Health Services


CMS Offers Flexibility for Physician Participation in MACRA
October 14, 2016 | Health Services
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
| Health Services
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 | Health Services | Compliance Investigations & White Collar
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 | Health Services
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 | Health Services | Compliance Investigations & White Collar
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 | Health Services | Compliance Investigations & White Collar
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 | Health Services | Professional Liability | Privacy, Data & Cyber Law
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 | Health Services
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 | Corporate | Health Services
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 | Health Services | Compliance Investigations & White Collar
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 | Health Services
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
| Health Services
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
| Health Services
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 | Health Services
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 | Health Services
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
| Health Services | Privacy, Data & Cyber Law
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
| Health Services | Compliance Investigations & White Collar | Privacy, Data & Cyber Law
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 | Health Services | Compliance Investigations & White Collar
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 | Health Services
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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OIG Work Plan for 2016
January 1, 2016 | Health Services
The Department of Health and Human Services, Office of Inspector General (“OIG”) has released its Work Plan for Fiscal Year 2016 (“Plan”). The Plan summarizes new and ongoing audits, investigations and evaluations that OIG will prioritize in the upcoming year. While many of the areas of focus addressed in the Plan are similar to those …
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Federal Government, New York State Pass New Medical Marijuana Laws
| Health Services
The Federal government and New York State have implemented additional legislation that will likely expand access to medical marijuana for patients hoping to use it. The Senate passed an appropriations bill that had previously been passed by the House of Representatives that contains additional funding for the Department of Veterans Affairs (the “VA”). H.R. 2029 …
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Wyndham Worldwide Corp. Settlement with the Federal Trade Commission: Consumer Data Protection Isn’t Only About HIPAA
| Health Services | Compliance Investigations & White Collar
On December 9, 2015, the Federal Trade Commission (“FTC”) announced a settlement ending its two-and-a-half year-long litigation with Wyndham Worldwide Corp., the parent of Wyndham Hotels Group (“Wyndham”).  The case arose from three breaches of Wyndham’s computer systems by hackers in 2008 and 2009 during which personal financial information of thousands of consumers was stolen.  …
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Health Republic Insurance of New York Announces that Coverage will End on November 30, 2015
November 23, 2015 | Health Services
Health Republic Insurance of New York (“Health Republic”) has announced that it will not offer coverage after November 30, 2015 leaving over 200,000 of its customers scrambling to find new health insurance. Health Republic is one of twenty-three non-profit insurance plans that were created under the Affordable Care Act to increase competition in the insurance …
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Compliance Season: Assessing Provider Readiness for OMIG Certification
November 3, 2015 | Health Services
Medical, health home, mental health, and other providers licensed by the New York State Department of Health, Office of Mental Health or other governmental agency, and any providers ordering, providing, billing or claiming at least $500,000 from Medicaid in a consecutive twelve month period, are required to have an effective compliance program. Those providers must …
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Changes to Minimum Wage Requirements for Home Care Workers
October 31, 2015 | Health Services | Employment & Labor
In 2014, the United States Department of Labor (“DOL”) issued a new regulation to be effective January 1, 2015 to modify the minimum wage and overtime requirements of home care workers (including companionship and live-in domestic workers).  Prior to the new regulation being effective, a Federal District Court vacated the regulation finding that the DOL …
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Judge Orders Reconsideration of “Two Midnight Rule” for Medicare Payment
| Health Services
Recently, a federal judge for the District of Columbia sided with several hospitals and health care organizations in ruling that the Centers for Medicare and Medicaid Services (“CMS”) must reconsider a regulation that reduced the provider payment rate for Medicare Part A services. While the decision did not overturn the regulation, it did push the …
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DOJ Policy Memo Urges Prosecutors to Hold Individuals Accountable for Corporate Misdeeds
September 17, 2015 | Health Services | Compliance Investigations & White Collar
A policy memo issued on September 9, 2015 from Deputy Attorney General Sally Quillian Yates of the Department of Justice (DOJ) outlines a strategy for holding individuals in both civil and criminal enforcement actions accountable for misconduct by corporations and other business entities.  The memo was the product of a working group of senior DOJ …
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OMIG Releases Revised Guidelines for PPS Compliance Training
September 8, 2015 | Health Services
The Office of the Medicaid Inspector General (OMIG) released supplemental guidance in April 2015 for performing provider system (PPS) lead entities (PPS Leads) on special factors that must be taken into account, in addition to the compliance program requirements of New York Social Services Law Section 363-d and Title 18 of the New York Codes …
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The New York Attorney General’s Dietary Supplement Investigation: Where We Stand Today
March 23, 2015 | Health Services
Marc Ullman’s article entitled, “The New York Attorney Geneal’s Dietary Supplement Investigation:  Where We Stand Today,” was published by Natural Products Insider. Click here to read. …
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Senators Introduce Bill to Decriminalize Marijuana
March 18, 2015 | Health Services
New York’s junior senator, Kristin Gillibrand, joined with New Jersey senator Cory Booker and Kentucky senator Rand Paul to introduce a bill that would decriminalize marijuana, removing the threat of federal prosecution for the growth and manufacture of medical marijuana in states that allow for it, including New York.  The bill addresses many issues medical …
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ACA Grace Period Places Burden on Providers and Hospitals
January 26, 2015 | Health Services
The Patient Protection and Affordable Care Act (ACA) was enacted to enable patients to make informed choices regarding their healthcare by providing stability and flexibility in insurance coverage.  To facilitate the implementation of stable coverage, the ACA requires that qualified health plans (QHPs) provide a grace period of three consecutive months if an enrollee, receiving …
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Governor Cuomo’s Executive Budget Proposes Changes to Healthcare Laws
January 23, 2015 | Health Services
On Wednesday Governor Andrew Cuomo laid out his proposed 2015-16 executive budget in his State of the State address. The executive budget proposes multiple changes to New York’s current healthcare laws, most notably regarding diagnostic and treatment centers (“DTC”), urgent care facilities, office-based surgery centers (“OBS”), and revisions to the Certificate of Need (“CON”) process.                                   …
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New York Releases Proposed Regulations on Medical Marijuana
December 23, 2014 | Health Services
The New York State Department of Health (“DOH”) has released proposed regulations on the growth, manufacture, sale, and use of medical marijuana in the state. The regulations are the first step in implementing the “Compassionate Care Act,” (the “Act”) signed into law in September, that contemplates the distribution of medical marijuana in the state in …
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An Overview of New York’s ACO Regulations
December 3, 2014 | Health Services
The New York State Department of Health (the “DOH”) released regulations which implement 2012 legislation expanding Accountable Care Organizations (“ACOs”) in New York State. The regulations create a new part of the New York Code of Rules and Regulations (“NYCRR”), Part 1003 under Title 10, which would lay the frame work under which ACOs will …
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New York Releases Proposed Changes to Certificate of Need
| Health Services
On October 15th, the Department of Health (the “DOH”) published proposed revisions to the Certificate of Need (“CON”) requirements in the state. The proposed regulations would, among other things, no longer require non-clinical facilities obtain a CON prior to beginning construction projects. The comment period for the proposed regulations is now open.                        The proposed regulations …
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New York State Paves the Way for Medical Marijuana
| Health Services
Earlier this year, Governor Cuomo signed into law a bill that will allow New York to join 22 other states and the District of Columbia by allowing residents of the state to purchase and use marijuana for medicinal purposes. However, as with the many other states that allow for the use of medical marijuana, the …
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OIG 2015 Work Plan Released
| Health Services
The Department of Health and Human Services, Office of the Inspector General (OIG) has released its Work Plan (Plan) for Fiscal Year (FY) 2015.  The annually published Plan summarizes new and ongoing compliance activities, audits, and enforcement priorities that OIG plans to pursue this upcoming year.  The OIG identified two new initiatives related to hospital …
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New SHIN-NY Rules Proposed
September 12, 2014 | Health Services
In an effort to advance health information technology (IT) adoption and interoperability across the state, the New York State Department of Health (the “DOH”) has issued draft rules for the Statewide Health Information Network for New York (“SHIN-NY”).  The purpose of the rules is aimed at formalizing and updating the current governance structure and process …
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The Expanded Breadth of HIPAA
June 30, 2014 | Health Services
