Accreditation, Licensing & Certification

shutterstock_428983732Last 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

Boston_StateHouseNext 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 CoxSteven BaddourDan ConnellyCaitlin BeresinMax 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

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”).  This much anticipated rule represents the first major update of these regulations in 25 years – setting new staffing, patient protections, and compliance requirements for LTC facilities.  CMS estimates that these changes will not necessarily be inexpensive for facilities, costing an average of $62,900 per facility in the first year and $55,000 in each subsequent year.  In response to the estimated financial burden and the complexity of the Final Rule, CMS has adopted a phased approach for the rollout, spreading out implementation of the various requirements over the next three years.  The implementation dates are November 28, 2016 for Phase 1, November 28, 2017 for Phase 2, and November 28, 2018 for Phase 3.  The three phases have been categorized based on CMS’s assessment of each revision’s complexity and the extent to which interpretive guidance and survey processes will need to be revised.

We highlight key provisions of the Final Rule below:

Prohibition against Pre-Dispute Binding Arbitration Agreements

In an effort to strengthen resident rights, under the Final Rule, CMS will prohibit LTC facilities from entering into pre-dispute binding arbitration agreements with residents or their legal representatives.  While the initial Proposed Rule set forth specific criteria to be met by LTC providers seeking to make use of pre-dispute binding arbitration agreements, the Final Rule bans them altogether.  CMS cites doubts about residents’ ability to understand the implications of such agreements as well as concerns about the arbitration process in general.  In response to comments regarding CMS’s legal authority to ban arbitration agreements, the agency clarified that the Final Rule would have no effect on existing pre-dispute arbitration agreements between LTC facilities and residents, and that any such existing agreements could still be enforced.  The prohibition against pre-dispute binding arbitration agreements is included in Phase 1. Continue Reading CMS releases Final Rule Overhauling Long-Term Care Facility Requirements

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).  DPH believes that the proposed amendments will streamline the Medical Use of Marijuana Program (the “Program”) by updating existing processes, providing additional clarity, and creating consistency with changes made to related laws, all with the goal of promoting patient access while assuring public safety is maintained.  At a meeting of the Public Health Council (PHC) held on September 14, 2016, DPH representatives, including Program Director Bryan Harter, MBA, LICSW, presented the proposed amendments.  DPH’s presentation to the PHC at the meeting includes a summary of the proposed amendments, as well as a brief history of the Program, including applications received, provisional Certificates of Registration to operate a Registered Marijuana Dispensary (RMD) (41), and number of RMDs currently open and dispensing marijuana for medical use (7).

Amendments are undoubtedly necessary. The current regulations, which became effective on May 24, 2013, were implemented in connection the creation of the Program, and DPH now has the benefit of experience with the RMD process to amend its regulations to reflect, in some cases, lessons learned.  As with proposed amendments to other regulations (see our prior posts here and here), these amendments are also necessary 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 their regulations.  Continue Reading Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations