Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements. As of July 1, 2018, laboratories doing business in Florida need only maintain CLIA certification. Continue Reading Florida Repeals Laboratory Licensure Requirements Effective July 1st
Last week, Governor Andrew Cuomo unveiled his proposed $168 billion budget for fiscal year 2019, which proposes several changes to New York’s healthcare landscape. Among other things, the budget contains amendments that would authorize the provision of certain health services by retail health clinics, and proposes a tax on private health insurance companies and not-for-profit health insurance conversions. Continue Reading New York Executive Budget Proposes Corporate Ownership of Retail Clinics, Tax on Not-for-Profit Health Insurance Conversions
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from the Board of Pharmacy, (b) to state that PBMs have fiduciary duties to their “purchaser” clients (i.e., health plans), and (c) to require PBMs to disclose to their purchaser clients data regarding drug costs, rebates, and fees earned. The favorable vote moves the bill to the Committee on Appropriations.
California is not the only state that is considering adopting a PBM “transparency” law. New York’s Governor Cuomo released a proposal that seeks to require PBMs to both register with the State and obtain a license (from the Department of Financial Services) as well as disclose financial incentives or benefits for promoting the use of certain drugs and financial arrangements that affect customers. The Governor would also like to impose price controls on pharmaceutical manufacturers. New York has a long history of regulating PBMs through a handful of systems because the services that PBMs offer often result in a PBM needing to hold a specific non-PBM license and to adopt a specific corporate structure. In addition, Senator Wyden (D-Ore.) introduced the C-THRU Act to the Senate Finance Committee in March. The C-THRU Act seeks to make PBM rebate data publicly available, require the Secretary of HHS to adopt a minimum percentage of drug rebates that a PBM would need to pass through to certain of its health plan clients, and amend the definition of “negotiated prices” under the Medicare Part D Program. Continue Reading California Advances PBM Licensing and “Transparency” Law
Next week, the Massachusetts House will continue the budget process and debate over 1000 amendments that members filed to the House Ways and Means Committee’s proposed $40.3 billion FY2018 budget. The Committee’s budget includes some notable departures from Governor Baker’s proposed budget, including changes to budget items impacting the health care industry. In an Alert released earlier this week, my ML Strategies colleagues Julie Cox, Steven Baddour, Dan Connelly, Caitlin Beresin, Max Fathy and Haejin Hwang describe some of the variances in health care and public health spending proposals. Continue Reading Massachusetts Budget Process Continues with Impact on Health Care
The Massachusetts Department of Public Health (DPH) has promulgated final Hospital Licensure Regulations. Approved by unanimous vote of the Massachusetts Public Health Council (PHC) on March 8, 2017, DPH anticipates that the Hospital Licensure Regulations (105 CMR 130.000, et seq.) will be published in the Massachusetts Register in April, 2017. The regulations will become effective as of the date of such publication.
As noted in our September 26, 2016 Blog Post, the amendments are part of DPH’s overall regulatory review process needed to comply with Governor Baker’s Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve regulations. At Wednesday’s PHC meeting, Commissioner Monica Bharel, M.D., MPH introduced the presentation of the final regulation by senior DPH staff, indicating that the regulation is part of DPH’s public health informed view of system transformation. In its materials accompanying the presentation of the regulations, DPH noted that the regulation is intended to ensure a high quality of care, industry standardization, and strong consumer protection for persons receiving hospital care.
In response to comments received in response to the proposed revisions, DPH made a number of further revisions to clarify definitions and licensure requirements, streamline administrative and staffing requirements, and remove duplicative and unnecessary reporting requirements (aligning, when possible, reporting requirements of other state agencies). A summary of comments received, and DPH’s responses to such comments, is contained in the Information Briefing provided to Dr. Bharel and the PHC. Continue Reading Massachusetts Department of Public Health – Final Hospital Licensure Regulations
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations (shown here compared against the draft revisions.) Approved by the Massachusetts Public Health Council (PHC) on January 11, 2017, DPH anticipates that the DoN regulations (105 CMR 100.000, et seq.) will be published in the Massachusetts Register on January 27, 2017, which will be their effective date.
