Category Archives: New York

2016 Is Ramping Up For Telemedicine Developments

Two months in and this year has already seen significant movement in regulatory action across the country to expand the ability to provide telemedicine services. Below please find some of the more significant items that have already gone into effect in 2016 or are under consideration, including commercial payor and Medicaid reimbursement coverage for telemedicine services, reciprocal licenses for out-of-state providers and the ability to prescribe without an in-person evaluation.

Parity Laws in New York and Connecticut

Effective January 1, 2016, New York passed a Chapter Amendment clarifying last year’s telemedicine commercial coverage statute.  Under the 2016 Chapter Amendment, private insurers are required to cover services via telemedicine if provided by hospitals, home care and hospice agencies, licensed physicians, physician assistants, dentists, nurses, midwives, podiatrists, optometrists, ophthalmic dispensers, psychologists, social workers, speech language pathologists and audiologists.  The parity law prohibits an insurer from excluding from coverage a service provided via telehealth if that service is otherwise covered in-person.

The law also provides for Medicaid reimbursement to providers for telehealth services, which is defined broadly to include real-time two-way electronic audio visual communications, asynchronous store and forward technology and remote patient monitoring. However, with the exception of remote patient monitoring, telehealth will not be reimbursed by Medicaid when the patient is located in their home.  The New York Department of Health is expected to release telemedicine regulations later this year.

Similarly, Connecticut also recently passed a new telemedicine parity law that went into effect January 1, 2016. Under Connecticut’s parity law, commercial insurers must provide coverage for services rendered via telemedicine under the same terms and conditions as would apply if that service was provided in-person.  Connecticut broadly defines telehealth to include services performed by a telehealth provider at a distant site as well as synchronous interactions, asynchronous store and forward transfers and remote patient monitoring.

Notably, Connecticut went even farther than New York in its telehealth parity law by expressly preventing a health plan from excluding a service from coverage solely because the service is provided through telehealth and not in-person. In this way, a health plan cannot exclude a telehealth service, such as remote patient monitoring, simply because it does not lend itself to an in-person professional service.

Florida’s Controlled Substance Teleprescription Law

Florida recently implemented a new rule to permit physicians to prescribe controlled substances via telemedicine exclusively for the treatment of psychiatric disorders, effective March 4, 2016. Specifically, the amended regulation provides that controlled substances may not be prescribed through the use of telemedicine, “except for the treatment of psychiatric disorders.”

However, after passing this new rule, the Florida Board of Medicine recognized that it is still restricted by the Federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008.  The Ryan Haight Act narrowly permits the remote prescription of controlled substances for patients without an in-person evaluation so long as the patient is: (1) physically located in a hospital or clinic with a valid DEA registration; and (2) treated by a DEA registered practitioner in the usual course of professional practice and in accordance with state law.  Accordingly, while Florida is expanding its telemedicine laws, the prescription of controlled substances via telemedicine will only be broadly permissible if the American Telemedicine Association, or other organizations, are successful in amending the Ryan Haight Act.

Newly Introduced Telemedicine Bills in New Jersey and Ohio

Various other states are also in the process of trying to pass telemedicine bills. For example, New Jersey recently introduced a bill on February 8, 2016, that would require private payors to provide coverage for telemedicine to the same extent that the services would be covered if they were provided through an in-person consultation.

Additionally, another NJ telemedicine bill was introduced on January 12, 2016, which would provide a mechanism for physicians and other health care providers to obtain reciprocal licenses to practice in New Jersey if the providers are licensed by another state in their particular specialty.  The bill would also provide a parity law for telemedicine services to be reimbursed under NJ Medicaid.  As a similar bill was proposed in 2015 and has now carried over into the 2016 session, the likelihood of its passing is even greater.

An Ohio legislative bill is also headed to the Senate that would allow patients to obtain prescriptions (for non-controlled substances) without an in-person exam or visit from a health care provider.

For more information on telehealth and telemedicine legal and regulatory considerations, continued legislative developments or related issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

Lessons Learned: May a Healthcare Professional Say No To Treating Ebola?

May a licensed healthcare professional refuse to treat a patient?  Healthcare providers have legal, ethical and professional duties to address a patient’s needs that fall within the provider’s scope of practice. However, are doctors, and other health care personnel, required to treat any and all patients, even if doing so might cost them their lives? While this is an issue that has arisen with the recent Ebola outbreak, it is not a new issue and has been previously addressed.

History of Refusing to Treat

During the early HIV/AIDS era in the 1980s, when there was little known about the disease, there were physicians and other health care workers who refused to treat HIV infected patients.  Accordingly, in 1992, the American Medical Association declared in an ethics opinion that “A physician may not ethically refuse to treat a patient whose condition is within the physician’s current realm of competence solely because the patient is seropositive for HIV. Persons who are seropositive should not be subjected to discrimination based on fear or prejudice.” AMA Opinion 9.131 (March 1992, updated June 1996 and June 1998).

