Health Services


Deadline Fast-Approaching for Medicaid Managed Care Participating Providers
November 7, 2017 | Geoffrey R. Kaiser | Ashley S. Osadon
The deadline for required enrollment with Medicaid under the Federal 21st Century Cures Act (Cures Act) is fast approaching. Currently, Medicaid Managed Care providers are sending mass mailings to their participating providers with notices of required compliance. By December 1, 2017 certain participating healthcare providers of New York State Medicaid Managed Care plans or the …
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OIG Audit Discovers $51.6 M in Overpayments to Acute-Care Hospitals
October 17, 2017 | Geoffrey R. Kaiser | Jonathan D. Salm
The Office of the Inspector General of the Department of Health and Human Services (OIG) issued a report last month regarding inappropriate payments made to acute-care hospitals for outpatient services provided to Medicare beneficiaries who were inpatients of other facilities. OIG’s findings highlight the need to diligently review claims before submitting them to Medicare. In …
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New York Legislature Broadens Telehealth Services Coverage for Adult Care Facilities
October 16, 2017
New York continues to drive legislative reform to promote telehealth services – clinical healthcare provided remotely through information technology. Most recently the state legislature passed a bill that expands the definition of “originating sites” where telehealth services may be provided to Medicaid patients in an effort to lower costs and health risks. For background, in …
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OMIG Issues New Compliance Alert for NY Medicaid Program
October 13, 2017 | Marc A. Antonucci
A recent Compliance Alert published by the New York State Office of Medicaid Inspector General (OMIG) underscores the need for Medicaid providers to re-evaluate their compliance programs in light of a shift toward new payment methodologies. On August 31, OMIG published its first Compliance Alert of 2017, entitled “Mandatory Compliance Programs’ Risk Assessments: Changes in …
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Shapiro Publishes Article in Natural Products Insider
September 14, 2017 | Steven Shapiro
Steven Shapiro has published an article in Natural Products Insider entitled, “A Legal Look at the Definition of ‘Clean Label’.” Click here to read the article. …
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NY Appellate Division, Third Dept., Rules EO-38 Soft Cap Unconstitutional
August 10, 2017 | Jeffrey P. Rust | Ashley S. Osadon
On June 22, 2017, a New York appeals court took aim at Gov. Andrew Cuomo’s Executive Order No. 38. The executive order and the accompanying Department of Health (“DOH”) regulations have been the subject of controversy and appeal since their 2012 debut. The New York State Appellate Division, Third Department, in Leadingage N.Y., Inc. v. …
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OIG Clarifies Hospitals’ Obligations to Patients with Psychiatric Emergencies
August 9, 2017 | Benjamin P. Malerba | Ada Kozicz
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently entered into a settlement with AnMed Health (“AnMed”), a South Carolina hospital, for over $1.2 million for a violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The settlement serves as an important reminder and clarification on the obligations imposed …
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NY’s Highest Court Hears Arguments on Physician-Assisted Suicide
July 21, 2017 | Benjamin P. Malerba | Ada Kozicz
The New York Court of Appeals recently heard arguments in the Myers v. Schneiderman lawsuit, which challenges the legality of physician assisted suicide and whether a patient should have the right to choose a peaceful death on his or her own terms. As the law currently stands, New York Penal Law Section 125.15 prohibits physician-assisted …
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.health Domain Name Now Available for Trademark Holders
June 8, 2017
Dothealth LLC, the company that operates the official registry for the .health domain name, has announced the first phase of .health’s public launch. During this initial “Sunrise Phase” trademark owners that are registered with ICANN’s Trademark Clearinghouse will have the first opportunity to register for the new domain name. This phase is open now through …
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‘Careless’ Disclosure of Sensitive Information Leads to HIPAA Settlement

