Home health care aides working twenty-four hour shifts can be paid for as little as thirteen hours under certain conditions, according to a March ruling from the New York Court of Appeals in Andryeyeva v. New York Health Care, Inc. The Court of Appeals remanded, however, for lower courts to consider whether employers were adhering to the sleep and meal time requirements of the minimum wage law.

The DOL Minimum Wage Order

New York’s Minimum Wage Act requires that all employees be paid a minimum wage for each hour worked. The Act delegates to the Commissioner of Labor the authority to set the minimum wage by issuing “wage orders.” In March 2010, the Department of Labor issued an opinion letter on the wage order applicable to home health care aides, including the calculation for “live-in employees,” who are assigned to a patient’s home on twenty-four hour shifts. The letter stated that:

  • Live-in employees must be paid at least thirteen hours for each twenty-four hour period, as long as they receive: (a) eight hours for sleep and actually receive five hours of uninterrupted sleep; and (b) three hours for meals.
  • If an aide does not receive five hours of uninterrupted sleep, the sleep period exclusion does not apply and the employee must be paid for all eight hours.
  • If the aide does not receive three work-free hours for meals, the three hour meal period does not apply and the employee must be paid for all three hours.

Plaintiffs’ Class Action Allegations and the Appellate Division Ruling

In two separate cases, plaintiffs sought to certify a class of home health care aides based on the employers’ failure to pay a required minimum wage for each hour of a twenty-four hour shift. In addition to the failure to pay for each hour of the twenty-four hours, plaintiffs alleged that they routinely did not receive five hours of uninterrupted sleep and were not allowed to take meal breaks.

The Appellate Division affirmed the certification of a class, rejecting the DOL interpretation of the wage order as “neither rational nor reasonable.” The Appellate Division reasoned that the employees were required to be present at the patient’s home and to perform services as needed and be available for work for the full twenty four hours.

In October 2017, DOL issued a Notice of Emergency Rulemaking in response, “to preserve the status quo, prevent the collapse of the home care industry, and avoid institutionalizing patients who could be cared for at home.” In a separate action in September 2018, the Supreme Court in New York County invalidated the emergency regulation.

Court of Appeals Sides With DOL and Employers

The Court of Appeals first cited authority that courts must defer to an administrative agency’s rational interpretation of its own regulations. Also, an agency construction that has been followed for a long period of time is entitled to great weight.

As applied to twenty-four hour shift workers, the DOL interpreted the requirement “to be available for work at a place prescribed by the employer” to exclude up to eleven hours for sleep and meal breaks, based on DOL’s understanding that these are regularly scheduled substantial periods of assignment-free personal time. The Court of Appeals concluded that the DOL interpretation was not inconsistent with the plain language of the wage order, and was not an irrational or unreasonable construction as applied to 24-hour shift workers.

The Court observed that the DOL interpretation had been consistent for nearly five decades, and had been set out in the DOL Investigator’s Manual and DOL memoranda and opinion letters. The DOL advanced its conclusion that employees who enjoy genuine sleep and meal breaks are not meaningfully available for work during those periods. The Court found that with respect to home health care aides, this interpretation was supported by DOL’s experience with the particularities of the home health aide occupation. The Court also found DOL’s interest in conforming state and federal guidance on the proper calculation of compensable hours to be reasonable.

Remand for Allegations of Lack of Sleep and Meal Times

Although the Court held for the employers on the DOL twenty-four hour interpretation, it remanded for the lower courts to consider the merits and class certification arguments concerning the plaintiffs’ other allegations. The Court described the DOL interpretation as a “hair trigger” that immediately makes the employer liable for paying every hour of the 24-hour shift if it fails to provide the minimum sleep and meal times required, and on remand the lower courts would have to consider whether the employers had complied with all DOL requirements.

The Court of Appeals stressed that it was not ignoring the “claims that a vulnerable population of workers is being mistreated.”

Plaintiffs’ allegations are disturbing and paint a picture of rampant and unchecked years-long exploitation. Plaintiffs allege, among other things, that they rarely received required sleep and meal time during 24-hour shifts, were expected and required to attend to patients numerous times each night, and that defendants failed to track actual hours worked or make a serious effort to ensure adequate sleep and meal times, as required by law.