Similarly, the American Dental Association stated in its Principles of Ethics and Code of Professional Conduct that, “[a] dentist has a general obligation to provide care to those in need. A decision not to provide treatment to an individual because the individual has AIDS or is HIV seropositive based solely on that fact is unethical.”  American Dental Association, ADA Principles of Ethics and Code of Professional Conduct III § 4.A.1 (2012).

During the recent Ebola outbreak, healthcare personnel were once again refusing to treat infected patients.  Is this acceptable?

EMTALA

The Emergency Medical Treatment and Labor Act (“EMTALA”) is a federal law that requires that any patients that present at an emergency department must be stabilized and treated in a non-discriminatory manner, regardless of their insurance status, ability to pay, national origin, race, creed or color.  42 U.S.C. § 1395dd.  Hospitals may not transfer or discharge patients needing emergency treatment except with the informed consent (itself a legal doctrine) or stabilization of the patient, or when their condition requires transfer to a hospital better equipped to administer the treatment.

Since Ebola qualifies as an emergency medical condition, patients with the disease would fall under EMTALA.  See CMS Bulletin (November 21, 2014).  Upon arrival at the emergency department, even if Ebola is suspected, EMTALA would require the patient be medically screened and treated until the emergency condition is resolved or stabilized.  Hospitals lacking the ability to provide care to such patients may transfer the patients to another facility under strict transfer guidelines.  Both individual providers and hospitals have a legal obligation to comply with EMTALA. If found in violation of the act, hospitals and healthcare providers may lose their Medicare provider agreement and be fined up to $50,000 per violation as well as be subject to any lawsuits that may arise.

Pre-existing or Contractual Relationships

Aside from EMTALA which governs treatment of patients in emergent situations within emergency facilities, U.S. law generally allows healthcare providers to accept or decline patients at will.  There are a few exceptions to this rule.  First, many hospital medical staff bylaws, state medical board licensing and discipline requirements and contractual arrangements require physicians to comply with American Medical Association ethics guidelines. These ethics guidelines may well require a physician to provide care to an Ebola patient, such as the AMA opinion cited above.  Additionally, managed care agreements may also require an assessment of the patient.

A second exception concerns a prior-existing provider-patient relationship. Breaking this relationship without transferring care to another provider constitutes “abandonment.”  For example a patient with whom a healthcare professional has previously established a professional relationship may present in the professional’s office with complaints of fever, muscle ache and abdominal pain.  That patient may also have a history showing that he or she recently travelled to an Ebola hot spot or area with a high risk of Ebola.  As with any other patient, the provider must provide treatment and/or refer them to another source for treatment. Otherwise, the healthcare professional is at risk for abandonment of the patient.

However, if a patient with whom the healthcare professional has no pre-existing care relationship presents in the professional’s office with the above-described complaints, and there is no other duty under any other basis (i.e. not an ER physician, or in any other way obligated to treat the patient), then the question becomes is the healthcare professional qualified to treat the patient.  In most situations, the professional typically has the legal right to decide whether to accept the patient or not.

Third, the American with Disabilities Act of 1991 prohibits providers from refusing care to patients on the basis of disability.

Lastly, states may have their own laws outlining when providers can and cannot refuse to treat certain patients. For example, the Rhode Island Department of Health recently released a statement providing that, “In Rhode Island, licensed healthcare professionals in active practice are obligated to treat and/or care for Ebola patients, while minimizing the risk of Ebola transmission to self and others.”  The statement notes that failure to comply is a potential breach of the state’s healthcare licensing laws and could result in sanctions.

Personal Safety

Healthcare providers also operate along ethical principles concerning their duty to treat.  The general guideline acts to ensure that the provider does not feel threatened for his or her personal safety.  In fact, the preparedness protocols that were designed by the Centers for Disease Control and Prevention (“CDC”) presents a mission to care for those in need, but has an underlying theme of safety as the number one priority.  The protocols emphasize that all healthcare workers involved in the care of Ebola patients:  (i) must have received repeated training and demonstrated competency in performing all Ebola-related infection control practices and procedures; (ii) should have no skin exposed; and (iii) must have an onsite manager at all times overseeing the safe care of Ebola patients in a facility.  Notably, the CDC has also stated that the risk of transmission of Ebola, in and of itself, does not provide a basis for the relaxation of a health professional’s duty to help a patient as the risk of disease transmission is understood and can be readily mitigated.

Ultimately, the decision to treat an Ebola patient is fact dependent, based on the overall safety of the healthcare professional.  For example, a healthcare worker may be situated in a rural area without proper equipment and without any safety mechanisms in place.  If the professional is confronted with a patient diagnosed with Ebola and in the active stages of the disease, the ethical concerns may be trumped by treatment concerns.  Similarly, a leading medical ethicist, Dr. Joseph J. Fins, has stated that a medical team should not try to resuscitate an Ebola patient whose heart has stopped beating.  Dr. Finns explained that the risks of cardiopulmonary resuscitation efforts are too great for health care workers and even for some Ebola patients whose heartbeat is restored.

