practices, it is essential that physicians and other licensed practitioners ensure that the structure of their practice complies with the Corporate Practice of Medicine (CPOM) doctrine and associated regulations.

While some states have done away with the CPOM doctrine, the doctrine is alive and well in both Pennsylvania[1] and New Jersey.[2]  In essence, the CPOM doctrine prohibits a practitioner from providing health care services as an employee of a general business corporation or a business entity in which the shareholders are not all licensed practitioners (however, there are several exceptions to this rule found in the regulations).[3]  The rationale behind the CPOM doctrine is to create a barrier between the practitioner, who must act in patient’s best interests, and corporate shareholders, who seek to maximize profits, thereby eliminating any influence in the provision of medical care from a corporate shareholder.

In light of the CPOM doctrine, a practitioner must be careful in how his/her practice is structured and the shareholders thereof. The following are several common structures which are generally permissible.

Solo Practice.  A practitioner may practice solo and/or may employ or otherwise remunerate other licensed practitioners to render professional services within the scope of practice of the employee’s license.   However, it is important to ensure that the scope of the employee’s license does not exceed that of the employer’s license.  For example, a nurse, chiropractor, optometrist, psychologist, or other professional holding a limited licensed may not employ a physician who holds a plenary license to practice medicine.

Limited Liability Company, Professional Association, Partnership.  While the CPOM doctrine generally prohibits the practice of medicine through a general business corporation, a limited liability company, partnership, and professional association are expressly allowed under the regulations, so long as such entity is composed solely of health care professional shareholders, each of whom is duly licensed or otherwise authorized to render the same or closely allied professional services.  Closely allied fields include chiropractic, dentistry, nursing, nurse midwifery, optometry, physical therapy, podiatry, psychology, and social work.

Associational Relationship with Other Practitioner or Professional Entity. In this scenario, a practitioner would be an employee or independent contractor, for any form of remuneration, of the other practitioner or professional entity; however, the scope of the employer’s license must be equal to or exceed that of the employee/contractor.

Shareholder or Employee of a General Business Corporation.  Such a form is permissible, but is limited to the following circumstances, in which the corporation is:

  • Licensed by the New Jersey Department of Health and Senior Services as a health maintenance organization, hospital, long- or short-term care facility, ambulatory care facility or other type of health care facility or health care provider, such as a diagnostic imaging facility;
  • Not in the business of offering treatment services but maintains a medical clinic for the purpose of providing first aid to customers or employees and/or for monitoring the health environment of employees;
  • A non-profit corporation sponsored by a union, social or religious or fraternal-type organization providing health care services to members only;
  • An accredited educational institution which maintains a medical clinic for health care service to students and faculty; or
  • Licensed by the State Department of Insurance as an insurance carrier offering coverage for medical treatment and the licensee is employed to perform quality assurance services for the insurance carrier.

In less common circumstances, a licensed health care professional may also have an equity interest or be employed by a professional practice (including a professional service corporation or limited liability company) which is a limited partner to a general business corporation which, in turn, has a contractual agreement with the professional service entity.  The general business corporation may contract to provide the professional practice with services exclusively of a non-professional nature, including routine office management, hiring of non-professional staff, provision of office space and/or equipment and servicing thereof, and billing services. The practitioner, however, remains responsible to assure that an appropriate licensed health care professional determines and carries out all services and medical care including retention of sole discretion regarding establishment of patient fees and modification or waiver thereof in an individual case. As a condition of such contractual arrangement, the general business corporation may make no representations to the public of offering, under its own corporate name, health care services which require licensure.

In all, there are a variety of business structures which allow practitioners to provide professional services while being employed, partnering with, and/or engaging the services of other licensed professionals.  However, given the structural complexity of many modern medical entities (i.e. captive practices, MSOs, etc.), it is vital to ensure that any corporate arrangements comply with the statutory and regulatory requirements of the CPOM doctrine.


[1] See Neill v. Gimbel Bros., Inc., 199 A. 178, 182 (Pa. 1938).  Please note that while the PA CPOM doctrine remains, this blog focuses on New Jersey’s regulations thereof.

[2]See N.J.A.C. 13:35-6.16; see generally Michal et al., CORPORATE PRACTICE OF MEDICINE DOCTRINE 50 STATE SURVEY SUMMARY, available at http://www.nhpco.org/sites/default/files/public/palliativecare/corporate-practice-of-medicine-50-state-summary.pdf.