This decision avoids the danger expressed by DOL that a ruling requiring twenty-four hour payment for all home health care aides could lead to “the collapse of the home care industry.” Nevertheless, it does signal that DOL and the Courts are likely to look very closely to whether home health care employers are rigorously adhering to the “hair trigger” minimum wage requirements for those workers.

The New York State budget, which took effect yesterday to start the new fiscal year on Monday, April 1, does not include a plan for the legalization of adult recreational marijuana use. Instead, Governor Cuomo and the New York Legislature intend to work on developing a more concrete plan for the legalization of recreational marijuana before the close of the session on June 19th.

Probably the biggest single issue that will not be addressed will be the legalization of marijuana,” Cuomo told reporters. “In concept we have an agreement, but…it is complex, and the devil is in the details…if it’s not done after the budget, I believe we get it done after the budget.”

There are currently ten states, including the District of Columbia, that have legalized adult recreational marijuana use: Colorado (2012), Washington (2012), Alaska (2014), Oregon (2014), District of Columbia (2014), California (2016), Maine (2016), Massachusetts (2016), Nevada (2016), Vermont (2018) and Michigan (2018).

Support for legalizing recreational marijuana remains high in New York, but groups such as the Parent Teacher Association, the American Academy of Pediatrics and certain law enforcement unions are becoming more vocal about their opposition to the establishment of a regulated marijuana program. On February 7, 2019, the New York State Sheriffs Association and State Association of Chiefs of Police spoke out against marijuana legalization because, among other reasons, there are no methods in place, or funding, to enforce laws against driving while under the influence of marijuana.

In addition, certain counties in New York, including Nassau, Suffolk, Rockland, Putnam and Chemung counties, have indicated that they would opt out of all cannabis related commercial businesses. As we discussed in one of our earlier posts, the New York Cannabis Regulation and Taxation Act includes a clause allowing counties and cities with populations over 100,000 to opt-out of allowing cannabis business license types within their jurisdictions. If opting out, as long as an individual is 21 years of age or older, they would still be permitted to possess, consume, and purchase cannabis from other counties that opt in.

On March 15, 2019, the Nassau County Task Force on Marijuana Legalization and Regulation issued its Report in which the Task Force “recommends that if the New York State Cannabis Regulation and Taxation Act is passed in its current form, that Nassau County Opt Out of all cannabis related commercial businesses.” Such potential opt outs do not seem to worry Governor Cuomo, however. “I don’t think it’s determinative,” he said back in March 2019. “It does make a difference on the statewide revenues and it will cost those municipalities, localities that opt out because then they would not get the local share of the revenues. But it’s not helpful politically to the passage.”

New York is not the only state hitting a roadblock in trying to get recreational marijuana legalized. Governor Phil Murphy attempted to have New Jersey be the second state to legalize marijuana legislatively (Vermont was the first), rather than through a public voter referendum. The vote on his bill, that would have legalized recreational marijuana for adults 21 and older in New Jersey, was called off at the last minute however due to a lack of support for the bill in the state Senate.

bankruptcy lawSection 351 of the Bankruptcy Code permits a health care business in bankruptcy to dispose of patient records if it lacks sufficient funds to pay to store the records in accord with applicable state or federal law.  Although section 351 was enacted in 2005, the provision appears to be little used.  That’s because the procedures required before patient records may be destroyed are time consuming, onerous and, in all likelihood, more expensive than storing them.

If the health care business in bankruptcy has insufficient funds to pay for patient records storage under applicable law, section 351 requires that it promptly publish notice in one or more appropriate newspapers that patient records not claimed by patients or insurers within one year will be destroyed.  Within six months after the publication, it must notify each patient by mail at the patient’s most recent known address, or the address of a family member or contact person for the patient, to claim his/her records within the one-year period.   The insurer for each patient must also receive notice by mail to claim the records or suffer their destruction.  For any patient records not claimed within the one-year period, the debtor health care business must send written requests to each “appropriate” federal agency asking permission to deposit the unclaimed records with the agency.  Whatever patient records remain in the possession of the health care business following this procedure must be shredded or burned, if they are written records, or destroyed, if magnetic, optical or electronic.  Bankruptcy Rule 6011 provides further guidance that the notice must be sent to patients and family members or contact persons for patients, and the Attorney General of the state where the health care facility is located.

In addition to being time consuming and somewhat vague, these requirements would be onerous for all with the possible exception of health care businesses with few patients.  A large physician practice group will have thousands or tens of thousands of patient records, many of which may be written.  The administrative effort to review each of them for patient addresses, family members and others such as health care proxies, and prepare and send the notices, will likely be time consuming, expensive and difficult.  A hospital will likely have tens or hundreds of thousands of patient records. The time, effort and expense needed to comply with section 351 for a hospital of any size would be herculean.

A number of hospitals which have filed chapter 11, ceased operations and confirmed plans of liquidation without a going concern sale of their business or assets in which the buyer that acquired the patient records, found an easier, much faster and more inexpensive alternative to section 351.  The buyer paid a records storage company to take all of the patient records.  The records storage company took possession of the records, converted paper records to electronic form, maintained them pursuant to applicable state and federal law, culled out and destroyed old records when state and federal law permitted, and, for a fee, provided access to the records to patients and litigation parties, in actions and proceedings where the records were relevant.  In this writer’s experience, there have often been several records storage companies willing to store and maintain the records and the debtor hospital has been able to obtain competing bids from them.  These hospitals had sufficient funds to pay a records storage company to take and administer the patient records.  Query whether they had sufficient funds to comply with section 351.

Debtor health care businesses that are insolvent on a post-bankruptcy basis, and intend to or are forced to shut down their operations and liquidate without a confirmed plan or in chapter 7, might consider disposing of patient records under section 351.  Except possibly for small businesses, however, the time, effort and expense of following the procedure mandated by section 351 will likely be much greater than the records-storage- company alternative, so long as this alternative is available.  Although it is not clear how such insolvent health care businesses would pay for records disposal under section 351 or, alternatively, pay to transfer the records to a records storage company, the latter will likely be less time consuming, take much less administrative effort and be less expensive.

EDNY Judge Nina Gershon analyzed several False Claims Act issues in United States ex rel. Omni Healthcare Inc. v. McKesson Corp., ruling on first-to-file, Rule 9(b), and statute of limitations issues.

Relator Omni Healthcare alleged that defendants improperly used “overfill” in vials of injectable drugs. “Overfill” is the amount of a drug in excess of the amount indicated on the label, typically included so the provider can withdraw a full dose from the vial. Relator alleged that defendants wrongfully broke into the vials, harvested the overfill, and then sold syringes with the overfill to providers who then billed the government.

Identify of Defendants Drives First-To-File Ruling

The Court initially addressed whether relator’s second amended complaint should be dismissed under the first-to-file rule, based on an earlier-filed case that also addressed alleged fraudulent repackaging of overfill. The Court reviewed Second Circuit law holding that a later-filed action is related and therefore barred if it “incorporate[s] the same material elements of fraud as the earlier action.” The Court concluded that the Omni Healthcare allegations were only related as to the one defendant that was a defendant in the earlier action, and dismissed the complaint only as against that defendant. The Court held that “the first-to-file bar would not reach a subsequent qui tam action otherwise alleging the same material elements of fraud, but alleging those elements concerning different defendants.” A later complaint is related if the earlier complaint equips the Government to investigate the fraud, and the Court determined that to be “‘equipped’ to investigate a fraud, the government must know whom to investigate.”

2017 Chorches Decisions Defeats Rule 9(b) Challenge

Defendants next asserted that the complaint did not satisfy the particularity requirement for pleading fraud under Rule 9(b), because it lacked allegations about the content of the false claims, who submitted them, and when they were submitted. Judge Gershon denied this argument based on the 2017 Second Circuit decision in United States ex rel. Chorches v. Am. Med. Response, Inc., which was discussed here. The Court held that “such information is not required where, as here, the relator’s allegations create a strong inference that specific false claims were submitted.”

Statute of Limitations Bars Claims Against Added Defendants

Omni Healthcare conceded that, to satisfy the False Claims Act six year statute of limitations, the new allegations in its second amended complaint would be timely only if they related back to its earlier-filed first amended complaint. The Court noted that the False Claims Act specifically allows a timely complaint to satisfy the statute of limitations even though the named defendants were deprived of notice while the complaint was sealed. New claims against defendants named by Omni Healthcare in the first amended complaint were therefore timely. The second amended complaint, however, had added five additional defendants, and the Court held that claims against these defendants were untimely. “The statute of limitations, like the first-to-file rule, encourages relators to come forward promptly with information to help the government uncover fraud … This purpose would be undermined if a relator were permitted to add additional defendants years later—and potentially after the government has declined to intervene.”

Judge Gershon’s rulings highlight the importance of naming all False Claims Act defendants as early as possible to avoid procedural dismissals.

On January 15, 2019, Governor Andrew Cuomo delivered his 2019 State of the State Address. Part of his address centered on the legalization of recreational marijuana in New York State.

The Cannabis Regulation and Taxation Act was introduced as part of the Governor’s Executive Budget, which is expected to be acted upon by April 1st. If it is approved, New York will join ten other states – Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington – and Washington D.C., in adopting laws legalizing marijuana for recreational use.

As you may recall from one of our previous posts, as part of his 2018 State of the State Address Governor Cuomo directed the Department of Health (“DOH”) to conduct a study to determine the potential impact of a recreational marijuana program in New York State.

The Report from the DOH, issued in July 2018, concluded that the positive impacts of a regulated marijuana program in New York State outweigh the potential negative aspects. The Report stated that the regulation of marijuana benefits public health by enabling government oversight of the production, testing, labeling, distribution, and sale of marijuana. The Report further found that the creation of a regulated marijuana program would enable New York State to control licensing, ensure quality control and consumer protection, and set age and quantity restrictions.

Details of the program are still being developed, but the Governor’s proposed bill would create a new Office of Cannabis Management (OCM) which would administer all licensing, production, and distribution of cannabis products in the adult-use, industrial and medical marijuana markets. Governor Cuomo predicts that a recreational marijuana program in New York State will generate approximately $300 million in tax revenue and create jobs. That number could vary slightly, however, as the program would allow counties, as well as cities with a population of more than 100,000, to affirmatively opt out of the program and pass laws blocking one or more types of allowed marijuana operations.

During his 2019 State of the State Address Governor Cuomo also emphasized that the any implementation of a regulated marijuana program will also provide for the implementation of quality control and consumer protections to safeguard public health. His proposal would also automatically seal criminal records for marijuana offenses that are no longer crimes.

As with the other states that have legalized recreational marijuana, recreational marijuana use in New York State will be restricted to adults over the age of 21.

While there is growing support for a recreational marijuana program in New York, not everyone is optimistic that the Legislature will vote to legalize recreational marijuana as part of the state budget, which is due on April 1. At an event on January 31, 2019, Assembly Speaker Carl Heastie indicated that six weeks may not provide enough time to parse out the terms of such a complicated issue. He later tweeted: “Being honest and saying six weeks may not be enough time to come up with regulations, deal with economic impact on communities and the criminal justice aspects, somehow gets reactions of outrage instead of understanding and acknowledgment of the commitment to get this done…And done right.”

In response, Governor Cuomo said on February 1st during an interview with WCNY radio that he remains confident the Legislature can vote to legalize recreational marijuana as part of the state budget. “We’ll work very hard to get it done,” Cuomo said on WCNY radio. “In this business, six weeks is a lot of time. If we can’t do it right, then we’ll do it later.”

Since the advent of the Medicaid managed care program there has been a lingering question as to when a Medicaid dollar stopped being a Medicaid dollar.

With fee-for-service providers that were paid directly by the Medicaid program, the answer was always clear-cut – each dollar received from the Medicaid program was a Medicaid dollar and therefore it and the provider who received it were subject to the audit authority of the New York State Office of the Medicaid Inspector General (“OMIG”).

But what about providers contracted through Medicaid managed care organizations (“MCO”) and not directly enrolled as Medicaid providers? Before Governor Cuomo issued his Executive Budget earlier this month, there was debate as to where the OMIG’s audit authority stopped with arguments on either side of the line.  Many argued that the OMIG’s authority stopped with at the doors of the MCO.  After the money was paid to the MCO it was able to negotiate contracts directly with providers and disburse the funds as it saw fit, with each MCO operating independently of each other.  The other side of the coin was that a dollar spent with the purpose of providing care to a Medicaid recipient established that the dollar was a Medicaid dollar from start to finish, regardless of whether it was passed through a MCO.

With the Executive Budget, however, all confusion and debate will be settled.  Per the proposed language of the Health and Mental Hygiene Article VII Legislation, Social Services Law Section 364-j will be amended to state that “[a]ny payment made pursuant to the state’s managed care program, including payments made by managed long term care plans, shall be deemed a payment by the state’s medical assistance program.”

The Executive Budget goes further, clearly defining the OMIG’s ability to recover overpayments made by a MCO to its contracted providers that were discovered during an OMIG audit or investigation, as well as during an investigation or prosecution by the New York State Office of the Attorney General Medicaid Fraud Control Unit (“MFCU”).  If the OMIG is unable to recover the overpayment, the MCO may be required to act on the OMIG’s behalf to recoup the overpaid funds and repay the State within six months of receiving notice of the overpayment.

The legislation sets January 1, 2018 as the start of the review period and, without any amendments to the budget bill by the Legislature, will go into effect immediately upon the Governor signing the bills into law.  With the OMIG poised to begin these audits, MCO-contracted providers should familiarize themselves with the OMIG’s audit protocols and procedures.

Medicaid providers, both fee-for-service and those contracted with MCO, who are interested in taking a proactive stance in preparing for an OMIG or MFCU audit or investigation, or providers who are already the subject of one are encouraged to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com to plan your next move.

When a health care business files for bankruptcy, the appointment of an ombudsman to monitor the quality of patient care and represent the interests of the patients is required unless the bankruptcy court finds that an ombudsman “is not necessary for the protection of patients under the specific facts of the case.” Bankruptcy Code §333(a)(1).[1]  Because many health care businesses which file for bankruptcy believe a patient care ombudsman is not necessary to ensure their quality of care and the cost of an ombudsman (which is paid by the debtor) may be material, motions for a determination that a patient care ombudsman is not required are fairly common.

Neither the Bankruptcy Code nor the Bankruptcy Rules provide a guide for the bankruptcy court’s analysis of whether an ombudsman is needed. The bankruptcy courts have developed standards that examine the operation of the health care business using a number of non-exclusive factors. One frequently cited decision listed and analyzed the following factors: (1) the cause of the bankruptcy; (2) the presence and role of licensing or supervising entities; (3) the debtor’s history of patient care; (4) the ability of patients to protect their rights; (5) the level of dependency of the patients on the facility; (6) the likelihood of tension between the interests of the patients and the debtor; (7) the potential injury to the patients if the debtor drastically reduced its level of patient care; (8) the presence and sufficiency of internal safeguards to ensure the appropriate level of care; and (9) the impact of the cost of an ombudsman on the likelihood of a successful reorganization.  In re Alternate Family Care, 377 B.R. 754 (Bankr. S.D. Fla. 2007). The Bankruptcy Court for the Eastern District of New York adopted the Alternate Family Care factors in In re North Shore Hematology-Oncology Associates, P.C., 400 B.R. 7, 11 (2008). The North Shore decision listed an additional four factors found in a 2008 California bankruptcy court decision: (1) the quality of the debtor’s current patient care; (2) the debtor’s financial ability to maintain quality care; (3) whether the debtor has an internal ombudsman program; and (4) the level of oversight of the debtor by governmental and professional association programs which might make the services of an ombudsman duplicative. The weight to be accorded each of the factors, according to the North Shore decision, is left to the sound discretion of the reviewing court.

A leading bankruptcy treatise concludes that, based on the language of the patient care ombudsman provision of the Bankruptcy Code, the court should conduct an evidentiary hearing on the motion. However, the bankruptcy courts in the Eastern District of New York more often decide the motions after argument on the motion papers, including the consideration of evidence through fact declarations, without live testimony. For the motion to succeed, the debtor must overcome the presumption in the statute in favor of appointing ombudsmen in health care bankruptcies, as well as the bankruptcy court’s likely conservative approach that an ombudsman will be appointed unless there is no realistic possibility that the quality of care will be compromised in any way, especially if the debtor provides in-patient services.

 

[1] A health care business is broadly defined in the Bankruptcy Code to mean any entity that provides medical or psychiatric services, or long-term care.

In federal criminal investigations, corporate health care providers have faced a Department of Justice increasingly focused on individuals, one that has limited or foreclosed cooperation credit for corporations not providing complete information on all individual involvement. At a conference in late November, Deputy Attorney General Rod Rosenstein outlined a modification of these stringent guidelines, to some extent for criminal prosecutions cases but more significantly for civil cases.

The 2015 Yates Memorandum established DOJ’s policy on individual accountability for corporate wrongdoing. This policy provided that corporations must provide all relevant facts about individuals to be eligible for any cooperation credit; criminal and civil investigations should focus on individuals from inception; no corporate resolution will provide protection from criminal or civil liability for any individuals; and considerations for civil suits against individuals should go beyond ability to pay, stressing deterrence and accountability.

Rosenstein first highlighted the consistencies of the new approach with the Yates Memorandum, as pursuing individuals responsible for wrongdoing is still a top DOJ priority. Any company seeking cooperation credit must identify all individuals substantially involved in or responsible for the criminal conduct. However, “investigations should not be delayed merely to collect information about individuals whose involvement was not substantial, and who are not likely to be prosecuted.” In criminal cases, this will allow cooperation credit without identifying every person involved, as long as the company discloses individuals who played significant roles or who authorized the misconduct.

Rosenstein said the changes were driven in large part by DOJ’s affirmative civil enforcement cases, where the changes are more substantial. The primary goal of these cases is to recover money, and DOJ found the Yates Memorandum’s “all or nothing” approach to cooperation counterproductive in civil cases. “When criminal liability is not at issue, our attorneys need flexibility to accept settlements that remedy the harm and deter future violations, so they can move on to other cases. … Our civil litigators simply cannot take the time to pursue civil cases against every individual employee who may be liable for misconduct.”

The new policy gives DOJ civil attorneys the discretion to offer some credit even if a company does not qualify for the maximum credit that comes with identifying every individual substantially involved in or responsible for the misconduct, as long as the company meaningfully assists the government’s investigation and does not conceal wrongdoing. DOJ civil lawyers can negotiate civil releases for individuals who do not warrant additional investigation and, importantly, can consider an individual’s ability to pay in deciding whether to pursue a civil judgment. Rosenstein said these “commonsense reforms” would return to DOJ civil attorneys the discretion they previously exercised in civil cases, to “use their resources most efficiently to achieve their enforcement mission.”

The practical implications of this change will play out over time. Rosenstein’s language suggests that a significant dividing line will be whether individual U.S. Attorney’s Offices view the conduct at issue as a joint criminal-civil matter or as a civil matter without a parallel criminal case. In the former, the only change may be an understanding that the company may be able to streamline the number of people that are the focus of investigation and disclosure. In a purely civil investigation or case, however, Rosenstein’s language indicates significant discretion will be given to DOJ civil attorneys to work out practical settlements that aim towards monetary recoveries for the government and victims, as well as an efficient use of resources to maximize recovery across all cases. In at least the purely civil cases, Rosenstein’s comments offer significant arguments to defense counsel to propose and advocate the practical resolution of government investigations and cases.

The Compassionate Care Act has expanded and changed each year since Governor Andrew M. Cuomo signed it into law in 2014 and 2018 was no different.

Among others, one big change that was made to the Medical Marijuana Program was the addition of opioid replacement as a qualifying condition[1] for medical marijuana. As a result of this change, patients with severe pain that doesn’t meet the definition of chronic pain can use medical marijuana as a replacement for opioids. The regulation also added opioid use disorder as an associated condition, allowing patients with opioid use disorder who are enrolled in a certified treatment program to use medical marijuana as an opioid replacement.

In 2019, New Yorkers will continue to see changes and tweaks to the Medical Marijuana Program as the State aims to improve the program. Change may also be on the horizon with respect to recreational marijuana use in New York State.

Medical Marijuana Update

On November 14, 2018, the New York State Department of Health published its Medical Use of Marijuana Under the Compassionate Care Act Two-year Report – 2016-2018. The purpose of the report is to provide an overview of the program’s activities since the last two-year report was published in 2016. You can view the Report for the years 2014-2016 by clicking here.

In the 2018 Report the DOH recommends “expanding the medical marijuana program to reach patients who may be self- medicating with marijuana from sources that are not regulated or held to the same high-quality standards as the medical marijuana products manufactured by registered organizations in New York State.”

In order to expand the program the DOH lists nine steps it will endeavor to undertake, some of which New Yorkers will likely see in 2019.

One of the changes the DOH wishes to make in order to expand and improve the program is to afford practitioners more clinical discretion in determining whether or not to certify patients for medical marijuana, based on an evaluation of the patient’s condition, past treatment and the overall risks versus benefits for each patient.

In addition, the DOH wants to increase the number of practitioners available to certify patients, by permitting all prescribers of controlled substances to humans to participate in the program. This is a change from current regulations that only allow physicians, nurse practitioners and physician assistants to certify patients to use medical marijuana.

In the 2018 Report the DOH also recommends increasing the number of caregivers for each certified patient to five caregivers per patient in hopes that this will allow for increased flexibility for families in providing care to their loved ones. Currently the number of caregivers for each certified patient is capped at two.

Recreational Marijuana Update

Nine states, plus Washington D.C., have all fully legalized marijuana use. As we had noted in New York May Consider Recreational Marijuana Legalization, in his January 2018 budget address Governor Cuomo called for an assessment of the possible impact of regulating marijuana in New York State. The Governor directed certain New York State agencies to evaluate the health, public safety, and economic impact of legalizing marijuana.

In July 2018, the DOH published its findings in the “Assessment of the Potential Impact of Regulated Marijuana in New York State.” Overall, the DOH indicated that it would be in favor of the establishment of a regulated marijuana program.

The positive effects of a regulated marijuana market in NYS outweigh the potential negative impacts. Areas that may be a cause for concern can be mitigated with regulation and proper use of public education that is tailored to address key populations. Incorporating proper metrics and indicators will ensure rigorous and ongoing evaluation.

A full summary of the DOH’s findings can be found in our previous blog post, NYS Department of Health Report Green Lights Legalization of Marijuana.

Following the issuance of the Report Governor Cuomo held Regulated Marijuana Listening Sessions, the purpose of which was to gather input from community members on the possible enactment of a regulated marijuana program in New York State. The Listening Sessions were held across New York State during September and October.

On November 21, 2018, a spokesperson for Governor Cuomo confirmed that creating a framework for legalizing adult marijuana use is among the administration’s 2019 legislative priorities.

The goal of this administration is to create a model program for regulated adult-use marijuana – and we determined the best way to do that was to ensure our final proposal captures the views of everyday New Yorkers,” said Tyrone Stevens, a spokesperson for the Governor. “Now that the listening sessions have concluded, the working group has begun accessing and reviewing the feedback we received and we expect to introduce a formal comprehensive proposal during the 2019 legislative session.

 

[1] Opioid replacement joins the following 12 qualifying conditions under the state’s Medical Marijuana Program: cancer; HIV infection or AIDS; amyotrophic lateral sclerosis (ALS); Parkinson’s disease; multiple sclerosis; spinal cord injury with spasticity; epilepsy; inflammatory bowel disease; neuropathy; Huntington’s disease; post-traumatic stress disorder; and chronic pain.

As New Yorkers are preparing for Thanksgiving and the official start to the holiday season (although some could argue it started a month ago), required Medicaid providers should also be reviewing their Compliance Programs in preparation to submit their Annual Provider Compliance Program Certification to the New York State Office of the Medicaid Inspector General (“OMIG”).  Required providers must submit a certification at the time of their enrollment and each December thereafter.

As defined by Social Services Law Section 363-d (“Section 363-d”) and Part 521 of Title 18 of the New York Code of Rules and Regulations (“Part 521”), required providers are considered any provider that can answer “Yes” to one of the following questions and therefore must implement a comprehensive Compliance Program:

  1. Is the provider organization subject to Article 28 or Article 36 of the NYS Public Health Law?
  2. Is the provider organization subject to Article 16 or Article 31 of the NYS Mental Hygiene Law?
  3. Does the provider organization claim or order, or can be reasonably expected to claim or order, Medicaid services or supplies of at least $500,000 in any consecutive 12-month period?
  4. Does the provider organization receive Medicaid payments, or can be reasonably expected to receive payments, either directly or indirectly, of at least $500,000 in any consecutive 12-month period?
  5. Does the provider organization submit Medicaid claims of at least $500,000 in any consecutive 12-month period on behalf of another person or persons?

There are two important concepts to be aware of when answering these questions.  First, as defined by the OMIG, Indirect Medicaid Reimbursement is any payment that a provider receives for the delivery of Medicaid care, services, or supplies that comes from a source other than the State of New York.  An example of this is when a provider provides covered services to a Medicaid beneficiary who is enrolled in a Medicaid Managed Care Plan, any payment from the Managed Care Organization is considered an indirect payment.

The second important concept is that the OMIG considers any consecutive 12-month period to be exactly that, any twelve consecutive months.  This determination should not be considered solely on a calendar year.  For example, if a provider established her practice on April 1, 2018 and will not reach $500,000 in either claims or payments by December 31, 2018 but can reasonably expect to hit that mark by March 2019, then that provider should have a Compliance Program in place and be prepared to certify to its implementation by December 31, 2018.

To assist providers, the OMIG’s website identifies seven compliance areas that a provider’s Compliance Program must apply to, as well as eight elements that should be included in all Compliance Programs, regardless of provider type.

The Seven Compliance Areas are:

  1. Billings;
  2. Payments;
  3. Medical necessity and quality of care;
  4. Governance;
  5. Mandatory reporting;
  6. Credentialing; and
  7. Other risk areas that are or should with due diligence be identified by the provider.

The Eight Elements required in every Compliance Program are:

Element 1: Establish written policies and procedures that clearly describe and implement compliance expectations, as well as provide guidance to employees and others on dealing with potential compliance issues.  The written policies and procedures must also identify how to communicate compliance issues to appropriate compliance personnel and describe how potential compliance problems are investigated and resolved.

Element 2: Designate a Compliance Officer who is responsible for the day-to-day operation of the Compliance Program.

Element 3: Establish an effective training and education program for all affected employees and persons associated with the provider, including executives and governing body members (“affected persons”).

Element 4: Establish clear lines of communication to the Compliance Officer that allow all affected persons report compliance issues.  Providers must also establish anonymous and confidential reporting systems.

Element 5: Establish disciplinary policies that are fairly and firmly enforced to encourage good faith participation in the Compliance Program by all affected persons.  The policies must include clear expectations for the reporting or and assistance in resolving compliance issues.  The policies must also include defined sanctions for:

  • failing to report suspected problems;
  • participating in non-compliant behavior; or
  • encouraging, directing, facilitating or permitting either actively or passively non-compliant behavior.

Element 6: Conduct routine compliance assessments for those risk areas specific to the individual provider type, including but not limited to self-audits. These self-audits can be conducted internally or a provider may choose to have an external party conduct the audit.

Element 7: Establish a system for responding to and investigating potential compliance problems as the Compliance Officer becomes aware of them, either by a report received from an affected person or as the result of an internal assessment.  Compliance Program must also establish systems for the provider to report compliance issues the OMIG, as well as repay any related overpayments.

Element 8: Establish a policy of non-intimidation and non-retaliation for good faith participation in the Compliance Program, including but not limited to reporting potential issues, investigating issues, self-evaluations, audits and remedial actions, and reporting to appropriate officials as provided in sections 740 and 741 of the New York State Labor Law.

As mentioned above, each December, required providers must submit a Provider Compliance Program Certification, attesting that they have a Compliance Plan in place and that Compliance Plan satisfies each of the OMIG’s Eight Elements.  If a provider is unable to unequivocally state that their plan meets these requirements then a certification should not be submitted and immediate steps must be taken to all necessary modifications to establish a satisfactory Compliance Plan.  Any provider who submits a false certification may be subject to sanctions, including monetary fines or provider enrollment termination.

If you are unsure whether your Compliance Plan would satisfy the OMIG’s Eight Elements, or if you are a provider who believes you are required to implement a Compliance Plan and have not done so, please do not hesitate to contact Farrell Fritz’s Regulatory & Government Relations Practice Group at 518.313.1450 or NYSRGR@FarrellFritz.com.