On the other hand, a healthcare professional may work in a health system that is ripe with safety protocols and mechanisms available.  If that professional is confronted with a patient diagnosed with Ebola, the concern for personal safety may not outweigh the ethical duty to treat.  Ultimately, it will be a decision for the healthcare professional to make concerning his or her personal safety.

National Guidelines

Conflicting laws, ethical guidelines and varying circumstances have created great uncertainty about the duty to treat.  In fact, the decision whether the duty to treat trumps safety concerns has sparked a thorny debate at hospitals across the country along with a call for national guidelines.  See U.S. Hospitals Weigh Staff Safety, WSJ (October 31, 2014).

For more information on legal concerns in the treatment of Ebola or related clinical legal issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

N.Y. Budget Includes Private Equity Healthcare Pilot Project

New York ‘s 2014-2015 budget legislation opens the door for a two-year pilot program allowing private equity firms to own and operate healthcare facilities in the state. The proposed plan would allow for the participation of up to five for-profit corporations with affiliations with at least one academic medical center or teaching hospital, while publicly traded entities and private corporations with more than thirty-five stockholders would be prohibited from participating. The move would represent a shift away from the state’s traditional regulations, which have created a system where almost all hospitals have been operated by non-profit entities.

Long Island Radiology Group Settles FCA Allegations That It Billed Medicaid And Medicare For Unnecessary Tests For $15.5M

A company operating diagnostic testing facilities in New York has agreed to pay $13.65 million to the federal government and $1.85 million to New York and New Jersey for a total of $15.5 million in penalties to settle claims it falsely billed federal and state health care programs for tests that were not performed or not medically necessary and for paying kickbacks to physicians. The company denies liability for the allegations that are part of the settlement.

The settlement resolves allegations that between 1999 and 2010 the radiology group submitted false claims to Medicare and state Medicaid programs in New Jersey and New York for Three Dimensional reconstructions of CT scans that, according to the complaint, were medically unnecessary, were not ordered by the treating physicians, and in some cases were never actually performed or interpreted.  These scans are often used in orthopedic, cardiovascular and neurologic imaging, including to visualize complex fractures, tumors in the lungs or soft tissues, and cardiac issues.  In addition, the group allegedly submitted false billings for expensive imaging services, including retroperitoneal ultrasounds, Doppler scans, transrectal ultrasounds and pelvic x-rays.  These imaging services allegedly resulted in a total of more than 40,000 false claims made to the New York Medicaid program. Continue reading

The UPMC – Highmark Dispute: The Beginning of the End of Medical Practices Using Hospitals’ Managed Care Contract Rates?

Recent trends across the country have health systems buying out private physician practices and reclassifying them as hospital-outpatient departments.  There are a number of motivations behind these transactions, the greatest being managed care contracting.  Typically, the physician practice will reassign its Medicare NPI Number to the Hospital and the Hospital will then bill exclusively under that NPI number.  The Hospital will also submit claims to the third party payor and receive payments based on the hospital’s negotiated contract rates and fee schedule.

Critics, including a number of insurers, have claimed that this practice allows the hospital to bill higher rates for the same service at the same location.  For this reason, on February 26, 2014, Highmark, a  Blue Cross Blue Shield company based in Pittsburgh, stated that it would stop reimbursing health systems at higher hospital-outpatient rates for cancer treatment performed in physician offices.  Highmark explained that this move would save patients’ money by reducing out-of-pocket costs for deductibles and co-insurance. Continue reading

NYS Identifies $496 Million in Medicaid Home Health Erroneous Payments

On October 30, 2013, the New York State Office of the Medicaid Inspector General (“OMIG”) issued a press release that New York recovered $211 million from the federal government out of an identified $496 million in Medicaid erroneous payments related to home care recipients who are dually eligible for both Medicare and Medicaid funds.  On October 1, 2013, the New York State Department of Health’s Fiscal Group received the $211 million payment through the action of OMIG, which was the largest single monetary recovery in OMIG’s history.

These payments were recovered by New York State as part of a federal project, the Third-Party Liability Home Health Care Demonstration Project, which is reviewing home health care involving dual eligible recipients, and is being conducted in conjunction with the University of Massachusetts Medical School.  Continue reading

New York Implements Federal Requirements Suspending Medicaid Payments for “Credible Allegations of Fraud”

Under Section 6402 of the Affordable Care Act, State Medicaid programs are required to suspend all Medicaid payments to providers under investigation for a “credible allegation of fraud”. After more than a year of delay and discussion, on August 22, New York adopted regulations implementing this requirement, joining a number of other states who have already done so. Prior to enactment of the new regulations in New York, the decision on whether to withhold payments was discretionary. Continue reading