Recent Publications - Benjamin P. Malerba


The Status of Telemedicine Reimbursement
December 20, 2017 | Benjamin P. Malerba | David E. Richman | Ada Kozicz | Health Services
Benjamin Malerba, David Richman and Ada Kozicz wrote an article published in Health eSource, a publication of the American Bar Association’s Health Law Section entitled, “The Status of Telemedicine Reimbursement: States’ Efforts to Incentivize Providers to Utilize Telehealth Technologies.” The article centers on the importance of creating legislation that will provide insurance reimbursement for telemedicine, as a means to …
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Year-End Deadline for NY Medicaid Providers and Third-Party Billers
December 13, 2017 | Benjamin P. Malerba | Ada Kozicz | Health Services
New York State Medicaid providers who claim, order or receive at least $500,000 from the Medicaid Program in any consecutive 12-month period have until December 31 to certify that they have implemented a compliance program aimed at detecting and preventing Medicaid fraud, waste and abuse. This requirement also applies to third-party billing companies that bill …
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New York Legislature Broadens Telehealth Services Coverage for Adult Care Facilities
October 16, 2017 | Health Services | Privacy, Data & Cyber Law
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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Delayed Notification of a PHI Breach Runs Afoul of HIPAA and State Law
August 17, 2017 | Benjamin P. Malerba | Ada Kozicz
New York Attorney General Eric Schneiderman recently announced a settlement with healthcare services company CoPilot Provider Support Services, Inc. (“CoPilot”), which was charged with unlawfully delaying patient notification of a data breach that involved more than 220,000 patient records. CoPilot waited over a year to notify patients of the breach of their protected health information. …
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OIG Clarifies Hospitals’ Obligations to Patients with Psychiatric Emergencies
August 9, 2017 | Benjamin P. Malerba | Ada Kozicz | Health Services
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 | Health Services
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 | Health Services
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
June 8, 2017 | Health Services
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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Digital Health Vendors Beware – OCR Continues Aggressive HIPAA Enforcement
May 12, 2017 | Health Services
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 | Health Services
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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HHS Finalizes Amendments to Confidentiality Rules for Alcohol and Drug Abuse Patients
February 15, 2017 | Health Services
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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New York Passes New Law to Allow Outpatient Clinics and ASCs to Provide Off-Site Services
January 24, 2017 | Health Services
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
January 24, 2017 | Health Services
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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N.Y. Announces Revisions and Delayed Implementation of Cyber Regulations
January 12, 2017 | Privacy, Data & Cyber Law
In September 2016, New York Governor Andrew Cuomo announced a new regulation that would require banks and insurers to implement cyber security programs. Specifically, the proposed regulation required covered entities, defined as any entity operating under a license or other authorization required by New York’s banking, insurance or financial services law, to establish and maintain …
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As Authorities Crack Down on Cyber Security Attacks, U.S. Copyright Office Lifts Ban on Hacking Your Own Devices
November 11, 2016 | Privacy, Data & Cyber Law
The U.S. Copyright Office (the “Office”) has recently issued an exemption to the Digital Millennium Copyright Act (the “Act”), which prohibits users from hacking their own digital devices. Pursuant to 17 U.S.C. § 702, the Office is authorized to promulgate rules and regulations regarding copyright policies and other intellectual property issues. The Act was first …
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New Guidance on HIPAA and Cloud Computing Issued by the Department of Health and Human Services
October 14, 2016 | Privacy, Data & Cyber Law
As the health care industry continues to utilize new cloud computing technologies, the U.S. Department of Health and Human Services (“HHS”) issued guidance on how such technologies can be implemented while remaining compliant with the HIPAA Privacy, Security and Breach Notification Rules (the “ HIPAA Rules”). Specifically, HHS explained that when covered entities or business …
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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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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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New York Proposes Cyber Security Regulations for Banks and Insurers
September 16, 2016 | Privacy, Data & Cyber Law
