This past July 26, 2018 was the 28th anniversary of the Americans with Disabilities Act (“ADA”), landmark civil rights legislation designed to protect the rights of individuals with disabilities. Specifically, the ADA prohibits discrimination on the basis of disability in employment, state and local government, public accommodations, commercial facilities, transportation and telecommunications. It protects anyone with a “disability”, defined as “a physical or mental impairment that substantially limits one or more major life activities,” which include but are not limited to “caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working.” This is clearly a broad list – and consequently, the ADA impacts many individuals and organizations on almost a daily basis.

ADA requirements impact the healthcare sector no less than any other sector, and more than most. In particular, the 2002 Supreme Court case of Olmstead v. L.C., 527 U.S. 581 (1999), held that the ADA requires individuals with disabilities receiving services from the state to be served in the most integrated setting appropriate to their needs –meaning in practice that they must be served in community settings rather than institutions if that (1) is appropriate, (2) is not opposed by the recipient, and (3) can be reasonably accommodated taking into account the resources available to the state and the needs of others. That case specifically addresses individuals with mental disabilities residing in a psychiatric hospital, but courts subsequently extended the principle to individuals with other disabilities in other settings, and has helped to drive healthcare policy nationwide, particularly in the long term care space.

To coordinate the implementation of the Olmstead decision, in late 2002 New York State established the Most Integrated Setting Coordinating Council, an interagency council comprised of representative of various state agencies that attempted to address the Olmstead mandate in a coordinated way. Governor Cuomo expanded on that effort in 2012, when he issued an Executive Order establishing the Olmstead Plan Development and Implementation Cabinet, a similar collection of agency representatives charged with issuing recommendations on how best to implement the Olmstead mandate. The Cabinet issued a report in October 2013 that identified four areas of focus: (1) the need for strategies to address specific populations in unnecessarily segregated settings, including psychiatric centers, developmental centers, intermediate care facilities, sheltered workshops and nursing homes; (2) the general need to increase opportunities for people with disabilities to live integrated lives in the community; (3) the need to develop consistent cross-systems assessments and outcome measurements regarding how New York meets the needs and choices of people with disabilities in the most integrated setting; and (4) the need for strong Olmstead accountability measure. This report informed many of the subsequent reforms implemented by Governor Cuomo in the health and human services space.

On July 26, 2018, the Governor expanded the State’s commitment to the ADA and furthered the State’s Olmstead compliance by announcing the first phase of the “Able New York” agenda, a series of regulatory initiatives designed to enhance the accessibility of a variety of state programs and services. This first phase focuses on the Department of Health (DOH), and includes a series of policy initiatives aimed at supporting community living for individuals with disabilities. Specifically, the Governor has charged DOH to take the following actions:

  • Dear Administrator Letter: DOH will issue a “Dear Administrator Letter” (DAL) to all nursing facilities reminding them of their obligations to provide assistance to any resident that wishes to return to the community. DALs are a form of subregulatory guidance used by DOH to set policy without issuing a formal regulation.
  • Immediate Need Program: DOH will issue new guidance to Local Divisions of Social Services regarding the immediate need program for authorizing personal care services. The Immediate Need Program, which was established pursuant to legislation enacted in 2015, is not a separate program so much as a set of procedures requiring expedited eligibility and assessment determinations for individuals who (1) have no informal caregivers, (2) are not receiving needed assistance from a home care services agency, (3) have no third party insurance or Medicare benefits available to pay for needed assistance, and (4) have no adaptive or specialized equipment or supplies that meet their need for assistance. In such cases, Medicaid eligibility must be determined within seven days. DOH has been instructed to intervene in counties that are not complying with the program.
  • MLTC Housing Disregard: DOH will provide education to nursing homes, adult homes, local governments, and Managed Long Term Care (MLTC) plans about the MLTC Housing Disregard, which provides nursing home residents who are discharged back to the community with additional housing allowance should they join a MLTC plan.  The Housing Disregard was established in 2013, and allows individuals to retain a dollar amount per month for housing without jeopardizing their Medicaid eligibility. The amount varies by region. In order to be eligible for the disregard, a person must (1) be at least 18 years of age, (2) have been a resident of a nursing home for at least 30 days, (3) have had nursing home care paid by Medicaid; (4) require community-based care for more than 120 days; and (5) have a housing expense such as rent or mortgage.

In addition to the foregoing, DOH will also “explore” (but presumably not necessarily implement) the following measures: 

  • Certification of Assessment & Discharge Education: DOH might require Medicaid-enrolled nursing homes to certify each year that they have (a) assessed all residents’ functional capacity; (b) asked residents about their interest in receiving information regarding returning to the community; and (c) provided sufficient preparation and orientation to residents to ensure safe and orderly discharge from the facility.
  • HCBS Evaluations as Part of Certificate of Need Review:  DOH might require any new application for additional nursing home beds or change of ownership to include, as part of its business plan, an assessment of the home and community based services (HCBS) in the service area, a description of its current or planned linkages to such HCBS services, and how its admission policies will ensure that residents are placed in the most appropriate and least restrictive setting. 
  • Discharge Rights Letter and Notice: DOH might require all nursing homes to inform residents and their families and representatives in writing of their discharge rights, including information on HCBS and community transition programs. DOH might also require all nursing homes to publicly post information regarding available resources and services that can assist residents in moving to the community, and explore additional ways to highlight discharge options. DOH may also engage the Long Term Care Ombudsman Program on this effort.
  • Nursing Home Discharge Incentive: DOH might incentivize nursing home discharges by developing a quality metric that rewards facilities that discharge long stay residents to the community, provided those residents are successfully maintained in the community for at least 90 days.

Thus, the new guidance to be issued by DOH to nursing homes and other long term care provider could be significant, particularly if it includes a new quality incentive for discharges. Even if DOH opts not to implement any of the proposed new initiatives, the obligations to be outlined in the new DAL could still impose significant new regulatory requirements on nursing home administrators.

We will continue to monitor the implementation of this phase of the Able New York agenda, as well as future phases. For additional information on this or other legislative or regulatory matters, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

The recent New York Court of Appeals decision in Stega v. New York Downtown Hospital provides strong support for defamation claims arising out of witness testimony in investigations and quasi-judicial hearings. In Stega, the Court held that statements made in administrative proceedings that allegedly defame a person are not absolutely immune where the person has no recourse to challenge the accusations.

The plaintiff, Dr. Jeanetta Stega, a medical scientist and employee of New York Downtown Hospital, was chair of the hospital’s Institutional Review Board (IRB). She assisted Dr. Leonard Farber in arranging a clinical trial of a compound Luminant Bio-Sciences had developed to treat patients with metastatic cancer, which included human subjects. Dr. Stega recused herself from the Downtown Hospital IRB decision approving the trial.

The clinical study went awry as conflicts developed between Dr. Farber and Luminant. Dr. Farber made several allegations against Dr. Stega, including that she had stolen Luminent study money from him, that she had taken funds that did not belong to her, and that the drug compound was toxic and unsafe for patients. Downtown Hospital accused plaintiff of taking funds that did not belong to her and engaging in a conflict of interest by seeking IRB approval when she was a member of the IRB board. Downtown Hospital terminated Dr. Stega after concluding that she had violated the hospital’s conflict of interest policy and improperly taken Luminent money.

Dr. Stega submitted a complaint to the FDA. FDA inspectors interviewed Dr. Stega as well as officials from Downtown Hospital. The FDA inspection report included statements from the Downtown Hospital Acting Chief Medical Officer, Dr. Stephen Friedman, that Dr. Stega was terminated because she channeled Luminent funds to a research group using her home address and added patients to the study that the IRB would not approve, and because the IRB and their approvals were tainted.

After becoming aware of the FDA inspection report, Dr. Stega commenced a defamation action against Downtown Hospital, Dr. Friedman, and others.   Defendants contended that Dr. Friedman’s statements were protected by an absolute privilege because the FDA inspection was a quasi-judicial proceeding.

The Court of Appeals, in a decision by Judge Fahey, held that the statements were not protected by absolute privilege. The Court held that, for absolute immunity to apply in a quasi-judicial context, the process must make available a remedy for the allegedly defamed party to challenge the defamatory statements. The Court focused on the fact that Dr. Stega was not entitled to participate in the FDA’s review and therefore could not challenge Dr. Friedman’s accusations against her. As the FDA investigation process did not provide Dr. Stega with procedural safeguards to contest what was said against her, absolute privilege did not apply. In the Court’s words, “The absolute privilege against defamation applied to communications in certain administrative proceedings is not a license to destroy a person’s character by means of false, defamatory statements.”