Commissioner Monica Bharel, M.D., MPH emphasized that the overarching goal of these revisions is to meaningfully infuse public health and population health principles within this longstanding health care regulation. The Commissioner noted that it is her belief that successful cost containment must occur in the context of tackling social determinants of health. Our previous blog post, published at the time the draft revisions were presented to the PHC, reviews in some detail the DoN Program’s public policy goals underpinning these revisions, and we refer you to that post for more information.
At the presentation of the draft revisions to the PHC on August 23, 2016, DPH announced its intent to solicit and encourage robust public comment, and the public did not disappoint. A January 11, 2017 memorandum from senior DPH staff to Commissioner Bharel and members of the PHC requesting approval of the final proposed DoN regulations stated that DPH received over 100 comments, submitted at two public hearings and in writing during the 45-day public comment period. The memorandum summarizes not only the comments received, but the stakeholders who submitted the comments and DPH’s public policy rationale for its reaction to many of the comments. Materials (available here and here) accompanying the presentation of the final proposed DoN regulations also summarize the draft revisions, comments received and final proposed DoN regulations.
Many comments addressed the requirements for DoN review of ambulatory surgery, transfer of ownership, Community Health Initiative (CHI) projects, as well as application requirements, review process and criteria, and standard conditions. Two areas that generated many of the public comments, and which resulted in adjustments to the proposed DoN regulations, are discussed below. Continue Reading Massachusetts Determination of Need Program – Final Regulations
Massachusetts Long Term Care Facility Regulations – Proposed Amendments
The Massachusetts Department of Public Health (DPH) continues its efforts to revise its regulations to comply with Executive Order 562, which requires all state agencies to review its regulations. Long-Term Care Facilities (LTCFs) must currently comply with 3 separate regulations: 105 CMR 150.00 (Licensing of Long-Term Care Facilities); 105 CMR 151.000 (General Standards of Construction for LTCFs in Massachusetts); and 105 CMR 153.000 (Licensure Procedure and Suitability Requirements for LTCFs). (Note: these links will bring you to DPH’s redlined versions, where applicable. The corresponding presentations by DPH staff to the Public Health Council (PHC) at the PHC’s November 9, 2016 meeting are available here.) Continue Reading Massachusetts Long Term Care Facility Regulations – Proposed Amendments
Last week, the Massachusetts Department of Public Health issued another round of proposed amendments to its regulations, continuing the Baker Administration’s regulatory reform efforts. Today, we take a closer look at the proposed amendments to the proposed regulations governing the licensure of hospice programs.
As expected, many of the proposed changes are aimed at making the hospice regulations consistent with the rules that govern other health facilities such as hospitals and clinics. For example, consistent with the hospital and clinic regulations, the Commissioner would be given broad authority to determine under what circumstances a change in control of the operation of the hospice rises to the level of a “transfer of ownership”. Another change for consistency purposes is the proposed revision to the rules governing incident reporting. Under the proposed rule, a hospice inpatient facility must report unanticipated deaths and any serious incidents or accidents as defined in guidelines of the Department. Continue Reading Massachusetts Licensure of Hospice Programs Proposed Regulations – Key Take-Aways
At yesterday’s Public Health Council meeting, the Massachusetts Department of Public Health (DPH) released yet another round of proposed regulatory amendments. On deck were regulations concerning Long Term Care Facilities, Hospice Programs, and Temporary Nursing Service Agencies, as well as requirements for Training of Nurses’ Aides in Long-Term Care Facilities. Also presented were updated regulations on the Drug Formulary Commission (formerly List of Interchangeable Drug Products regulations). Senior DPH staff presented the proposed regulations, highlighting key objectives. Council members were highly engaged in the discussions, asking numerous questions and offering comments. Commissioner Monica Bharel, MD, MPH, commended DPH staff for their hard work on the amendments and the Council for its support of these ongoing efforts. Continue Reading Massachusetts Regulatory Overhaul Continues
In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations. DPH’s presentation to the Public Health Council is available here. As with the proposed amendments to the hospital and dialysis clinic regulations, many of the changes to the clinic licensure regulations are technical in nature and aimed at reducing the regulatory burden on clinics, aligning reporting obligations with other state and federal Massachusetts requirements and updating regulatory language. DPH did, however, propose some a number of substantive amendments to the clinic licensure regulations, including the following: Continue Reading Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways