2020 OIG COMPLIANCE WORK PLAN

By Mathew J. Levy, Esq., & Stacey Lipitz Marder, Esq.

Investigations by Medicare and Medicaid are constantly on the rise. Each year, a Work Plan is published by the Office of the Inspector General (OIG) (which is updated monthly) showing the priorities and major initiatives that it intends to investigate during the fiscal year. The OIG’s updated 2020 Work Plan has been announced on its website: https://oig.hhs.gov/.

The OIG has recently advised that it has added new items to its 2020 Work Plan addressing concerns surrounding COVID-19 treatment. As a result of COVID-19, Centers for Medicare & Medicaid Services (CMS) has made a number of changes that allow Medicare beneficiaries to access a wider range of telehealth services, and providers have been engaging in these new and innovative ways to treat patients. While these forms of treatment have certainly provided a great benefit to patients, the government is concerned that providers are taking advantage and not being compliant, putting patients at risk, and costing the government a significant amount of money. 

As per the OIG’s most recent Work Plan, some of the key Target areas are as follows:

  • The OIG will continue investigations of fraud, waste, and abuse in the Medicare and Medicaid programs. Such reviews often result in providers being subject to an overpayment demand, and potential prepayment audit review.
  • The OIG will be reviewing the top 25 laboratory tests and analyzing the payments made under the new payment system.
  • The OIG will continue to monitor and combat the current opioid crisis which remains a public health emergency. The OIG has expressed concern that individuals with opioid use disorder could be hit particularly hard by the current pandemic.  

In connection with the COVID-19 pandemic, the OIG has further recently advised that it will be targeting the following areas:

  • Audit of CMS’ controls over the expanded “Accelerated and Advance Payment Program,” which serves to provide healthcare providers and suppliers with emergency funding and address cash flow issues when there is a disruption in claims submission or claims processing.
  • Review of Medicare and Medicaid telehealth utilization, including how the use of these services compares to the use of the same services delivered face-to-face, and the different types of providers and beneficiaries using telehealth services. The OIG will also be identifying program integrity risks with telehealth services. Data will also be reviewed in order to determine providers’ appropriate use and reimbursement during the COVID-19 pandemic in compliance with applicable state and federal law.  
  • Review of laboratory testing, specifically concerning add-on tests in conjunction with COVID-19 testing, particularly related to potentially fraudulent billing for associated respiratory pathogen panel (RPP) tests, allergy tests, and genetic tests. 

For a complete list please refer to the OIG’s website.

Based upon the OIG’s updated Work Plan, healthcare providers need to be ever more diligent in assuring that services being provided and billed are compliant with applicable rules and regulations, including those relating to telehealth and COVID-19. Healthcare providers should review and update their current compliance programs, as well as educate their staff with respect to their compliance programs. Providers should consult with a coding/billing expert and work with their legal team to conduct internal and external audits to determine whether the practice is compliant. To assist providers in reaching these goals, Weiss Zarett Brofman Sonnenklar & Levy, P.C. is providing a free initial snap shot review with a certified coder. All providers should take advantage of this program. Establishing an effective compliance plan taking into consideration the OIG’s targeted areas, as well as applicable federal and state rules and regulations, can help providers avoid or limit potential liability. It is imperative that providers take compliance seriously as failure to comply can result in serious repercussions, including for instance an audit and subsequent overpayment demand in connection with services previously rendered and paid for, criminal action and potential loss of license. 

Should you have any questions regarding the OIG Work Plan, compliance, or the free snap shot audit of documentation and coding please contact Mathew Levy at 516-926-3320 or MLevy@weisszarett.com or Stacey Marder at 516-926-3319 or SMarder@weisszarett.com.

About the Authors: 

Mathew J. Levy is a Partner of the firm and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in, defending healthcare professionals in actions brought by State licensing authorities and the Federal agencies (OIG, Medicare, OMIG, Medicaid, DEA, OSHA, OCR OSHA, Hospital Review Boards, Office of Professional Medical Conduct and Office of Professional Discipline.) Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits including Prepayment Review, Post Payment Review, Medicare Hearings and Hospital Discipline Investigations.

Mr. Levy has successfully structured and negotiated joint venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements and commercial leases. Among the areas in which he focuses are coordinating mergers and acquisitions, compliance programs, ambulatory surgery centers, the establishment of diagnostic and treatment centers, HIPAA privacy regulations, fee-splitting issues, Stark law issues, fraud and abuse rules and regulations and Medicare/ Medicaid, Oxford, Americhoice, Fidelis, Healthfirst and other third-party payor settlements.

Stacey Lipitz Marder is Senior Counsel at Weiss Zarett Brofman Sonnenklar & Levy, P.C., with experience representing healthcare providers in connection with transactional and regulatory matters including the formation and structure of business entities, negotiating and drafting contracts and commercial real estate leases, stock and asset acquisitions and general corporate counseling. Ms. Marder also has experience advising healthcare clients on a wide range of regulatory issues including Stark, the Anti-Kickback Statute, fraud and abuse regulations, HIPAA, reimbursement and licensing matters.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

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Out and Back: COVID-19 Paid Leave Changes in New York

By: Carla Hogan, Esq. & Toni-Ann M. Buono, Esq.

In previous articles, we summarized the federal paid-leave laws and regulations under the Families First Coronavirus Response Act (“FFCRA”) and the New York State Paid Sick Leave for COVID-19, and the benefit interplay between the federal, state and New York City laws and regulations.

As previously reported, under the New York State Paid Sick Leave for COVID-19, New York employees who were self-quarantined because they voluntarily traveled for non-business purposes to a country with a level 2 or 3 CDC notice, and knew of the restriction and were provided with the travel notice, were ineligible for the New York State Paid Sick Leave for COVID-19.  Until now, no similar disqualification restriction existed for interstate travel. 

With COVID-19 cases escalating across the United States, Governor Cuomo took immediate and decisive steps to sustain New York’s positive recovery by requiring travelers coming into New York from a list of hot-spot states to self-quarantine for 14 days.  This list, which continues to change based on “a seven day rolling average, of positive tests in excess of 10%, or number of positive cases exceeding 10 per 100,000 residents”, currently includes 16 states.

On June 26, Governor Cuomo issued Executive Order No. 202.45 (effective through July 26), stating that New York employees required to self-quarantine because they traveled domestically to a hot spot will not be eligible to receive any paid COVID-19 sick leave benefits during their 14-day mandatory self-quarantine.  Keep in mind that New York employees working for employers with over 500 employees, are already ineligible for sick leave benefits under FFCRA, and the only available paid COVID-19 sick leave would otherwise be under the New York State Paid Sick Leave for COVID-19.  Clearly, this recent Order was designed to further discourage New York workers from travelling to states with high rates of COVID-19.

Consequently, going forward, if:

  • The New York employee travels after June 25, 2020; and
  • The employee travels to a “hot spot” state as designated by the NYS Commissioner of Health; and
  • The travel is voluntary (“not taken as part of the employee’s employment or at the direction of the employee’s employer”) 

then the New York employee may be eligible for paid sick leave under FFCRA (if the employer has less than 500 employees), but will be ineligible for the New York State Paid Sick Leave for COVID-19.  

Notwithstanding an employer’s obligations under the FFCRA and/or the New York State Paid Sick Leave for COVID-19, if an employee is subject to an order of quarantine, but remote work is available, the New York self-quarantined worker could avoid unpaid leave by working remotely. In addition, please keep in mind that employers have always had the discretion to refuse paid sick leave under FFCRA to medical providers and other enumerated workers.

As the COVID-19 leave laws continue to evolve to meet changing circumstances and policy considerations, employers are encouraged to review their particular circumstances with counsel to avoid making errors in benefit determinations.

Weiss Zarett represents healthcare providers and business owners in a wide variety of employment matters, including advising clients on current leave laws and reasonable accommodations under COVID-19.  If you have any questions regarding the above, please email Carla Hogan, Esq. at chogan@weisszarett.com or Toni-Ann M. Buono, Esq. at tbuono@weisszarett.com.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including employment, corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

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Preliminary Injunctive Relief and Medical Staff Privileging Disputes

By David A. Zarett, Esq. & Zoila Sanchez, JD, MPH (Legal Intern)

Adverse action by a hospital against a physician’s medical-staff appointment or clinical privileges—such as summary suspension, termination or non-renewal—poses potentially catastrophic consequences to a physician’s practice and career. While most hospitals afford the physician internal “due process” hearing rights to challenge the adverse action, such a remedy could drag on for months and afflict serious ongoing damage to the physician while the adverse action remains in effect. After the internal “due process” mechanism is complete, the physician must then proceed to an administrative review by the New York Public Health and Health Planning Council (“PHHPC”), which only has the power to request that the hospital reconsider its determination. See Public Health Law Sections 2801-b and c. Again, while the PHHPC’s review process drags on, the hospital’s sanction remains in place, and the damages and harm to the physician mount.   

Compounding that problem, New York’s highest court in Gelbard v. Genesse Hospital ruled

that a physician is precluded from running to court to seek preliminary injunctive relief to “stay” the adverse action imposed by the hospital, until the physician first exhausts administrative remedies both within the hospital and before the PHHPC. See Gelbard v. Genesee Hosp., 87 N.Y.2d 691, 664 N.E.2d 1240 (1996); see also Farooq v. Millard Fillmore Hosp., 172 A.D.2d 1063, 569 N.Y.S.2d 320 (1991) (“Physician’s claim for injunction based on hospital’s allegedly wrongfully denying him staff privileges was premature where physician had failed to allege that he had exhausted administrative remedies by presenting claim to Public Health Council”); see also Raggi v. Wyckoff Heights Med. Ctr., 123 A.D.3d 1044, 999 N.Y.S.2d 174 (2014) (“Physician and professional corporation seeking reinstatement of physician’s clinical privileges at medical center were required to file an administrative complaint with New York State [PHHPC] and await the administrative disposition of that complaint before seeking redress in the courts”). This exhaustion requirement significantly handcuffs physicians, because the physician would have already suffered irreparable harm that could not be undone even by an ultimate court victory.

However, a recent decision by the Appellate Division, First Department may change the legal landscape when it comes to the availability of preliminary injunctive relief. Specifically, in Anyichie v. Lincoln Medical and Mental Health Center, the First Department held that a claim by a physician that a hospital did not follow its own bylaws in imposing the adverse corrective action—such as the summary suspension—was not subject to PHHPC review in the first place. See Anyichie v. Lincoln Med. & Mental Health Ctr., 176 A.D.3d 616, 110 N.Y.S.3d 674 (2019). 

Accordingly, it should follow under Anyichie that if a physician’s challenge to the hospital’s action were based on a claim the hospital failed follow its own bylaws, a physician could immediately seek judicial intervention and request immediate injunctive relief—since his or her claims were beyond the jurisdiction of the PHHPC and the doctrine of exhaustion of administrative remedies articulated in Gelbard would not apply. 

While Anyichie was decided only recently, it will be interesting to see whether this quite significant court decision alters the procedural landscape in which physicians dispute these types of issues with hospitals.

David A. Zarett, Esq., is a founding member of Weiss Zarett Brofman Sonnenklar & Levy, P.C., a Long Island law firm providing a wide array of legal services to the members of the health care industry, including physicians. Mr. Zarett devotes a substantial amount of his time counseling physicians who are the subject of adverse or corrective action imposed by hospitals. 

Zoila Sanchez, J.D., M.P.H. joined the firm as a Legal Intern from the U.S. Department of Health and Human Services Office of Counsel to the Inspector General (HHS-OCIG) where she worked as a Legal Clerk with a focus on health care fraud and abuse. Ms. Sanchez holds a Bachelor of Arts degree from Stony Brook University, Master of Public Health from the University of Arizona, and a Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University where she was awarded the Honorable David A. Paterson Award in Public Service.

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Impact of COVID-19 on Healthcare Providers Involved in Litigation

By: Toni-Ann M. Buono, Esq.

As healthcare providers continue to focus their efforts on battling the COVID-19 pandemic, litigators across New York have welcomed once-thought unconventional modes of conducting depositions, hearings and oral arguments with open arms.  As the courts, for the most part, remain closed to all but court personnel, attorneys and clients alike have opted to utilize video conferencing technology in order to keep their cases active and moving forward.  

Recognizing the concern for litigants, witnesses and others involved in pending litigation who are physicians or medical personnel treating COVID-19 patients, the courts have recently issued orders outlining new protocols for litigation in the COVID-19 era.  

Initially, on May 2, 2020, Chief Administrative Judge  Marks issued Administrative Order 88/20 which stated in part: “The court shall not order or compel, for a deposition or other litigation discovery, the personal attendance of physicians or other medical personnel (including administrative personnel) who perform services at a hospital or other medical facility that is active in the treatment of COVID-19 patients.” 

Subsequently, however, on June 22, 2020, in Administrative Order 129/20, Judge Marks cancelled Administrative Order 88/20 and ordered that litigation discovery should proceed electronically to the extent possible.  Judge Marks also placed the onus on the courts to resolve scheduling issues involving physicians and other medical or administrative personnel who are unavailable for depositions or other discovery due to their treatment of COVID-19 patients.  A copy of Administrative Order 129/20 can be accessed here.

One large concern, however, is the potential prejudice which might result to any litigant required to take part in a court proceeding (for example, a deposition or hearing) without their attorney present in the same room.  While the law continues to evolve on this issue, the statute governing civil practice in New York does allow for remote depositions, but only by stipulation of the parties.  Notwithstanding this provision, another provision in the statute grants courts the authority to issue protective orders “conditioning or regulating the use of any disclosure device.”  This latter provision gives courts authority to order alternate means for parties to discover information relevant to litigation. 

Earlier this month, Justice Baker of the Albany County Supreme Court considered whether a deposition by videoconference results in the witness forfeiting his right to the presence of counsel.  While the decision, in part, focused on the interpretation of now-cancelled Administrative Order 88/20, Justice Baker, relying on both statutory and case law, stated that “requiring depositions to be conducted by remote electronic means is neither novel nor without legal authority, or beyond The Courts authority[.]”  To alleviate any concerns of prejudice, Justice Baker held that, as a prerequisite, counsel was allowed to be physically present in the same room as the witness when the video deposition is conducted.

Also presented with concerns of prejudice as a result of an attorney’s inability to physically sit next to his witness at a deposition, Justice Kalish of the New York County Supreme Court, acknowledged what is considered the “new normal” and stated:

To delay discovery until a vaccine is available or the pandemic has otherwise abated would be unacceptable.  It goes without saying that business as usual is no longer the normal.  The legal profession and its clients are currently coming to grips with the “new normal” brought about by the COVID-19 pandemic.  Among other things, this “new normal” means that it is no longer safe and practical for depositions to be taken in person, as was the default during the “old normal.”

Justice Kalish ultimately exercised the Court’s discretion and ordered that depositions be conducted by remote means, and held that “to the extent the law and social distancing guidance allow”, counsel may be physically present in the same room as his witness.  A copy of the decision can be accessed here.   

To the extent that an attorney and witness are not able to be physically present in the same room with one another during a remote deposition or hearing, the potential prejudice to a litigant is somewhat alleviated through the availability of platforms like Zoom and a host’s ability to create private “breakout rooms”.  In these “breakout rooms”, an attorney and client can “meet” and have a confidential discussion – similar to what would take place during “normal” circumstances during a break in proceedings.

Weiss Zarett continues to monitor all updates from the courts regarding the rights and responsibilities of all parties involved in litigation.  If you are a healthcare provider treating COVID-19 patients and are currently involved in litigation, we encourage you to speak with your attorney regarding the use of remote technology to comply with your discovery obligations. 

Weiss Zarett represents healthcare providers and business owners in a wide variety of litigation matters, including advising clients on current COVID-19 issues.  If you have any litigation-related questions, please email Toni-Ann M. Buono, Esq. at tbuono@weisszarett.com or call us at (516) 627-7000.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including employment, corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

New Investigations Related To COVID-19

By Mathew J. Levy, Esq. & Zoila Sanchez, JD, MPH (Legal Intern)

PRICE GOUGING INVESTIGATIONS:

On March 16, 2020, the Department of Justice (DOJ) added new prosecutorial tools to its arsenal, directing each U.S. Attorney’s Office to prioritize the detection, investigation, and prosecution of criminal conduct relating to the current pandemic. DOJ has created a COVID-19 Hoarding and Price Gouging Task Force to protect scarce materials including: personal protective equipment (PPE) face masks and shields, PPE gloves, portable ventilators, medical gowns/apparel, and sanitizing and disinfecting products usable in a clinical setting. These materials are designated under the Defense Production Act (DPA) Section 102 and Executive Order “Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19” which criminalizes hoarding for the purpose of charging exorbitant prices.[1]

FRAUDULENT BILLING INVESTIGATIONS:

The DOJ recently stated that they are “committed to pursuing all manner of fraud in federal health care programs, including violations disclosed by whistleblowers under the False Claims Act, especially during this critical time as our nation responds to the outbreak of COVID-19.” The DOJ is requiring each office to name a Coronavirus Fraud Coordinator to spearhead efforts to investigate and prosecute COVID-19-related crimes and engage in outreach and awareness efforts. New York Attorney General James recently issued press releases warning New Yorkers of Coronavirus-related scams such as medical providers obtaining patient information for COVID-19 testing and then using that information to fraudulently bill for other tests and procedures. Recently, the U.S. Attorney for the Eastern District of New York urged the public to report such suspected fraud schemes by calling the National Center for Disaster Fraud (NCDF) at 1-866-720-5721 or sending an e-mail to disaster@leo.gov. As part of the coordinated nationwide response to unlawful COVID-19 related conduct, the NCDF complaints are available to all U.S. Attorneys and DOJs to help identify, investigate and prosecute fraud schemes. Further, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) is utilizing data analytics to desk audit monies spent on COVID related activities and materials affecting HHS programs and beneficiaries. OIG is coordinating with law enforcement partners including the Pandemic Response Accountability Committee and federal and state entities. For more information, see the new COVID-19 Portal.

TELEHEALTH INVESTIGATIONS:

Telehealth is a key area that is expected to draw increased oversight and attention due to its use during the COVID-19 pandemic and relaxation of billing requirements to facilitate access to these services. A report by Fair Health highlights the explosion of services rendered via this route, noting that private insurance telehealth claims grew by 4,347 percent when comparing March 2019 and March 2020 claims data. Providers using telehealth should keep current with HHS provider policies, information about insurance coverage and reimbursement, legal considerations for providing telehealth specifically with respect to privacy and security, informed consent and liability and malpractice and review guidance from the HHS Office for Civil Rights on the use of audio or video communication technology to deliver telehealth services during the public health emergency. Additionally, providers should keep up to date with state-specific telehealth requirements such as those relating to buprenorphine prescribing discussed here as well as telemental health services, which require specific informed consent forms.

HHS-OIG’s recent policy statement notifies providers that during the emergency period they will not be subject to administrative sanctions for reducing or waiving any cost-sharing obligations that federal health care program beneficiaries may owe for telehealth services delivered in accordance with applicable coverage and payment rules. Providers should keep records showing when cost-sharing was waived and document justification for the waiver as they may need it in the future to show eligibility and address potential billing issues.

COMPLIANCE RELATED TO MEDICARE AND MEDICAID REIMBURSEMENT:

Another area that is anticipated to see increased oversight is the CARES Act Provider Relief Fund (PRF), which initially reached over 1 million providers. Recently, the PRF expanded its reach to safety net hospitals serving vulnerable uninsured or Medicaid patient populations by $10 billion in funds, and is expected to meet the needs of several hundred thousand additional providers.

PRF provider recipients can take important measures to remain compliant by keeping up to date with requirements and attestation deadlines that HHS regularly updates for providers here. For example, the initial $30 Billion General Distribution requires a “commitment to full compliance with all Terms and Conditions” that were “material to the [HHS] Secretary’s decision to disburse these funds” to the recipient. Also, recipients must use the PRF Attestation Portal to sign an attestation confirming receipt of the funds and agree to the terms and conditions within 90 days of payment. 

As a general rule, health care providers and entities can protect themselves by maintaining documentation that may be requested at a later date. For example, to prevent fraud and fund misuse, HHS instructs PRF recipients to submit documents sufficient to ensure that funds were used for healthcare-related expenses or lost revenue attributable to COVID-19.

[1] HHS Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures Under Executive Order 13910 and Section 102 of the Defense Production Act of 1950, 85 FR 17592 (March 25, 2020).

Mathew J. Levy, Esq. is a Principal of Weiss Zarett Brofman Sonnenklar & Levy, PC. Mr. Levy is nationally recognized as having extensive experience representing healthcare clients in transactional and regulatory matters. Mr. Levy has particular expertise in advising health care clients with respect to contract issues, business transactions, practice formation, regulatory compliance, mergers & acquisitions, professional discipline, criminal law, healthcare fraud & billing fraud, insurance carrier audits, litigation & arbitration, and asset protection-estate planning. You can reach Mathew Levy at 516-926-3320 or mlevy@weisszarett.com.

Zoila Sanchez, J.D., M.P.H. joined the firm as a Legal Intern from the U.S. Department of Health and Human Services Office of Counsel to the Inspector General (HHS-OCIG) where she worked as a Legal Clerk with a focus on health care fraud and abuse. Ms. Sanchez holds a Bachelor of Arts degree from Stony Brook University, Master of Public Health from the University of Arizona, and a Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University where she was awarded the Honorable David A. Paterson Award in Public Service.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.