Judges Rivera and Garcia dissented, arguing that whether an absolute privilege applies in a quasi-judicial proceeding depends on the nature of the proceedings rather than the status of the subject of the communication. Judge Rivera opined that the majority decision undermined the public policy of encouraging greater openness in communications with government officials. The dissenters would have applied absolute immunity, on the ground that the statements were made in a quasi-judicial proceeding, a federal investigation regarding clinical trials involving human subjects and treatment of life-threatening conditions.   The interesting oral argument before the Court of Appeals can be found here.

For the question of whether absolute immunity applies, the Stega decision places the focus on the allegedly defamed person rather than the nature of the proceedings.  Witnesses who are giving statements or testimony in administrative proceedings and investigations should be counseled to take care in what they say and how they say it, as absolute immunity may not protect them if their comments lead to a defamation claim.

 

In January 2018, during the Executive budget address, Governor Cuomo directed the Department of Health (DOH) to review the health, criminal justice and economic impacts of regulating recreational marijuana in New York. In doing so, he requested DOH to act in consultation with other NYS agencies and to evaluate the experience, consequences and effects of legalized marijuana in neighboring states and territories.  Seven months later, on July 13, the DOH released their highly anticipated assessment and recommendations.  The report follows DOH’s recent promulgation of emergency regulations that added opioid use as a qualifying condition for medical marijuana and allowing medical marijuana to be used as an alternative treatment for pain relief in lieu of opioids.  Additionally, the Governor recently directed the Department of Financial Services to issue guidance to encourage NYS chartered banks and credit unions to consider establishing banking relationships with medical marijuana-related businesses in New York that are operating in full compliance with all applicable State laws and regulations, including the Compassionate Care Act.

DOH’s report reviews the current landscape of state laws surrounding marijuana usage in the United States: Twenty-nine states and Washington D.C. have adopted medical marijuana programs, and 8 states and Washington D.C. have legalized marijuana for regulated recreational use by adults.  The report concedes the recent activities in surrounding states and Canada have prompted the need for New York to consider the legalization of marijuana thoughtfully and responsibly.  The report examines how the prohibition of marijuana led to a significant number of arrests for possession of marijuana and caused adverse and disproportionate economic, health, and safety impacts for individuals with low incomes and communities of color.  Additionally, the report highlights several studies that have illustrated reductions in opioid prescribing and overdose deaths with the availability of marijuana products.    

While the report acknowledges marijuana use is not without its risks, it concludes that the benefits of an adult regulated marijuana program would have significant health, social justice and economic benefits that outweigh any potential negative impacts for New York.  The report recommends harm reduction strategies and principles be incorporated into the regulated marijuana program to help ensure consumer and industry safety.  For example, a regulated adult-use only marijuana program should prohibit use by youth (those under 21 years of age) and simultaneously implement strategies to reduce youth use of marijuana.  Regulating marijuana would allow for laboratory testing, product labeling, guidance and consumer education at dispensaries.  This would allow consumers to be better informed about the products they are purchasing, understand the dosage options, various ingestion methods, what products and techniques may work best for them, as well as understand potential adverse consequences and potential harms of marijuana use.  An adult regulated marijuana program could also help promote marijuana as an effective alternative pain treatment to opioids.  Additionally, a regulated marijuana program should create guidelines to ensure packaging is child proof and contains appropriate warning labels to avoid accidental consumption.    

The report outlines the impact marijuana legalization would have on the criminal justice system.  In 2010, the marijuana arrest rate in New York was the highest in the country and twice the national average.  Unfortunately, despite equal marijuana use among racial groups, black individuals were nearly four times more likely than whites to be arrested for possession.  Subject matter experts echoed similar sentiments to DOH and stated the most appropriate way to rectify this issue would be to legalize marijuana.  Marijuana-related convictions have a lasting impact on individuals, their families and the communities where these individuals live.  Individuals with a criminal record typically experience lifelong challenges with securing stable employment, housing and economic stability.  The DOH report indicates if marijuana was regulated, there would be a reduction of expenditures related to enforcement, prosecution and punishment for illegal marijuana offenses.  This would allow law enforcement to devote more of their time to community oriented policing and other more pressing focus areas.

The DOH study illustrates that NYS would be one of the largest regulated marijuana markets in the country and that there is great potential for tax revenue for the State.  DOH stated this funding could be used to help provide financial support for other programs, such as public health, community reinvestment, education, transportation, research, law enforcement, workforce development, and employment initiatives.  The report estimates there is projected to be 1,290,000 consumers in NY that would access regulated marijuana within the first year.  Based on certain inputs, assumptions, and average retail prices for marijuana, the estimated revenue for the first year could be between $1.7 billion and $3.5 billion annually – based on the sale of 6.5-10.2 million ounces being sold at $270 – $340 per ounce.  It should be noted, however that the average price of an ounce of marijuana in the United States, according to a recent Forbes article is around $247 an ounce.  Thus, these projections are arguably inflated.   Furthermore, depending on the retail tax rate that is ultimately imposed (the analysis used 7% and 15% for comparison purposes), NYS could receive between $248 million to upwards of $677 million in tax revenue annually.  However, the higher the tax rate imposed, the more likely users will continue to resort to the black market to obtain marijuana.          

The report acknowledges the implementation of a regulated marijuana program would require legislative and regulatory actions to appropriately address the diverse geographic needs throughout New York.  NYS must determine what type of licenses to offer under the regulated marijuana program and whether or not vertical integration would be allowed.  DOH recommends NYS limit the number of licenses available initially, and adopt a licensure model that is similar to Massachusetts, which prioritizes applicants for licensure based on providing equal opportunities for individuals who meet certain criteria (those living in areas of disproportionate impact, employment of residents in such areas, employment of people with drug-related criminal offender record that are otherwise employable, and ownership by persons of color).  Additionally, NYS would need to develop regulations and requirements for each element of the supply chain, cultivation and production practices, laboratory guidance, packaging and tamper proofing of products, and how marijuana will be retailed.  DOH recommends NYS place limits on the amount of THC allowed in marijuana, the types of products that may be offered for sale, and limit the maximum amount an individual may purchase to one ounce.

Regarding the taxation of regulated marijuana products, DOH recommends NYS begin with a low taxation rate, between 7% and 10%, to help encourage users to transition to the legalized market.  The report also emphasized that the workforce needs for this emerging industry must be addressed as the program continues to be developed to ensure safe working conditions.

Lastly, the DOH report recommended NYS convene a workgroup of subject matter experts, with relevant public health expertise, to: (1) contemplate the nuances of a regulated marijuana program; (2) review existing legislation; and (3) make recommendations to the State that are consistent with the overarching goals of harm reduction and public education.

For additional information on this report or other legislative or regulatory matters, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

Check out and subscribe to Farrell Fritz’s NY Health Law Blog at https://www.nyhealthlawblog.com

Unlike most other types of employment arrangements involving physicians, physicians acting as a medical director are compensated purely for the performance of administrative services related to patient care services. That is not to say that a medical director does not play a crucial role in the operation of a health care provider. In fact, the New York State Department of Health recommends, or even requires, medical directors be put in place for certain types of providers, and federal law similarly requires medical directors for certain types of services and facilities.

 

Because medical directors are not performing medical services, many physicians feel comfortable entering into medical directorship with little or no written documentation. However, physicians should proceed with caution when undertaking a medical director role. In particular, medical director arrangements are often scrutinized by the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services to determine whether the arrangement is, in reality, being used as a vehicle to provide remuneration to physicians for patient referrals. For this reason, where the contracting provider participates with federal payors and the physician may refer patients to the contracting provider, the physician should enter into a written medical director agreement that is structured to fall within an exception (or safe harbor) to the federal Stark and anti-kickback statutes.

