January 25, 2020

January 24, 2020

Subscribe to Latest Legal News and Analysis

January 23, 2020

Subscribe to Latest Legal News and Analysis

January 22, 2020

Subscribe to Latest Legal News and Analysis

Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long review of each and every regulation under the Executive Department’s jurisdiction, which includes the regulations falling under the primary oversight agency for health care in Massachusetts – the Executive Office of Health and Human Services.

As the Secretary of Health & Human Services, Marylou Sudders leads the largest executive agency in Massachusetts – there are nearly twenty departments and divisions under her oversight, including the Department of Public Health, Department of Mental Health, and the Division of Health Care Finance and Policy. These agencies (and others) promulgate health care rules and regulations about licensing and certification, quality and data reporting, clinical, recordkeeping, operational and facility requirements, and more – leaving providers and payors to wind through a labyrinth of legal requirements.

Enter Executive Order 562.

Through March 31, 2016, all of the Commonwealth’s executive agencies will be undergoing a coordinated, comprehensive review process intended to streamline Massachusetts regulations so “only those that are essential to the public good” remain. Under the Executive Order, a regulation must be revised or removed by next March unless it is mandated by law or essential to the health, safety, environment or welfare of the Commonwealth’s residents. To meet this standard, a regulation must address a clearly identified need for governmental intervention, be cost-effective, and not exceed federal requirements.

The health care industry is a driving force for the Commonwealth’s economy.  Providers and companies engaged in health care activities must be able to operate in an efficient environment so they can provide high-quality, affordable health care to the state’s residents. Despite continuing federal and state mandates to reduce costs, improve the quality of care and provide greater access to care, health care companies often find themselves spending a disproportionate amount of resources navigating compliance with a complex federal and state legal framework. The Executive Order states that “confusing, unnecessary, inconsistent and redundant government regulations” are a stress to health care institutions, and the Commonwealth will be better served by “an efficient, coherent and consistent regulatory framework.” We have seen first-hand the negative effects of conflicting, redundant or unclear regulations, and regulations with unintended burdensome consequences.

Health care industry stakeholders should take advantage of the opportunity to participate in this Massachusetts regulatory review process, and voice their concerns about negative impacts caused by the current regulatory framework. The Secretary of Administration and Finance, Kristen Lepore, is overseeing the collaborative executive agency process to gather and analyze stakeholder input

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

TRENDING LEGAL ANALYSIS


About this Author

Julie Cox, Legislative Affairs, Mintz Levin, Criminal Justice Counsel,
Vice President, Legislative Affairs

Julie has more than a decade of government affairs and legislative counsel experience. She clerked for several justices in the Superior Court of Massachusetts. She served as legal counsel to the Committee on Criminal Justice and as legal counsel to the House Committee on Ways and Means in the Massachusetts House of Representatives.

Julie also served as general counsel, legislative liaison, and spokesperson for the Retailers Association of Massachusetts. Prior to joining ML Strategies, she held an of counsel position in the public policy and public finance practices of a large Boston...

617-348-1885
Ellen L. Janos, Health care attorney, mintz levin law firm,Digital Health PBMs & Pharmacies Hospitals & Health Systems Post-Acute & Long-Term Care Retail & Urgent Care Physician Organizations
Member

Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. She has successfully argued two cases before the US Supreme Court.

Ellen specializes in providing regulatory and strategic advice to health care providers and payors of all types, including hospitals, managed care organizations, long-term care facilities, pharmacies, pharmaceutical and device manufacturers, telemedicine providers, and urgent care and retail health clinics. She also represents companies doing business with, and investing in, health care providers. One of Ellen’s provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen's practice focuses on Medicare, Medicaid, and third-party payor audits and investigations, the development of corporate compliance programs, and hospital/physician relationships, including compliance with the state and federal anti-kickback laws and the Stark Law. In addition, she advises clients on how to deploy telemedicine and internet based health initiatives, electronic health records, and how to address HIPAA privacy and security matters.

Before joining Mintz, Ellen was an assistant attorney general for the Commonwealth of Massachusetts, representing state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions.

Ellen served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

She has written about and speaks frequently on state and federal telehealth laws, the corporate practice of medicine, compliance programs, board governance matters, HIPAA privacy and data security, technology and health care, and hospital/physician relationships. Ellen has successfully argued two cases before the US Supreme Court.

617-348-1662
Rachel Irving Pitts, Mergers Attorney, Mintz Levin, Compliance Review Lawyer
Associate

Rachel's practice primarily involves transactional and regulatory matters, including mergers and acquisitions, regulatory compliance review, telemedicine issues, and provider and service contracting matters for various health care providers, administrative organizations, payors, and health systems. Rachel has worked on over 20 transactions valuing more than $200 million since starting at Mintz Levin. She works with hospital systems, dialysis, long-term care, and retail providers, individual providers and practice groups, management companies, independent practice associations, and third-...

617.348.4454