October 27, 2016

Monica Bharel, M.D., MPHCommissionerDepartment of Public Health250 Washington St.Boston, MA 02108-4619

Re: Proposed Regulations Amending Hospital Licensure (105 CMR 130.000)

Dear Commissioner Bharel:

The Massachusetts Health & Hospital Association (MHA), on behalf of our member hospitals and health systems, appreciates the opportunity to submit comments on the proposed amendments to the Department of Public Health (DPH) hospital licensure regulations. At the outset, MHA commends DPH for prioritizing both the revision and modernization of these regulations.

While we believe that many of the proposed changes are helpful and well-intentioned, we are concerned with these proposed changes in three specific areas: 1) the proposed changes expand/increase hospital reporting and hospital notifications that are duplicative, costly, and provide no additional value to the healthcare system; 2) the proposed regulatory standards do not take into consideration and, in many cases diverge from, nationally recognized professional standards; and 3) the terminology used in the proposed regulations is not based on terms used in national, or even local, standards of practice.

Attached please find our detailed set of comments, requested clarifications, and suggested amendments to various terms and requirements outlined in the proposed regulations. We support these changes to ensure that healthcare providers are best able to effectively improve their services and facilities in a manner consistent with state and federal healthcare reform implementation and delivery system innovation goals to reduce administrative burdens while promoting simplification.

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

Sincerely,

Anuj K. Goel, Esq.Vice President, Legal & Regulatory Affairs

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DPH Hospital Licensure Regulations – 105 CMR 130.000

Definitions (105 CMR 130.020) 1) Ambulatory Care Service

a. The definition in the current draft could be read to mean patients cannot go to a hospital for outpatient care if the facility provides services overnight. Also, there have been significant changes in how federal, state, and private payers (through federal and state laws) are able to determine when a patient is receiving inpatient or outpatient/ambulatory care services. Given these changes and to ensure consistency in various state law provisions, we request that the language be updated to reflect the following: “means health care services for patients where the treating clinician determines the patient does not require to remain overnight in a facility”

2) Birth Center and Birth Center Servicesa. While we agree with adding the birth center requirements within the hospital

licensure regulations, we urge DPH to update and align the old definitions with the requirements laid out in the Facility Guideline Institute’s Guidelines for Design and Construction of Health Care Facilities (FGI 2014 edition). DPH already has these requirements set forth in its administrative guidelines, which are based on the Facility Guideline Institute’s Guidelines for Design and Construction of Health Care Facilities as referenced in 105 CMR 130.107. Under these guidelines, there are specific definitions and operational requirements for a birth center that the two hospitals with a free standing birth center are using. It is critical that in this definition, DPH reference the FGI guidelines (as updated from time to time) as the default in order to meet the purpose of the governor’s executive order and reduce duplicative and conflicting standards and terms.

3) Campusa. As drafted this definition would preclude campuses from providing any services that

DPH defines as non-essential even when allowed under Medicare Conditions of Participation or other accreditation requirements. Therefore we propose changing the definition to remove the words “essential healthcare services” and add in the words “health care services” in its place.

4) Chronic Carea. The assumption is that this definition was created to reflect long-term care hospitals

(LTCH) as that is the term the federal Centers for Medicare and Medicaid Services (CMS) uses. The state historically used the antiquated terms chronic care hospitals or chronic disease hospitals to reference facilities that provide a minimum of 25 days lengths of stay. If the intent of this definition is to reflect such facilities, then we urge DPH to change the terminology and usage to reflect the current practices that are used nationally and within the state. Section 1206(a) of Public Law 113–67 (2013 Bipartisan Budget Act) amended Section 1886(m) of the Social Security Act to establish patient-level criteria for determining services LTCH are allowed to perform or receive reimbursement for, effective for discharges on or after October 1, 2015. While CMS still maintains that the primary criteria for designation of an LTCH is a length of stay greater than 25 days, it does not allow a facility to be held out publicly as an LTCH without it being able to meet the specific patient criteria that CMS has

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developed. We strongly request that this term and definition be changed to reflect the new designation criteria the federal government uses.

b. Therefore we request that this entire definition be amended to reflect the following: 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.”

5) Data Analysis Centera. We urge DPH to remove this definition from the regulations and instead consider

changes outlined in our comments related to the requirements for Cardiac and PCI services

6) Emergency Servicea. For consistency with the licensure application and definition use by providers,

patients, payers, government agencies and legislators, we urge DPH to use the common definition of emergency services that is used in federal and state law and regulations, as outlined below. All hospitals are mandated to use this definition in several hospital policies and practices and itis the definition CMS uses (and DPH as the state surveying agency), so it would be logical for these terms to be consistent for federal and state purposes.

b. “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).”

7) Intensive Care Unita. Similar to our comments above, we urge DPH to refer to the federal definition of

intensive care unit for the purpose of consistency and standardization. Creating additional context for what is appropriate in a unit that differs slightly from how the federal government defines a unit will create operational and clinical problems for providers when required to meet two potentially different standards. This proposed definition would also pose conflicts with applying the recently enacted ICU patient assignment law. To that end we propose the following definition.

b. “means a unit that meets the Medicare requirements in 42 CFR 413.53(d) for intensive care type inpatient hospital units.”

8) Rehabilitationa. For the reasons that we cite above, we assume that this term is also used to define an

inpatient rehabilitation facility. If that is the intent, then similar to the comments on the term “Chronic Care”, we request that DPH change its use of an antiquated term and definition and use the national term 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

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surveyors in their evaluation and review of an existing IRF or changes to an IRF will refer to the federal regulatory requirements outlined above. Therefore we strongly urge the state to remove the term “rehabilitation” and use the term “inpatient rehabilitation facility” to be consistent with the federal requirements used by the DPH surveyors.

b. “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.”

9) Satellite Emergency Facilitya. While we do not oppose the changes outlined in the hospital licensure regulations, we

strongly urge DPH to consider the changes to the clinic licensure regulations which we will be commenting on separately. While the state is requiring very specific and strict safety and quality standards on hospitals for providing emergency level services, it would appear that the state is not providing a similar level of patient protection for similar coordination of care when a patient seeking emergency level services at a clinic. Therefore we request the following:

i. Specifically, DPH should require that any clinic seeking to provide emergency services as a free standing clinic or service in the state should be required to (1) be an affiliate of an existing Acute Care Hospital licensed pursuant to M.G.L. c. 111, § 51 or (2) constitute a joint venture with an existing Acute Care Hospital licensed pursuant to M.G.L. c. 111, § 51, provided that there is an integration and communication of patient health records between the joint entities.

ii. DPH should NOT remove the current requirements that clinics procure a written agreement with a nearby hospital for emergency services and have a written plan for transfer/transport of patients with an emergency service.

10) Transfer of Ownershipa. We are very concerned with subpart (5) as drafted, which could be read to include

one or two changes to the Board which currently occur routinely as individuals step down from their various positions. In addition, with investor owned hospitals that are publicly traded companies, there can often be a change in a percentage of investor ownership that should not trigger a review by DPH if that change has not resulted in a change of control and management of the hospital. Any changes as described above would require numerous unnecessary filings with the state which is a large waste of resources for the provider and DPH, and goes against administrative simplification. Instead, we encourage DPH to remove this subpart in whole and replace the last clause as follows

i. “Transfer of ownership” also means any material change in the ownership interest, corporate membership of the hospital (including but not limited to the hospital’s organization or parent organization(s)), or a substantial change in trustees that the commissioner determines to effect a change in control of the operation of the hospital. The commissioner may, in his or her discretion, determine that a proposed transaction does not rise to the level of a transfer of ownership.

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Waiver Requirements 105 CMR 130.050We are specifically opposed to, and very concerned with, the proposed changes in this section which currently allows the commissioner discretion on licensure requirement amendments. By removing “the Commissioner” and inserting in “the Department”, the state has effectively required that all amendment changes be reviewed and approved by the Public Health Council. This goes against the Administration’s goal of administrative simplification and would increase costs and staff time in order for providers and the state to go through extensive reviews that do not improve or increase operational efficiencies. We strongly urge that these changes be removed and the current language remain.

Application for Licensure (105 CMR 130.101)MHA requests that DPH amend both parts (D) and (E) as drafted. While we are not opposed to the goals of these two provisions, they are actually adding additional duplicative requirements that go against the goals of the Governor’s executive order for administrative simplification.

1) Under Subpart (D) we specifically request that by-laws, articles of organization, and other ownership documents only be provided when the provider is submitting a new application, a transfer of ownership, or if the documents have changed. Requiring the submission of these documents every time a hospital renews its license only adds unnecessary paperwork time, and costs for both providers and the state. It is not clear why it is necessary to submit the same documents each time if nothing has changed.

2) Under Subpart (E), we are very concerned with the requirements that the provider must submit information on all financial transactions related to a transfer of ownership (E)(1) and that the board publicly presents all proposals on a proposed transfer of ownership or merger in (E)(2). We first request that the following changes be made as outlined below.

a. In subpart (E)(1) – remove the word “all” as there are considerable financial paperwork and materials that are not relevant to the transfer that the state does not need to review; the focus should be on the actual paperwork that outlines the financial transaction so DPH is aware of the actual transaction.

b. Also in subpart (E)(1), replacing the words “including remuneration of all officers of hospitals affected by the transaction” with the following “including any specific payments that are provided to an officer of the hospital that was part of the transfer agreement”. There are many officers of a facility who are not part of the transaction but may be deemed an officer whose salary is not public information. It is not fair to provide this information and should be directed to those that are part of the transaction

c. In Subpart (E)(2) - remove the word “publicly presented” as board meetings are not subject to public open meeting laws, and instead require “was presented with” as this would ensure a public document to DPH to show that the entire board was given the opportunity to evaluate the proposals within the framework of normally occurring Board meetings.

Local Approvals (105 CMR 130.102)MHA is very concerned with the unintended consequences of the draft changes that require an inspection certificate issued by the Department of Public Safety, Division of Inspection and the head of the local fire department at the time of an application (new and renewal). While these are important, many certificates (such as the DPS certificate or the local fire department

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inspection) are not issued until there is a major renovation or are only issued once every two years. As drafted, a hospital would need to delay its licensure or request an inspection when it is not necessary, thereby increasing costs and adding additional paperwork for no improvement to the overall licensure process. So we urge that DPH require that all such certificates be kept on file and provided upon request as this would eliminate substantial paperwork. Therefore, we urge DPH to consider the following:

1. The applicant shall maintain and furnish upon request an updated inspection certificate when issued by the Department of Public Safety, Division of Inspection, and the head of the local fire department.

Evidence of Responsibility (105 CMR 130.104)MHA is requesting clarification from DPH as to the purpose of the changes in this section. The regulations are essentially repeating the various operational requirements twice within the newly developed subpart (A) and again in what is now subpart (B), which goes against the purpose of removing duplicative and unnecessary requirements.

In addition, we request that DPH revise Subpart (A)(4) which requires a general mandate that persons residing in the service areas of the hospital participate in the oversight of the hospital. All hospitals have created initiatives, pursuant to existing state laws and accreditation standards, which integrate patient/family/community perspective – such as the development of patient family advisory councils (PFAC) – in clinical and operational activities. To that end, we suggest revising this language with the following: “If the applicant is a non-profit entity, demonstrating patient and community participation in hospital working groups and Boards that review operational and clinical practices.”

Submission and Approval of Architectural Plans and Specifications (105 CMR 130.107)This entire section would fall within the plan review process and is a serious concern to the entire hospital industry, not to mention several other provider types and businesses that are affected by this requirement. As the state is aware, the administrative paperwork that the state requires has delayed a number of projects and has prevented patient access to services while adversely affecting hospitals’ ability to function as an economic engine of the commonwealth. Therefore, we first request that the proposed changes be removed and the current language should remain. By allowing information to be provided to the Commissioner and not the Department, providers are not required to go through a full Public Health Council review. Any major projects are already going through such review as part of the Determination of Need program. As proposed, the changes would remove many of the streamlined processes that the state developed and would also create more administrative reviews, time delays, costs, and staff time for the state and the provider community.

We also request that DPH develop an advisory committee as part of the regulations that would allow providers and other direct stakeholders to work with DPH to review and provide suggestions on how to improve the overall plan review system. For example, there are several instances where providers are given inconsistent determinations of how various patient rooms in the emergency department should be developed to care for behavioral health and other populations. We suggest that DPH consider the approach that it is taking on its Determination of Need regulatory changes where it is meeting with stakeholders to review guidance on several

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critical elements to determine best practices and other information to help improve the overall process prior to finalizing the regulations. As the section already calls for the development of administrative guidance based on the Facility Guidelines Institute, we would urge DPH to consider an advisory committee to help streamline the overall plan review system using FGI and other best practices.