Most often, the exception used under both Stark and anti-kickback laws will be the “personal services” safe harbor. Although slightly different under each statute, some key elements in complying with the “personal services” safe harbor are as follows:

 

  • Written Agreement: The agreement between the physician and the provider should be in writing, with a term of not less than one year. [1]
  • Duties: The agreement should provide for all of the services which the physician is expected to perform.[2]
  • Commercially Reasonable: The services provided by the medical director should be necessary to the provider and not exceed the amount of services required by the provider. This analysis is focused not only on whether the contracting physician’s services in and of themselves are necessary, but also whether there are other medical directors and whether numerous medical directors are performing duplicative services.[3]
  • Compensation: [4]
    • Fair Market Value – The physician should be paid fair market value for the services provided. To this end, it might be helpful to obtain a fair market value analysis, taking into account the geographic location, the experience of the physician, the certification of the physician, and they type of facility. While having such an analysis is not an absolute defense in an investigation, it is useful to demonstrate that fair market value was analyzed and that the remuneration falls within what was believed to be an acceptable range.
    • Hourly Rate – It is recommended that the medical director be paid on an hourly basis, with such hourly rate being paid at the fair market value rate.
    • Cap on Compensation – it is also recommended that the aggregate compensation a physician can earn for his documented hours be capped, to further ensure reasonableness.[5]
  • Documentation: The physician should keep daily time logs of services performed and the time spent on each service. This shows that the physician is performing real work, for which he or she is being paid fair market value, and also can be used to demonstrate that the services being performed are necessary for the facility.

While it is always best to consult with an experienced professional before entering into medical director arrangement, adhering to the criteria set forth above can offer protection for both the physician and the facility.

[1] 42 CFR 1001.952(d)(1): “The agency agreement is set out in writing and signed by the parties.” 42 CFR 1001.952(d)(4): “The term of the agreement is for not less than one year.” 42 U.S.C. 1395nn(e)(3)(A)(i): “the arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement.” 42 U.S.C. 1395nn(e)(3)(A)(iv): “the term of the arrangement is for at least 1 year.”

[2] 42 CFR 1001.952(d)(2): “The agency agreement covers all of the services the agent provides to the principal for the term of the agreement and specifies the services to be provided by the agent.” 42 U.S.C. 1395nn(e)(3)(A)(ii): “the arrangement covers all of the services to be provided by the physician.”

[3] 42 U.S.C. 1395nn(e)(3)(A)(iii): “the aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement.”

[4] 42 CFR 1001.952(d)(5): “The aggregate compensation paid to the agent over the term of the agreement is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs.” 42 U.S.C. 1395nn(e)(3)(A)(v): “the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and . . . is not determined in a manner that takes into account the volume or value of any referrals of other business generated between the parties.”

[5] In OIG Advisory Opinion No. 01-17 (2001), the OIG said that even though total aggregate compensation over the contract has not be set in advance, the totality of facts and circumstances in the specific circumstances at hand yield a conclusion that there is no significant increase in risk of fraud and abuse – however, this finding was likely due to the presence of a monthly payment cap. In 2003, in Advisory Opinion 03-8, the OIG found that a proposed arrangement does not qualify for protection under the safe harbor because the aggregate compensation paid under a management agreement would not be set in advance.

This post marks the end of our series on recent activity by the New York State Legislature in the health sector (introduced here), and follows posts on legislation impacting the pharmaceutical industry (here), hospitals (here), long term care and aging (here), behavioral health (here), and intellectual/developmental disability services (here).  As the last entry in the series, it serves as a bit of a catch-all for significant bills that have not been included in previous posts.  We have brought those bills together under the rubric of “public health.”

The challenges tackled by the Legislature in this space were wide and varied.  As is typical of public health legislation year after year, the bills largely focus on restricting unhealthy behaviors, shifting the cost of screening and prevention, deploying resources more efficiently and effectively, and educating the public and healthcare providers on the State’s various existing and newly created public health programs.  The following public health bills passed both houses of the Legislature and were either already signed into law (where noted) or currently await the Governor’s signature (more information on the legislative process can be found here).

Living Donor Protection Act (A297C Assemblymember Gunther /  S2496B Senator Hannon):  This bill, entitled the “Living Donor Protection Act of 2018” (the “Act”), seeks to encourage live organ donation, protect those who choose to donate their organs from insurance discrimination and provide paid family leave benefits to organ donors.  The Commissioner of Health, in cooperation with the Transplant Council and other interested parties, would be tasked with developing and distributing (online and in paper format) informational material expressing the benefits of live organ and tissue donation, including the impact on the donor’s access to insurance and assistance, the available state and federal tax credits for live organ donors, and the protections and benefits granted pursuant to the Act.

With respect to discrimination by insurers, the bill would make it unlawful for insurers who are authorized to provide life, accident, or health insurance to discriminate against a live organ donor by: declining or limiting insurance coverage under any life or accident and health insurance policy; or in the premium rating offering, issuance cancellation, amount of coverage or any other condition based solely on the donor’s status; or from precluding or preventing any individual from donating all or part of an organ or tissue as a condition of receiving or continuing to receive life or accident and health insurance coverage.

The bill further amends § 201(18) of the Workers Compensation Law to include transplantation and recovery from surgery related to organ or tissue donation one of the “serious health conditions” covered under paid family leave.

Smoking in Private Homes Licensed for Child Care (A397B Assemblymember Gunther / S7522-A Hannon):  This bill takes aim at reducing the harmful effects of “third hand smoke” – “residual contamination from cigarette smoke toxicants that can linger on surfaces” on children.  The bill would prohibit smoking at all times in private homes that are required to be licensed or registered for child care services, including but not limited to, registered, certified or licensed care in family day care homes, group family day care homes, school-age child care programs; head start programs, day care centers; child care which may be provided without a permit, certificate or registration in accordance with this statute; early childhood education programs approved by the state education department; and care provided in a children’s camp, regardless of whether or not children receiving such services are present.

Smoking Near Public Libraries (S169B Senator Rivera / A330-B Assemblymember Dinowitz):  This bill prohibits smoking within 100 feet of an entrance or exit of a public or association library (as defined in § 253(2) of the Education Law); unless such area falls within the boundaries of a private home or property, in which case, the prohibition shall not apply within the boundaries of such home or property.   

Marketing of Electronic Cigarettes to Minors (S1223 Senator Akshar / A8014 Assemblymember Rosenthal):  This bill prohibits the distribution of free electronic cigarettes to persons who appear to be less than 25 years old without first demanding proof of identification establishing the recipient is at least 18 years old.  This legislation was signed by the Governor on April 18, 2018, and became effective immediately.

Use of Tanning Facilities by Minors (A7218A Assemblymember Jaffee / S5585-A Senator Boyle):  Citing evidence that the use of tanning booths before the age of 35 increases the risk of melanoma by 59%, squamous cell carcinoma by 67% and basal cell carcinoma by 29%, the Legislature passed this bill to prohibit minors from using indoor tanning facilities, and eliminate the procedures under § 3555(2) of the Public Health Law that currently allow 16 and 17 year olds to access tanning facilities where the facility witnesses a parent or guardian sign a consent form in person at the facility.

Prostate Cancer Screening (S6882A Senator Tedisco / A8683A Assemblymember Gottfried):  This bill seeks to eliminate barriers to prostate cancer screening by providing diagnostic screening at no cost to certain populations of men considered to be at risk, and would require the Commissioner of Health to develop and distribute information about these no-cost screenings.  More specifically, the bill requires insurance companies to provide diagnostic testing for prostate cancer at no cost to men with a prior history of prostate cancer, to those men who are over 40 with a family history of prostate cancer, and men 50 and over who are asymptomatic.  A similar measure was passed in 2015 regarding women’s access to breast cancer screening.

Lyme and Tick-Borne Disease Work Group (S7170A Senator Serino / A8900-A Assemblymember Hunter):  This bill would create a Lyme and Tick-Borne Disease Work Group under the auspices of the Executive.  The work group will be made up of the Commissioners of the Department of Health, the Office of Mental Health, and the Department of Environmental Conservation, the Superintendent of Financial Services, six additional members to be appointed by the Governor at his sole discretion, and eight additional members on the recommendation of the Legislature (three by the Temporary President of the Senate, three by the Speaker of the Assembly, and one each by the Senate and Assembly Minority leaders).  The membership of the work group must include an infectious disease specialist, general practitioner, mental health practitioner, entomologist, epidemiologist, health insurance representative, and a representative of a tick-borne disease advocacy organization; all of whom must have prior experience working with tick-borne illness.