On September 13, 2016, New York Governor, Andrew Cuomo, announced a new regulation that would require banks and insurers to implement cyber security programs. The regulation is the first of its kind not only in New York but in all of the United States. While the regulation would only apply to banks and insurers licensed …
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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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Office of Medicaid Inspector General Releases Work Plan for 2016-2017
May 26, 2016 | 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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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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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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Federal Government, New York State Pass New Medical Marijuana Laws
January 1, 2016 | 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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CMS Creates New Stark Exceptions
November 5, 2015
On October 30, 2015 the Centers for Medicare and Medicaid Services (“CMS”) released a final rule that makes significant changes to the Medicare Physician Fee Schedule as well as other payment policies for 2016. Below is a summary of the major policy changes reflected by the rule, specifically provisions regarding the physician self-referral law, payment …
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Judge Orders Reconsideration of “Two Midnight Rule” for Medicare Payment
October 31, 2015 | 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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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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Public Health and Health Planning Council Poised to Release Charity Care Report
August 6, 2015
The Public Health and Health Planning Council (“PHHPC”) is poised to release a report prepared by the Ad Hoc Advisory Committee on Freestanding ASCs and Charity Care (the “Committee”). The report, which has been discussed at previous PHHPC meetings and is now in its final form, details the difficulties ambulatory surgery centers often have in …
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New York’s Medical Marijuana Program
May 31, 2015
Benjamin Malerba and Gregory Mitchell have been published in the June edition of Nassau Lawyer. Their article, entitled “New York’s Medical Marijuana Program” explores the issues surrounding medical marijuana in New York, including certified users, authorized marijuana dispensaries and interstate conflicts. Click the link below to read the full article. Adobe Reader is required to view the bulletin. …
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PHHPC Considers Report on Charity Care in ASCs
May 26, 2015
While there has long been a regulatory requirement that ambulatory surgery centers (“ASCs”) provide a certain level of charity care pursuant to 10 NYCRR § 709.5(d), the Public Health and Health Planning Council (“PHHPC”) and an Ad Hoc Advisory Committee on Freestanding ASCs and Charity Care (the “Advisory Committee”) have been reviewing how to measure …
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New York Issues Final Regulations for Medical Marijuana Program
April 3, 2015
The New York State Department of Health (“DOH”) has released the final regulations for the state’s medical marijuana program. The regulations have been released on the DOH’s website, available here, and will be made official when published in the April 15 State Register. Applications from interested entities, as well as physician education and patient certifications, …
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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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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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New York Releases Proposed Changes to Certificate of Need
December 3, 2014 | 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
December 3, 2014 | 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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Governor Cuomo’s Budget Includes Legislative Amendments to Urgent Care
February 10, 2014 | 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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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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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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New York State Department of Health Discusses Future of Urgent Care and Freestanding Emergency Room Regulations
September 30, 2013 | Health Services | Corporate
On September 13th, the New York State Department of Health’s (“DOH”) Public Health and Health Planning Council’s Health Planning Committee (the “Committee”) convened a meeting in New York City to discuss the oversight of various ambulatory service settings. Specifically, the Committee discussed freestanding emergency departments (“FEDs”), urgent care clinics, upgraded diagnostic and treatment centers, and …
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CMS and OIG Propose Changes to the Electronic Health Record Services Stark Exception and Anti-Kickback Safe Harbor
May 31, 2013
Recently, the Center for Medicare & Medicaid Services (“CMS”) and the Health and Human Services Office of Inspector General (“OIG”) published proposed rules that if enacted would modify certain aspects of the electronic health records Stark Law exception and Anti-Kickback safe harbor by extending its sunset date.[1]   The proposed rules would extend the December 31, …
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The Omnibus Rule: Major Changes
May 31, 2013 | Health Services
On January 17, 2013, the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) released the final Omnibus Rule (“Omnibus Rule” or “Final Rule”) amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules.  As described by HHS OCR Director Leon Rodriguez, “[t]his final omnibus rule marks the most sweeping changes …
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The Affordable Care Act and Health Insurance Exchanges
May 31, 2013 | Health Services
The Affordable Care Act (“ACA”) provides for the establishment of State or regional health insurance exchanges where individuals can shop, compare and purchase medical care coverage beginning the last quarter of this year for coverage effective January 1, 2014.  In connection with establishing a state-based health insurance exchange by October 1, 2013, there are so …
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Office of Medicaid Inspector General Releases New Work Plan
May 31, 2013
The New York State Office of the Medicaid Inspector General (“OMIG”) recently released its Work Plan for fiscal year 2013-2014 (the “Work Plan”). The Work Plan describes activities that OMIG plans to initiate or continue during 2013 and 2014, including its outline of areas of fraud that the agency will target in the new fiscal …
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Section 638 of the Fiscal Deal: Extension of Recovery Time For Non-Fraudulent Medicare Overpayments
March 8, 2013 | Health Services
An obscure provision in the American Taxpayer Relief Act of 2012 (“ATRA”) extends the time period to recover non-fraudulent Medicare overpayments from three to five years.  However, its impact on healthcare providers remains uncertain.  Previously, the Centers for Medicare & Medicaid Services (“CMS”) was limited to recovering non-fraudulent overpayments by a three year limitation period …
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CMS Releases Proposed Payment Rule for Hospital Outpatient Payment Systems and Ambulatory Surgery Centers
August 14, 2012 | Corporate | Health Services
On July 6, CMS released its proposed rule (the “Rule”) for Hospital Outpatient Prospective Payment Systems (“HOPS”) and Ambulatory Surgery Center Payment Systems (“ASC Payments”) which was published in the Federal Register on July 30, 2012.  The final rule is expected to be published on November 30, 2012.  The Rule would increase reimbursement for HOPS …
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Supreme Court Upholds Affordable Care Act, Limits Medicaid Expansion Provision – A Rivkin Radler LLP Analysis
June 29, 2012 | Health Services
In what many are calling its most important decision since Bush v. Gore, the Supreme Court largely upheld the Patient Protection and Affordable Care Act (the “Act”). Chief Justice Roberts delivered the 5-4 ruling of the Court, upholding all of the provisions of the Act, except for a narrow portion of the Act’s Medicaid expansion. …
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OIG Warns Against Certain Arrangements Between Anesthesiologists and ASCs
June 15, 2012 | Health Services | Corporate
The Office of the Inspector General (the “OIG”) recently issued Advisory Opinion No 12-06 (the “Opinion”) on two proposed arrangements between the exclusive providers of anesthesia services to a group of ASCs (the “Provider”) and physician-owned ASCs (the “ASC”).  Briefly stated, the Provider wished to enter into one of two possible arrangements to provide anesthesia services …
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Closet Cleaning Tips: The DMEPOS Standard Against Sharing Practice Location
August 31, 2011 | Health Services | Corporate
Before considering arrangements involving the provision of durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) as part of their practice, healthcare providers must be mindful of not only the Stark Law and Anti-kickback Statute, but also of the CMS standards applicable to DMEPOS suppliers.[1] These standards are contained in 42 CFR § 424.57(c), and all …
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State Hospital Review & Planning Council & Public Health Council Merge
August 31, 2010 | Health Services | Corporate
Please click the link below to view The State Hospital Review and Planning Council and the Public Health Council Merged into the Public Health and Health Planning Council. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. The State Hospital Review …
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NYS Dept. of Health Proposes Amendments to the Cert. of Need Process
May 31, 2010 | Health Services
Please click the link below to view the Health Law Bulletin – June/July 2010. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Health Law Bulletin – June/July 2010 Reprinted with permission.  All rights reserved. …
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The Impact of the Patient Protection and Affordable Care Act
April 30, 2010 | Health Services | Corporate
Please click the link below to view the Health Law Bulletin – April/May 2010. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Health Law Bulletin – April/May 2010 Reprinted with permission.  All rights reserved. …
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