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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

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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...

Ellen L. Janos, Health care attorney, mintz levin law firm

Ellen specializes in providing regulatory and strategic advice to health care clients of all types, including hospitals, long-term care facilities, hospices, retail pharmacies, PBMs, and pharmaceutical manufacturers.

She also represents companies doing business with, and investing in, health care providers. She represents clients in Medicare, Medicaid, and third-party payor audits and investigations; in the development of corporate compliance programs, HIPAA, privacy and security compliance initiatives; and in the negotiation and implementation of Corporate Integrity Agreements. She also provides strategic and regulatory advice on telemedicine issues and hospital/physician relationships, including compliance with the state and federal anti-kickback laws and the Stark Law.

Before joining Mintz Levin, Ellen was an assistant attorney general for the Commonwealth of Massachusetts. She represented state agencies responsible for health care reimbursement, licensing, and regulation in administrative and court proceedings, and prosecuted Medicaid fraud cases. She was also administrative counsel to the Massachusetts Attorney General, coordinating special health care projects and working with other state attorneys general through the National Association of Attorneys General.

Ellen is a member of the advisory committee that is working 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 corporate compliance programs, board governance matters, HIPAA privacy and data security, technology and health care, and physician/hospital relationships.

Rachel Irving Pitts, Mergers Attorney, Mintz Levin, Compliance Review Lawyer

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-...