The work group would be required to meet at least bi-annually, and shall have the following powers and responsibilities:

  • Review  current  best  practices for the diagnosis, treatment and prevention of Lyme and tick-borne diseases, as well as  any  reports  or recommendations  from  the  Twenty-first  Century Work Group for Disease Elimination and Reduction, which is charged with  reviewing existing vaccines, international research and development for vaccines, as well as health threats which could be addressed by the development of vaccines;
  • Provide recommendations including, but not limited to:
    • Improvements to the delivery of care for patients and suspected patients of Lyme and tick-borne diseases, particularly those from endemic areas of the state;
    • Collaborations among county departments of health to promote effective  strategies to combat Lyme and tick-borne diseases, including best practices for prevention and reporting;
    • Collaborate with other agencies to streamline state efforts to combat the spread of Lyme and tick-borne diseases;
    • Identifying opportunities to collaborate with the federal government, non-profit entities, or private organizations on projects addressing these diseases;
    • Data collection and reporting requirements of Lyme and tick-borne disease, including but not limited to those for healthcare providers; and
    • Any other regulations or guidelines concerning Lyme and tick-borne diseases.

The work group would be required to submit a report detailing its findings and recommendations to the Governor and Legislature by May 1, 2019.

Lupus Education (A2788B Assemblymember Peoples-Stokes / S5489-B Senator Parker):  This bill would establish the Lupus Education and Prevention Fund, and would allow the fund to be financed by optional contributions through a taxpayer check-off on New York State corporate and personal income tax forms.

Lymphedema Education (A8819B Assemblymember Rosenthal L / S7765-B Senator Golden):  The Legislature has expressed concern that despite the fact that lymphedema afflicts 10 million people in the United States, the disease is relatively unknown – even among medical providers.  Accordingly, this bill would require every hospital or general hospital to distribute information to patients at high risk of developing lymphedema.  The information will assist patients to understand and identify the signs and symptoms of lymphedema and provide instructions on how to seek appropriate care.

The bill defines high risk patients as those with:

    • Any significant injury to soft tissue that could reasonably be expected to compromise or cause to be ineffective the drainage of the lymphatic system;
    • Recurrent or persistent bacterial infections that could reasonably be expected to compromise or cause to be ineffective the drainage of the lymphatic system; or
    • Have had corrective surgical procedures performed that may have interfered with the lymph drainage by severing local lymphatics in a manner that may jeopardize reconstitution and recovery of lymph drainage.

Lead Poisoning (S7295 Senator Alcantara / A8992 Assemblymember Dinowitz):  Section § 1373 of the Public Health Law permits the Commissioner of Health to designate any geographic area within the State as having a high risk of lead contamination, and upon written notice, may demand that lead abatement be conducted on any building within such area within a specified time period.  This bill amends § 1373 to also allow the Commissioner of Health to “take enforcement action as deemed appropriate by the Commissioner or his or her representative” in the event that such abatement is not undertaken.  Formal action may include a formal hearing and/or penalties not to exceed $500.  This bill was signed by the Governor on April 18, 2018.

Testing for Cytomegalovirus in Newborns (A587C Assemblymember Rosenthal / S2816-B Senator Hannon):  Cytomegalovirus is four times more prevalent than Zika virus in the United States and is the leading non-genetic cause of deafness in children.  Parents infected with the disease may not show any signs or symptoms, making it difficult to prevent the passing of this infection to their newborn babies.  This bill seeks to prevent the spread of this virus by educating pregnant women regarding the manner in which the disease is transmitted, and promote earlier detection of the disease in infants by requiring infants suspected of having hearing impairment to undergo a urine polymerase chain reaction test, unless the parent objects.

New Born Safe Sleep Study (S7408 Senator Hannon / A8957 Assemblymember Simotas):  This bill makes technical amendments to Chapter 401 of the Laws of 2017, which established the Newborn Health and Safe Sleep Pilot Program under the Department of Health (DOH).  This pilot program would have required the Department of Health to provide baby sleeping boxes in areas of NYS with high infant mortality rates or poor birth outcomes.  However, the 2018 bill instead amends § 2508 of the Public Health Law to require the Department of Health, in consultation with health care providers, hospitals, safe sleep product manufacturers, provider groups, the New York State Office of Children and Family Services, and other interested parties to conduct a study on the effectiveness of existing safe sleep practices that reduce infant mortality rates, as well as review baby boxes and other products designed to encourage safe and healthy sleeping among infants.  The Department will be required to utilize the study to conduct a pilot program aimed at improving caregiver education and continued safe sleep practices in counties or areas with high infant mortality rates, and to pursue public private partnerships and funding opportunities to obtain donations for these purposes.  This legislation was signed into law by the Governor on April 18, 2018.

Blood Drive Support (A2381 Assemblymember Gottfried / S2701 Senator Parker):  This bill would authorize the Commissioner of Health to issue grants to not-for-profits and elementary, secondary and post-secondary schools to help pay for the costs of conducting local blood drives.  This legislation was also passed by the Legislature in 2015 but was vetoed by the Governor due to the “increased and unbudgeted costs” the measure would inflict on the Department of Health.  This version of this bill is exactly the same as the prior version.

Physical Fitness Education Campaign (A4426 Assemblymember Cusick / S8716 Senator Sepulveda):  In an attempt to reduce the public health costs associated with obesity and obesity related illness (estimated to be $117 billion annually nationwide), this bill would create the New York Physical Fitness and Activity Education Campaign to increase awareness regarding the health and economic problems associated with obesity and to promote recreational and physical fitness activities within the State.  The Campaign would utilize social and mass media, including the internet, radio, and print advertising and recruit public ambassadors to promote the message, including professional and amateur athletes, fitness experts, and celebrities.  The Campaign would focus on seniors, youth, and other populations at high-risk for obesity.

Emerging Contaminant Education (S6655 Senator Hannon / A10927 Assemblymember Gottfried):  As part of the 2017-18 Enacted Budget, the Department of Health was instructed to create certain information and educational materials related to emerging contaminates and notification levels for emerging contaminants within the public water system.  Emerging contaminants are defined as any physical, chemical, microbiological or radiological substance listed as an emerging contaminant pursuant to §1112 (3) (c) of the Public Health Law.  The current list of contaminants includes: 1,4-dioxane, perfluorooctanesulfonic acid, and perfluorooctanoic acid.  This bill would build on the former educational material requirements to direct the Department to post this information on their website so it is easily accessible to the public and public water systems.

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If you have any questions concerning the foregoing legislation, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

Our series highlighting recent activity by the NYS Legislature (introduced here) continues with a recap of bills passed in 2018 that relate to intellectual and developmental disabilities (I/DD). This synopsis follows previous summaries we have done concerning the pharmaceutical industry (here), hospitals (here), long term care and aging (here), and behavioral health (here).

In a session characterized by intermittent paralysis in the Senate, the Legislature was still able to come together on several key initiatives in the I/DD space. Many of these create additional burdens on the Executive (e.g., requiring the Executive to create identification cards for individuals with I/DD).  Others focus on curtailing Executive authority in the I/DD space (e.g., prohibiting any change of auspice in state-operated individualized residential alternatives or setting a statutory minimum for reinvestment of facility sale proceeds).  In particular, an increasing amount of legislative activity in the I/DD space focuses on the identification of and services for autism spectrum order.

The following bills in the I/DD space currently await action by the Governor:

Identification Cards (A249C by Assemblymember Santabarbara/S2565C by Senator Helming):  This bill would require the Commissioner of the Office for People with Developmental Disabilities (OPWDD) to develop an identification card denoting that a person has been medically diagnosed with a developmental disability, which can be presented to law enforcement, firefighters and medical services personnel as necessary.  The front of the card would have to indicate that it was issued by OPWDD and include the bearer’s name, address, date of birth, and a specific statement that the bearer has a developmental disability, may have difficulty following directions, and may become physically agitated.  The reverse of the card would have to include, at the bearer’s discretion, a contact name and phone number, and a space for inclusion of additional information.  OPWDD may charge a fee for the card.

Same Gender Transportation (A10708 by Assemblymember Gunther/S8592 by Senator Ortt):  Under a current law adopted in 1927, a female patient receiving services for mental disability who is being transported to or from a facility must be accompanied by another female, unless accompanied by her father, brother, husband or son.  This bill, which was introduced at the request of OPWDD, would amend that law to make it gender-neutral, make it permissive rather than mandatory, and provide that it is conditioned upon applicable staffing limitations and upon request.

