When the President has declared a national emergency under authorizing legislation, the Secretary of the U.S. Department of Health and Human Services is authorized to grant waivers to certain prohibitions under the Social Security Act, which includes the Stark Law, during a declared public health emergency in order to ensure (i) sufficient health care items

As part of the U.S. Department of Health and Human Services’ “Regulatory Sprint to Coordinated Care,” the U.S. Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) coordinated their efforts in issuing proposed changes to the federal fraud and abuse laws which prohibit certain patient referrals. The changes are intended

A recent U.S. Department of Health and Human Services, Office for Civil Rights (OCR) settlement illustrates why health care facilities must carefully consider potential privacy risks and take precautionary steps before allowing a camera crew to film on their premises.

OCR settled with three Massachusetts hospitals for a total amount of $999,000 for violations of

In a recent advisory opinion, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) concluded that a proposed donation of telehealth equipment to a referral source presented a low risk of fraud and abuse under the federal Anti-Kickback Statute. The conclusion was premised on several factors, one of which included OIG’s

The Centers for Medicare and Medicaid Services (CMS) recently issued a proposed rule that revises the Medicare Physician Fee Schedule and other Medicare payment policies for telehealth services.

Over the past decade, stakeholders in the health care industry have voiced their support for telehealth services, explaining how modern communication technology can promote care coordination, ensure

The Department of Health issued guidance in May 2018, about a law, which took effect on April 1, 2018, that places a two-year moratorium on the processing and approval of applications for Licensed Home Care Services Agencies (LHCSAs). The moratorium applies to applications that have not yet been submitted as well as to those that

Cybersecurity breaches have become commonplace. In 2017, the global economy incurred an estimated loss of over $450 billion for cyber-related crimes and security breaches. It is no longer a question of whether a business will fall victim to a security breach or malware attack, but only a question of when.  A cybersecurity event can have

A recent report issued by the U.S. Department of Health and Human Services, Office of Inspector General (OIG), estimates that 61% of claims submitted to Medicare for outpatient physical therapy (PT) services failed to comply with Medicare requirements. The OIG report serves as a reminder to PT providers about the importance of accurate billing and

A recent settlement between the U.S. Department of Health and Human Services, Office of Civil Rights (the Department) and Filefax, Inc. serves as a stark reminder for covered entities and business associates that their obligation to comply with the Health Insurance Portability and Accountability Act (HIPAA) does not end simply because they close their business

Governor Andrew Cuomo has signed a new law, known as “Lavern’s Law,” that extends the amount of time a patient has to file a medical malpractice claim for a missed cancer or malignant tumor diagnosis. Patients now have 2 1/2 years to file a claim from the date the misdiagnosis is discovered by the patient,

Recognizing that texting has become a valuable and essential means of communication among providers, the Centers for Medicare and Medicaid Services (CMS) recently issued new guidance regarding its position on texting of patient information. The guidance clarifies that texting patient information may be permissible if certain security standards are met, but it also distinguishes between

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

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

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

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.

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

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

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

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)

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,

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

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

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

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

The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) recently announced a new initiative to investigate the causes of “small breaches” under the Health Insurance Portability and Accountability Act (“HIPAA”) that involve the protected health information (“PHI”) of fewer than 500 individuals. OCR has discretion in deciding which breaches to

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

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

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

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

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.

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

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

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