The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that St. Luke’s-Roosevelt Hospital Center Inc. (“St. Luke’s”) entered into a HIPAA settlement for $387,200 resulting from the impermissible disclosure of two patients’ protected health information (“PHI”). In addition to the settlement, St. Luke’s has entered into a specific Corrective Action Plan. …
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Hidden Risks In Practice Acquisitions And Joint Ventures
May 25, 2017
There is a potential compliance “blind spot” associated with what many in the healthcare industry would regard as ordinary practice acquisitions and joint ventures involving hospitals and other provider organizations. This area of possible vulnerability arises from the payment of consideration for what are sometimes insufficiently delineated assets of the target or partner entity. If …
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Do Your Contracts Inadvertently Waive the Right to Exemplary Damages and Attorney Fees for Disclosure of Trade Secrets?
May 15, 2017
On May 11, 2016, the Defend Trade Secrets Act of 2016 (“DTSA”) was signed into law, which includes a lesser-known provision affecting the rights and remedies of employers, including hospitals, health systems and private practices, seeking to protect their trade secrets and confidential information. In part, the DTSA (18 USC §1833) provides Federal and State …
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OMIG Releases Work Plan for 2017-2018

The New York State Office of Inspector General (“OMIG”) has released its Work Plan for its new fiscal year, April 1, 2017 – March 31, 2018. The Work Plan summarizes new and ongoing activities OMIG will prioritize in the upcoming year, all of which aim to achieve three over-arching objectives: (i) enhance provider compliance; (ii) …
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Shapiro Quoted in Natural Products Insider

Steven Shapiro was quoted in a Natural Products Insider article entitled, “Dietary Supplement Industry Blasts N.Y. Labeling Legislation.” In the article, Steven and other industry professionals weigh in on Assembly Bill 7607 which would require a dietary supplement in package form to bear a label containing the name and address of the manufacturer, distributor and …
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UK Health System Infected by Ransomware
May 12, 2017
In a cautionary tale for all companies, but especially healthcare organizations, on May 12, 2017, multiple news sources reported that a broad cyberattack using ransomware caused substantial interference with critical systems across Europe, Russia and Asia. (See e.g., New York Times, BBC News and Silicon Angle.) According to the New York Times, the  attacks were …
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Digital Health Vendors Beware – OCR Continues Aggressive HIPAA Enforcement

The US Department of Health and Human Services, Office for Civil Rights (“OCR”) recently announced that CardioNet, Inc., a cardiac monitoring services company, entered into a HIPAA settlement for $2.5 million resulting from the impermissible disclosure of unsecured electronic protected health information (“ePHI”). In addition to the settlement, CardioNet is required to engage in a …
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NY Continues to Increase Access to Medical Marijuana
April 18, 2017
Under New York’s medical marijuana program, which is tightly regulated by the New York Department of Health (“DOH”), patients with serious medical conditions can become certified for use of medical marijuana under the supervision of a licensed healthcare provider. As of March 2017, DOH added two enhancements to the program to increase patient access. First, …
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OIG Releases Compliance Program Update

On March 27, 2017, the U.S. Office of Inspector General (“OIG”) released a new compliance program guide, Measuring Compliance Program Effectiveness—A Resource Guide (the “Guide”). The Guide was developed by compliance professionals and staff from the U.S. Department of Health and Human Services and OIG, as an effort to help healthcare organizations measure the effectiveness …
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Trump Administration Issues New Regulations for Affordable Care Act Insurance Marketplaces
March 10, 2017
On February 17th, the Department of Health and Human Services (“HHS”) released proposed new regulations aimed at stabilizing the individual and small business insurance marketplaces set up under the Affordable Care Act (“ACA”). According to the proposed rule, the marketplaces “have recently been threatened by issuer exit and increasing rates in many geographic areas.” The …
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OIG Rejects Laboratory’s Offer to Provide Free Labeling to Dialysis Facilities