Care Demonstration Program (A8990 by Assemblymember Gunther/S7291 by Senator Ortt):  This bill is an agreed-upon chapter amendment (see discussion of chapter amendments in our introductory post here) to Chapter 491 of the Laws of 2017, which was intended to codify OPWDD care demonstration programs originally developed and implemented in 2015, pursuant to which members of the state workforce provide community-based care to individuals with developmental disabilities.  The services provided by such programs include, but are not limited to, community habilitation, in-home respite, pathways to employment, supported employment, and community prevocational services.  The original bill requires OPWDD to monitor the quality and effectiveness of these programs, requires OPWDD to issue a report by December 31, 2020, and expires March 31, 2021.  This bill would eliminate the reporting requirement, make the selection of services provided by those programs permissive rather than mandatory, and change the expiration date to March 31, 2020.

Change of Auspice of State-Operated Individualized Residential Alternatives (A10442 by Assemblymember Gunther/S8200 by Senator Marcellino):  Current law imposes expansive notice requirements on any effort by OPWDD to close or transfer a state-operated individualized residential alternative (IRA), which is a type of community residence that provides room, board and individualized service options.  This bill would prohibit any change of auspice of any IRA currently operated by OPWDD, thus completely preventing OPWDD from outsourcing such IRAs to private entities.

Reinvestment of Sale Proceeds (A10951 by Assemblymember Lentol/S8633 by Senator Ortt):  This bill would require that 85% of the proceeds from the sale of any property that was previously used, operated or maintained by OPWDD be used exclusively to increase funding for state-operated residential or community-based services.

Study on Early Diagnosis and Long-Term Treatment of Autism (A261 by Assemblymember Abinanti/S3895 by Senator Parker):  This bill would require the Commissioner of OPWDD, the Commissioner of the State Education Department, the Commissioner of the Department of Health, the Commissioner of the Office of Children and Family Services, and the Commissioner of the Office of Mental Health to conduct a study to be performed on the future costs to the state for the early diagnosis and long-term treatment of autism spectrum disorder.  The report, along with legislative recommendations, is due to the Governor and the Legislature on or before April 1, 2021.

Autism Outreach to Minorities (A7976 by Assemblymember De La Rosa/S5534-A by Senator Hamilton):  This bill would require the Autism Spectrum Disorders Advisory Board established in 2016 to identify strategies and methods of improving coordination of services associated with autism spectrum disorders for minority group members, including but not limited to African American, Latino and Asian children.

Autism Screening for Children Aged 3 and Under (A9868A by Assemblymember Santabarbara/S8955 by Senator Ortt):  Current law requires the Commissioner of Health to establish best practice protocols for the early screening of children for autism screening disorder, which must incorporate standards and guidelines established by the American Academy of Pediatrics.  This bill would provide that those standards must include developmental screening for children aged 3 and under, and must be updated at least once every two years.

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For additional information on any of the foregoing bills, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

Our series highlighting recent activity by the NYS Legislature continues with a recap of bills passed in 2018 that relate to behavioral health. This synopsis follows previous summaries we have done concerning pharmacy (here), hospitals (here), long term care and aging (here).

Except where otherwise noted, these bills await action by the Governor.

Mental Health and Substance Use Disorder Parity Report (A3694-C by Assemblymember Gunther / S1156-C by Senator Ortt):  This legislation would establish the Mental Health and Substance Use Disorder Parity Report Act, which, beginning September 1, 2019,  would require the Department of Financial Services (DFS) to include in the annual Consumer Guide to Health Insurers (here) information concerning insurers’ and health plans’ compliance with NYS and federal requirements for the provision of mental health and substance use disorder treatment.

Insurers and plans would be required to annually provide the DFS and Department of Health (DOH) all of the information necessary to prepare the report, including:

  • Rates of utilization review for mental health and substance use disorder (SUD) claims as compared to medical and surgical claims, including the rates of approval and denial, categorized by benefits provided by the following classifications: inpatient in-network, inpatient out-of-network, outpatient in-network, outpatient out-of-network, emergency care, and prescription drugs;
  • The number of prior or concurrent authorization requests for mental health and SUD services and the number of denials, compared with similar authorization requests for medical and surgical services, categorized by the same classifications noted above;
  • Rates of appeals, adverse determinations, adverse determinations upheld and overturned for mental health and SUD services, as well as such rates for medical and surgical claims;
  • The percentage of claims paid for in-network and out-of-network mental health and SUD services compared with in-network and out-of-network medical and surgical services;
  • The number of behavioral health advocates or staff that are available to assist policyholders with mental health and SUD benefits, pursuant to an agreement with the Attorney General’s office;
  • A comparison of cost sharing requirements, co-payments, co-insurance, and benefit limitations between mental health and SUD services and medical and surgical services;
  • The number and type of providers licensed in NYS that provide mental health and SUD services in-network and the number of providers that are out-of-network;
  • The percentage of providers of services for mental health and SUD who remained participating providers; and
  • Any other information DFS determines necessary to track mental health and SUD parity, including but not limited to an evaluation of: the company’s in-network mental health and SUD provider panels and reimbursement practices for in-network and out-of network services compared with those of medical and surgical services.

Discharge Planning for Individuals with Mental Health Disorder (A10644 by Assemblymember Gunther / S8769 by Senator Ortt):  This legislation would require the Office of Mental Health (OMH), in conjunction with DOH, to develop guidance and educational materials regarding effective discharge planning for individuals with a mental health disorder.  Information will be provided to hospitals across NY and would also be provided to individuals with a documented mental health disorder or those who appear be at risk for a mental health disorder during the discharge planning process.  This legislation was previously highlighted in our post on legislation affecting hospitals (here).

Maternal Depression Treatment (A8953 by Assemblymember Richardson / S7409 by Senator Krueger):  This legislation makes technical amendments to Chapter 463 of 2017 (S4000/A8398), which would have required DOH, in collaboration with the OMH, to compile and maintain a list of providers who treat maternal depression, and ensure adequate investment in treatment resources, including a statewide hotline, peer support, adequate referral networks and telehealth or telemedicine services.  This bill amends that law to instead require DOH, in consultation with OMH, to simply “inform providers of the need to raise awareness and work to address maternal depression,” and to provide information on their websites to assist people in locating mental health professionals, other licensed professionals, peer support, not-for-profit corporations and other community resources that treat or provide support for maternal depression.  The bill was signed by the Governor on June 1, 2018.

Mental Health and Home Care Collaboration (A10938 by Assemblymember Gunther / S8632 by Senator Ortt):  This legislation would allow the existing Geriatric Service Demonstration Program, which provides grants to providers of mental health care to the elderly (here) to foster and support collaboration between mental health providers and home care services, including certified home health agencies and licensed home care service agencies.  It is intended to help promote integrated physical and mental health care services in NYS communities for individuals with co-occurring physical and mental health needs.

Tick-Borne Disease Study (A9019-A by Assemblymember Gunther / S7171-A by Senator Serino):  This legislation would require DOH, in conjunction with OMH, to conduct a tick-borne diseases and blood-borne pathogen impact study to examine their impact on  mental illness rates in endemic areas of the state.  This report would be due by October 1, 2019 and would detail:

  • Considerations on how Lyme, tick-borne illnesses and other blood-borne pathogens or vector-borne diseases may have correlations with mental illness in infected individuals;
  • Populations at risk, including individuals that work outside or that have elevated exposure risks;
  • Diagnostic indicators of mental illness that can be used as guidance for health and mental health providers;
  • Historical considerations of infection rates and mental illness indicators that may have gone undiagnosed or misdiagnosed in endemic areas; and,
  • Recommendations for intervention and coordinated care for individuals who exhibit mental illness symptoms and also have physical health indicators.

Effects of Trauma on Child Development (A10063-B by Assemblymember Joyner / S8000-B by Senator Bailey):  This legislation would require the Commissioner of Education to conduct a study on the effects of trauma on child development and learning.  The study would include, but not be limited to, the following information:

  • The types of trauma experienced by students;
  • The impacts of trauma on child development and learning;
  • Screening and assessments of trauma available in schools;
  • Programs, interventions, and services related to trauma available in schools; and
  • Best practices for school personnel in the area of trauma as it relates to child development and learning.

The State Education Department (SED) would be required to submit its findings and recommendations to the Governor and NYS Legislature within one year.

Suicide Prevention Education (A3210-A by Assemblymember Ortiz / S5860-A by Senator Ritchie):  This legislation would require OMH, in consultation with SED, to develop and publish educational materials regarding suicide prevention measures and signs of depression among students in  NYS universities, community colleges, and city universities.  Such educational materials would include, but not be limited to:

  • Information regarding symptoms of depression;
  • How depression manifests itself in different cultures;
  • Warning signs of suicide;
  • Actions to take once a student is identified at risk of suicide; and
  • A list of educational websites regarding suicide and students attending university or college.

These educational materials would be available to faculty and staff in these educational institutions via the OMH website and by any other means OMH deems appropriate, within 90 days after it is signed into law.

Adolescent Suicide Prevention (A8961 by Assemblymember De La Rosa / S7322 by Senator Alcantara):  This legislation makes technical amendments to Chapter 436 of 2017 (S5500-C/ A7225-B), which would have established a nine-member Adolescent Suicide Prevention Advisory Council to facilitate the coordination of adolescent suicide prevention services.  As outlined in the Governor’s 2017 approval memo, the bill presented implementation challenges.  The current bill would repeal the prior bill and instead require OMH to assure the development of plans, programs, and services in the research and prevention of suicide, to reduce suicidal behavior and deaths through consultation, training, implementation of evidence-based practices, and use of suicide surveillance data.  OMH would develop such plans, programs, and services in cooperation with other agencies and departments in NYS, local governments, community organizations, entities, and individuals.  OMH would also consider the impact of differing demographic groups, gender, race and ethnicity, cultural and language needs.

Substance Use Education (A7470 by Assemblymebmer Davila / S8318 by Senator Comrie):   This legislation would require the Office of Alcoholism and Substance Abuse Services (OASAS), in consultation with SED, to develop educational materials to be provided to school districts and boards of cooperative educational services for use in any drug and alcohol related curriculum regarding the misuse and abuse of alcohol, tobacco, prescription medication and other drugs.  These materials would be age appropriate, and to the extent practicable, include information for parents to identify the warning signs and to address the risks of substance abuse.

Additionally, the bill would require the Superintendent of each school district, in consultation with the related district superintendent of a board of cooperative educational services, to designate a member of the school district’s staff or an employee to provide information to any student, parent, or staff regarding available substance use related services.  Where practicable, this individual should be a school social worker, school guidance counselor, or any other health practitioner or counselor employed by the school.  These designated individuals will be required to undergo any necessary training required by OASAS.  Information received by designated individuals would be kept confidential, however, nothing would relieve them of any legal duty to otherwise report such information.

Substance Abuse Disorder Referrals (A7689-A by Assemblymember Rosenthal / S6544-B by Senator Akshar):  This legislation would prohibit any SUD provider from intentionally soliciting, receiving, accepting or agreeing to receive payment, benefit, or any other consideration to induce the referral of a potential patient for SUD services.  This legislation does not prohibit:

  • Lawful payments by a health maintenance organization or health insurer acting on behalf of their enrollees for such SUD services or benefits to be provided;
  • Lawful payments to or by a provider to a health maintenance organization or health insurer as payment for services provided, a refund for an overpayment, a participating provider fee, or any similar remuneration;
  • Payment for an activity that, at the time of such activity, would have been lawful as specifically exempt, or otherwise not prohibited under any federal statute or regulations, including but not limited to 42 U.S.C. § 1320a-7b, or the regulations promulgated thereafter if conducted by a person, firm, partnership, group, practice, association, fiduciary, employer representative or any other entity providing SUD services;
  • Any employee or representative of a provider conducting marketing activities, where the employee or representative identifies the provider represented for whom the employee works, identifies themselves as a marketer and not a clinician or individual who can provide diagnostic, counseling or assessment services;
  • Commissions, fees or other remuneration lawfully paid to insurance agents as provided under the Insurance Law.

Providers who intentionally violate these provisions would be guilty of a misdemeanor as defined under the Penal Law.

OASAS Provider Directory (A8151 by Assemblymember Rosenthal / S8552 by Senator Golden):  This legislation would require OASAS to maintain a directory of all providers and programs operated, licensed, or certified on their website.  The searchable directory would include the following information:

  • Location(s) of each provider or program;
  • Contact information for each provider or program;
  • Services offered by each provider or program at each location of the provider or program, as well as which medications are available at any medication-assisted treatment provider;
  • Special populations served;
  • Insurance accepted;
  • Availability of beds and services; and
  • Any other information OASAS deems appropriate.

Medical Marihuana as Alternate Treatment for Substance Use Disorder (A11011B Rules, Assemblymember Gottfried / S8987-A by Senator Amedore):  As we previously reported in another blog post, this legislation would help provide alternative treatment options for pain management and substance use disorder by including “pain that degrades health and functional capability where the use of medical marihuana is an alternative to opioid use” and “substance use disorder” to the list of qualifying conditions for patients to access medical marihuana.

Notice of Service Reductions at State-Operated Hospitals (A9563-A by Assemblymember Gunther / S7207 by Senator Ortt):  This legislation amends the notice requirements to local governments, community organizations and other interested parties regarding the potential for significant service reductions at state-operated hospitals.  The bill would require notice of closure or significant service reductions at state operated hospitals and state operated research institutes be a maximum length of twenty-four months prior to commencing such service reduction.  This legislation is intended to allow appropriate planning to take place and ensure a thoughtful transition plan is developed for all affected stakeholders.

Continuing Education for Psychologists (A9072-A by Assemblymember Fahy / S7398-A by Senator Valesky):  This legislation would require psychologists to obtain a minimum of 36 hours of mandatory continuing education, including 9 hours of professional ethics, every 3 years.

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For additional information on any of the foregoing bills, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

 

 

The latest installation in our series on legislation recently passed by the New York State Legislature (introduced here) addresses legislation in the long term care and aging space.  It follows upon descriptions of legislation in the pharmacy space (here) and hospital space (here).  Like those areas, the long term care area was impacted by the same political turmoil that limited the number of bills passed – but some significant legislation was enacted nonetheless.

One of the more interesting aspects of the long term care and aging space is that it tends to be comprised of two very different regulatory regimes.  The first, primarily overseen by the Department of Health (DOH), regulates licensed long term healthcare providers like nursing homes, assisted living residences, home care and others.  The second, overseen by the State Office for the Aging (SOFA), focuses on the elderly more generally.  Sometimes, it can seem like these two agencies occupy two entirely different worlds; other times, they coordinate comprehensively and effectively.  Bills passed this year by the Legislature affect both agencies.

Except where otherwise indicated, these bills all await action by the Governor.

Assisted Living Programs and Hospice (A10459-A by Assemblymember Lupardo/S8353-A by Senator Hannon):  Continuing the State’s recent focus on expansion of assisted living program services (see our post on long term care provisions in the State Budget, here), this bill would allow hospice services to be delivered to individuals residing in assisted living programs.  Current Medicaid policy does not allow the delivery of hospice services in an assisted living program, requiring many residents to transfer to a nursing home in their last few weeks of life, compounding the issues they already face at the end of their lives.

Adult Care Facility Temporary Operators (A8159 by Assemblymember Wright/S766 by Senator Stewart-Cousins):  This bill would require the DOH to provide written notice when a temporary operator is appointed at any adult home, enriched housing program, residence for adults or assisted living program.  Temporary operators are entities appointed by DOH to operate a facility where an operator’s license has been suspended.

Deaths in Adult Care Facilities (A9034 by Assemblyman Gottfried/S7282 by Senator Alcantara):  This bill is a chapter amendment (see discussion of chapter amendments in our introductory post here) to Chapter 459 of the Laws of 2017, which added enriched housing programs to the list of adult care facilities that must report the death or attempted suicide of a resident or any felony committed against a resident to DOH, and to the Justice Center for the Protection of People with Special Needs, if they are receiving mental hygiene services.  That bill also reduced the time within which facilities must make such a report from 48 to 24 hours.  This bill eliminates the statutory time period in which a report must be made.  The bill was signed by the Governor on June 1, 2018.

Long Term Care Ombudsman (A11050 by Assemblymember Lupardo/S9002 by Senator Dilan):  This bill would make various changes to bring the provisions of state law establishing the Long Term Care Ombudsman Program (LTCOP) in line with federal statute and regulations.  The LTCOP investigates and resolves complaints made by or on behalf of residents, promotes the development of resident and family councils, and informs government agencies, providers and the general public about issues and concerns impacting residents of long term care facilities.  The bill would clarify (1) the structure of the LTCOP and the relationship between the LTCOP and the SOFA; (2) the required qualifications of the state ombudsman and assistant ombudsmen; (3) the state ombudsman’s duty to refer complaints to appropriate investigative agencies; (4) the state ombudsman’s duty to comment on actions pertaining to the health, safety, welfare, and rights of the residents of long term care facilities and services; (5) the state ombudsman’s duty to provide timely access to LTCOP services; (6) the state ombudsman’s duty to recommend changes to law, regulation and policy; (7) the state ombudsman’s duty to develop a certification training program and continuing education for ombudsmen; (8) the state ombudsman’s duty to provide administrative and technical assistance to ombudsmen; (9) the state ombudsman’s duty to support citizen organizations, resident and family councils, and other statewide systems advocacy efforts; and (10) the state ombudsman’s duty to advise SOFA in regard to plans or contracts governing local ombudsman entity operations.  The bill requires the state ombudsman to develop a grievance process to offer an opportunity for reconsideration of any decision regarding the appointment of any local ombudsman, and any decision of an ombudsman.  The bill also clarifies (a) the records to which ombudsmen must have access and the limitations on the use and further disclosure of such records; (b) that ombudsmen must be granted access to and cooperation from long term care facilities, and facilities may not retaliate against anyone for cooperating with ombudsmen; and (c) the conflict of interest rules applicable to the LTCOP.

Informal Caregiver Best Practices (A3958 by Assemblymember Dinowitz/S8730 by Senator Sepulveda):  This bill would require SOFA to develop a guide for businesses containing best practices for retaining employees who are also informal caregivers (i.e., who care for elders at home), and make that guide available on the agency’s website or via paper copy.

Veterans in Nursing Homes (A9981-A by Assemblymember Wallace/S8968 by Senator Helming):  This bill would add “assisted living” (presumably assisted living programs), assisted living residences, and adult care facilities to the list of entities which may report to SOFA on the veteran status or veteran spouse status of residents, so that SOFA may link them to counselors for review and potential linkage to veteran services.  SOFA would be required to include the number of such reports within its annual report.

Locator Technology Businesses (A1118-A by Assemblymember Rosenthal/S5221-A by Senator Stavisky):  This bill would require DOH to develop a list of businesses that manufacture, distribute or otherwise offer locator technology services designed to assist in the expedited location of individuals afflicted with Alzheimer’s disease or dementia who become lost or disoriented.  DOH must make the list available to physicians and the general public.  “Locator technology” includes, e.g., wrist transmitter tracking systems, software programs, data bases and products like necklaces and bracelets that contain identifying information.

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For additional information on any of the foregoing bills, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

As we noted in previous blogs, the New York State Legislature has addressed a number of significant hospital related issues during the 2018 session, including indigent care funding (discussed here), the third iteration of the Statewide Health Care Facility Transformation Program (discussed here) and the funding of the Health Care Transformation Fund in connection with the acquisition of a New York-based payor Fidelis (discussed here). Yet, just like the legislative session, momentum on hospital related issues seems to have slowly fizzled out.  Between the enactment of the 2018-19 Budget (discussed at length here) and the close of session only a small number of the bills that made it through both houses directly addressed hospitals.  The following hospital related bills currently await the Governor’s signature, veto or amendment.   

Discharge of Patients with Mental Health Issues: (S.8769 by Senator Ortt/A.10644 Assemblymember Gunther) – This bill Requires the Office of Mental Health (OMH) to develop educational materials to be provided to individuals who have or appear to have a mental health disorder at the time they are discharged from a hospital and provide such materials to general hospitals across the state.  Pursuant to the bill, OMH, in cooperation with the Department of Health (DOH), must:

  • provide guidance to all general hospitals regarding the utilization of new or existing policies and procedures for the identification, assessment and referral of individuals with a documented mental health disorder or who appear to have or be at risk for a mental health disorder;
  • establish and implement training for all individuals licensed or certified pursuant to Title Eight of the Education Law who provide direct patient care regarding the policies and procedures developed pursuant to the bill.

If a general hospital does not directly provide mental health disorder services, then OMH and DOH will provide the necessary information to refer individuals in need of such services to, and coordinate with, mental health service programs licensed under Article 31 of the Mental Hygiene Law that provide such services.

Hospital and Nursing Home Bond Bill: (S.8648 by Senator Hannon/A.10673 Assemblymember Paulin) –  This bill increases the authorization of the Dormitory Authority of New York (DASNY) to issue hospital and nursing home project bonds and notes from $15.8 billion to $16.6 billion.   To date, DASNY – which provides funding mortgage loans and project loans to not-for-profit hospitals and nursing home corporations through bonds authorized by the Medical Care Facilities Finance Act (MCFFA) – has already issued bonds exceeding $14.8 billion, and has an additional $840 million in bond financing projects in its pipeline.  This would be the third increase under the MCFFA since its inception; the Legislature granted $800 million extensions in 2009 and 2011.

Sexual Assault Victim’s Bill of Rights: (A.8401C by Assemblymember Simotas / S.8977 Senator Hannon) – This bill requires the Division of Criminal Justice Services (DCJS), the Office of Victim Services, hospitals and other health care providers and victim advocacy organizations to publish a Sexual Assault Victim Bill of Rights, informing victims of sexual assault of their rights under state law.  More specifically the Bill of Rights:

  • will be prominately published on the DCJS’s website, in the ten most commonly spoken languages in New York, and updated by DCJS as state law changes;
  • hospitals will be required to provide the Bill of Rights to every presenting sexual offense victim; and
  • must include a plain English explanation that the victim has the right to:
    • consult with a local rape crisis or victim assistance organization, or have such organization summoned by the hospital or authorities on their behalf, and have a representative of such organization accompany the victim through the sexual offense examination;
    • certain post-exposure treatment therapies, including a seven day starter pack of HIV prophylaxis, at no cost;
    • a health care forensic examination at no cost, as well as the right to decline seeking coverage for the same from their own insurance company and have the procedure be reimbursed instead through the Office of Victim Services;
    • receive information regarding the provision of emergency contraceptives;
    • be offered contact information for the law enforcement or prosecutorial agency with jurisdiction over the offense and its prosecution, and to be informed, upon request, of the date and location at which such sexual offense evidence kit was assessed for Combined DNA Index System eligibility and whether or not a DNA profile match was identified (though law enforcement will have the ability to delay release of the suspect’s information to the victim in appropriate circumstances);
    • be notified between 10 and 30 days prior to the transfer of a sexual offense evidence kit from the hospital to another storage facility;
    • be notified of their right to have their sexual offense evidence kit maintained at an appropriate storage facility for at least 20 years from collection, and the right to be notified by such facility at least 90 days before the expiration of the storage period;
    • to decide whether or not to report the offense to law enforcement

Importantly, prior to commencing a physical examination or commencing an interview of a sexual offense victim, a medical provider or law enforcement entity must inform the victim of the Bill of Rights, provide a copy of the same, and offer to explain the Bill of Rights to the victim.

Standing Orders for the Care of Newborns: (A.9950B Assemblymember Gottfried/S.8774-B Senator Hannon) –   This bill aims to clarify confusion surrounding the utilization by hospitals of standing orders governing the care of healthy newborn infants by registered nurses.  The Legislature expressed concern that such standing orders were not being widely used as a result of confusion over their legality.  The bill provides that hospitals may utilize non-patient specific standing orders for the care of healthy newborns by attending registered nurses when directed by the attending practitioner, or when the attending nurse determines it would be clinically appropriate and consistent with hospital policies and procedures, provided that the following requirements and conditions are met:

  • the standing order must include the circumstances under which departure from the order is required due to the health of the baby, mother, or both;
  • an attending nurse may determine that a departure from the standing order is required prior to receiving direction from the attending practitioner, so long as such an action is within his or her lawful scope of practice and the policies and procedures of the hospital;
    • to the extent an attending nurse determines a departure is necessary, he or she must notify the attending practitioner;
  • the standing order must provide, the times and manner that an attending practitioner shall review and acknowledge in writing the services and care provided to the newborn under the standing order and the newborn’s condition;
  • a standing order may provide for circumstances in which it shall not be implemented , or implemented only at the order of an attending practitioner, including in circumstances involving insufficient prenatal care; a birth not attended by an attending practitioner, a birth that occurs outside of the hospital, or premature or low birthweight; and,
  • a standing order must be dated, timed, and authenticated promptly in the patient’s medical record by the attending practitioner in keeping with the laws, regulations and rules and procedures of the hospital;

Standing orders may only be implemented if the implementing hospital:

  • establishes that the order has been reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership, and signed by a physician affiliated with the hospital (or by a midwife associated with the hospital in the case of a midwifery birth center);
  • demonstrates that the order is consistent with the nationally recognized evidence-based guidelines; and,
  • ensures that the periodic and regular review of the order is conducted by the hospital’s medical staff and nursing and pharmacy leadership to determine the continuing usefulness and safety of the order.

