Vanessa Bongiorno

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As pundits continue to argue about the nature and extent of the “Blue Wave” that did or did not wash across the country this past Election Day, its impact in New York State was undeniable.  What happened in New York on Tuesday was notable for several reasons.  First, according to the New York State Board of Elections (BOE), the state had the highest voter turnout for a midterm election since 1994.  BOE data illustrates over 45% of active NYS voters cast ballots in congressional, state legislative and gubernatorial races, before any absentee ballots are even considered.  Second, the election results represent a historic shift in the balance of power for the NYS Legislature, returning control of the State Senate to the Democrats for the first time since 2010, and for only the third time in the last half century.

While the Senate Democrats only needed one additional seat to achieve majority control of the Senate, it appears they secured a total of eight additional seats, bringing the conference majority to 39 of the 63 seats in the chamber, excluding Senator Simcha Felder, who while nominally a Democrat has until now conferenced with the Republicans.  However, results for two of these races are very close and the final outcome will be determined following the tabulation of all the absentee ballots and potential recounts.  According to BOE results available at this juncture, the eight seats that shifted to the Democrats include:

Senate Counties Republican Incumbent Elected Democrat
3rd Long Island Tom Croci (retired) Monica R. Martinez
5th Long Island Carl Marcellino James Gaughran
6th Long Island Kemp Hannon Kevin Thomas (close)
7th Long Island Elaine Phillips Anna Kaplan
22nd Brooklyn Marty Golden Andrew Gounardes (close)
39th Orange, Rockland and Ulster Bill Larkin (retired) James Skoufis
40th Westchester, Putnam and Dutchess Terrance Murphy Peter Harckham
42nd Delaware , Sullivan, Orange and Ulster John Bonacic Jen Metzger

 

Another seat, the 41st District held by Republican Susan Serino, appears at this point to remain in her hands, although an absentee ballot count is pending.

Similarly significant changes occurred at the Congressional level, where former Assembly Majority Leader Joseph Morelle was elected to fill Louise Slaughter’s seat in Rochester, and three other seats shifted from the Republicans to the Democrats.  However, other races generally ended predictably.  The Governor, Comptroller and Attorney General all remain Democratic, and the Democrats in the State Assembly continue to have a super-majority with 107 of the 150 seats.

A more detailed chart containing  a more comprehensive recap of all of the election results is available here.  Significant party changes are noted in yellow, new members are highlighted in blue, and members who ran unopposed are noted with an asterisk.

 

Implications — What This Means for Healthcare Policy

 

Senator Andrea Stewart-Cousins, (35th Senate District, Yonkers) will become New York’s first female Majority Leader and the Senate will announce additional leadership posts, committee chairs, committee assignments and staff changes/additions.  While many anticipate that former ranking committee members may be named as the chairs of their committees, it is uncertain how this may be addressed given the seniority of the various members, the former alignment of some members with the now-defunct Independent Democratic Conference or the Republicans more generally, and the potential needs of the newly elected members.  There has even been some talk of Republican senators switching parties.

However, one thing is clear:  the return to one-party rule and the displacement of certain key senators, including Kemp Hannon, former long-time Chair of the Senate Health Committee, will no doubt cause reverberations in the healthcare space.  For one, there will be the inevitable challenges faced by any new leadership – namely, the loss of institutional knowledge (keeping in mind, e.g., that Senator Hannon served as Health Chair for most of the last quarter-century) and the need to staff up, and the jockeying for position and profile among new members, where it remains to be seen which of the new majority senators will become the most prominent advocates for each of the various sectors of the healthcare industry.

Moreover, one can expect the issues that will be considered during the 2019-20 Legislative Session to be far more progressive than in years past.  There will likely be serious consideration of such issues as single-payer healthcare, codifying reproductive rights and comprehensive contraception coverage, and the legalization of marijuana.  Notwithstanding that the Executive, Senate and Assembly are all under one party-rule, there will also likely be intraparty differences that will come into play and will need to be balanced out, such as the needs of the New York City liberals and the needs of more moderate members from upstate and the suburbs.

Governor Cuomo has made it clear his first priority will be to pass the Reproductive Health Act, to make good on his campaign promise to codify Roe v. Wade in New York within the first 30 days of the new Session.  Additionally, the Governor has also signaled that the Comprehensive Contraception Coverage Act, which would codify a current Executive order and statutorily require insurers to cover all FDA-approved contraceptive drugs and devices at no cost to consumers, and legislation to address New York’s maternal mortality rates, are also among his top priorities.  Other key legislative initiatives identified by the Governor include the Dream Act, which would provide financial aid to students who came to the country illegally; the Child Victims Act, which would extend the statute of limitations for survivors of sexual abuse; ethics reform, including the closing of the LLC loophole; legalization of recreational marijuana; congestion-pricing to bring additional funding to the ailing Metropolitan Transportation Authority; and, increased gun control measures.  Some of these are more clearly connected to healthcare policy than others, but in the ebb and flow of legislative negotiations, any of them could impact the advancement of otherwise unrelated health policy goals.

Senator Stewart-Cousins and Senator Gustavo Rivera, the current ranking member of the Health Committee, are also both on record stating that their top legislative priorities would include enacting the New York Health Act, which would create a single-payer healthcare system. This legislation has been a long-time priority for Assemblymember Gottfried, chair of the Assembly Health Committee, and it has been passed by the Assembly in each of the past four sessions. Additionally, Senator Rivera has stated that passing Dakota’s Law, which addresses ongoing lead poisoning and remediation issues, is another of his top legislative priorities.

One of the dynamics to watch in the year ahead is the extent to which policymakers are able and willing to maintain their prior commitments in the healthcare space.  To some extent, the Republican majority in the Senate provided some cover to the Governor and the Assembly, allowing them to advance politically useful but otherwise problematic legislation that they knew would never be approved by the Senate.  Now, that check no longer exists.  This may create a particular challenge for the Executive branch, which is ultimately responsible for implementing enacted legislation, and which therefore has an institutional interest in preserving the public fisc.

We will continue to monitor events and report back on key developments.  If you have any questions or would like additional information on any of the above-referenced issues, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

 

 

 

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

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.

 

 

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.

*  *  *  *  *  *  *  *  * * *

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.

The New York State Department of Health (DOH), in consultation with the Department of Labor (DOL), recently announced a Request for Applications for the Health Workforce Retraining Initiative (HWRI).  This program was established pursuant to NYS Public Health Law §2807-g and is funded through the State’s Health Care Reform Act.  The 2018-19 Enacted New York State Budget included $9 million for this initiative and DOH anticipates an additional $9 million to be available for this grant in SFY 2019-20.

The DOH is soliciting applications from eligible organizations that seek to train or retrain health industry workers for new or emerging positions in the health care delivery system.  The purpose of this initiative is to:

  • Assist health care workers in the development of new skills to maintain employment and achieve licensing/certification requirements;
  • Enable health care workers to pursue new career opportunities created due to market changes, new employment for displaced health care workers and those at risk of displacement;
  • Provide health care workers with the education and training necessary to utilize emerging health technologies and data analytics to support population health management and delivery of high quality, cost effective care;
  • Address current and future occupational shortages;
  • Provide expertise to support integrated and interdisciplinary team-based care;
  • Meet increased demand for home and community-based long-term care services; and
  • Ensure health care workers can effectuate appropriate care transitions, reduce avoidable hospital readmissions and emergency room visits.

Funding is based on the total amount available in each region and will be awarded on a competitive basis by project and region.  Interested organizations may submit up to 50 applications for multiple projects.  Below please find further information regarding the counties included in this initiative, as well as the amount of funding available per region.

Maximum Funding Levels by Region

Western

Rochester

Central

Utica/ Watertown

Northeastern

Northern Metropolitan

New York City

Long Island

Allegany

Livingston

Broome

Chenango

Albany

Columbia

Bronx

Nassau

Cattaraugus

Monroe

Cayuga

Franklin

Clinton

Delaware

Kings

Suffolk

Chautauqua

Ontario

Chemung

Hamilton

Essex

Dutchess

New York

Erie

Seneca

Cortland

Herkimer

Fulton

Orange

Queens

Genesee

Wayne

Schuyler

Jefferson

Greene

Putnam

Richmond

Niagara

Yates

Steuben

Lewis

Montgomery

Rockland

Orleans

Tioga

Madison

Rensselaer

Sullivan

Wyoming

Tompkins

Oneida

Saratoga

Ulster

Onondaga

Otsego

Schenectady

Westchester

Oswego

Schoharie

St.

Warren

Lawrence

Washington

$526,458

$1,045,833

$561,481

$66,643

$483,425

$861,535

$12,866,527

$1,908,098

Maximum Regional Funding Amounts

$67,784

$135,110

$73,280

$8,015

$63,662

$109,920

$1,588,115

$244,114

The following organizations may apply for funding under this initiative:

  • Health worker unions;
  • General hospitals;
  • Long term care facilities;
  • Certified home health agencies, licensed home care services agencies, long term health care programs, hospices, ambulatory care facilities, diagnostic and treatment facilities;
  • Office of Mental Health or the Office of Alcohol and Substance Abuse Services licensed providers;
  • Health care facilities trade associations;
  • Labor-management committees;
  • Joint labor-management training funds established by the Federal Taft-Hartley Act; and
  • Educational institutions.

Additionally, applicants must:

  • Be a legally established organization located in NYS;
  • Have a minimum of two years of training experience with health care workers;
  • Be capable of entering into a master contract with DOH; and
  • Identify a need for training in one or more areas:
    • Occupations with known shortages;
    • Educational opportunities in shortage occupations;
    • Provide training to affected health care workers who have experienced or will likely experience job loss/displacement due to changes in health care delivery;
    • New job certification or licensing requirements; and
    • Knowledge and use of emerging technologies.

Applicants that are able to thoroughly demonstrate a need for such training will be given higher scores.  Additionally, preference points will be provided to projects that increase workforce supply in the following professions:

    • Clinical laboratory technologists;
    • Registered Nurses and Licensed Practical Nurses;
    • RN Care coordinators;
    • Certified Nursing Aides;
    • Nurse Practitioners and Psychiatric Nurse Practitioners;
    • Nurse Managers and Directors;
    • Physician Assistants;
    • Licensed Master Social Workers and Licensed Clinical Social Workers;
    • Minimum Data Set Coordinators;
    • Home Health Aides;
    • Emergency Technicians and Paramedics;
    • Physical Therapists;
    • Occupational Therapists; and
    • Diagnostic Medical Sonographers.

Applicants must also clearly demonstrate an ability to:

    • Develop and manage the structure necessary to implement proposed projects;
    • Develop project curriculum and select program participants within three months of contract execution;
    • Ensure assessment, training and placement services for proposed program participants;
    • Provide DOH with monthly or quarterly outcome and expenditure reports, as well as a two year final report; and
    • Cooperate with DOH and DOL during the program review process and provide supporting documentation regarding outcomes, expenditures and any other information required to evaluate programmatic progress.

Interested organizations must submit applications via the NYS Grants Gateway on or before June 22, 2018 by 4:00 pm.

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

 

The Broadest Impact:  2018-19 NYS Managed Care Budget Highlights

This, the last of our posts on the 2018-19 New York State Health Budget (the “Enacted Budget”), focuses on an area of healthcare that has perhaps the broadest impact of the sector as a whole — managed care.  A prior post in the series (here) discussed the central role that hospitals have traditionally played in healthcare reform efforts, but even they have less influence (at least, as a matter of policy) than managed care, which controls the funding that fuels virtually every other part of the healthcare system.  For purposes of this article, “managed care” really means Medicaid managed care in all its various guises, since that is the funding most directly controlled by the State – while the various forms of Medicare managed care (Medicare Advantage, Medicare Part D, etc.) and commercial managed care are important, and even critical, to the healthcare system in New York, they are generally not a focus of State budgeting (at least directly).  So this post will focus on the various forms of Medicaid managed care, including managed long term care (MLTC) that provide long term care services, fiscal intermediaries for consumer-directed consumer assistance, mainstream managed care plans that provide acute and primary care services, health homes that coordinate care for people with chronic illnesses, and others.  Note that one species of Medicaid managed care, Development Disabilities Individual Support and Care Coordination Organizations, are not addressed in this post, but were addressed in a prior one (here).

Just a quick word before examining the key provisions impacting managed care:  this series has not pretended to be a comprehensive analysis of all the healthcare provisions in the 2018-19 New York State Health Budget.  It has merely provided a survey of the highlights of certain key areas in the healthcare space.  Inevitably, some areas have not been directly addressed; particular ones that come to mind include primary care, professional practice, life science research and others.  In part, this was due to the lack of significant reforms in those areas; however, it was also true that the sectors we did address often included references to those other sectors.  Nowhere is this truer than in regard to managed care, which, as noted, touches on every other area of healthcare.  Key provisions in the managed care space are summarized below.

Managed Long Term Care & Fiscal Intermediaries

Managed Long Term Care (MLTC) Eligibility.  Since 2012, adults have been eligible for MLTC enrollment if they require community-based care for more than 120 days.  The Enacted Budget provides that, effective April 1, such individuals are only eligible if that 120 days is a continuous, not aggregate, period.

Changing MLTC Plans.  Effective October 1, 2018, the Enacted Budget allows MLTC enrollees to switch plans without cause anytime within 90 days of notification or the effective date of enrollment (whichever is later), but thereafter, the Department of Health (DOH) is authorized to prohibit changing plans more than once every 12 months, except for good cause.  “Good cause” includes poor quality of care, lack of access to covered services, and lack of access to providers “experienced in dealing with the enrollee’s care needs,” and may include other categories identified by the Commissioner of Health.

Nursing Home Resident Eligibility.  Effective April 1, 2018, the Enacted Budget provides that individuals who are permanently placed in a nursing home for a consecutive period of three months or more will not be eligible for MLTC, but instead will receive services on a fee-for-service basis.  In a side letter, DOH has promised to provide guidance highlighting information about an individual’s rights as a nursing home resident, nursing home and MLTC plan responsibilities, and supports for individuals who wish to return to the community.

Plan Mergers.  Effective April 1, 2018, surviving plans in a plan merger, acquisition or similar arrangement must submit a report to DOH within 12 months providing information about the enrollees transferred, a summary of which DOH will make available to the public.

Licensed Home Care Services Agency (LHCSA) Contracting.  As discussed in a prior post (here), beginning October 1, 2018, the Commissioner of Health may limit the number of LHCSAs with which an MLTC plan may contract, according to a formula tied to region, number of enrollees and timing (before or after October 1, 2019), with some exceptions.  In a side letter, DOH has indicated that it will issue guidance to assist both MLTC programs and LHCSAs in minimizing the disruption of care for Medicaid members and the impacted workforce from this initiative.

Fiscal Intermediary Advertising.  The Enacted Budget includes provisions that limit the advertising practices of fiscal intermediaries under the Consumer Directed Personal Assistance Program (CDPAP).  CDPAP provides chronically ill and/or physically disabled Medicaid enrollees receiving home care services with more flexibility and freedom of choice to obtain such services.  Fiscal intermediaries help consumers facilitate their role as employers by: providing wage and benefit processing for consumer directed personal assistants; processing income tax and other required wage withholdings; complying with workers’ compensation, disability and unemployment requirements; maintaining personnel records; ensuring health status of assistants prior to service delivery; maintaining records of service authorizations or reauthorizations; and monitoring the consumer’s/designated representative’s ability to fulfill the consumer’s responsibilities under the program (in this regard, they are not truly managed care, although there are some similarities).  The Enacted Budget prohibits false or misleading advertisements by fiscal intermediaries.  Furthermore, fiscal intermediaries are now required to submit proposed advertisements to DOH for review prior to distribution, and are not permitted to disseminate advisements without DOH approval.  The DOH is required to render its decision on proposed advertisements within 30 days.  In the event DOH has determined the fiscal intermediary has disseminated a false or misleading advertisement, or if an advertisement has been distributed without DOH approval, the fiscal intermediary has 30 days to discontinue use and/or remove such advertisement.  If DOH determines a fiscal intermediary has distributed two or more advertisements that are false or misleading or not previously approved by DOH, the entity will be prohibited from providing fiscal intermediary services and its authorization will be revoked, suspended or limited.  Additionally, DOH will maintain a list of these entities and will make this list available to local departments of social service, health maintenance organizations, accountable care organizations and performing provider systems.  These limitations apply to marketing contracts entered into after April 1, 2018.

Fiscal Intermediary Reporting.  The Enacted Budget allows the Commissioner of Health to require fiscal intermediaries to provide additional information regarding the direct care and administrative costs of personal assistance services.  DOH may determine the type and amount of information that will be required, as well as the regularity and design of the reports.  These cost reports must be certified by the owner, administrator, chief administrative officer or public official responsible for the operation of the provider.  The DOH must provide at least 90 days’ notice of this report deadline.  If DOH determines the cost report is not complete or inaccurate, it must notify the provider in writing and specify the correction needed or information required.  The provider will have 30 days to respond to DOH’s request for supplementary information.  In the event a provider cannot meet this filing deadline, DOH may provide an additional 30 day extension if the provider sends written notice prior to the report due date which details acceptable reasons beyond their control which justify their failure to meet the filing deadline.

Mainstream Managed Care and Health Homes

Quarterly Meetings on Medicaid Managed Care Rates.  In a side letter, the Executive has committed to providing quarterly updates to the Legislature regarding Medicaid managed care rates, including the actuarial memorandum which, pursuant to statute, is provided to managed care organizations 30 days in advance of submission to the federal Centers for Medicare and Medicaid Services (CMS).  This is intended to increase the transparency of Medicaid managed care rates.

Separate Rate Cells or Risk Adjustments for Specific Populations.  In a side letter, DOH has committed to exploring separate rate cells or risk adjustments for the nursing home, high cost/high need home and personal care, and Health and Recovery Plan (HARP) populations.  DOH will re-engage CMS regarding this reimbursement methodology with the assistance of health care industry stakeholders impacted by these changes (e.g. advocates, providers and managed care organizations).  This will hopefully lead to a fairer rate structure for plans serving higher-risk patients.

Health Homes Targets.  The Enacted Budget requires the Commissioner of Health to establish reasonable targets for health home participation by enrollees of special needs plans and other high risk enrollees of managed care plans to encourage plans and health homes to work collaboratively to achieve such targets.  The DOH was also empowered to assess penalties for failure to meet such participation targets where they believe such failure is due to absence of good faith and reasonable efforts.

Health Home Criminal History Checks.  The Enacted Budget requires criminal history checks for employees and subcontractors of health homes and any entity that provides community-based services to individuals with developmental disabilities or to individuals under 21 years old.

Health Home Reporting.  Similar to fiscal intermediaries (above) and LHCSAs (here), the Enacted Budget allows the Commissioner of Health to require health homes to report on the costs incurred to deliver health care services to Medicaid beneficiaries.

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So that concludes our series on the 2018-19 New York State Healthcare Budget.  If you have any questions or would like additional information on any of the above referenced issues, or any of the other items covered (or not covered) in the series, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

 

Responding to the Opioid Crisis and More:  2018-19 NYS Behavioral Health Budget Highlights

Several provisions in the recently adopted 2018-19 New York State Budget (the “Enacted Budget”) are intended to address the ongoing opioid crisis.  As discussed in a prior post (here), some were focused on pharmaceutical manufacturers.  Some of the most significant provisions, however, relate to the behavioral health services available to patients, including both mental health and substance use disorder (SUD) services.  Other provisions will affect behavioral health services more generally. Key provisions are summarized below.

Substance Use Disorder and Mental Health Ombudsman.  The Enacted Budget establishes the Office of the Independent Substance Use Disorder and Mental Health Ombudsman, which will be operated or selected by the Office of Alcoholism and Substance Abuse Services (OASAS), in conjunction with the Office of Mental Health (OMH).  The Ombudsman will assist individuals with SUD and/or mental illness to ensure they receive appropriate health insurance coverage.  The Ombudsman will identify, investigate, refer and resolve complaints that are made by or on behalf of consumers and treatment providers regarding health insurance coverage and network adequacy for substance use disorder and mental health care services.  The Enacted Budget appropriated $1.5 million for this program.

Prohibit Prior Authorization for Outpatient Substance Abuse Treatment.  The Enacted Budget amends several provisions of the Insurance Law to prohibit prior authorization for outpatient, intensive outpatient, outpatient rehabilitation and opioid treatment provided by OASAS-certified facilities that are within the insurer’s provider network.  The coverage provided cannot be subject to concurrent review for the first two weeks of treatment if the facility notifies the insurer of the patient’s initial start date of treatment and the treatment plan within 48 hours.  The facility is also required to perform a patient clinical assessment at each visit and consult with the insurer to ensure the facility is using the appropriate evidence-based/peer reviewed clinical tool utilized by the insurer and designated by OASAS to ensure treatment is medically necessary.  Insurers may deny coverage for any portion of the initial two weeks of treatment if the treatment was deemed not medically necessary and contrary to the insurer-designated, OASAS-approved, evidence-based/peer reviewed tool.  If such coverage is denied by the insurer, the patient is liable for the copayment, coinsurance, or deductible required pursuant to the insurance contract.

Children and Recovering Mothers Program.  The Enacted Budget authorizes the Department of Health (DOH), in consultation with OASAS, to establish the Children and Recovering Mothers Program to provide health care providers, hospitals, and midwifery birth centers with guidance, education and assistance when providing care to expectant mothers with SUD.  The program will provide information to health care providers and expectant mothers on medication-assisted treatment, a referral list of SUD providers in the area, and information on other benefits and services they may be eligible for while expecting or after birth.  The program will develop a statewide system for rapid consultation and referral linkage services for obstetricians and primary care providers who treat expectant mothers.  Additionally, the DOH, in consultation with OASAS, will convene a workgroup of stakeholders, including hospitals, local health departments, obstetricians, midwives, pediatricians and substance use disorder providers, to study and evaluate the obstacles in identifying and treating expectant mothers, newborns and new parents with SUD.  The workgroup is required to submit a report of its findings to DOH, OASAS and the Legislature by April 2019.   The Enacted Budget appropriated $1 million for this initiative and $350,000 to establish an infant recovery pilot program to support up to four recovery centers in NYS.

Peer Recovery Advocate Services.  The Enacted Budget establishes the Certified Peer Recovery Advocate Services Program which builds upon the existing NYS Peer Recovery program.

The program provides patient-centered services that emphasize knowledge and wisdom obtained through life experience, where peers share their own personal journey with SUD to support the recovery goals of others.  The program standards, training and certification process will be developed and administered by OMH.  Certified peer recovery advocate services may include: developing recovery plans; raising awareness and linking participants to existing social and formal recovery support services; working with individuals to model coping skills and develop individual strengths; assisting individuals applying for benefits; attending medical appointments and court appearances; educating program individuals about the various modes of recovery; providing non-crisis support; and working with hospital emergency services, law enforcement departments, fire departments and other first responders to assist patients that have been administered an opioid antagonist establish connections to treatment and other support services.   

Opioid Stewardship Act.  As previously discussed, the Enacted Budget establishes an “Opioid Stewardship Fund” which imposes a “stewardship payment” (essentially a tax) on manufacturers and distributors that sell or distribute opioids in New York.  More detail can be found here.

Opioid Treatment Plans. The final budget includes language which prohibits prescribing opioids beyond three months, unless the patient’s medical record contains a written treatment plan that follows generally accepted national professional or governmental guidelines.  Exceptions are provided for patients being treated for cancer or palliative care.  More detail can be found here.

Social Work, Psychology and Mental Health Practitioners Scope of Practice.  The Enacted Budget includes provisions to clarify the activities and services that may be performed by licensed practitioners and those that do not require licensing.  These provisions eliminate the need to continue the licensure exemption which has been in place for persons employed by programs regulated or operated by OMH, OPWDD, OASAS, DOH, the State Office for Aging, the Office of Children and Family Services, the Office of Temporary and Disability Assistance, the Department of Corrections and Community Supervision, and local government or social services districts since 2002.

Behavioral Health/Primary Care Integration.  The Enacted Budget includes provisions building on the State’s prior efforts to integrate the licensure of behavioral health and primary care services. Prior state regulations established standards to determine how a facility offering integrated mental health, SUD and/or primary care services must be licensed.  Unfortunately, the ability to streamline such licensure was restricted in part by applicable statutes.  The Enacted Budget revises those statutes to clarify that primary care services providers licensed by Article 28 of the Public Health Law, mental health service providers licensed by Article 31 of the Mental Hygiene Law, and SUD providers licensed by Article 32 of the Mental Hygiene Law can each provide the other types of services so long as they are authorized to provide integrated services in accordance with DOH, OMH and OASAS regulations, without obtaining additional operating certificates.

Significant Appropriations

School Mental Health Resource and Training Center.  The Enacted Budget includes $1 million to create a Resource Center to help schools provide mental health education as part of their kindergarten through 12th grade curriculum, as required by Chapter 390 of 2016.

Children’s Mental Health.  The Enacted Budget includes $10 million for services and expenses of not-for-profit agencies licensed, certified or approved by OMH to support the preservation, restructuring or expansion of children’s behavioral health services.

Jail-Based SUD Treatment and Transition.  The enacted budget includes $3.75 million for jail-based SUD and transition services.  The Commissioner of Mental Health, in consultation with local government units, county sheriffs and other stakeholders, will implement a jail-based program that supports the initiation, operation and enhancement of SUD services for individuals incarcerated in county jails.

Mental Health Facilities Capital Improvement Fund.  The enacted budget includes $50 million for the acquisition of property, construction, and rehabilitation of new facilities, to develop   residential crisis programs.  Funds may be used for the renovation of existing community mental health facilities under the auspice of municipalities, and other public or not-for-profit agencies, as approved by the Commissioner of Mental Health.

OASAS Treatment Funding.  The enacted budget includes $30 million for the development, expansion, and operation of treatment, recovery, and/or prevention services for persons with heroin and opiate use and addiction disorders. This funding will be distributed by the Commissioner of Office of Substance Abuse Services, subject to the approval of the Budget Director.

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If you have any questions or would like additional information on any of the above referenced issues, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

Pharmaceutical provisions in the 2018-2019 Enacted New York State Budget

Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once again seek to enact substantial reforms impacting the pharmaceutical industry. The recently adopted 2018-19 New York State (“NYS”) Budget included several provisions that relate to access to pharmaceutical treatments, insurance coverage, cost sharing, and reimbursement. Below please find an overview of these key provisions.

Medicaid Drug Spending Cap.  The final budget extends the Medicaid drug cap enacted last year through the 2019-20 fiscal year, at the same amount as the 2018-19 fiscal year (CPI + 4%, less an $85 million savings target). The provisions clarify that the Medicaid drug expenditure growth target shall be calculated and projected on a cash basis and requires the Department of Health (DOH) and Division of Budget to report quarterly to the Drug Utilization Review Board (DURB) the projected (state funds) Medicaid drug expenditures. These reports shall include the aggregate amounts attributable to the net cost of changes in utilization, changes in the number of Medicaid recipients, and changes in the cost of brand and generic drugs. This information cannot be publically released in a manner that will allow for identification of individual drugs or manufacturers. DOH will also be required to provide an annual report (by February 1) to the DURB which details how savings were achieved, calculated and implemented in the last year. Additionally, language was included to clarify the authority the DOH has to require prior approval of drugs and to remove such drugs from managed care formularies when they have not reached a supplemental agreement with a manufacturer.

Opioid Stewardship Act. The final budget establishes an “Opioid Stewardship Fund” which imposes a “stewardship payment” (essentially a tax) on manufacturers and distributors that sell or distribute opioids in New York. The total opioid stewardship payment is $100 million annually, and each manufacturer and distributor that sells or distributes opioids in New York will pay a portion of the total opioid payment amount based on that manufacturer’s or distributor’s ratable share. The ratable share will be calculated based on the total milligram of morphine equivalents (MMEs) sold or distributed during the preceding year, as reported by the manufacturer and distributor, and shall be divided by the total amount of MMEs sold in New York by all manufacturers and distributors. The payment percentage will be multiplied by the total opioid stewardship payment to determine the ratable share. The calculation of total MME’s shall not include opioids sold or distributed to entities certified to operate as hospices and chemical dependence services. Opioid stewardship funds will be used to support programs operated by OASAS for opioid treatment, recovery, prevention, education and the I-STOP program, pursuant to approval of NYS Budget Director. 

Opioid Treatment Plans. The final budget includes language which prohibits prescribing opioids beyond three months, unless the patient’s medical record contains a written treatment plan that follows generally accepted national professional or governmental guidelines. Exceptions are provided for patients being treated for cancer or palliative care.

Direct Negotiations for Supplemental Rebates in Medicaid Managed Care. The enacted budget extends authority through March 31, 2020 to allow DOH to negotiate directly with drug manufacturers to obtain supplemental rebates for pharmaceutical utilization of anti-retrovirals and Hepatitis C treatments for Medicaid managed care recipients. The manufacturer is not required to pay supplemental rebates to a managed care provider, or any of a managed care provider’s agents when NYS is collecting such supplemental rebates. This statute was originally enacted in 2015.

Rebates for Generics.  The final budget agreement extends DOH authority through March 31, 2020 to require additional rebates/penalties for drugs that have a state maximum acquisition cost (SMAC) of more than 75% over a one year period under the Medicaid program. This statute was first enacted in 2016.

Pharmacy Benefit Manager Clawbacks and Pharmacy Gag Prohibition. The final budget includes language to prohibit pharmacy benefit managers (PBMs) and their contracting agents from penalizing a pharmacist or a pharmacy from disclosing pricing information, the availability of therapeutic equivalents, and alternative payment methods that may be less expensive for patients. PBMs are further prohibited from imposing a co-payment that exceeds the total cost of the drug. Moreover, if an individual pays a co-payment, the pharmacy is entitled to retain the adjudicated costs and the PBM is prohibited from recouping the additional funds.