[3] See N.J.A.C. 13:35-6.16(f)(4); Selective Ins. Co. of America v. Medical Alliances, LLC, 362 N.J. Super. 392, 395, fn.1 (Law Div. 2003) (“the Legislature has carved several statutory exceptions from this common law ban against the corporate practice of professional services to permit hospitals, nursing homes and certain other “ambulatory care” facilities to operate as general business corporations. The rationale for this exception is that the adverse influences and countervailing interests peculiar to a business corporation are minimized and overshadowed by their public necessity, by a public need to assure institutional continuity, and by the fact that such entities are regulated and inspected by the State Department of Health and Senior Services, thus providing similar protections otherwise provided by the regulations of the State Board of Medical Examiners, N.J.A.C. 13:35-6.16(f)(4), which limit the ability of its licensees to be shareholders or employees of a general business corporation to five settings.”)

 

Questions regarding this article may be sent to Publications@Capehart.com

In a recent decision, Druding v. Care Alternatives, Inc.[1], the United States District Court for the District of New Jersey held that Medicare hospice certification provisions are conditions of payment, thereby effectively expanding the reach of the False Claims Act (“FCA”).

The Defendant in the matter is a for-profit provider of end-of-life hospice care in New Jersey. The Plaintiffs, former employees of the Defendant, allege the Defendant fraudulently billed Medicare for patients admitted into its facilities, who were not eligible under the Medicare regulations for hospice care. Per its regulations, Medicare will pay for hospice services if a patient’s life expectancy is six months or less. The Plaintiffs’ complaint identified fifteen patients whose conditions allegedly did not meet Medicare’s life expectancy criteria for hospice care. The Plaintiffs further allege that the Defendant engaged in aggressive marketing tactics to bring in more patients, by providing gifts and meals to physicians, administrators, directors, and social workers to induce referrals.

The Plaintiffs initially filed the lawsuit in 2008, but after nearly seven years of investigating the Plaintiffs’ claims, the United States Department of Justice elected not to intervene. Nonetheless, the Plaintiffs served their complaint on the Defendant in July of 2015. The Defendant subsequently moved to dismiss the Plaintiffs’ complaint, arguing that the applicable Medicare regulations are not conditions of payment. Conditions of payment are requirements that must be met prior to payment by Medicare. On the other hand, conditions of participation are prerequisites to participation in a federal program such as Medicare. Noncompliance with conditions of payment result in nonpayment and are actionable under the FCA; whereas, noncompliance with conditions of participation result in administrative sanctions.

The District Court rejected the Defendant’s argument and held that hospice certification provisions of the Medicare regulations are conditions of payment because Medicare explicitly conditions payment for hospice care on a written certification from a physician with supporting documentation concerning the patient’s condition. In April of 2016 the United States Supreme Court will hear oral arguments in Universal Health Services, Inc. v. United States ex rel. Escobar, and the Court will likely decide whether compliance with Medicare requirements must be expressly delineated as conditions of payment in order to trigger FCA liability. The Supreme Court’s decision will be significant for health care organizations, because it will impact the scope of cases that are actionable under the False Claims Act.


[1] Druding v. Care Alternatives, Inc., 2016 U.S. Dist. LEXIS 21488 (Feb. 22, 2016).

 

Questions regarding this article may be sent to Publications@Capehart.com. 

In a series of recent Pennsylvania cases, the state appellate courts have squarely addressed the oft-asked question of who, or what, is the general counsel’s client, particularly in the scenario of legal proceedings wherein the general counsel has interacted closely with corporate executives.  As the U.S. Department of Justice (“DOJ”) has ramped up its enforcement of individuals for corporate wrongdoing, these decisions provide a reminder to general counsel to advise agents of institutions that counsel represents the institutions, rather than the agents in their individual capacities.

The factual background of the cases[1] revolve around criminal investigations of executives of a higher educational institution in the aftermath of sexual abuse scandals regarding coaches of a certain university football team.  In each of the cases, the general counsel appeared on behalf of the university and the executives in a grand jury proceeding.  Subsequently, the executives were charged with perjury in connection with their grand jury testimony. The charges, in turn, were significantly based on the grand jury testimony of the general counsel.  Each of the executives thereafter brought actions to quash the grand jury presentment, claiming they had been denied effective counsel, as they each alleged they believed the general counsel had represented them individually.

After the Pennsylvania trial court rejected their requests for relief, the state appellate courts reversed and dismissed the criminal charges against the executives, finding that the general counsel had an attorney-client relationship with the executives and that such a privilege was violated through her testimony against the executives in the grand jury proceeding.  The appellate courts found that the general counsel communicated with the executives regarding the grand jury proceedings and appeared at the proceedings on their behalves, while failing to explain to the executives, or to the grand jury, any limitations on the scope of her representation, and that as such, the executives could reasonably believe that the general counsel was their personal attorney.

While the prosecutor argued that the general counsel only represented the university, and the executives solely as agents of the university, the appellate court determined that the general counsel did not appropriately explain to the executives the difference between representing the executives as corporate agents versus representing the executives in their individual capacities.

The appellate courts stated that the right to counsel is personal and designed to ensure that the party offering testimony does not provide incriminating testimony and, thus, counsel must properly explain the limitations of any representation.  Since said limitations were not adequately communicated to the executives, the courts found that the executives were deprived of their personal counsel during their grand jury testimony.

Importantly, although the executives were aware that the general counsel represented the university, the court found that such knowledge does not automatically establish the conclusion that the general counsel is only representing the executives in their capacities as agents for the university.

The courts also noted that since certain communications between a corporate attorney and a corporate employee may be personally privileged, the prosecutor’s argument, that none of the communications between general counsel and an executive are privileged, did not logically follow.  Rather, the courts distinguished discussions between general counsel and executives for the purposes of 1) business operations and internal investigations and 2) the executive’s personal legal issues, in these cases, the individual subpoenas to the executives.

The instant cases confirm the importance of the “Upjohn”[2] warnings, or the obligation to advise members of an institution that corporate/general counsel represents the institution and is not the personal attorney of the members/executives/directors of the institution.  Such an obligation arose from the United States Supreme Court opinion in Upjohn Co. v. United States, 449 U.S. 383 (1981), wherein the Supreme Court held that communications between corporate counsel and certain lower-level employees are privileged and, that in order to avoid such a misunderstanding, warnings should be given to advise the corporate employee that the attorney-client privilege belongs to the corporation, that said privilege cannot be invoked by the employee, and that the corporation may disclose such communications in its discretion.

Although the instant cases do not raise many new issues of law, they reflect the uptick in cases wherein liability of individuals has been sought, in both criminal and civil investigations, for what was arguably corporate wrongdoing, as well as the pressure on corporations to cooperate in governmental investigations.  On September 9, 2015, the DOJ issued guidelines, the so-called Yates Memo[3], on corporate conduct which allow corporations to receive credit for cooperating with DOJ investigations, including the requirement that the corporation “completely disclose” all facts regarding “individual misconduct” and identify all individuals involved with or responsible for the misconduct under investigation.  Moreover, the Yates Memo instructs prosecutors to concentrate on the wrongdoing of individuals from the beginning of the investigation through its resolution.

Given the increased focus on individual culpability by the DOJ, general counsel must be vigilant to provide an accurate and timely Upjohn warning and ensure that any dual representation issues are resolved.  Moreover, general counsel must be aware that participating in legal proceedings or investigations raises ethical hazards when the general counsel knows, or has reason to know, that an agent of the corporation may face individual legal liability.

Conversely, while many healthcare executives have been made aware of the Yates Memo, particularly given the breadth of health care laws and regulations which provide for individual penalties, executives down to lower-level employees must be aware of the limitations on the representation of the general counsel, whether an Upjohn warning is issued or not and, that most importantly, the general counsel is not personal counsel, from the early stages of an investigation, during grand jury proceedings, or through trial.


[1] Commonwealth v. Curley, 2016 PA Super 13 (Pa. Super. Ct. 2016); Commonwealth v. Schultz, 2016 PA Super 12 (Pa. Super. Ct. 2016); Commonwealth v. Spanier, 2016 PA Super 14 (Pa. Super. Ct. 2016)

[2] Upjohn Co. v. United States, 449 U.S. 383, 101 S. Ct. 677, 66 L. Ed. 2d 584 (1981)

[3] http://www.justice.gov/dag/file/769036/download

 

Questions regarding this article may be sent to Publications@Capehart.com. 

On December 18, 2015, President Obama signed the Consolidated Appropriations Act of 2016 (H.R. 2029) into law. The legislation affects several taxes implemented by the Affordable Care Act (“ACA”), however, the ACA’s substantive provisions will remain intact.

Notably, the legislation delays the effective date of the excise tax imposed on high cost employer-sponsored health coverage, colloquially referred to as “Cadillac plans.” Initially non-deductible and set to go into effect in 2018, the Cadillac tax will now be delayed until January 1, 2020 and will be tax deductible for employers. The Cadillac tax is intended as a tool to finance the ACA and curb the rate of healthcare costs by discouraging overuse of healthcare services. In 2020 a 40% tax will be assessed on annual plan premiums that exceed threshold amounts. The 2018 threshold amount was set to $10,200 for individuals and $27,500 for families and will adjust prior to the 2020 implementation. The threshold amount can also increase for certain employers based on the group’s age, gender, and the risk of the profession.