Furthermore, all standing orders must be consistent with the lawful scope of practice of a registered nurse, and are subject to further regulations promulgated by the Commissioner of Health governing the terms, procedures and implementation of such orders.

Clinical Laboratory Supervision: (A.10781A by Assemblymember Gottfried / S.7521-A Senator Hannon) –  This bill establishes the supervisory requirements for clinical laboratories.  At present, clinical laboratories are required to have a supervisor physically present on site at all times.  The Legislature has expressed concern that such a requirement is far in excess of what is required under the federal Clinical Improvement Act, and compliance is too costly and onerous for hospitals – particularly those hospitals in rural and upstate locations.  This bill seeks to reduce the cost of compliance by allowing supervision via phone or synchronous 2-way AV communication, and by allowing a single supervisor to oversee up to five laboratories.   More specifically, pursuant to this bill:

  • each clinical laboratory must have at least one or more supervisors available to oversee the technical personnel and reporting of findings, the performance of tests requiring special scientific skills, and be responsible for the proper performance of all laboratory procedures in the absence of the laboratory’s director;
  • a person is qualified to act as a supervisor if:
    • they are qualified to act as a director pursuant to regulations promulgated under 573 of the Public Health Law;
    • additionally, the DOH has discretion to allow a director to also serve as the supervisor, depending on the size and functions of the lab;
  • the supervisor must be on site or available by phone or two-way synchronous electronic audio visual communications (pursuant to yet to be drafted regulations on the subject);
  • where the supervisor is off site, and the person performing the test qualifies as a medical technologist pursuant to regulations promulgated under § 574, 576 and 3121 of the Public Health Law, the results of such work must be reviewed by the supervisor or director during his or her next duty period and a record of such review must be maintained; and
  • technical personnel in the specialty of cytology must be supervised by an individual qualified pursuant to regulations promulgated under § 574, 576 and 3121 of the Public Health Law.

For additional information on any of the foregoing bills, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills, several of which would affect the pharmaceutical sector. While the Governor has until the end of the year to consider and act on these proposals, we wanted to provide a brief summary of this legislation as it currently stands.

Drug Take Back Act (S.9100 by Senator Hannon / A.9576-B Assemblywoman Gunther): This bill would establish a statewide pharmaceutical take back program that would be overseen by the Department of Health. Pharmaceutical manufacturers engaged in the manufacture of covered drugs sold in New York would be required to either individually or jointly develop, and fully fund all administrative and operational fees associated with this take back program.

Under this legislation, the definition of “covered drugs” includes substances recognized under 21 USC §321 (g) (1) that are sold or offered for sale in NYS, but does not include:

  •  drugs used in the clinical setting;
  •  biological drugs if the manufacturer already provides a take back program;
  •  drugs that are already part of a manufacturer FDA managed Risk Evaluation and Mitigation Strategy (REMS) program;
  •  emptied injector products or emptied medical devices and their component parts or accessories;
  • vitamins, supplements and herbal remedies;
  • cosmetics;
  • soaps and shampoos;
  • household cleaning products;
  • sunscreens;
  • personal care products;
  • pet pesticide products contained in collars, powders, shampoos or other topical applications.

Affected manufacturers would be required to submit a proposed drug take back plan to the Department of Health (DOH) for approval which specifies their intent to either:

  • operate a program individually or jointly with other manufacturers;
  • enter into an agreement with a take back organization to operate and implement a take back program; or
  • enter into an agreement with DOH to operate a program on its own behalf.

Manufacturers of covered drugs must submit their proposed plan to DOH within 180 days after the bill is signed into law. The proposed plan must:

  • ensure the program will take back all covered drugs, regardless of who produces them;
  • include contact information for the person charged with submitting and overseeing the manufacturer take back initiative;
  • detail how the program will provide convenient, geographically distributed, ongoing collection services to all individuals wishing to dispose of such items;
  • describe other collection efforts by which covered drugs are collected;
  • explain how covered drugs will be safely and securely tracked and handled during the collection, disposal and destruction process;
  • outline the public education and outreach activities, including advertising of locations on a website, signage, other written materials and how effectiveness will be evaluated;   
  • detail how the cost of pharmacy collection will be reimbursed, retroactive to the effective date of legislation, and if there is more than one manufacturer involved in the take back program, a plan for fair and reasonable allocation of costs that is reasonably related to the volume or value of covered drugs sold in NY.

The DOH, in consultation with the Department of Environmental Conservation, will review and determine if the manufacturer take back plan meets the program requirements within 60 days of receipt and will notify the manufacturer of their decision in writing.  If the plan is not approved, the manufacturer will have 30 days to submit a revised plan to DOH. If a subsequent plan is rejected by DOH, the manufacturer(s) will be out of compliance with take back statutory requirements and will be subject to enforcement provisions. The DOH will put a list on their website of all manufacturers that are participating in an approved drug take back program and will update this website annually.    

Moreover, affected manufacturers are required to update their drug take back program at least once every three years and to submit an updated proposal to DOH.  Any proposed change to the take back program must be submitted in writing and approved by DOH.

Additionally, a manufacturer who begins to offer a covered drug after the effective date of this bill, is required to notify the DOH they have joined an existing approved take back program or submit a proposal to operate a take back program within 90 days after the initial sale of the covered drug.

Each approved take back program is required to submit a report, at a date and in a manner set forth by DOH. The DOH is then required to submit an annual report to the Legislature which details:

  • all drug take back program activities;
  • the weight collected by each program;
  • a description of collection activities;
  • the name and location of all collection sites;
  • public education and outreach activities;
  • evaluation of efficacy of the program and each collection method; and
  • manufacturers that are out of compliance or subject to penalties.

This legislation would also require all pharmacy chains that operate 10 or more establishments and all registered non-resident pharmacies that provide covered drugs to state residents by mail, to offer one or more of the following take back options to consumers:

  • on-site collection,
  • drop box or receptacle;
  • mail back collection by voucher for a prepaid envelope; or
  • any other federal DEA approved collection methods.

Participation in the drug take back program by other authorized collectors is voluntary. All program costs incurred by pharmacies and other authorized collectors will be paid or reimbursed by the affected manufacturers, either jointly or individually.

Additionally, the Commissioner of Health will establish a drug take back distribution plan by regulation for cities with a population of 125,000 or more that ensures collection receptacle placement is accessible yet provides for program cost efficiency.

Lastly, this legislation preempts any county/municipal action on drug take back and includes language to clarify the jurisdiction of all matters relating to drug disposal is vested at the State level.   

Reclassification of Controlled Substances by Regulation (A.10468-B by Assemblymember Ryan / S.8275-B by Senator Jacobs): This bill would allow the Commissioner of Health to reclassify any drug (compound, mixture or preparation) containing any substance listed in Schedule I of §3306 of the Public Health Law as a Schedule II, III, IV, or V substance, or exempt it from the schedules entirely, by regulation or emergency regulation instead of through the enactment of legislation, as is currently required.  The Commissioner of DOH would only be able to reclassify or delete drugs that have been similarly reclassified or deleted under the federal Controlled Substances Act. The Commissioner would be permitted to reclassify drugs to the same numbered schedule or a higher numbered schedule. This bill seeks to increase treatment options for those seeking compassionate care, and corrects a long-standing barrier that sometimes resulted in inconsistencies between the federal and state schedules.

Medical Marihuana as Alternative Treatment for Pain and Substance Use Disorder (S8987-A by Senator Amedore / A. 11011-B by Assemblymember Gottfried (Rules): This legislation would help provide alternative treatment options for pain management and substance use disorder by including “pain that degrades health and functional capability where the use of medical marihuana is an alternative to opioid use” and “substance use disorder” to the list of qualifying conditions for patients to access medical marihuana.

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It is unclear when and how the Governor will act on these bills.  However, all of these issues have been the focus of increased attention and advocacy this year.  As discussed in our previous post, the Governor must consider and act upon these bills by the end of 2018.  The Governor may also negotiate any additional language or “chapter amendments” he believes may be necessary to fully implement such provisions.

For additional information on any of the foregoing bills, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.