May 12, 2017

Monica Bharel, M.D., MPH

Commissioner

Department of Public Health

250 Washington St.

Boston, MA 02108-4619

Re:Public Hearing on Hospital Licensure (105 CMR 130.000)

Dear Commissioner Bharel:

The Massachusetts Health & Hospital Association (MHA), on behalf of our member hospitals and health systems, requests your consideration of the following comments on the currentDPH hospital licensure regulations. While it is our understanding that DPH is solely conducting this public hearing due to a clerical error in the filing of the final regulations adopted by the Public Health Council on March 8, 2017, we are strongly urging your consideration of our comments to correct a few substantive errors in the revised regulations.

While we are aware of the substantial comments provided to DPH during the first open comment period on these regulations, we are very concerned that proceeding with the most recently issued regulations without the correction of these errors will result in unintended problems such as confusion regarding patient access and increased costs for both providers and DPH. While DPH may prefer that providers simply submit waivers to various provisions that may be confusing or in error,MHA strongly recommends that with this open comment period the issues we have identified can be corrected and reduce the need for increased paperwork.

Using waiver processes to address errors that can be remedied during the comment period is a perspective that we believe goes toward the goals of the Governor’s administrative reform executive order and would help reduce unnecessary costs and time for busy DPH staff to review waivers from the majority of hospitals in the state. To that end, we are submitting these comments in the spirit of collaboration to reduce unnecessary administrative burdens and costs on the healthcare system.

If you have any questions about our comments, please do not hesitate to contact me at (781) 262-6034 or .

Sincerely,

Anuj K. Goel, Esq.

Vice President, Legal & Regulatory Affairs

DPH Hospital Licensure Regulations – 105 CMR 130.000

Definitions (105 CMR 130.020)

1)Chronic Care

  1. In the revised definition, DPH created a conflicting and problematic definition for long-term care hospitals (LTCH) as that is the term utilized by the federal Centers for Medicare and Medicaid Services(CMS), not the more antiquated term of Chronic Care Service. Specifically the revised regulations continues to reference a 25 day length of stay (LoS) as well as the CMS patient level criteria despite the federal government not emphasizing a minimum 25 day LoS in the CMS recently issued revised facility and patient level requirements (see Section 1206(a) of Public Law 113–67 (2013 Bipartisan Budget Act) amended Section 1886(m) of the Social Security Act) that sets forth the designation criteria that all LTCHs must be in compliance. As DPH is also the designated CMS survey contractor in the state, we are very concerned that DPH now has a conflicting mandate when it reviews LTCHs, specifically requiring LTCHs to demonstrate the 25 day LoS under a DPH review, but using a different standard for purposes of the federal review. This type of conflict and redundancy is a direct contradiction to the goals of the Governor’s Executive Order. Instead of requiring every LTCH to repeatedly seek and file a waiver with DPH, we would ask DPH to please consider our request, similar to our last comment during the open comment period, to revise this definition and use the updated terminology as listed below.
  2. Revising Chronic Care Service to be defined as “Long Term Care Hospital “means a service, other than a rehabilitation, psychiatric, substance use disorder, intermediate care facility, or skilled nursing facility service, that meets the long term care hospital patient level criteria issued by the federal Centers for Medicare and Medicaid Services.”

2)Emergency Service

  1. Similar to our request during the open comment period, we strongly believe that it is critical that the DPH change and align this definition with the definition and language used by providers, patients, payers, government agencies and legislators. There is a specific definition in federal and state law and regulations (as we have outlined below), however the definition currently proposed by DPH is too generic and will only create confusion for providers, patients, and payers. By not using consistent definitions, DPH will be applying two different standards to hospitals during licensure reviews, one criteria for DPH surveysand another when conducting CMS reviews. In addition, without this change, other state agencies like MassHealth, DMH, and the Health Safety Net would need to change their regulations to align with the DPH terminology, which is unnecessary administrative time and costs throughout EOHHS. Instead of creating such confusion and given that there is an opportunity to amend this definition during this public notice period, we would urge DPH to consider the following definition change.
  2. “Means a medical condition, whether physical or mental, manifesting itself by symptoms of sufficient severity, including severe pain, that the absence of prompt medical attention could reasonably be expected by a prudent layperson who possesses an average knowledge of health and medicine, to result in placing the health of the insured or another person in serious jeopardy, serious impairment to body function, or serious dysfunction of any body organ or part, or, with respect to a pregnant woman, as further defined in section 1867(e)(1)(B) of the Social Security Act, 42 U.S.C. section 1395dd(e)(1)(B).”

3)Intensive Care Unit

  1. As previously stated during the previous comment period, we urge the DPH to remove the words “(and other)” as it appears in the new definition. While the definition links the requirements to the federal regulations, and the federal regulation does provide guidance as to what would constitute “other areas”, there are no further determinations or clarifications in the DPH regulationas to the clinical or operational areas that relate to the usage of the “and other” term. This will result I subjective determinations by surveyors, providers, and labor organizations. To align with the Governor’s Executive Order to remove confusing or unnecessary language and to help alleviate confusion (especially given that there is reference to the federal regulations that provides more clarity), we would strongly urge that these words be removed.

