Garfunkel Wild’s Investigations, Audits and Regulatory Compliance Practice Group is comprised of a team of experienced attorneys who focus on the unique regulatory and business concerns of the health care industry. Our attorneys are counsel to a wide variety of providers, including hospitals and health systems, licensed clinics, skilled nursing facilities, physician practices, clinical laboratories, pharmacies, and community based providers. We routinely advise clients on federal and state Stark and anti-kickback laws and their applicable exceptions and safe harbors, False Claims Acts, Medicare and Medicaid billing and enrollment issues, health care fraud, professional misconduct rules, and other fraud and abuse laws.
Our team is adept at handling complex matters and is well-known for providing practical, real-word compliance advice that clients can implement in their day-to-day operations. With a team of attorneys who are former government prosecutors and criminal defense attorneys, we vigorously defend clients in federal and state criminal, civil and administrative investigations, as well as payer audits, and counsel clients through government oversight actions, such as Corporate Integrity Agreements.
The Investigations, Audits and Regulatory Compliance Practice Group advises our clients in the following representative areas:
Development and implementation of effective corporate compliance programs
Internal Investigations
False Claims Act investigations
State and Federal criminal health care fraud investigations
Responding to government inquiries and subpoenas
Payor and government Audits
Nursing Home regulatory issues, investigations and appeals of deficiencies/citations
Review of compensation methodologies under Federal and State “Stark” and Antikickback Laws
Review of compliance with billing rules and regulations (e.g., “incident-to” rules, modifier use, out of network billing)
Medicare/Medicaid enrollment, revocation, and exclusion matters
Office of Professional Medical Conduct (“OPMC”) matters
Legal audits of relationships under “Stark,” Antikickback and related laws
Regulatory issues related to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
Clinical Laboratory compliance, billing and investigations
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) released a Report outlining concerns about the rapid growth of and significant oversight gaps in the Centers for Medicare & Medicaid’s (“CMS”) use of remote patient monitoring (“RPM”) services, particularly with traditional Medicare patients (the “Report”). Given RPM’s dramatic growth, especially since the COVID-19 pandemic, the Report likely foreshadows OIG enforcement actions in this area.
The U.S. Department of Health and Human Services, Office of Inspector General (the “OIG”) posted an unfavorable Advisory Opinion (24-08) prohibiting a Corporation offering Medicare Advantage (“MA”), MA-Prescription Drug (“PD”), and MA/MA-PD Employer Group Waiver Plans (“EGWPs”) from sharing a percentage of its savings with its covered groups via a gainshare payment (“Payment”).
The cybersecurity attack on Change Healthcare (“Change”), a subsidiary of the UnitedHealth Group, has caused widespread disruption, impacting health care providers and individuals whose personal data was compromised. This breach has led to numerous class action lawsuits, divided into two main groups: providers affected by the claims processing shutdown and individuals whose data was leaked. In June 2024, approximately 50 lawsuits were centralized into a Multi-District Litigation (MDL) in federal court in Minnesota. On September 17, 2024, the first conference in the matter occurred. As the litigation progresses, motions to dismiss, potential mediation, and class certification are expected to shape the case.
On August 29, 2024, the Federal Department of Health and Human Services (“HHS”) withdrew its appeal of a federal court decision that invalidated certain aspects of HHS guidance regarding the use of tracking technologies (e.g., pixels that collect data on website usage to create directed marketing campaigns).
A Texas Federal Judge issued a decision blocking the FTC’s proposed ban on non-compete agreements, which was set to go into effect on September 4, 2024. As previously reported, the Texas Federal Court had issued a preliminary injunction limiting the enforceability of the FTC’s non-compete ban for the individual plaintiff in that lawsuit only. The Judge has now expanded that ruling nationally – preventing the FTC non-compete ban from going into effect.
In a recent ruling, the New Jersey Supreme Court concluded that the “self-critical analysis” privilege under the Patient Safety Act (“PSA”) and its implementing regulations can only be applicable if the information sought was generated for purposes of an independent patient safety committee that is created solely for the purposes of the PSA (i.e., the information generated from committees established to meet CMS or other New Jersey quality assurance or process improvement purposes is not protected by the privilege, even if such committees conduct a self-critical analysis).
