Weiss Zarett & the PAP (Physician Advocacy Program)

Weiss Zarett will continue to offer the PAP (Physician Advocacy Program) for 2021 and we’ll be providing the same services with no increase in pricing since 2017. The 3 plans offered by the 2021 PAP (including the prorated cost from March 1, 2021 to December 31, 2021 are as follows.

Premium Plan

  • $671 per year 
  • Legal representation in connection with a matter before the OPMC, OPD, OMIG, MAC, OIG, QIO, OSHA or OCR.  
  • Providers WITH administrative coverage from their insurance company will receive legal representation pursuant to the PAP without additional cost until the later of the following: (1) the limits of the administrative coverage under their insurance policy are reached; or (2) through the initial interview/appearance before the applicable governmental authority.
  • Providers WITHOUT administrative coverage from their insurance company receive legal representation without additional cost through the initial interview/appearance before the applicable governmental authority.
  • Legal representation pursuant to the PAP does not include subsequent services during any hearing process following the initial interview/appearance. 
  • FREE review of your medical records by a certified coder and a conference call to discuss.
  • FREE 30-minute consultation on ANY legal matter within the scope of practice of Weiss Zarett.    

Comprehensive Plan

  • $446 per year 
  • Legal representation in connection with a matter before the OPMC, OPD, QIO, OIG, OSHA or OCR. 
  • Providers WITH coverage from their insurance company will receive legal representation pursuant to the PAP without additional cost until the later of the following: (1) the limits of the administrative coverage under their insurance policy are reached; or (2) through the initial interview/appearance before the applicable governmental authority.
  • Providers WITHOUT administrative coverage from their insurance company receive legal representation without additional cost through the initial interview/appearance before the applicable governmental authority.  Legal representation pursuant to the PAP does not include subsequent services during any hearing process following the initial interview/appearance.  
  • *Please note that the Comprehensive Plan does NOT include a review of your medical records, a conference call between you and the coder and no 30-minute call. 

Basic Plan

  • $221 per year 
  • Legal representation in connection with a matter before the OPMC or the OPD.
  • Providers WITH administrative coverage from their insurance company will receive legal representation pursuant to the PAP without additional cost until the later of the following: (1) the limits of the administrative coverage under their insurance policy are reached; or (2) through the initial interview/appearance before the applicable governmental authority.  
  • Providers WITHOUT administrative coverage from their insurance company receive legal representation without additional cost through the initial interview/appearance before the applicable governmental authority.  Legal representation pursuant to the PAP does not include subsequent services during any hearing process following the initial interview/appearance.  
  • *Please note that the Basic Plan does NOT include a free review of your medical records by a certified coder and a conference call to discuss the findings related to your documentation and coding or representation in connection with matters before QIO, OIG, OSHA, OCR, MAC or OMIG, or the annual 30-minute consultation. 

If you are interested in enrolling in the 2021 PAP or have any questions, please contact Mathew Levy, Esq. at 516-926-3320 or MLevy@weisszarett.com.

OCR’s Audit Report Reveals Concerns that Continue to Guide HIPAA Enforcement

By Mathew J. Levy, Esq. & Zoila Sanchez, MPH, JD
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Recently, the Office of Civils Rights (OCR) within the U.S. Department of Health and Human Services (HHS) published its 2016-2017 Health Insurance Portability and Accountability Act (HIPAA) Audits Industry Report. HHS is required to periodically audit a sample of covered entities and business associates for HIPAA compliance under the Health Information Technology for Economic and Clinical Act (HITECH) Act. 

Across this sample, OCR found failures with the Notice of Privacy Practices requirements, the HIPAA Breach Notification Rule, the individual right of access to health information rule and the HIPAA Security Rule. Since the Audit was completed in 2016-2017, we would expect that a number of the fundamental deficiencies that OCR identified have been rectified by covered entities and business associates, as the OCR has been very aggressive in its enforcement activities during the last five years imposing significant financial penalties on non-compliant entities. Nonetheless, it is worth noting that these are the areas that OCR chose to focus on then and they remain as serious in 2021 as they were during this audit period:

  • Notice of Practices: of the 166 covered entities sampled, 98% failed to fully include required content for HIPAA-mandated Notice of Privacy Practices including content related to individual rights and the use of plain language as required by the Privacy Rule.
  • Breach of Notification to Individuals: findings uncovered failures to include the required description of Protected Health Information (PHI) and steps for individual protection. 
  • Individual Right of Access: the majority of covered entities failed to correctly implement individual right-of-access requirements, such as  granting reasonable access to PHI records within 30 days and charging a reasonable cost-based fee – due to Electronic Health Record (EHR), health care entities and business associates should only charge per-page fees that represent actual cost of the paper and manpower to print the record.
  • HIPAA Security Rule: findings showed failures to implement the detailed requirements for risk analysis and risk management. 

These areas of concern will continue to guide OCR’s continuing HIPAA enforcement efforts, which is intended to ensure that covered entities (and business associates) carefully and thoroughly identify security risks to protected health information in their custody and meet their duty to provide patients with understandable documents that describe their HIPAA rights and their timely and cost-based access to their medical records. 

It is critical for covered entities, including health care entities, and business associates to know the minimum requirements for HIPAA compliance. One way to assess whether your practice is ready for audit is to familiarize yourself with “Self-Audit For HIPAA Compliance – Is Your Practice Ready?”

Should you have any questions regarding HIPAA compliance, please contact Mathew Levy at 516-926-3320 or MLevy@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.

Zoila Sanchez, J.D., M.P.H. joined the Firm full-time upon graduating with her Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University. During law school, Ms. Sanchez served as a Legal Clerk with the U.S. Department of Health and Human Services Office of Counsel to the Inspector General in Washington, DC, where her work focused on health care fraud and abuse.  In addition, Ms. Sanchez clerked for over a year at the Firm while in law school. Ms. Sanchez has experience in supporting the Firm’s business and health care law, and litigation practice areas.

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.

New York State Adopts Extensive Rule Changes Affecting Investment Community

By Mauro Viskovic, Esq.
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New York State Attorney General Letitia James recently announced major changes to rules affecting a broad range of investment professionals and the investment industry in general.  The new rules will change the regulatory process for offering investment securities to New York residents and will implement registration requirements for business brokers or “finders” who are in the business of connecting prospective investors to companies seeking investment capital.  In addition, investment adviser representatives (including representatives of private equity fund managers and hedge fund managers) will be subject to state registration and examination requirements. 

Notice of Investment Offerings:

One of the key changes will harmonize the New York and the federal notice filing requirements for private investment offerings that are exempt from registration under federal law.  The state notice requirements for such offerings will now be complied with by filing the federal Form D through the electronic filing depository system of the North American Securities Administrators Association. This amendment will aim to streamline the securities offering filing process in New York, which had still been using an antiquated paper filing system.

Finder Registration:

Conversely, the state imposed additional regulatory burdens that will affect finders who connect businesses to sources of investment capital in exchange for compensation.  Such finders will be subject to all of the registration requirements that New York demands of brokers, broker-dealers, and salespersons.  The new requirements include the following: (i) finders not associated with a registered broker-dealer must file Form M-1; (ii) finders associated with a non-Financial Industry Regulatory Authority, Inc. (“FINRA”) member broker-dealer must file Form M-2; and (iii) finders associated with a FINRA member broker-dealer must file Form U4.  Finder registration periods for non-FINRA members are four years, while FINRA members must follow applicable FINRA registration rules.

This adds another layer of regulation for those not registered as well as expense because these newly registered finders will have to pay fees to the State of New York as part of the registration process. Further, these new regulations are in stark contrast to the recent proposed federal registration exemption applicable to finders.  See SEC Proposes Eliminating a Significant Burden on Raising Capital in Private Markets.

Investment Adviser Registration and Examination:

New York will require “investment adviser representatives” – a very broad statutory term that includes individual professionals managing hedge funds and private equity funds – to register with the state and meet certain examination requirements.  Such individuals must register by filing Form U-4 with the web-based Investment Advisor Registration Depository (IARD) or Central Registration Depository (CRD) operated by FINRA.  Within two years prior to the registration date, registrants must take and pass either (1) the Series 65, Uniform Investment Adviser Law Examination or (2) the Securities Industry Essentials Examination, combined with the Series 7, General Securities Representative Examination, and the Series 66, Uniform Combined State Law Examination.  Individuals who have been serving as investment adviser representatives for at least two years will be eligible to apply for a waiver of the examination requirement. 

Other Changes:

The new rules will add a new bookkeeping requirement for investment advisers.  The revision requires that New York State registered investment advisers take reasonable steps to verify the “accredited investor” and “qualified client” status of any client so designated, including making and maintaining documents used in the course of such verification.  The terms “accredited investor” and “qualified client” are defined under applicable SEC regulations and generally refer to high net-worth investors who are financially sophisticated and have a reduced need for the protection provided by heightened disclosure requirements.

Weiss Zarett represents a broad range of professionals in the New York investment community. If you have any questions regarding these new regulations, please email Mauro Viskovic, Esq. at mviskovic@weisszarett.com or call us at (516) 627-7000.

About the Author: 

Mauro Viskovic is a Partner in the Firm’s corporate and transactions practice group, where he focuses on providing high quality and cost-effective solutions to clients’ legal matters.  He represents entrepreneurs through all stages of their ventures’ development, including advice on structure, initial company formation and organization, private financings, commercial transactions, mergers and acquisitions and liquidity events.  In addition, Mauro represents investors in all aspects of corporate finance transactions and also focuses his practice on the representation of private investment fund advisers and portfolio managers.

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 and financial services industries, including corporate and transactional matters, employment, civil and administrative litigation, regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

CLIENT ALERT: CMS and OIG Move to Expand Exceptions and Safe Harbors to Stark Law and Anti-Kickback Statute

By Mathew J. Levy, Esq. and Mauro Viskovic, Esq. 
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On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) adopted significant changes to regulations regarding the Anti-Kickback Statute (“AKS”) and the Physician Self-Referral Law (“Stark Law”).  Among the changes are those that expand, and create new, AKS safe harbors and Stark Law exceptions.

Background:

As a general matter, AKS and the Stark Law and AKS prohibit medical providers from paying or receiving kickbacks, remuneration, or anything of value in exchange for referrals of patients who will receive treatment paid for by government healthcare programs such as Medicare and Medicaid, and from entering into certain kinds of financial relationships.  There are various exceptions to the Stark Law, together with certain safe harbors to AKS, that permit certain referrals under limited circumstances.  The recent changes adopted by CMS and OIG aim to expand those exceptions and safe harbors in order to modernize and clarify regulations that were enacted back in 1989.  Summarized below is a general overview of the key AKS and Stark Law changes.  

AKS Changes:  

The main AKS revisions are as follows:

  • Value-Base Arrangements:  Three new AKS safe harbors will be added to protect certain arrangements entered into with, or by, a value-based enterprise (VBE) and its eligible participants for a number of value-based network arrangements, as follows:
  • Care coordination arrangements to improve quality, health outcomes, and efficiency, involving “no risk”, where in-kind renumeration such as technology or services are exchanged between VBE participants used to engage in value-based activities directly connected to care coordination for the target patient population.
  • Value-based arrangements involving both monetary and in-kind renumeration between a VBE and VBE participants where the VBE assumes “substantial downside financial risk” for providing or arranging for the provision of items and services for the target patient population, and the VBE participants assume a “meaningful share” of that risk.
  • Value-based arrangements involving both monetary and in-kind renumeration between a VBE and VBE participants where the VBE assumes “full financial risk” for all items and services covered by a payor for each patient in the target population for a term of at least one year.

These “value-based” safe harbors vary by the type of remuneration protected, the type of entities eligible to rely on the safe harbors, and the types of safeguards included as safe harbor conditions. The value-based safe harbors exclude pharmaceutical manufacturers, distributors, and wholesalers; PBMs; pharmacies that primarily compound or dispense compounded drugs; laboratories; medical device and supply manufacturers; medical device distributors and wholesalers; DMEPOS suppliers; and physician-owned medical device companies. The care coordination safe harbor can be accessed by medical device and DMEPOS manufacturers to protect digital technology arrangements under certain conditions.

  • Patient Engagement:  A new safe harbor will be added for patient engagement tools and supports to improve care quality, outcomes and efficiency, furnished by a VBE participant or “eligible agent” to a patient in a “target patient population,” subject to a $500 annual cap, with an inflation adjuster. This safe harbor includes the same general exclusions as outlined above but allows medical device and supply manufacturers to provide some digital health technology.
  • CMS-Sponsored Models:  A new safe harbor will be added for CMS-sponsored model arrangements and CMS-sponsored model patient incentives that is expected to reduce the need for separate fraud and abuse waivers for new CMS-sponsored models.
  • Cybersecurity:  A new safe harbor will be added to protect non-monetary donations of certain cybersecurity technology, including both software and hardware, and related services. This safe harbor permits the donation of cybersecurity technology to physician groups or other providers so long as the technology is “necessary and used predominantly to implement, maintain, or reestablish cybersecurity.” The safe harbor limits donors from making donation decisions considering volume or value of referrals or other business generated between the parties.
  • Electronic Health Records:  The existing electronic health records (EHR) safe harbor will be modified to update provisions regarding interoperability, remove the prohibition on donation of equivalent technology, and provide clarification to protections for cybersecurity technology and services included in an electronic health records arrangement.
  • Personal Services and Management Contracts:  The existing personal services and management contracts safe harbor will be modified to increase flexibility for part-time or unpredictable compensation arrangements, and to provide new protection for outcome-based payment arrangements, with the same entity-exclusions that are applied to the new value-based safe harbors.
  • Warranties:  The existing safe harbor for warranties will be modified to revise to definition of “warranty” and provide protection for warranties for one or more items and related services.
  • Local Transportation:  The existing safe harbor for local transportation will be modified to increase mileage limits from 50 to 75 miles for rural areas, and to eliminate distance limitations for transporting patients discharged home from an inpatient or observation setting.

The AKS changes will become effective January 19, 2021.

Stark Law Changes:

Many of the Stark Law changes track similar revisions made to AKS, with some distinctions.  The main revisions are as follows: 

  • Exceptions for Value-based Arrangements. As with the AKS changes, new, permanent exceptions for value-based arrangements were adopted to permit value-based arrangements that satisfy certain requirements based on the level of financial risk undertaken (full financial risk, meaningful downside financial risk, or no risk).  These exceptions will allow health care providers to design and enter into more flexible value-based arrangements without fear that legitimate activities to coordinate and improve the quality of care for patients and lower costs would violate Stark Law.
  • New Guidance and Clarifications. SMS provided additional guidance on key requirements of the exceptions to the Stark Law to make it easier for health care providers to comply with the law. For instance, compensation provided to a physician by another health care provider must generally be at “fair market value.” The new rules clarify how to determine whether compensation meets this requirement.  An additional clarification was effected by adding new definition of “commercially reasonable”, which requires that an arrangement “furthers a legitimate business purpose of the parties to the arrangement and is sensible, considering the characteristics of the parties, including their size, type, scope, and specialty” and clarifies that an arrangement may be commercially reasonable even if it does not result in a profit for one or more of the parties.
  • Other New Exceptions. The final rule establishes new exceptions to protect non-abusive, beneficial arrangements between physicians and other health care providers that apply regardless of whether the parties operate in a fee-for-service or value-based payment system—such as donations of cybersecurity technology that safeguard the integrity of the health care system. In addition, CMS finalized a new exception to protect compensation not exceeding an aggregate of $5,000 per calendar year, adjusted for inflation, to a physician for the provision of items and services without the need for a signed writing and compensation that is set in advance if certain conditions are met, including that the compensation does not exceed fair market value and is not determined in any manner that takes into account the volume or value of referrals or other business generated.

The new Stark Law regulations will become effective January 19, 2021. Certain provisions relating to value-based care arrangements will not be effective until January 1, 2022.

Should you have any questions regarding the foregoing rule changes, please contact Mathew Levy at 516-926-3320 or MLevy@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.

Mauro Viskovic is a Partner in the Firm’s corporate and transactions practice group, where he focuses on providing high quality and cost-effective solutions to clients’ legal matters.  He represents entrepreneurs through all stages of their ventures’ development, including advice on structure, initial company formation and organization, private financings, commercial transactions, mergers and acquisitions and liquidity events.  In addition, Mauro represents investors in all aspects of corporate finance transactions and also focuses his practice on the representation of private investment fund advisers and portfolio managers

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.

New OPMC Signage Requirements: Updates to New York Public Health Law Mandate that Medical Practices Post Visible Sign Directing Patients to OPMC Website

By Seth A. Nadel, Esq.
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Effective October 7, 2020, updates to New York’s Public Health Law have imposed a new requirement on physician practices to post conspicuous signage directing patients to the website of the Office of Professional Medical Conduct (OPMC) and advising them that they may visit the OPMC website to report suspected instances of professional misconduct. Specifically, the new Public Health Law § 230(11)(h) provides as follows:

The office of professional medical conduct shall post on its website information on patients’ rights and reporting options under this subdivision regarding professional misconduct, which shall specifically include information on reporting instances of misconduct involving sexual harassment and assault. All physicians’ practice settings shall conspicuously post signage, visible to their patients, directing such patients to the office of professional medical conduct’s website for information about their rights and how to report professional misconduct.

Notably, the new provision does not specify the exact contents of the required signage other than to state that it should “direct” the patients to OPMC’s website “for information about their rights and how to report professional misconduct.” At a minimum then, the sign should contain a link to OPMC’s website (located at https://www.health.ny.gov/professionals/doctors/conduct/) and contain a short statement that patients may learn more about their rights or report suspected physician misconduct using the information at that link.

Likewise, the law does not specify precisely where in a medical office the sign should be posted, beyond saying that it should be posted “conspicuously” and be “visible to their patients.” Presumably, placing the sign where it can be plainly viewed in a practice’s waiting room or near a reception desk would likely be considered satisfactory for these purposes. 

Although practitioners and practice associations, including the Medical Society of the State of New York (MSSNY), have taken umbrage at this new rule, it remains effective as of this writing. This being so, physicians should take immediate steps to comply with the signage requirement in their respective practices to the extent they have not already done so.

Weiss Zarett represents numerous physicians in connection with regulatory and compliance issues, as well as proceedings before OPMC. If you have any questions about the new signage requirements or about the OPMC process, please reach out to Seth A. Nadel, Esq. at snadel@weisszarett.com or 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 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.