Condition of Licensure (105 CMR 130.108)It is not clear what the purpose of the new subpart (B) is intended to accomplish as drafted. The language is duplicative and redundant of the Determination of Need CBHI and Health Priorities requirements, the Attorney General and IRS Community Benefits requirements, and population health initiatives filed by many provider organizations under accountable care organization and alternative payment methodology initiatives. The goal of the regulatory changes was to remove duplication of paperwork requirements that add costs to the overall system. But under this proposal, hospitals must now develop the same, duplicative and detailed report for the IRS, the Massachusetts Attorney General’s office, DPH, and, in some instances, the city of Boston (PILOT programs). In addition, the proposed language also ties community benefits to essential health services, which does not make sense. Any determination of community benefits or the type of primary/preventive care provided in a community by a hospital should be based on a community health needs assessment as dictated by the IRS and Massachusetts AG; this assessment may include several services that are not essential services as defined by DPH but include many critical community based needs. It is also clear that, as drafted, this language would affect a hospital that is seeking a licensure renewal or filing a new application, therefore adding additional paperwork that is redundant as information on community benefits is already filed with the IRS and Massachusetts Attorney General. It is also important to note that legally and technically both the IRS and the Attorney General’s community benefit requirements (as stated by the agencies) would only apply to a non-profit, non-municipal hospital. Therefore if the intent was to ensure that a hospital is providing community benefits, then we would urge that DPH clarify the intent and correct the legal application of this section. Specifically we urge the following as an example of language that supports the governor’s executive order relating to removing requirements that are adding unnecessary paperwork.

(B) Applicants for a license for a non-profit and non-municipal acute-care hospital must submit an attestation that it has conducted a recent community health needs assessment and as a result developed community based services following federal Internal Revenue Services and the Massachusetts Attorney General’s office.

We also request that DPH amend subpart (C), which requires a hospital to comply with all federal and state laws/regulations pertaining to healthcare facilities. It is not clear what is intended in this section, which could be interpreted incorrectly, especially as we have several types of hospitals in Massachusetts and not all facilities follow the same rules. We assume that this section is intended to require that “a hospital comply with all federal and state laws and regulations that apply to the specific services provided in that facility.” If that is the case, then we strongly urge that this section be amended as we have suggested. However, the state should be aware that by adding this section it is creating a unique and problematic issue for hospitals. Specifically, hospitals will not be able to comply with the federal requirements that prohibit the use of marijuana for any purposes (medical or other) on its campus, while the hospital is also trying to comply with the state requirement on the usage of Medical marijuana, as well as DPH’s

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proposal within 105 CMR 725.000 that would permit caregivers to allow patients or others to use medical marijuana on its premises. We urge DPH to consider guidance on how a hospital can comply with this section if it is included in the final regulations.

Transfer of Ownership or Location (105 CMR 130.109)We strongly urge DPH to consider several unintended problems with the drafting of this section, and urge DPH to consider the following clarifications:

1) In subpart (B), revise the language as follows “A licensed hospital must notify the Department within 30 days in writing of any proposed change in name or location of a facility. A license shall not be transferred from one person or entity to another or from one location to another, unless it has been approved by the Department. As drafted the proposed language would prevent any transfers at any time, when it should be tied to an approval from the DPH before that can occur.

2) In subpart (C)(2), similar to our prior comments we request that DPH remove the terms “publicly presented” and in its place put the words “was presented with” to ensure that board meetings are able to meet the legal and regulatory requirements on board governance.

3) In subpart (G), we urge DPH to remove (G)(5) – which requests information on the “consequences of a transfer”. The purpose of a DPH review is to determine the impact on the delivery of essential health services and patient access to such services within a community. Adding in the vague and subjective language of “consequences of a transfer”, could cause an appropriate transfer of ownership or location to be denied (with no appeal) for reasons that have nothing to do with health planning. It is critical that DPH provide some specific parameters for this vague term, which, as written, would lead each provider to spend DPH staff time trying to understand what is and is not being considered. This again goes against the goals of administrative simplification and should be redrafted or eliminated as it would assume the terms of the transfer in (G)(4) provide the same protection as this provision.

Beds Out of Service and Discontinuation of Service (105 CMR 130.122)While the hospital community remains committed to providing notice to appropriate parties when there is a change in services, we are very concerned with the expanded notice and paperwork process that the proposed regulations are adding. A hospital does not choose to close or discontinue a service without taking into account many factors – the foremost of which is the ability to sustain the operations of a service at a time when providers are facing significant cuts in reimbursement from public payers, new taxes/assessments, and continued 9C cuts by the government. In addition we are very concerned that the changes in this section go against the goal of the governor’s executive order, which was to specifically ensure that the current regulations are reviewed to remove duplicative and unnecessary requirements that add costs to the system.

For example, we are concerned with the changes that would require that a hospital notify each of its staff members, including those that are not affected by the changes. This could also be read to include contractors and others unaffiliated with the hospital. Further, we are very concerned with the inclusion of a required notice to any and all unions. While unions do have certain rights afforded under federal law and can request certain information, there are no state laws that

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require a state agency to mandate such notices to unions. If the hospital staff is being informed, then the union should be receiving the information from their unionized members. DPH has never until now, included a union as part of its regulatory requirements and we believe this sets a unique precedent that is not based or supported by a state or federal law.

We are also concerned with the additional time that is added to a notice. In addition to the 90 days for notice to DPH, there is the additional 30 days to notify the expanded list of groups. Finally, we urge DPH to consider additional exceptions to the overall notice and review process where the provider is able to demonstrate that there are other providers who are able to provide the care and services in a nearby service area. To that end, we ask for the following changes:

1) Within 130.122(C)(1), amend the following:a. In Subpart (b), revise the language as follows: “the specific staff directly

employed by the hospital that are impacted by the proposed closure”;b. Remove in its entirety subpart (c), as there is no specific law or requirement that a

state mandate must include contacting unions groups if staff and the state and local representatives are contacted;

2) We are also opposed to, and request removal of, the following words within 130.122(C): “Center for Health Information and Analysis, Executive Office of Labor and Workforce Development, as well as each of the healthcare coalitions and community groups identified by the hospital it its notice to the department”. There is no statutory requirement to provide notices to CHIA or EOLWD; this adds to additional paperwork filing and does not advance healthcare planning discussions. Further, the proposed requirements in 130.122 already require a hospital to provide in its notice a detailed account of how the provider is coordinating with appropriate community groups prior to issuing notice to DPH. By adding in this second notice, the state is again requiring a secondary, duplicative, and unnecessary notice to go to groups that have already been contacted and would be aware of the public notice and hearing on such closures. Further, the state has the ability to provide this information easily to its sister agencies without adding costs and duplicative processes to the provider community.

3) Within 130.122(E), the proposed regulations provide for three exceptions to the hearing and notice requirements but only list two of them. While we appreciate that there are legitimate exceptions to the public review and notice process, we would ask that the state consider the following changes to the exceptions:

a. Within 130.122(E)(2), this exception provides that a notice and review is not necessary when a hospital discontinues a service at one location to move it or consolidate it with another location. At a time when providers are seeking to develop integrated care delivery systems, this is an important exception. We strongly urge that DPH change the requirement that the change is with a location within five miles and instead use a more appropriate distance such as 35 miles from another healthcare facility providing the same or similar services, which is the standard the federal government uses. With several changes in the healthcare field and as the designated state surveyor for CMS, it is critical that DPH use the same standards in any exceptions for determining changes in provider based locations.

b. We also request that DPH add in a new 130.122(E)(3), which appears to be intended by the proposed regulatory changes. At a time when this administration

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is promoting the adoption of integrated care organizations and health system planning, there should be an exception for a provider to demonstrate that there is another healthcare provider that is available to provide similar services in a nearby service area, within 35 miles from the services that are being provided. The current exceptions are only applicable to providers where there is either a new provider going to be licensed to provide the same services that are being discontinued, or if the provider is able to demonstrate that it is moving the services to another location that is still within the service area. As providers are seeking to create accountable care organizations that integrate care through different arrangements, there may be changes that would close a service in one location if there are available providers in the service area. This exception should be considered and the following should be added:

130.122(E)(3): The requirements at 105 CMR 130.122(D) through (I) for a public notice, hearing and subsequent determinations, planning and reporting by the Department and the hospital shall not be applicable when a hospital proposes to discontinue services at an existing campus or site and is able to demonstrate that the same or similar services are being provided by another provider within 35 miles from the service area where service(s) are being discontinued. The existing provider should have sufficient physical capacity and resources to serve the patient volume where service(s) are to be discontinued

Prohibition Against Discrimination (105 CMR 130.206)Within 130.206(A), we ask that DPH update its current requirements to be consistent with state law and regulations as well as those required by the federal ACA anti-discrimination rules. The state has updated its general set of protected groups that should be part of any hospital notices (through the Attorney General’s office and the Health Safety Net) as well as internal policies. The list that hospitals must follow states: 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.

Within 130.206(B), we would like to point out that this outdated section must also reflect that many providers may not be able to or are not contracting with specific MassHealth programs (PCC or MMCO). This is in compliance with federal and state laws, as well as a recent Supreme Judicial Court opinion exactly on point (please see 463 Mass 447 (2012)). Further, federal and state laws allow providers to refrain from providing non-covered services to a Medicaid member. To that end, we request that DPH remove the sentence and replace it with the following language: : “No hospital which provides services to Medicaid members shall discriminate in the provision of covered services against any Medicaid recipient. MHA is happy to meet with DPH to review the specific laws and case law that support this proposal.

Director of Nursing (105 CMR 130.310)MHA and the Organization of Nurse Leaders (ONL) appreciate and supports changes to this section that will set forth a specific standard for an individual to be a director of nursing. While we support the removal of language that would allow any person to waive certain requirements (such as allowing a non-nurse to run the nursing department), we are concerned that the current

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language does not go far enough in promoting the specific education and skill set goals for those that are running a nursing department. Both of our organizations have been promoting the importance of specific education requirements and would request that DPH replace the entire section as outlined below. It would also be critical to allow for a grandfathering provision for any individual that is currently in the nursing director role, but is not able to meet the education requirements outlined below. Specifically we would request that DPH issue a circular letter that allows any individual who is currently serving in such a role as of the effective date of the regulations, to continue to hold that position despite not having the specific education requirements outlined below. The purpose of this change would allow multiple pathways for a person to pursue a nursing degree and be a chief nurse, but also ensuring that they are obtaining a specific level of education necessary for this position.

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.

Requirements for Personnel to be Vaccinated Against the Influenza Virus (105 CMR 130.325)MHA and our member hospitals have been and remain strongly committed to adopting policies to ensure that all healthcare workers and our patients are offered the vaccination against the influenza virus (“flu”). The flu affects thousands of people across the U.S. and, according to the CDC, death totals in a flu season range from 3,000-49,000 people. MHA and our members have been collaborative and supportive of efforts made by DPH and other stakeholders in promoting the importance of influenza vaccination and working with healthcare workers to improve our statewide vaccination rates. However, due to current regulatory barriers, the provider community continues to run into several problems with ensuring that all healthcare workers, as well as contracted and vendor employees that come into a hospital, are vaccinated. In addition, at a time when both federal and state agencies are promoting the importance of influenza vaccination for patients (in particular special populations like the elderly), we urge the state to consider additional requirements to ensure that hospitals are offering this important vaccination to patients. To advance the shared goal of DPH and providers to vaccinate 100% of the workforce and patient populations, we strongly urge the following changes to the regulations

1. We urge DPH to consider renaming this section to reflect influenza vaccination of employees and patients:

a. Requirement for Influenza Virus Vaccination for Personnel and Patients2. We request that DPH amend 130.325(A)(1), to include vendors and other staff. As drafted

the language only applies to staff that are employed or contracted to work in a hospital. It does not address vendors or others who have staff on site to provide supplies, fix equipment, or perform other duties in patient care areas. Without expressed guidance in the regulations, hospitals are precluded from asking contracted vendors to mandate that their staff also be vaccinated. Therefore we urge the following words be added after the word “entity” – “through a vendor or other supplier to the hospital”

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3. DPH should not allow any healthcare personnel to decline vaccination without an acceptable or valid reason. MHA recognizes that valid reasons may extend beyond medical contraindication and sincerely held religious beliefs however, to allow workers to continue to decline without a valid reason places those who cannot be vaccinated at higher risk for contracting the flu. As DPH is aware, in populations where the vast majority of persons are vaccinated, the flu is less likely to be transmitted to those who cannot safely be vaccinated. This so-called “herd immunization” underscores the importance of high vaccination rates to protect the vulnerable minority who can’t be vaccinated. Many hospital patients are those with weaker immune systems and those who are less likely to have received a flu vaccine. The CDC specifically lists persons who are at higher risk for developing flu-related complications as children under 5, adults over 65, pregnant women, and people with chronic health problems that include asthma, neurological and neurodevelopmental conditions, chronic lung disease, heart disease, morbid obesity, disorders of the blood, kidney, liver, or metabolism, among others. These are exactly the types of patients who frequent health care settings, again underscoring the importance of healthcare settings achieving near 100% vaccination rates. To that end we request the following changes:

a. Within 130.325(B), we urge DPH to remove the words “unless an individual declines vaccination” and replace it with the following “unless an exception applies”

b. MHA further urges DPH to consider the following substantive change to the regulations by removing the phrase in 130.325(F)(1)(c) “the individual declines the vaccine” and replacing it with “for other reasons approved by DPH or the employer on a case-by-case basis.” Further, we strongly urge the removal of 130.325(F)(2), consistent with the changes requested in (F)(1)(c)

4. With the shared goal of ensuring that all vulnerable populations are protected against the flu, healthcare providers should also be directed to offer and provide the vaccination to patients if they have not had the opportunity to get the flu shot. This would allow an opportunity for patients to have a conversation with their treating clinician should they have questions that may have precluded them from seeking the vaccination. To that end we request inserting at the end of 105 CMR 130.325 within a new subpart (J), that would promote our shared goal of ensuring that patients are aware of and offered the influenza vaccination:

a. (J) Consistent with guidelines issued by the Department, each hospital shall ensure that all patients 65 years of age and older are offered an influenza vaccination when receiving services, as medically appropriate.

Serious Incident Reporting (105 CMR 130.331)MHA is very concerned with and requests that DPH remove the proposed addition within 130.331 (A)(7), which would include surgery- and anesthesia-related complications as a serious incident report. This proposal would go against the entire goal of the regulatory review by removing duplicative and unnecessary reporting. Many of these cases fall within an existing reporting requirement as a serious reportable event to DPH and/or the Quality and Patient Safety Division (QPSD) at the Board of Medicine. To the degree that DPH does not believe that these events are being reported correctly, we would urge DPH to work with the Board of Medicine to update their reporting requirements as necessary. By adding in this clinical reporting to serious incident reporting, the state has completely changed the interaction between state agencies. Historically, DPH has focused on ensuring that the provider community has developed an internal operational system of care that promotes patient safety and quality assurance. However,

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when it comes to specific medical procedures, that regulatory review falls within the authority of the individual board that licenses a specific provider providing the service. The Board of Medicine’s QPSD has actively worked with providers to develop detailed reports and best practices (as well as taking licensure action when needed) on such clinical cases as being proposed in 130.331(A)(7). Given the statutory mandate for clinical reporting to the Board of Medicine, we strongly urge DPDH to remove this proposed addition, and work with the Board as appropriate to update its QPSD reporting if necessary to include this information.

We are also very concerned with the proposed changes in 130.331(C) and (E), which seeks to remove Serious Reportable Events (SRE) and adds in Serious Adverse Drug Events (SADE) to the serious incident requirements. The actual SRE report is part of the serious incident reporting structure and reporting system and therefore should continue to be incorporated in the overall process. It does not make sense as to why the state is decoupling these requirements and removing the reference of SRE but adding in a reference to SADE within this section. We would request that SRE be added back as a reference as currently provided in the regulations.

Serious Reportable Event Reporting (105 CMR 130.332)MHA fully supports the various operational changes that are proposed for SREs within 130.322 (B) and (C) as it actually removes unnecessary administrative reporting that only contributed to patient and insurer confusion, duplicative reporting, and increased resources with no measurable outcomes.

MHA requests that DPH consider providing clarification on the changes provided in 130.332(C)(2)(b)(4), which now requires that corrective action plans for an SRE must be developed, implemented, and monitored by the hospital. Our request for clarification is to remove any potentially conflicting interpretations and to fully understand the expectations of DPH in regards to these changes. It is our belief that the intent of this change is to ensure that the hospitals can demonstrate that they are aware of what corrective actions were put into place and implemented. To that end, we request that DPH update and reissue its guidance on SREs to reflect its intent with the change cited above and also consider consolidating various updates into a revised document (as providers have to currently go through several updates to determine which requirement to follow).

MHA further requests that DPH consider a few technical corrections and develop further guidance on the new language related to Serious Adverse Drug Events (SADE). In particular, MHA is concerned with the new definition of an SADE as outlined in 130.322(A). Specifically, the definition includes reporting on occurrences related to all controlled substances. Massachusetts law defines controlled substances to include drugs within a Schedule I through VI drug. The number of drugs that this could impact as well as the number of reports that would be filed would go against the goal of Chapter 159 of the Acts of 2014 as well as the governor’s executive order of administrative simplification. Chapter 159 in particular was developed for identifying adverse events related to compounded drugs issued from non-institutional pharmacies. We urge DPH to consider including within the definition that the term “controlled substances” reflects a specific subset of high-risk drugs, such as a compounded drug within a Schedule II through IV that are not provided from an institutional pharmacy.

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In addition to the changes in the definition, we also request that DPH consider the following changes within 130.332(E), which outlines the criteria for reporting an SADE to DPH:

1) Subpart (E)(1), requires that a medication error that occurs on the premises of a hospital must be reported within 7 days to DPH. We are very concerned that this provision is a direct contradiction of the requirements of Chapter 159 of the Acts of 2014. The purpose of the law was to ensure reporting and appropriate notice to all affected parties when a hospital identifies that a patient is being treated for a condition caused by a drug that was compounded/manufactured from outside the hospital. It is important to note that the law was developed as a result of the patient safety violations by Ameridose and the New England Compounding Center for drugs that were distributed to patients on an outpatient basis. The intent was never to require a reporting of medication errors that are the result of drugs developed within a hospital (as that would fall under other reporting requirements). Instead, the goal was to ensure that the hospital community is reporting all patient harm that is caused by inappropriate drug manufacturing by non-institutional pharmacies. To that end, we request the following clarifications to (E)(1):

a. Within seven days of the treatment of a patient whose condition was caused by a medication error from a non-institutional pharmacy, a hospital shall report this as an SADE to the Department as specified in guidelines of the Department.

2) Subpart (E)(2), would require a hospital to submit a duplicative SADE and SRE report on the same incident. This would go against the goal of the governor’s executive order for removing duplicative reporting requirements. To that end, we request that DPH remove the word “also” as it appears the second time in the sentence and replace it with “instead”. If an SADE is identified, then the hospital should only be following the SRE reporting requirements for the Department and not complete two separate reports on the same incident.

3) In subpart (E)(4), DPH is planning to require a new fine and hospital licensure revocation if there is a delay or failure to submit one of the SADE reports in this section. We are very concerned with the strict nature of this provision and the lack of a mechanism to work with a provider to ensure reporting is done in a timely manner. As the state is aware, the number of reporting requirements has increased exponentially and there is no way that any one staffer in a large or small hospital can keep up with every requirement. However, while staff is doing their best, if they miss a reporting requirement then the state should at least try and work with a provider before taking such a harsh and unrealistic position. A hospital is not like many companies where revocation of license has limited impact; this provision would significantly impact the health and welfare of several communities due to what may very well be simple mistakes in missing a reporting deadline or requirement. Further, there is nothing in Chapter 159 of the Acts of 2014 that supports a hospital’s license being revoked or fined for failure to report. There is no similar requirement in the SREs provision, so we are confused as to how this was included in the hospital licensure requirements.

Retention of Records (105 CMR 130.370)This section generally removes the specific retention period for hospital records within 130.370(A) in favor of a general reference to “the retention period specified in M.G.L. c. 111, § 70.” However, this change was not picked up in subsection F, and we would urge DPH to provide for the same changes in that section.

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Electronic Medical Records 105 CMR 130.375)While we understand that the provisions of this section were developed in accordance with state law, the state should be aware that with recent federal regulatory changes, it is impossible for any hospital (as well as clinic and individual provider) to be in compliance with this entire section. The federal government had passed the Medicare Access and CHIP Reauthorization Act (MACRA) and recently issued the final regulations implementing the law. Within that regulation, CMS has adopted “Advancing Care Information” as a replacement to Meaningful Use requirements. As articulated, CMS recognizes that technology, infrastructure, physician support systems, and clinical practices will change over the next few years, so over reliance on a highly prescriptive and broadly scoped certification rule must be avoided. As a result, we would instead urge that this entire section be removed and in its place the state indicate that the hospital (acute and non-acute) shall meet the applicable federal EMR requirements based on Department guidance. If the changes are not made, then every hospital will need to request a special waiver and effectively make this entire section meaningless. We urge DPH to consider developing a workgroup with hospital CIOs, the HIway, and other stakeholders to work through this significant change.

Discharge Planning Services (105 CMR 130.340 – 130.349)Within 130.340(B), the state is proposing to add new requirements that would allow patient and their representatives to meet with discharge planning staff to review and discuss post-hospital transition and services. While MHA and our members are supportive of the intent and goals outlined in the proposed language of this subpart (B), we encourage DPH to remove this language in full. Both MHA and AARP have been working collaboratively on legislation that would develop specific caregiver obligations and rights to be part of a patient’s discharge planning process. Once it is passed, the law will require substantial changes to the discharge planning process that will go beyond, and will be in conflict with, the proposed provisions in Subpart (B) and therefore cause significant care coordination confusion and operational inconsistencies. We share the goal of this proposed regulation section, but would urge the state to delay this section to ensure that the pending legislative bill can occur and provide patients with the greater rights that are being discussed.

Within section 130.341, we request that DPH consider updating the regulations to reflect that federal and state licensure as well as professional societies recognizes the allowance of other licensed and/or certified staff as appropriate to provide discharge planning. Limiting the process to just nurses and social work staff goes against the expansion and allowance by the federal government and standards developed by the Case Managers Society of American and the American Case Managers Association. We request the following:

Remove the words “Social Services Department” in 130.341(A) and instead replace it with “case management department”

We also request removal of the words “licensed social worker or a registered nurse, preferably a community health nurse” as occurring in 130.341(B) and (C). In its place, use the words “licensed professional approved by the hospital” which would allow for an expanded number of appropriate staff who can do discharge planning successfully and timely for the patients. Currently, the hospital community has been changing operations to ensure that discharge planning functions are not a distinct service area for all patient

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and that discharge planning is a part of the patient’s care that can be executed by any appropriate licensed professional.

Within section 130.342(A), we request removal of the phrase “concerning the operation of the discharge planning service” and in its place insert “concerning the implementation of discharge planning services”. For the reasons cited above, discharge planning functions are not a distinct service area; in an age of accountable care organizations and other integrated care organizations we need to ensure that the patient’s care can be executed by any appropriate licensed professional. We would also ask that that the entire subsection of 130.342(C)(1)(c) be removed, which requires that all patients shall be high risk screened within 24 hours of admission. This is an old antiquated requirement that does not fit within the current discharge planning process. All patients are screened as high or low risk and the plan is developed based on their individual need. Requiring that all patient be screened as high risk is inappropriate and against the standards that all providers are currently following.

While the hospital community has been and remains committed to ensuring that all discharges occur within a patient centered focus, we are very concerned with the drafting of the new language in 130.343(C)(1). This provision would require that a discharge plan be provided to a patient at least one working day prior to discharge, and signed by the patient at that time. It is also not clear what exceptions or factors would be considered and leaves this up to the subjective determination of a surveyor or others –resulting in inconsistent determinations and guidance. For hospitals that strive to provide discharge planning on a 24/7 basis, we are very concerned with the confusion and unintended conflicts that this provision would generate. There are distinct federal requirements that outline the discharge planning process, requiring that information should be provided to the patient within 48 hours of admission and then within appropriate time frames from discharge. For example, the Medicare Conditions of Participation guidance states “When a hospital can anticipate the discharge, it should give information 1 or even 2 days before discharge. However, when the hospital cannot anticipate the discharge, it should deliver the follow up copy as soon as the discharge can be anticipated. If necessary, the notice may be delivered on the day of discharge, again, as early as possible, and at least several hours before the time of discharge.” This guidance takes in account that many patients are only admitted with a short length of stay, in Observation, patients managed in an ACO, etc. In addition, many times there are post-acute services (SNF, IRF, LTACH, Home Health, and more) that are not finalized, available, or known until the day of discharge. If a hospital is forced to do a discharge plan the day before when all of the information is not available, there will be major confusion for the patients and their families between the written plan signed by the patient and the final plan that is developed when they leave. Furthermore, many patients’ do not have a representative or one is not available at the time of discharge. Given that the next section (130.343(C)(2)) also requires hospitals to meet Medicare requirements for discharge planning, there are conflicts with (C)(1) and (C)(2) that should be fixed. To that end, we encourage DPH to consider the following changes to 130.343(C)(1):

130.343(C)(1): As soon as the plan is completed, the patient (and/or as appropriate and if available the patient's family/representative) shall receive a written discharge plan that is also discussed with the patient and the appropriate patient family/patient representative in understandable language that includes the post-hospital services that are required and the arrangements made for the provision of these services. Said plan

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shall be provided within 24 hours of discharge if the hospital is able to anticipate the discharge and coordinate services in advance, if it cannot then it should deliver the plan as soon as the discharge and necessary post-discharge services can be anticipated to allow the patient sufficient time to review the plan.

Within 130.347, we do not believe that this section takes into account the current environment and changing technology used in hospitals (including using electronic not written). The language now assumes that only certain patients receive discharge planning (discharge, transfers, other), which are all routine. In the current environment more patients are getting specialized discharge planning services and the process is not a function of the unit coordinator. To that end, we ask that this entire section be revised as follows:

The hospital shall maintain records that enable appropriate hospital personnel to prepare periodic reports about discharge planning services including placements and referrals.

Within 130.349, we also do not believe that this section takes into account the current coordination of care environment that has developed since these regulations were initially developed. While there are many patients who are connected with appropriate post-acute level services to ensure continuity of care (such as the skilled nursing facility, the home health service, or other groups), there are an equal number of patients who are able to be safely discharged home. This is mandated by various payers to ensure that the post-acute provider who is actually providing services is appropriately monitoring the patient’s care and submitting information back to the payer to approve the coverage. This process has most recently been outlined in federal home health requirements and state MassHealth regulations. In addition, the state MassHealth program is also promoting an effective ACO or integrated care system that would implement a program to monitor patient’s post-discharge by various groups. To that end, we urge DPH to replace the first sentence with the following and also strike subsections (1) and (2) as they do not take into consideration the current care coordination process and system of care:

For those patients for whom post-hospital services were arranged, the discharge plan shall ensure that the post-discharge service provider is providing follow up monitoring and care coordination for the patient as part of the post-discharge provider’s scope of services.

Definitions Applicable to 130.601 through 130.650 (105 CMR 130.601)Within the definition of a “lactation consultant” we urge DPH to also include after the phrase “(IBCLC)”, the following: “an individual who is generally certified as a lactation consultant.” As drafted, the regulations are specifically limiting the group of trained individuals that are able to provide this important service to mothers following delivery. An individual may be certified as a lactation consultant but not from a program that is “equivalent to IBCLC”. Therefore adding in our requested change is important.

We also urge DPH to revise the definition of “Family-Centered Care” by removing the terms “father, mother and child”, and instead consider using the terms “Mother, child,” as that would allow the family situation to reflect other types of family arrangements and not just a mother, father and child.

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Within the definition of a Maternal Fetal Medicine Specialist, we urge DPH to re-insert the language that is being proposed to be removed – “or is an active candidate for certification". Board eligible MFMs have seven years after their fellowship to pass their subspecialty boards. During that time, they are practicing as MFMs. Removing this provision would prevent many units from providing effective and appropriate care following national and professional standards.

Please note that the phrase “or is an active candidate for certification" is also being removed from the definition of a neonatologist, obstetrician, and pediatrician as outlined in this section and throughout 130.601 through 130.650. For the reasons cited above, this terminology must be re-inserted throughout the regulations. While we do support the changes in many section that remove a specific specialist and inserts the term “physician” we are very concerned with the removal of active candidate for certification language.

Perinatal Advisory Committee (105 CMR 130.610)While we support the general changes to this section, we are very concerned that this section also removes the requirement that the committee “be representative of all parts of the state and all levels of perinatal care.” For hospitals that have staff that are committed to being part of this important service, we are concerned that the state is removing the opportunity for providers from various parts of the state to be represented on this group. We would ask that this be added back into the regulations.

Administration and Staffing (105 CMR 130.616 (H))Similar to the comments raised above, we ask that in subsection (H) of this section, that the state also allow staff who are certified generally as a lactation consultant by including after the words “(IBCLC”), the following: “an individual who is generally certified as a lactation consultant.”

Labor-delivery Suite (1`05 CMR 130.619)Similar to other comments provided above, we urge DPH to consider further amending the terms to ensure that the spacing requirements are consistent with the Facility Guideline Institute. There are several places where the room configuration and set up are not consistent in the regulations. We urge DPH to remove the spacing allocation in the regulations and simply refer to the FGI (as it changes over time) as those are the standards that hospitals should be applying for consistency and standardization.

Level IIA and IIB: Community-based Maternal and Newborn Service with a Special Care Nursery (105 CMR 130.640)Within section 130.604(E)(4) – policies and procedures for transfer, we request that DPH make several changes to reflect the current standards and practices that are used by hospitals. This includes the following:

1. Within 130.640(E)(4)(a)(i) and 130.640(E)(4)(b)(i), we request that DPH remove the word “neonatologist” and instead use the words “licensed clinician approved by the hospital”. Clinically speaking it may be appropriate to have a neonatal nurse practitioner or a pediatrician available at the bedside instead of a neonatologist who may not always be available at those times. In addition, the current process only unnecessarily adds to operational and clinical costs by needing to have a specialist staff the bed when it is

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effectively managed by other licensed professionals that meet national and professional standards of practice.

2. We also request the removal of 130.640(E)(4)(a)(iv) and 130.640(E)(4)(b)(iv). Following national and professional standards of practices, many hospitals may use other clinical practices to ensure that the patient is stable and ready for transport. We urge DPH to consider a revision to current guidelines or state that “Pursuant to Department guidelines and following national and professional standards of practice, the hospital shall utilize an appropriate clinical practice while the infant is awaiting the transport.”

Level III Maternal and Newborn Service or a Freestanding Pediatric Hospital with Neonatal Subspecialty Service (105 CMR 130.650)Within 130.650(D)(1)(e), we request the removal of the words “and be Advanced Cardiac Life Support certified” and in its place insert the following: “and professional standards.” Similar to other comments outlined above, clinical staff are cross-trained to provide care that meets national and professional standards. Requiring a specific certification at a time when the DPH regulations requires rapid response teams and other integrated services, this requirement on specific staff is outdated and needs to be removed.

Minimum Lengths of Stay (105 CMR 130.660)As a redundant and outdated requirement, we also request that DPH removes the words “No discharge shall occur between the hours of 8:00 P.M. and 8:00 A.M. without the mother’s agreement.” as it appears in this section. While we understand that the initial intent of this language when included several years ago was to prevent inappropriate patient discharges, we are also concerned that this goes against the goal of working with patients to ensure appropriate discharge when the patient and mother is ready. This section also provides patient protection by providing that an attempt to shorten a stay should only occur when the mother and the attending is in agreement to shorten the stay. But to prevent discharges when the patient is ready and agrees is an outdated requirement that does not meet national and professional practices and should be removed.

Standards for Operation of invasive Cardiovascular Services (105 CMR 130.900 -130.982)MHA, on behalf of our member hospitals, are opposed to and very concerned with the proposed changes in 105 CMR 130.900 through 130.982.  The proposed changes do not take into account the significant amount of time and effort that was spent by the provider community (in coordination with DPH staff) to determine an appropriate set of clinical and operational guidance that should be used in determining licensure requirements for hospitals.  For example, in 2014, DPH had issued a detailed report that looked at the specific inventory of and need for certain cardiac surgery and PCI services (see attached presentation from DPH issued 9-22-2014).  The goal of this study was to determine if a new hospital should be developing cardiac surgery or PCI if they have not had a program in place.  In addition, at the same time, DPH also issued detailed guidance (DPH Circular letter and PCI guidelines) that was developed by the provider community based on national and professional society standards.

These presentations and guidance materials were developed in the interest of furthering patient safety and quality improvement in providing this critical service, by establishing standard workload minimums among other standards for existing hospital locations.  In particular, the

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goal was to ensure that an existing hospital that is providing this critical and important service was able to maintain their skills and experience. As a result, there is a strong concern among the provider community that the proposed changes to the hospital licensure regulations within 130.900 through 130.982 would have the opposite impact without having appropriate guidance in place prior to promulgating the regulations.

To that end, we would ask that DPH please consider the following comments related to the changes in the proposed regulations:

1. DPH is proposing to essentially remove the grandfathering provisions for many providers who have been providing this critical service for several years (see the stricken language in 130.940(A)(2) and 130.94(D)(1)).  Removing this language would prevent many providers from practicing without any indication of the impact on current hospitals providing this service.  As a result, we would request that this language remain in the final regulations;

2. We also request the removal of the new language in 130.915(B), which requires a hospital to seek re-approval of its entire cardiac catheterization program with every licensure review. The purpose of the data reporting system and various quality reviews by DPH is to ensure that services provided from a cardiac and PCI program is resulting in good patient care and quality outcomes. As drafted, this new requirement adds considerable new requirements on providers to go through an entire evaluation of the service. Currently providers are only required to provide information on the licensure form that it is continuing its “Cardiac Catheterization Services”. We feel that this new language adds to the administrative reviews at a time when the providers are already reporting data that DPH can determine if the service should be reviewed and/or closed;

3. We would also request that the regulations provide that any policies and procedures should not be based on hospital policies, but through guidance issued by DPH that has been reviewed and approved by ICSAC (see 130.950).  While we do support the allowance for a hospital to determine certain clinical and operational practices, we do believe that certain distinct services like cardiac surgery and PCI services should be based on national and professional society standards to ensure consistency in this critical service;

4. We would also strongly request that ICSAC be convened prior to issuing the final regulations (similar to what DPH has done with its DoN, MIH, and other regulatory discussions) to determine appropriate guidance for operational workload minimums that is based on national and professional society standards.  As part of this discussion, DPH should consider the 2014 DPH Health Planning Council presentation to determine whether there should be any new hospitals that are seeking to develop a cardiac surgery or PCI service.  However, we do believe that the guidance should also take into account and allow an existing program to modify its services (for either cardiac surgery or PCI services) as appropriate to ensure staff are able to keep up their skills and experience;

5. Toward the goal of #3, we would specifically urge DPH to keep in existence a mandatory meeting of the Invasive Cardiac Services Advisory Committee (ICSAC) within 130.930.  As drafted, this proposed change would remove any necessity in allowing the group to meet to discuss sub-regulatory guidance and allow existing providers to request any changes in current guidance, as the national and professional society standards may change over time; and

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6. We would also request that DPH meet with a representative group of hospital staff, MHA and MassDAC to review the current regulatory requirements in 105 CMR 130.1202/1203 and 130.1302/1303.  The provider community is currently in the final year of a five year contract to ensure payment for the services of a data vendor for the state to analyze utilization and outcome data for cardiac surgery and PCI services.  Without knowing the direction and expectations of the state in regards to the data reporting, the provider community is unable to provide comments on these sections.  Therefore we urge DPH to convene a meeting of the parties mentioned above prior to promulgating the regulations to discuss the future plans and how the groups can work better if the data reporting is to occur in the same or potentially different manner to provide more timely information to the state and the provider community; which could be done through an ICSAC or other meeting.

Interpreter Service – Coordinator (105 CMR 130.1103)While MHA and our members continue to be committed in providing interpreter services to our patients when requested, we are concerned with the specific provision within 130.1103(A). This provision requires an annual language needs assessment by the hospitals. However, recent federal and state law changes require hospitals to conduct a routine community health needs assessment that includes several issues including language needs of the hospital’s identified service areas. Requiring an annual review goes against the goal of streamlining the overall administrative process and would allow this section on interpreter services to be aligned with the requirements of the revised section 105 CMR 130.108(B) as we commented on earlier. To that end, we propose the following language in place of 130.1103(A):

(A) conducting a language needs assessment of the service area as part of the hospital’s community health needs assessment that includes input from community-based organizations, and that includes identification of those languages for which notices shall be posted.

Broadening terminology from Physician to ClinicianAt a time when healthcare providers are looking to develop integrated models of care that includes the appropriate use of different care providers pursuant to state law and regulatory Board changes, we believe that DPH should consider amending several provisions of the regulations to use a more generic term of “clinician” instead of the word “Physician.” There are several places in the regulations, where a practitioner such as a Nurse Practitioner or a Physician Assistant can competently and appropriately monitor and direct patient care and treatment, pursuant to their scope of practice and licensure provisions. However, there are also several places where the term “Physician” is appropriate. To that end, we would ask the state to consider the following changes that would allow the hospital the opportunity to consider which staff is appropriate to provide certain services:

1. Within the definition of Medical/Surgical Service, change the work “physician’s” to “clinician’s”;

2. Within 130.340(A) and (B)(5) – remove the word “Physician” and insert the word “clinician”

3. Within 130.342(B) and (E) – remove the word “physician” and insert the word “clinician”

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4. Within 130.343(F), (G), (H) – remove the word “physician” and insert the word “clinician”

5. Within 130.536(2) and (4) - remove the word “physician” and insert the word “clinician”

6. Within 130.616(D)(2)(j) and (D)(2)(l) - remove the word “physician” as it appears and insert the word “clinician” in each place

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