Claudia Hinrichsen, Counsel in the firm’s Health Services Practice Group, has written an article entitled, “The Expanded Breadth of HIPAA,” which was published in Volume 8 of Best Practices. Please click the link below to view the article. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, …
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FDA is Broken
May 16, 2014 | Health Services
The Mission Statement posted on FDA’s Office of Regulatory Affairs webpage by Associate Commissioner Melinda Plaisier on Jan. 21, 2014, stated we can expect the agency to be “Protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.” The problem, however, is that when it comes …
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New York State and Federal Government Reach Deal on MRT Waiver
February 18, 2014 | Health Services
After months of negotiation, Governor Andrew Cuomo announced on February 13th that New York State has reached an agreement in principle for the Medicaid redesign waiver the Cuomo administration had long-sought. The waiver will allow the state to reinvest $8 billion of federal savings generated by the State back into programs designed to improve health …
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Federal District Court Orders Hospital to Unwind Acquisition of Physician Group
February 10, 2014 | Health Services
On Friday, January 24th, Judge B. Lynn Winmill blocked the acquisition of Saltzer Medical Group (“Saltzer”) by St. Luke’s Health System (“St. Luke’s”) in Idaho.  The District Court Judge held that the merger violated antitrust laws, and allowing the merger to remain in place would give St. Luke’s greater bargaining leverage with health plans and …
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Measuring Compliance Risk in Health Care Transactions
| Health Services
Health care compliance attorneys are frequently asked to “rate” the risks around various existing or proposed business arrangements involving medical professionals.  Could a given arrangement be viewed as a violation of the Stark Self-Referral Law (“Stark”) or Anti-Kickback Statute (“AKS”)?  Are there compelling, or at least plausible, arguments for why the arrangement should instead be …
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Executive Budget Proposes Changes to Out-of-Network Billing
| Health Services
Governor Cuomo’s budget contains many proposed changes to the Public Health Law (some of which are discussed here), but another set of significant changes that will affect providers and patients is contained in the Insurance Law. The Transportation, Economic Development, and Environmental Conservation (“TED”) Article VII bill contains proposed legislative changes that would alter the …
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Governor Cuomo’s Budget Includes Legislative Amendments to Urgent Care
| Health Services
Governor Cuomo recently announced his 2014-15 executive budget for New York State. The new budget contains some relevant legislative changes for healthcare within the State, including a pilot program for private business to partner with academic medical centers to own or operate hospitals, an expansion of office-based surgery (“OBS”), and expansion of urgent care services.  …
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The Growing Role of Telehealth and Possible Pitfalls for Providers
| Health Services
Long wait times and difficulty for a patient to get convenient doctor’s appointments have long been issues for patients seeking medical treatment.  The expansion of individuals with health insurance due to the Affordable Care Act will cause the issue to grow as more individuals have access to health care services they previously did not.  With …
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Public Health and Health Planning Council Approves Recommendations To Create Retail Clinics, Reform Urgent Care
January 9, 2014 | Health Services | Corporate
The Public Health and Health Planning Council (the “Council”) voted on January 7th to approve its report on ambulatory services (the “Report,” viewable here), completing an initial step in the process of expanding and reforming ambulatory service clinics in New York.1 The Report seeks to regulate various classes of ambulatory service centers in the State. …
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New York State Not for Profit Reform Law
January 2, 2014 | Health Services
On December 18, 2013, New York Governor Andrew Cuomo signed into law the Non-Profit Revitalization Act of 2013 (the “Act”), the full text of which is available here.  The Act, which takes effect on July 1, 2014, represents the first extensive overhaul of New York’s nonprofit laws in over four decades.  The Act is intended …
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Public Health and Health Planning Council Releases Ambulatory Care Services Report
November 30, 2013 | Health Services
The New York State Public Health and Health Planning Council (the “Council”) recently released a draft report on ambulatory care services, including most notably a discussion of retail clinics, urgent care centers, and freestanding emergency departments. The report was reviewed at a full meeting of the Council on December 12th, and is slated to be …
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Measuring Compliance Risk in Health Care Transactions
| Health Services
Health care compliance attorneys are frequently asked to “rate” the risks around various existing or proposed business arrangements involving medical professionals.  Could a given arrangement be viewed as a violation of the Stark Self-Referral Law (“Stark”) or Anti-Kickback Statute (“AKS”)?  Are there compelling, or at least plausible, arguments for why the arrangement should instead be …
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