Pharmacy Dispensing Fees.  The final budget increases the professional pharmacy dispensing fee from $10.00 to $10.08 per prescription.

Prescriber Prevails.  The final budget agreement continues prescriber prevails consumer protections in both Medicaid fee-for-service and Medicaid managed care. Under current law, a prescriber’s determination can prevail over prior authorization limitations for any drug in fee-for-services, and for eight protected classes of drugs in managed care.

 

If you have any questions or would like additional information on any of the above referenced issues, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.

Governor Cuomo's 2018-19 Healthcare Budget
New York State Healthcare Budget 2018-19

In the wee hours of the morning on March 30, almost two days ahead of the April 1 deadline, the Legislature passed and the Governor signed a $168.3 billion State Budget for the 2018-19 fiscal year. The Enacted Budget maintains a self-imposed cap of 2% on spending increases, and averts a predicted $4.4 billion spending gap.  As in prior years, a significant portion of this year’s spending has been devoted to healthcare, and particularly Medicaid.

One of the key issues faced by the healthcare sector in New York State during budget negotiations this year was whether and how to address potential future cuts in federal financial support. The Enacted Budget addresses that general concern in two ways.  First, at the prompting of the Greater New York Hospital Association and 1199SEIU (the health care workers union), the Enacted Budget creates a new “Health Care Transformation Fund.”  The fund will be supported in part by a portion of the proceeds of the sale of Fidelis, a not-for-profit Medicaid managed care plan acquired by Centene, a national for-profit insurer, as well as a portion of Fidelis’ excess reserves, for a total expected amount of around $2 billion.  Moneys in the fund will be available for transfer to any other fund in the State to “support health care delivery, including for capital investment, debt retirement or restructuring, housing or other social determinants of health, or transitional operating support to health care providers.”  This amounts to a very significant source of funds which can be deployed by the State in a very flexible manner.

Second, the Enacted Budget includes language providing that, where federal legislation, regulation or other executive or judicial action in federal fiscal year 2019 is expected to reduce federal financial participation in Medicaid or other federal financial participation by $850 million or more in state fiscal years 2018-19 or 2019-20, the Director of the Division of the Budget must submit a plan to the Legislature identifying the resulting cuts to be made in State spending. The Legislature will then have 90 days to adopt an alternative plan; if it does not, then the Division of the Budget’s plan will go into effect immediately.  In short, this language could, in effect, completely undo the budget just adopted by the Legislature, with minimal legislative input.

The 2018-19 Enacted Budget includes a plethora of other financial and policy reforms affecting virtually every segment of the healthcare sector. Some highlights include:

  • Health Care Facility Capital Funds: The Enacted Budget includes $525 million for the latest iteration of the Statewide Health Care Facility Transformation Program, which provides capital grants to healthcare providers.
  • Pharmacy: The Enacted Budget makes a variety of changes to address the opioid crisis, including establishing a $100 million “Opioid Stewardship Fund” to be supported by manufacturers and distributors of opioids, which will be used to support a variety of opioid-related programs.
  • Mental Hygiene: The Enacted Budget expands and clarifies the ability of mental health, substance use disorder and developmental disabilities services providers to offer integrated services, and provides $1.5 million for the creation of a new Independent Substance Use Disorder and Mental Health Ombudsman to assist individuals in receiving appropriate health insurance coverage.  It also includes a variety of provisions related to the transition of developmental disabilities services to managed care.
  • Long Term Care: The Enacted Budget sets out a plan for limiting the number of licensed home care services agencies that a managed long term care plan may contract with, effectively forcing consolidations in that sector.  It also allows the Commissioner of Health to reduce reimbursement to poor-performing nursing homes.  At the same time, it makes a significant number of additional assisted living program beds available at the discretion of the Commissioner.
  • Hospitals: The Enacted Budget establishes a new category of “Enhanced Safety Net Hospitals” that would be eligible for additional reimbursement.
  • Managed Care: The Enacted Budget includes a variety of reforms related to health homes, and makes a variety of changes to the rules governing managed long term care eligibility and enrollment.

These highlights are just the tip of the iceberg. Over the next several days, we will provide additional detail on each of the areas outlined above.  In the meantime, any questions about the 2018-19 New York State Healthcare Budget can be addressed to Farrell Fritz’s Regulatory & Government Relations Practice Group at (518) 313-1450 or NYSRGR@FarrellFritz.com.