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
Pharmacy revocations for non-compliance with Medicare Part B and Durable Medical Equipment, Prosthetics, Orthotics and Supplies enrollment requirements are on the rise. Garfunkel Wild’s latest webinar in our Compliance Webinar Series discusses common risks and provides strategies to protect your pharmacy.
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
On June 4, 2024, the New York State Supreme Court, Orleans County held that courts cannot appoint independent health care and financial monitors to make binding “recommendations” – the centerpiece of the New York State Attorney General’s campaign against for-profit nursing homes.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024. The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS.
The Court of Appeals recently upheld New York State’s elimination of residual equity, a capital cost component of Medicaid rates afforded to for-profit nursing homes with older facilities (the “Elimination”).
On May 23, 2024, the AHCA filed a lawsuit challenging the CMS's Federal Minimum Staffing Mandate, calling it "irrational" and "unattainable" due to staffing shortages and lack of statutory authority.
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
Garfunkel Wild's Salvatore Puccio and Elisabeth Pimentel will present "FTC Ruling on Employment Non-Compete Clauses" at the Fairfield County Medical Association and Hartford County Medical Association's Webinar on Thursday, May 16, 2024.
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-02) permitting a non-profit organization (Non-Profit) to provide financial support to eligible patients with specific rare diseases through assistance programs (Programs) it operates.
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
Join the health care professionals of Garfunkel Wild and Withum as they dive into the technical, legal, and financial steps you will need to take to come into compliance with the new cybersecurity regulations for New York hospitals.
This session will explain the medical equipment waiver process and provide clarity on what steps Adult Care Facilities (ACFs) should take to get their waivers approved and remain compliant with State regulations.
On March 1, 2024, the United States District Court for the Northern District of Alabama declared the Corporate Transparency Act (CTA) unconstitutional.
Nursing homes being cited for Life Safety Code (LSC) deficiencies by the New York State Department of Health (DOH) are on the rise. The difficulty achieving substantial compliance or obtaining a waiver places nursing homes at risk for termination from Medicare and Medicaid, denial of payments, and monetary penalties.
The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits. HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.
Steven R. Antico and J. David Morrissy will break down the Beneficial Ownership Information Reporting Requirements and how the requirements will affect your business.
The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records.
This alert is intended to warn recipients to be wary of fraudulent notices demanding recipients to provide their Beneficial Ownership Information ("BOI") through channels other than those secured by FinCEN.
On January 1, 2024, the United States Department of Treasury’s Financial Crimes Enforcement Network ("FinCEN") opened its Beneficial Ownership Secure System ("BOSS") portal to the public and began accepting Beneficial Ownership Information Reports ("BOI Reports") from Reporting Companies pursuant to the Corporate Transparency Act (“CTA”).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-11) that allows a medical device manufacturer (Manufacturer) to subsidize Medicare cost-sharing obligations as part of a U.S. Food & Drug Administration (FDA)-approved clinical study involving a Category B Investigational Device Exemption.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-15) permitting a consulting company’s (Consultant) proposal to offer gift cards to its current physician practice customers for referring potential new physician practice customers to Consultant. Notably, OIG determined that the proposed arrangement did not implicate the Anti-Kickback Statute (AKS).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a new toolkit to help Medicare Advantage (MA) organizations replicate OIG audit methodologies to detect and correct inaccurate diagnosis codes in their own systems.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently designated oversight of managed care as a “priority area”, and developed a coordinated strategic plan (the Plan) to better align its audits, evaluations, investigations, and enforcement of managed care.
The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.
Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted two favorable Advisory Opinions (23-09 and 23-10) to allow a licensed offeror of Medicare Supplemental Health Insurance (Medigap Plan) policies and a preferred health organization (PHO) (collectively, “the requestors”) to incentivize Medigap Plan policyholders to seek inpatient care from a hospital within the PHO’s network. Notably, OIG issued these favorable opinions even though the proposed incentives implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Money Penalty (CMP), and there was no applicable exception or safe harbor.