The recent legislation also imposes moratoriums on the health insurance providers fee (HIP) and the medical device excise tax. The HIP fee or tax is an assessment on covered entities engaged in the business of providing health insurance for United States health risks, and whose annual premium revenue exceeds $25 million. Health insurers share in the payment of this industry-wide annual tax in an amount proportionate to the insurer’s market share. The federal government will forgo collection of the $13.9 billion HIP tax for 2017. The HIP tax, which will resume in 2018, is meant to fund subsidies for low-income individuals and families when purchasing insurance on exchanges established by the ACA. Additionally, the 2.3% medical device excise tax will be in moratorium for 2016 and 2017. This tax has been in effect since 2013 and is imposed on the sale of certain medical devices by the manufacturer or importer of the devices.

ACA opponents tout these tax adjustments as the beginning of the ACA’s unraveling. However, the Cadillac tax delay and moratoriums on the HIP and medical device taxes do not alter the substantive provisions of the ACA.

 

Questions regarding this article may be sent to Publications@Capehart.com. 

On September 29, 2015, the New Jersey Supreme Court, in Jarrell v. Kaul,[1] clarified what is actionable under the statutory medical malpractice insurance mandate imposed on physicians practicing medicine in the State of New Jersey.

Notably, under the Court’s decision in Jarrell, healthcare facilities which grant privileges to physicians, both employees and contractors, have a continuous responsibility to ensure that the physicians comply with licensure requirements, including the maintenance of proper malpractice insurance. However, the Court ruled that patients have neither a private cause of action against a physician who violates the malpractice insurance mandate nor the ability to bring an informed consent claim against the physician premised upon said physician’s uninsured status.

According to the Court’s opinion, Dr. Richard Kaul performed a spinal fusion procedure on his patient, James Jarrell, at the Market Street Surgical Center, however, his insurance policy expressly excluded spinal surgical procedures from coverage.  Following the procedure, Jarrell experienced a new pain in his left side and “drop foot.” Jarrell underwent a revision surgery, performed by another doctor, to correct Dr. Kaul’s work.  Jarrell thereafter asserted several claims against Dr. Kaul, among them: (1) a direct negligence claim against Dr. Kaul based on his uninsured status; (2) a claim seeking damages for lack of informed consent; and (3) a negligent hiring claim against Market Street Surgical Center, the facility granting privileges to Dr. Kaul.

Physicians in New Jersey, pursuant to N.J.S.A. 45:9-19.17, must maintain medical malpractice liability insurance in the sum of $1,000,000.00 per occurrence and $3,000,000.00 per policy year or provide a letter of credit for at least $500,000.00. Failure to maintain these minimum standards is punishable via civil penalties and license revocation or suspension. The public policy consideration behind these provisions is to provide some level of recourse in the event of medical malpractice.

While neither the statute nor the regulations expressly permit a patient to bring claims against a treating physician who does not comply with the insurance mandate, the Supreme Court in Jarrell clarified that the statutory and regulatory scheme does not implicitly provide for such a private cause of action against a noncompliant physician. The Court reasoned that the Board of Medical Examiners’ oversight and enforcement was the legislature’s chosen mechanism to enforce the law’s compliance — an aggrieved patient bringing a lawsuit is not the vehicle by which the legislature wished to enforce compliance.

The Court further held that Dr. Kaul’s lack of malpractice insurance did not implicate the doctrine of informed consent. The Court was unwilling to expand informed consent jurisprudence to the financial consequences of an uninsured physician’s negligence.  The Court so ruled because a physician’s medical malpractice insurance or lack thereof has little bearing on the nature of the attendant risks of the patient’s treatment. A patient’s inability to recover a judgment is not the injury contemplated by the informed consent doctrine.

However, and importantly, Jarrell’s claim against the Market Street Surgical Center for negligent hiring survived. The Court held that when a principal, in this case the surgical center, retains an independent contractor, here the physician, for a task that requires certain permits and licenses, the principal has a continuing duty to ensure that the contractor maintains the requisite licensure. Because medical malpractice insurance is an essential condition for a license to practice medicine in New Jersey, the surgical center had a continuous duty to ensure that physicians with privileges to practice at the facility carry the required malpractice insurance.

In the wake of the Court’s decision in Jarrell, healthcare facilities granting privileges to physicians must be vigilant and take extra care in ensuring that physicians at their facility, whether employees or contractors, have the minimum required professional liability insurance as well as any other required licenses.


[1] Jarrell v. Kaul, 2015 N.J. LEXIS 963 (Sept. 29, 2015)

 

Questions regarding this article may be sent to Publications@Capehart.com. 

Capehart Blogs

Subscribe to Blog Updates

Capehart Blogs