4)Rehabilitation

  1. Similar to the points outlined in the need to amend the “Chronic Care” definition above and similar to the comments we made during the initial open comment period, we are again asking DPH to update an antiquated reference and ensure that the application of the definition to an inpatient rehabilitation facility is consistent with federal criteria, as that term is used by the federal Centers for Medicare and Medicaid Services. An inpatient rehabilitation facility is designated as such if it is able to meet the patient and facility level criteria specified in 42 Code of Federal Regulations (CFR) 412.29. This unique designation is used by the Joint Commission and other accreditation bodies as well as the Medicaid program. Further, DPH surveyors in their evaluation and review of an existing IRF or changes to an IRF will refer to the federal regulatory requirements outlined above, but would also need to determine how such facilities also meet the state definition which creates substantial confusion. Therefore we strongly urge the state to remove the term “rehabilitation” and use the term “inpatient rehabilitation facility” and also ensure that the use of the phrase is consistent with the federal requirements used by the DPH surveyors.
  2. “Inpatient Rehabilitation Facility – means a service other than a long term care hospital, psychiatric, substance use disorder, intermediate care facility, or skilled nursing facility service, that meets the inpatient rehabilitation hospital patient and facility criteria issued by the federal Centers for Medicare and Medicaid Services.”

Prohibition against Discrimination (105 CMR 130.206)

The Hospital community statewide has been and remains committed to working with ALL patients that seek care in our facilities. Following federal and recently adopted state law (which was supported by the Legislature, the Attorney General, and other public officials), we strongly urge DPH to update its current prohibition against discrimination requirements. As proposed, the current prohibition is inconsistent with state law and regulations and those required by the federal ACA anti-discrimination rules.

It is also important to note that hospital requirements established by the Attorney General’s office and the Health Safety Net provide for a specific policy requirement that despite our initial request, DPH chose not to adopt. If this change cannot occur in the DPH regulations during this new open comment period, then other state agencies would need to amend their regulations in a manner that conflicts withthe goals of several public officials in the commonwealth.

We would therefore ask that the language in 130.206(A) be amended as follows: The hospital does not discriminate on the basis of race, color, national origin, citizenship, alienage, religion, creed, sex, sexual orientation, gender identity, age, or disability.

Director of Nursing (105 CMR 130.310)

MHA and the Organization of Nurse Leaders (ONL) strongly urgeDPH to amend this entire subsection following the provisions outlined below. As drafted, the new definition creates problems for several hospital CNOs, many of whom have a master’s and not a baccalaureate degree in nursing. As a result, many providers in this state will be required to submit waivers to the Department for CNOs and other nursing directors to continue in their current roles.This is an unnecessary use of staff time and increases unnecessary spending, both of which go against the goals of the Governor’s Executive Order.

Both MHA and ONL have been promoting the importance of specific education requirements among the nursing field. However, many nurses, given the shortages of nursing educators and the limits in nursing school programs, are entering the profession through multiple pathways that allow them to pursue different degrees in order to obtain a specific level of education necessary for this position. To that end we would strongly urge DPH to amend the current definition and use the following:

Each hospital shall establish a nursing service under the direction of a registered nurse, currently registered by the Board of Registration in Nursing, who has obtained a minimum of a master's degree or a bachelor's degree, one of which degrees must be in nursing, and who has had at least four years' experience in nursing practice, at least two of which were in an administrative or supervisory capacity.

Discharge Planning Services (105 CMR 130.340)

Within the revised hospital licensure regulations (130.340(A)), DPH appears to have created an unintended problem regarding discharge planning services. As drafted the revised regulation reads that only acute care hospitals are required to have a discharge planning service. This is contrary to the federal requirements on all hospitals, contrary to the process utilized by DPH surveyors, and contrary tothe Joint Commission standards and expectations for the other hospital types (including Rehabilitation, Long Term Care, Substance Use Disorder, and Psychiatric hospitals). Given this change, one could also read that the entire discharge planning requirements pursuant to the regulations only apply to acute care hospitals and no others. To that end, we would strongly urge DPH to remove the words “acute-care” within 130.340(A) to remove potential confusion.

Board Certification Requirements

While this is not an issue specifically identified in the initial comment period by MHA or others, we have identified a unique inconsistency in the regulations that we are seeking your immediate attention and consideration for change. Throughout the regulations, there are various places where DPH specifically requires that a director of a program be “Board Certified” within a specialty. However, the regulations also allow in some places that a medical staff member or program director can be Board certified, Board eligible, or have equivalent training and experience in that specialty to be the director of the service.

While all hospitals are committed to ensuring that medical staff has core competencies within their practice area, we are very concerned that the regulations are creating inappropriate requirements that do not focus on the more appropriate requirement to ensure that medical staff have the specific core competency. Both The Joint Commission and the Medicare Conditions of Participation specifically state that core competency should be based on reviewing knowledge, skills, trainings, and experience, as reliance on board certification as the only requirement is not appropriate. Board certification only demonstrates that a person has the ability to take a test in a specific specialty and is not a measurement of competency and experience.

Without addressing this problem, providers are going to have to seek several licensure specific waivers that will be a significant waste of time and resources by providers and DPH. Determination of the medical staff ability to perform a service should be based on a full review of all competency factors. To that end, we would ask that the use of the “Board certified”language in the regulations be changed as it is appearing to “say Board certified, Board eligible, or have equivalent training and experience” in the following sections of the revised DPH hospital licensure regulations:

  • Page 67 – 130.520 Stem Cell Transplant Program Director definition
  • Page 122 – 130.640(E)(1)(a) and 130.640(E)(1)(b) – which should also be amended to reflect a neonatologist with full privileges
  • Page 129 – 130.650(D)(1)(a)
  • Page 131 – 130.650(E)(1)(a)
  • Page 144 – 130.740(B)(1)
  • Page 146 – 130.750(E)
  • Page 146 – 130.750(G)(1)
  • Page 146 – 130.750(G)(2)
  • Page 146 – 130.750(G)(5)
  • Page 148 – 130.761 (A)(5)
  • Page 167–130.940(A)(1)
  • Page 167 – 130.940(A)(2)
  • Page 169 – 130.940(D)
  • Page 170 – 130.940(D)(1)
  • Page 171 – 130.940(D)(2)
  • Page 193 – 130.1504(C)

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