As of January 1, 2024, many companies in the United States will have to file a Beneficial Ownership Information Report with FinCEN pursuant to the implementing regulations of the Corporate Transparency Act passed in 2021. Join us for an in-depth review of the Corporate Transparency Act.
On November 17, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) published a final rule (“Final Rule”) imposing new ownership disclosure requirements on Medicare skilled nursing facilities and Medicaid nursing facilities (“nursing homes”). Due to concerns over the quality of patient care in facilities owned by certain types of nursing facility owners, including private equity companies and real estate investment trusts, CMS believes these new disclosure requirements will allow them to monitor and hold nursing homes accountable.
As we have noted in a previous Garfunkel Wild alert, the Department of Health and Human Services (“DHHS”) Office of Civil Rights (‘OCR”) published guidance regarding the use of tracking technologies (i.e., technologies that collect and analyze information about how users interact with websites and mobile applications).
This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.
In the last few months of 2023, there has been a flurry of legal activity pertaining to the use, disclosure, and protection of health information. Here is a summary of the latest legal initiatives impacting New York providers.
The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.
On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
Beginning on January 1, 2024, the Corporate Transparency Act (CTA) will require many companies to file a Beneficial Ownership Information (BOI) report with the Financial Crimes Enforcement Network (FinCEN).
On October 13, 2023, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) posted Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain outpatient surgical procedures the employed physicians perform at the employer’s two planned ambulatory surgery centers (ASCs).
In Advisory Opinion No. 23-06, the U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) declined to approve a proposed arrangement in which an anatomic pathology laboratory operator would purchase the technical component of anatomic pathology services from Physician and Non-Physician Laboratories for commercial payors.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
Garfunkel Wild's Robert Del Giorno will present at the Community Health Care Association of New York State (CHCANYS) 2023 Finance University on June 14, 2023.
On May 10, 2023, MCR Health, Inc. (“MCR” or the “Center”), a federally qualified health center (“FQHC”) based in Florida entered into a voluntary resolution agreement with the Department of Health and Human Services, Office of Civil Rights (“OCR”) to resolve a disability discrimination complaint against the Center.
Given the government’s increasing enforcement of EKRA, now is a good time for providers to understand the enforcement landscape, understand EKRA’s application and to reassess potentially noncompliant compensation structures.
On March 17, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced that independent dispute resolution (“IDR”) process called for in the Federal No Surprises Act should resume, and that the IDR entities could again make payment determinations in disputes between out-of-network providers and health plans that are subject to the NSA.
On January 5, 2023, the Federal Trade Commission (“FTC”) announced and released a notice of proposed rulemaking (NPRM) to prohibit employers from entering into non-competes with workers, including independent contractors.
On March 8, 2023, the New York Office of the Medicaid Inspector General (“OMIG”) posted materials on its website that provide further guidance on OMIG’s new regulations adopted on December 28, 2022.
Garfunkel Wild’s Susan L. St. John will present the Webinar “Florida Telehealth – What Florida and Non-Florida Practitioners Need to Know” on February 28, 2023 from 12:00 PM - 1:00 PM ET.
On February 22, 2023, the Department of Justice announced a new nationwide voluntary self-disclosure policy that gives companies the opportunity to receive a more favorable outcome when criminal misconduct is identified and the company chooses to voluntarily report the misconduct. The new voluntary self-disclosure policy applies to all United States Attorney’s Offices (“USAOs”) in the Country and it is effective immediately.
On February 17, 2023, Florida Medicaid released a Health Care Alert reminding providers of their obligations under the Centers for Medicare and Medicaid Services (“CMS”) Payment Error Rate Measurement (“PERM”) program.
Associate, Weston Harty authored the article "Franchise Regulations in the Context of the MSO Model", published in the New York State Bar Association Health Law Journal (2023 - Vol. 28 - No.1).
Garfunkel Wild’s Robert Del Giorno and Celia J. Morel will present the Webinar “Often Overlooked: Compliance Program Obligations Under Managed Care Agreements (For Providers in All States)” on January 19, 2023 from 12:00 PM - 1:00 PM ET.
Beginning January 18, 2023, New Jersey hospitals and clinical laboratories must demonstrate compliance with cultural competency requirements recently issued by the New Jersey Department of Health (“DOH”).
On December 28, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) finalized a significant set of new compliance-related regulations. The rules were initially proposed on July 13, 2022 (see our prior Client Alert on the proposed rules here: https://www.garfunkelwild.com/insights/omig-proposes-significant-new-compliance-program-regulations). The final rules contain minimal revisions to the proposed regulations.
Garfunkel Wild’s Robert Del Giorno and Peter M. Hoffman will present the Webinar “Prepare Now: Refresher on NY’s Compliance Program Proposed Regulations (For New York Providers)” on December 20, 2022 from 12:00 PM - 1:00 PM ET.
On November 17, 2022, the New York Public Health and Health Planning Council (“PHHPC”) held a meeting (“Meeting”) to discuss the adoption of regulations addressing Direct Care Nursing Home Spending and Minimum Staff Requirements. The Department of Health (“Department”) first introduced these regulations on November 17, 2021, after which they were published in the Federal Register with a 60-day comment period that ended January 18, 2022. Due to a COVID related workforce shortage, Governor Kathy Hochul suspended the implementation of the regulations through April 1, 2022 and gave the Department until November 17, 2022 to hold a meeting to vote on the regulations.
On October 3, 2022, the Supreme Court of the United States denied the request to review the Eighth Circuit’s decision that upheld a federal rule that limited the use of arbitration agreements in nursing homes.
Garfunkel Wild's Susan St. John discusses the things providers need to know about the new minimum wage requirements, and a new civil cause of action for non-compliance.
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (“SDP”) (proposed 18 NYCRR Subpart 521-3).
On July 13, 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) published a significant set of proposed compliance-related rules. If finalized, the new rules would repeal the existing regulations governing provider compliance programs (found in 18 NYCRR Part 521), and replace them with three new subparts concerning, respectively: (i) Compliance Programs (proposed 18 NYCRR Subpart 521-1); (ii) Medicaid Managed Care Organization Fraud, Waste and Abuse Prevention (proposed 18 NYCRR Subpart 521-2); and (iii) OMIG’s Self-Disclosure Program (proposed Subpart 521-3).
In Advisory Opinion 22-08, posted on April 27, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) stated that it would not impose sanctions on a federally qualified health center (“FQHC”) that had loaned smartphones to its patients.
On April 7, 2022, the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum, QSO-22-15, announcing the restoration of certain minimum regulatory requirements that had been waived in response to the COVID-19 Public Health Emergency. CMS will end the waivers in two groups, under two time frames.
On January 13, 2022, the U.S. Supreme Court permitted the vaccine mandate for health care workers in facilities regulated by Centers for Medicare and Medicaid Services (CMS). Specifically, the CMS vaccine mandate requires all staff of facilities participating in Medicare/Medicaid to be vaccinated.
As of October 1st, residential health care facilities must inform residents and their families regarding the availability of facility compliance information as part of an intake application. This disclosure must be in a separate document, in no less than twelve point font, and include the following:
Effective October 1, 2021, residential health care facilities in New York will be required to provide potential residents and their families with a separate document, in no less than twelve point font, as part of their admission packet that includes the following information:
On June 11, 2021, Governor Cuomo signed Senate Bill S6767 into law. The amended law, which takes effect on October 21, 2021, will continue to greatly impact the ownership and operation of nursing homes in New York by imposing broad notice and contract disclosure requirements on nursing homes.
On June 18, 2021, Governor Cuomo signed into law two bills related to clinical staffing for hospitals and nursing homes. As reported in our prior Alerts, dated May 7, 2021:
The New Jersey Health Care Transparency Act (the “Act”) becomes effective on July 1, 2021. The Act requires health care professionals to clearly inform patients of their training and qualifications when they are providing in-person care to patients and when advertising their practice.
On June 11, 2021, the New York Department of Health (DOH) posted a “Dear Applicant Letter” informing applicants for certificates of need (CON), licensure for adult care facilities (ACF) or licensed home care services agencies (LHCSA) or transfer of ownership interest notices of its new policy regarding evaluation of the applicant’s character and competency.
In a Dear Administrator Letter (“DAL”) dated May 28, 2021, the New York State Department of Health highlights the differing requirements long-term care (“LTC”) facilities must meet regarding COVID-19 vaccinations under recent federal and state regulations.
