Massachusetts Board of Registration in Medicine Makes Significant Changes to Regulations Governing Licensure and Practice of Medicine

By Conor Duffy on Posted in Hospitals and Health Systems, Legislation, Long Term Care Facilities, Physicians and Allied Health Professionals

The Massachusetts Board of Registration in Medicine (BORM) recently approved significant changes to regulations governing the licensure and practice of medicine. The new regulations became effective on August 9, 2019. Physicians and health care organizations in Massachusetts would be well-advised to review the updated regulations closely – among the new provisions are regulations that will potentially affect current practices regarding the delegation of services to non-licensed individuals, procedures for obtaining informed consent, and other aspects of medical practice.

BORM’s regulations concerning licensure (and discipline) of physicians and the practice of medicine can be found at 243 Code of Massachusetts Regulations (CMR) Chapter 2. BORM initially proposed changes to its regulations in 2017 that were opposed by groups representing physicians and other providers. Despite this opposition, BORM recently approved the changes. Continue Reading

Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

By Robinson+Cole's Health Law Group on Posted in Academic Medical Centers, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, HIPAA, Hospitals and Health Systems, Medicare and Medicaid, Privacy and Security, Reimbursement, Stark Law

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached. Continue Reading

AdvaMed Revises Code of Ethics on Interactions with Health Care Professionals

By Melissa (Lisa) Thompson on Posted in Clinical Research, Fraud and Abuse, Life Sciences, Medical Devices, Pharmaceuticals and Biologics

The Advanced Medical Technology Association (AdvaMed) has revised its U.S. Code of Ethics for Interactions with Health Care Professionals, with updates that take effect January 1, 2020. Until then, the current AdvaMed Code remains in effect.

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Connecticut Expands Minors’ Confidential Access to Treatment for HIV and AIDS, Adds Reporting Requirement

By Robinson+Cole's Health Law Group on Posted in 2019 Connecticut Legislative Update, Academic Medical Centers, HIPAA, Hospitals and Health Systems, Legislation, Pharmaceuticals and Biologics, Physicians and Allied Health Professionals

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-109 “An Act Concerning The Prevention Of The Human Immunodeficiency Virus” (PA 19-109) which increases access to preventative and prophylactic human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) interventions for minor patients, and adds two exceptions to the confidentiality requirements for HIV/AIDS treatment of a minor patient. The Act is effective July 1, 2019. Continue Reading

Connecticut Empowers DSS to Expand Medicaid Coverage of Telehealth Services

By Robinson+Cole's Health Law Group on Posted in 2019 Connecticut Legislative Update, Accountable Care Organizations, Healthcare Technology, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Telehealth, Telemedicine

On June 28, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-76 “An Act Expanding Medicaid Coverage of Telehealth Services” (PA 19-76).  PA 19-76 revises the criteria and process by which the Connecticut Department of Social Services (DSS) determines the telehealth services covered by the Medicaid program. PA 19-76 is effective July 1, 2019. Continue Reading

SHIELD Act Becomes Law, Expanding Breach Notification and Data Security Requirements

By David Gilboa and Leslie Levinson on Posted in Healthcare Technology, HIPAA, Privacy and Security

On July 25, 2019, New York Governor Andrew Cuomo signed the Stop Hacks and Improve Electronic Data Security Act (SHIELD Act) into law. The SHIELD Act modifies the current Breach Notification Law to expand the types of data elements that are considered “private information” and to expand the data breach disclosure requirements for individuals and businesses. Moreover, the law creates a requirement that owners or licensors of private information meet a new “reasonable security requirement.” Continue Reading

Connecticut Revises Physician Assistant Statute to Clarify Collaborative Nature of Practice Relationship Between Physician Assistants and Physicians

By Robinson+Cole's Health Law Group on Posted in 2019 Connecticut Legislative Update, Legislation, Physicians and Allied Health Professionals

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act 19-144, “An Act Concerning A Collaborative Relationship Between Physician Assistants And Physicians” (19-144). This legislation revises the statutory definition of a “physician assistant” (PA) under Connecticut law to provide that a PA functions in a “collaborative” relationship with a physician – not a “dependent” relationship – effective July 1, 2019.  The legislation retains the current requirement that a PA is also an individual licensed under Connecticut law “to provide patient services under the supervision, control, responsibility and direction of said physician.”

Connecticut Expands Scope of Practice for Advanced Practice Registered Nurses

By Robinson+Cole's Health Law Group on Posted in 2019 Connecticut Legislative Update, Commercial Health Insurance, Hospitals and Health Systems, Managed Care, Pharmacy Law, Physicians and Allied Health Professionals

Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-98 “An Act Concerning The Scope Of Practice Of Advanced Practice Registered Nurses” (PA 19-98), which generally expands the scope of practice for Connecticut-licensed advanced practice registered nurses (APRNs). Among other things, PA 19-98 addresses matters related to medical records, emergency treatment, insurance coverage, and workers’ compensation, as further described below. PA 19-98 becomes effective October 1, 2019. Continue Reading

CMS Announces Pilot Program for Clinicians to View Claims Data of Medicare Beneficiaries

By Melissa (Lisa) Thompson on Posted in Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Managed Care, Medicare and Medicaid, Privacy and Security

On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced “Data at the Point of Care” (DPC), a pilot program that will provide clinicians with access to claims data. The pilot program follows on the heels of the recently proposed Interoperability and Patient Access Proposed Rule, which would require regulated health plans to make patient data available through an application programming interface (API). These actions are also part of the MyHealthEData initiative spearheaded by the White House Office of American Innovation. Continue Reading

DOJ Intervenes in FCA Suit Against Spinal Device Manufacturer and Senior Executives that Allegedly Paid Kickbacks to Surgeons

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medical Devices, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of Life Spine. DOJ alleges that the company – a maker of spinal implants, devices and equipment – offered and paid kickbacks in the form of consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce the use of its products in violation of the Anti-Kickback Statute (AKS). DOJ further alleges that Life Spine’s President and Chief Executive Officer (who is also its founder and majority shareholder), as well as its Vice President of Business Development, had knowledge of and participated in the alleged kickback arrangements, and named the individuals as co-defendants. DOJ claims that by paying the alleged kickbacks to physicians in order to induce the use of Life Spine products, Life Spine “caused false claims to be submitted to Medicare and Medicaid.” Continue Reading

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