The U.S. Office of the Inspector General (“OIG”) recently issued Advisory Opinion No. 16-12 (the “Opinion”) regarding a proposed arrangement between a laboratory and a dialysis facility. Briefly stated, the laboratory proposed to offer the dialysis facility free labeling of test tubes and specimen collection containers, a task which is typically performed by the dialysis …
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CMS and OMIG Provide Guidance on Combating Opioid Epidemic
February 15, 2017
The Healthcare Fraud Prevention Partnership (“HFPP”), in conjunction with the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (“CMS”), has recently issued a White Paper that outlines recommended actions to reduce opioid misuse and opioid-use disorders (“OUDs”) in the United States. It has been estimated that prescription opioid …
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HHS Finalizes Amendments to Confidentiality Rules for Alcohol and Drug Abuse Patients

For the first time in thirty years, the Substance Abuse and Mental Health Services Administration (“SAMHSA”), a branch of the U.S. Department of Health and Human Services (“HHS”), issued a final rule amending 42 CFR Part 2 (commonly referred to as “Part 2”) which governs the confidentiality of alcohol and drug abuse patient records. The …
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Kutner quoted in Part B News
February 6, 2017
Christopher J. Kutner was quoted in a Part B News article entitled, “Beyond QPP: Check Your Readiness for Insurer-Based Physician Incentive Programs.” Regarding non-federal physician incentive programs, Chris said they are about shifting to value-based payment options, so be sure you’re in a position to take it on. “Even without downside risk, you have to think about …
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New York Passes New Law to Allow Outpatient Clinics and ASCs to Provide Off-Site Services
January 24, 2017
New York Governor, Andrew Cuomo, has signed a new legislation that may pave the way for outpatient clinics and diagnostic and treatment centers, which includes ambulatory surgery centers (“ASCs”), to provide primary care services to their patients off-site under limited circumstances. The new law, codified in the Public Health Law § 2803(11), requires that the …
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OIG Releases Work Plan for 2017

The Department of Health and Human Services, Office of Inspector General (“OIG”) has released its Work Plan for Fiscal Year 2017 (the “Plan”). The Plan, available through the OIG website, summarizes new and ongoing audits, investigations and evaluations that OIG will prioritize in the upcoming year. Some of the new initiatives that OIG intends to …
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OIG Adds New Safe Harbor Protections in 2017

In December 2016, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services amended existing safe harbors and issued a number of new safe harbors to   protect certain business practices and arrangements of doctors, hospitals, and pharmacies from sanctions under the anti-kickback statute (42 U.S.C. § 1320a-7b(b)). Additionally, OIG amended …
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The Future of the Affordable Care Act
January 23, 2017
Since its enactment six years ago, the Patient Protection and Affordable Care Act (the ACA) has faced numerous challenges from Republicans attempting to repeal the law. Though previous efforts, through both legislation and litigation, have been unsuccessful, the election of Donald Trump and a Republican-controlled Congress likely portends at least a partial repeal of the …
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Five Essential Questions To Mitigate Corporate Compliance Risk
November 18, 2016
In an increasingly intense and unforgiving regulatory environment, all healthcare organizations — from small physician practice groups to large health systems — must closely scrutinize areas where they may be vulnerable to fraud and abuse allegations. Corporate compliance programs are useful in this effort, but only if they are well-constructed and aggressively implemented, not merely …
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The Future of the Affordable Care Act
November 11, 2016
Since its enactment six years ago, the Patient Protection and Affordable Care Act (the “ACA”) has faced numerous challenges from Republicans attempting to repeal the law. Though previous efforts, through both legislation and litigation, have been unsuccessful, the election of Donald Trump and a Republican-controlled Congress likely portends at least a partial repeal of the …
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Reminder to New York Medicaid Providers: Certification of Compliance Program Must be Completed by December 31, 2016

New York State Medicaid providers who claim, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program are required to implement a compliance program aimed at detecting and preventing Medicaid fraud, waste and abuse. This requirement also applies to third party billing companies that bill or receive the threshold amount …
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Safe Harbor, Safe Passage Under the Anti-Kickback Statute

For providers contemplating a business arrangement with a potential referral source for items or services reimbursable under a federal health care program, fitting that arrangement within a recognized safe harbor under the Anti-Kickback Statute (“AKS”) is the “holy grail,” for it ensures that the arrangement will be immunized against civil and criminal enforcement actions.  And …
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CMS Offers Flexibility for Physician Participation in MACRA
October 14, 2016
Pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), in April 2016, the U.S. Department of Health and Human Services issued a proposed rule that will require physicians who receive Medicare payments to participate in one of two payment programs: (1) the Merit-Based Incentive System (“MIPS”); or (2) the Alternative Payment Models …
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Reminder: Health Care Providers Must Post Nondiscrimination Notices by October 16, 2016

Pursuant to a final rule issued by the U.S. Department of Health and Human Services (the “HHS Rule”), certain health care providers covered by Section 1557 of the Affordable Care Act (“Section 1557”) will be required to post nondiscrimination notices and taglines by October 16, 2016. Section 1557 prohibits discrimination on the basis of race, …
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Caffeine’s Rise to Controversy and Popularity in Helping Consumers Attain Energy
September 29, 2016
Caffeine seems to have been around forever. I do not remember my first cup of coffee or my first can of cola, but I do remember the over-the-counter (OTC) stimulant drug products containing 200 mg of caffeine that were an absolute necessity for most of my classmates to survive freshman year of college and first …
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HIPAA Phase 2 Audit Protocol: Would Your Client Pass the Test?
September 22, 2016
Benjamin Malerba’s and Ada Kozicz’s article entitled HIPAA Phase 2 Audit Protocol: Would Your Client Pass the Test was published by the American Bar Association. The United States Department of Health and Human Services’ Office for Civil Rights (OCR) recently released its protocol for the next phase of audits that will be conducted throughout the second …
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Ransomware: A Threat to Any Business, Large or Small
September 20, 2016
Marc Ullman’s article entitled, “Ransomware: A Threat to Any Business, Large or Small,” was recently published by Natural Products Insider. According to a recent report by Malwarebytes, an anti-malware software company, a whopping 39 percent of the 540 companies from the United States, Canada, Germany and the United Kingdom surveyed in June 2016 suffered some form …
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Kaiser Publishes Article in Corporate Compliance Insights
August 22, 2016 | Geoffrey R. Kaiser
Geoffrey Kaiser has published an article entitled, “False Claims Violations in a Post-Escobar World,” in the August 15, 2016 issue of Corporate Compliance Insights. Click Here to read the complete article. © Copyright 2016 Corporate Compliance Insights. All rights reserved. Geoffrey Kaiser has published an article entitled, “False Claims Violations in a Post-Escobar World,” in …
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Lessons From Privacy-Related Enforcement
August 16, 2016
Federal and state regulators are bringing more and more enforcement proceedings to challenge the adequacy of corporate privacy practices. Although the best course for businesses is to be proactive and develop privacy rules that meet all applicable requirements before government steps in, a review of various privacy-related settlements that agencies recently have reached suggests a …
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Proposed Rule On Hospital Outpatient Prospective Payment System May Create Challenges for Hospitals and Physicians
July 21, 2016
The Centers for Medicare & Medicaid Services (“CMS”) recently released a proposed rule that would implement Section 603 of the Bipartisan Budget Act of 2015 (the “Act”) and could significantly limit payments made under the Hospital Outpatient Prospective Payment System (“OPPS”), effective January 1, 2017. Specifically, the proposed rule would greatly affect Medicare payment for …
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IRS Ruling Is Cause For Tax-Exempt Provider Concern
July 20, 2016
A recent ruling[1] by the Internal Revenue Service has raised concerns about the applicability of tax-exempt status to accountable care organizations. The IRS has taken action which will cause tax-exempt organizations to pause and carefully examine their participation in ACOs or other provider networks, particularly when such an ACO or network does not participate in the Medicare Shared …
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Health Care Compliance: Tips For A Corporate Body Self-Exam
July 14, 2016
Given the proliferation of health care regulations and white-hot spotlight of government enforcement efforts, it is becoming increasingly important for all health care organizations, ranging from small physician practice groups to large regional or national health systems, to attain a heightened level of self­awareness concerning areas in which they could be vulnerable to allegations of …
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New Bill Proposed in Senate to Regulate Upper Endoscopic Procedures
May 26, 2016
A new bill has been introduced in the New York Senate that would require the Department of Health to promulgate rules governing all upper endoscopic procedures, including all examinations of vocal cords, esophagus, and stomach that utilize a flexible endoscopic instrument. Approximately ten million upper endoscopic procedures are performed in the United States each year. …
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Office of Medicaid Inspector General Releases Work Plan for 2016-2017

The New York State Office of the Medicaid Inspector General (“OMIG”) released its Work Plan for fiscal year 2016-2017 (the “Plan”) summarizing new and ongoing activities that OMIG will prioritize in the upcoming year. The Plan includes auditing, outreach and compliance initiatives to enhance Medicaid beneficiaries’ access to high-quality and cost-effective health care and prevent …
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Phase 2 HIPAA Audits and Secure Disclosure of Patient Information

I. Department of Health and Human Services Commences Phase 2 of HIPAA Audit Program As part of its efforts to minimize risks to consumers created by the increased use of health information technology, and as required by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), the U.S. Department of Health and Human …
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ACO Compliance Waivers: Finding the Right Fit and Developing a Checklist to Stay in Shape
April 15, 2016
Introduction Established the by Patient Protection and Affordable Care Act, the Medicare Shared Savings Program was designed to provide better care for individuals, better health for populations, and lower growth in expenditures through the investment in infrastructure and redesigned care delivery.¹Early in the development of the Shared Savings Program, it was apparent that such arrangements, …
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Department of Health and Human Services Proposes Changes to Confidentiality Rules for Substance Abuse Patient Records
April 12, 2016
The Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the federal Department of Health and Human Services (HHS), has published a proposed rule that would amend 42 CFR Part 2 (commonly referred to as “Part 2”) which governs confidentiality of drug and alcohol abuse patient records. Part 2 was last revised in …
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FDA Issues New Draft Guidance on Cybersecurity in Medical Devices

Many medical devices used in modern medical care—from pacemakers to robotic surgical equipment and CT scanners—contain embedded software.  The amount of software content built into devices doubles about every two years, as advances in computer technologies encourage production of new generations of devices with ever more functionalities.  In addition, more and more medical devices are …
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The Emerging Threat of Ransomware

Ottawa Hospital in southeast Ontario, Canada; Hollywood Presbyterian Medical Center in Los Angeles; Lukas Hospital in the German city of Neuss; the California law firm Ziprick and Cramer LLP; solo law practitioner Paul Goodson; and the town of Plainfield, New Jersey all have something in common:  they learned about the cyber threat posed by ransomware …
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Kaiser publishes article entitled, “Prosecutorial Discretion” in Nutrition Business Journal
March 7, 2016 | Geoffrey R. Kaiser
Geoffrey Kaiser published an article in the Nutrition Business Journal entitled, “Prosecutorial Discretion.”  The article discusses the exercise of prosecutorial discretion under the Food, Drug & Cosmetic Act.  It analyzes the factors that enter into a decision by prosecutors to recommend criminal charges, using the recent indictment of USPlabs to illustrate the types of aggravating circumstances …
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OIG Fraud Alert: Physician-Owned Medical Device Manufacturers
January 26, 2016
Recently, the U.S. Department of Health and Human Services Office of the Inspector General (DHHS-OIG) issued a fraud alert.  The alert concerned physician owned distributors (PODs) that derive revenue from selling, or arranging for the sale of implantable medical devices ordered by their physician-owners for use on their own patients at hospitals or ambulatory surgical …
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