On May 5, 2021, the New York State legislature approved two bills with differing requirements related to clinical staffing for hospitals and nursing homes. With a goal of improving both patient and staff safety, as well as patient outcomes, the Governor is expected to sign each bill (A07119 and A00108B) into law soon. This Alert addresses the requirements for nursing homes. Please see a separate Alert here addressing the hospital staffing requirements.
The Office of Inspector General (“OIG”) posted OIG Advisory Opinion 20-08 on Tuesday, December 30, 2020. The Opinion permits an FQHC to offer $20 gift cards to incentivize pediatric patients who have missed two (2) or more previously scheduled preventative and early intervention care appointments within the previous six (6) months.
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
On November 16, 2020, the U.S. Department of Health and Human Services, Office of the Inspector General (the “OIG”) issued a Special Fraud Alert (“SFA”) emphasizing the fraud and abuse risks inherent in speaker programs run by pharmaceutical and medical device companies.
In legislation enacted on October 7, 2020, New York State is requiring physicians’ practice settings to post notice, visible to patients, that direct patients to the Office of Professional Medical Conduct’s (“OPMC’s”) website to obtain information about their rights and how to file a complaint regarding professional misconduct. The requirement is effective immediately.
Andrew E. Blustein will present at Medicus It Town Hall Webinar – Successfully Navigating the ‘New Normal’: What Ascs Need to Know on September 16, 2020.
On September 2, 2020, the New York State Department of Health submitted a proposal to the Centers for Medicare & Medicaid Services (“CMS”) to remove the annual Medicaid caps for physical therapy, occupational therapy, and speech therapy visits available to Medicaid recipients. The change, planned to take effect on October 1, 2020, would remove the current limitation on the number of therapy visits a Medicaid recipient may have and, in its place, allow medical necessity to dictate the number of visits a recipient can receive in a year.
On April 3, 2020, New York State Governor Andrew Cuomo signed the fiscal year 2021 budget, which included an overhaul of statewide paid sick leave requirements under the New York State Labor Law. Under the new law, all employers must provide sick leave to their employees.
New York State recently enacted legislation amending Public Health Law Section 2803 to require that each residential health care facility submit a pandemic emergency plan to the Department of Health no later than September 15, 2020, and annually thereafter.
The Equal Employment Opportunity Commission has issued new guidance for workplaces, dated April 17, 2020, as they start the process of preparing for the impending re-opening of their entities in the face of the Covid-19 pandemic.
On April 24, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a letter to State Agency Directors announcing that it will temporarily maintain the inspection rating for the Five Star Quality Rating System and that it will publish reported nursing home staffing levels to assist local governments in identifying nursing home needs. CMS also issued Frequently Asked Questions (“FAQs”) for nursing homes.
Garfunkel Wild Partner/Director Leonard M. Rosenberg will present at the Strafford Webinar – National Practitioner Data Bank: Hospital Reporting Obligations, Reporting Immunity, and Physician Strategies on April 22, 2020.
Garfunkel Wild Vice Chairman Andrew E. Blustein and Lisa A. Winkler, Executive Director, Connecticut Association of Ambulatory Surgery Center will present the webinar “A State Update: How to Operationalize the Connecticut Administration’s Expectation Regarding Elective Cases in ASCs” on March 27, 2020.
Garfunkel Wild Partner/Director Debra A. Silverman and Partner Stacey L. Gulick along with Certified Professional Coder and President of ProCode Compliance Solutions, LLC, Alicia Shickle will present the webinar “COVID-19 Billing for Telemedicine Services and Q&A Session” on March 25, 2020.
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Eve Green Koopersmith will present at the Greater New York Health Care Facilities Association’s (GNYHCFA) Seminar – Regulatory Updates – March 5, 2020.
Garfunkel Wild Partner/Director Jeffry Adest and Partner Barbara Knothe will present the webinar “340B Contract Pharmacy Issues for FQHCs” on March 4, 2020.
On January 21, 2020, Governor Phil Murphy signed bills A5916 and A5918 into law which are intended to increase the financial transparency of New Jersey hospitals and to ensure that such hospitals do not suddenly shut down, leaving residents without access to adequate health care in their respective communities as a result of a hospital’s financial distress.
Afsheen A. Shah will present at the Healthcare Financial Management Association’s (Hfma) Metropolitan New York Chapter Regulatory Compliance Seminar December 11, 2019.
Garfunkel Wild Partner/Director Jeffry Adest and Partner Sandra Jensen will present the webinar “FTCA Compliance and Preparing for an FTCA Specific On-Site Visit” on November 20, 2019.
A proposed rule was issued on November 6, 2019 to amend regulations regarding the approval of Licensed Home Care Service Agencies (“LHCSAs”). To comply with changes made to the Public Health Law in 2018, Subpart 765-1 of Title 10 NYCRR must be updated to include the new requirements of public need review and financial feasibility review. This Rule, effective April 1, 2020, would require the following:
The New York State Education Department (“SED”) has implemented a major procedural change, requiring that new professional practice entities submit an affidavit to SED when applying for Certificates of Authority to operate in New York State (whether in connection with original formation or foreign qualification to do business in New York). SED’s new process also requires that an affidavit be submitted for professional practice entity name changes.
he New York SHIELD Act has gone into effect today (October 23, 2019) and entities that maintain electronic information regarding New York residents will need to ensure compliance.
John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.
On September 9, 2019, the Department of Health and Human Services, Office of Civil Rights (“OCR”) announced that Bayfront Health – St. Petersburg, a 480-bed Florida hospital (the “Hospital”), paid $85,000 to settle an investigation regarding the Hospital’s failure to provide one patient with timely access to her medical records. In its press release, the OCR emphasized that this settlement is consistent with its Patient Access Initiative, which was announced earlier this year.
On October 23, 2019, the Stop Hacks and Improve Electric Data Security (“SHIELD”) Act goes into effect and significantly modifies the existing New York State breach notification requirements, including the addition of new requirements for covered entities (e.g., all health care providers and health plans) to report HIPAA breaches to the New York State Attorney General, as well as the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”).
The New York State Department of Health has made changes to the Medical Orders for Life Sustaining Treatment (MOLST) form and Nonhospital Order Not to Resuscitate, DOH Forms 5003 and 3474, respectively. These changes were made to comply with statutory changes, which granted authority to Nurse Practitioners to sign the MOLST and Nonhospital Order Not to Resuscitate.
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.
Zocdoc has announced that its pricing model for doctors in New York will change effective April 1, 2019. Zocdoc currently charges its customers a flat annual fee. Under the new pricing model, customers will pay a reduced annual fee, as well as a booking fee. The amount of the booking fee will vary based on the physician’s specialty.
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Hospital Settles CMP Case Over Inpatient Admissions; Another OIG Short-Stay Audit Looms", in Report on Medicare Compliance (Volume 33, Number 31) published by the Health Care Compliance Association (HCCA).
David Traskey was quoted in a Politico Pro article discussing a Supreme Court decision that could significantly affect the federal health agencies' authority to impose fines.
David Traskey was quoted in the article, "Baptist Health Settles FCA Case Over Copay Waivers, Benefited From DOJ Cooperation Credit", in the Report on Medicare Compliance published by the Health Care Compliance Association (HCCA).
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Health System, Cardiologist Settle Related FCA Cases Over Cath Procedures, Admissions".
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Exagen Settles FCA Case for Restitution, Paid Physicians Specimen Fees Despite OIG Alert".
Garfunkel Wild, P.C. is pleased to announce the opening of an office in Washington, D.C., and to welcome two D.C.-based partners, David Morrissy and David Traskey, to co-head the expansion. The D.C. location marks the firm's sixth office in the United States and the second opened in the past two years.
Garfunkel Wild Chairman Andrew Blustein and Partners David Traskey and Robert A. Del Giorno, are quoted in a Law360 article, “Longtime Gov't Health Care Atty Joins Garfunkel Wild,” regarding David joining the firm.
Garfunkel Wild is pleased to announce that David Traskey, former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), has joined the firm as Partner in its Investigations, Audits, and Regulatory Compliance Practice Group.
