651 CMR 12.03
Certification Process
(1) Requirements and Limitations.
(a)
No person or legal entity shall advertise, operate, or maintain an Assisted Living
Residence until it has been certified by EOAI.
(b) No person or legal entity shall advertise, market, or provide Basic Health Services until
it has been certified by EOAI to provide such services.
(c) Notwithstanding the requirement of 651 CMR 12.03(1)(a), prior to the commencement
of operations, an Applicant may advertise an uncertified Assisted Living Residence only if
it first initiates the application process for Certification by notification to EOAI, and if it
clearly states in all advertising and marketing materials that it has not completed the EOAI
Certification process.
(d)
An Applicant must have sufficient property rights, as an owner or lessee, as the
Secretary or a designee finds necessary for the operation of an Assisted Living Residence.
(e) An Application for Certification shall not be approved until the Applicant and premises
meet the requirements of 651 CMR 12.03(2).
(2)
Application for Certification. Application for initial Certification or renewal of such
Certification shall be made on forms and in the manner prescribed by EOAI. Every Application
shall be notarized and signed under the pains and penalties of perjury by the Applicant. Except
as set forth in 651 CMR 12.03(10), an Application for initial Certification shall be submitted to
EOAI at least 90 days prior to the date the Applicant plans to commence operation of the
Assisted Living Residence. EOAI shall charge a non-refundable fee set by the Secretary of
Administration and Finance pursuant to M.G.L. c. 7, § 3B for the filing of the Application for
Certification of an Assisted Living Residence. An Applicant shall file a separate Application for
each Assisted Living Residence for which Certification is sought. In support of the Application
for Certification, each Applicant shall provide:
(a) The name and address of each officer, director, and trustee; and the names and addresses
of each owner, general partner, limited partner, or shareholder with a 5% or greater interest
in the Assisted Living Residence. For each such individual or entity identified in 651 CMR
12.03(2), the Applicant shall provide to EOAI documentation of the history of each such
individual or entity, including, but not limited to:
1. all multifamily housing, Assisted Living or health care facilities in which the
individual or entity has been or is an officer, director, trustee, or partner and, if
applicable, evidence from the relevant regulatory authority that said individual or entity's
multifamily housing, Assisted Living, or health care facility has met criteria for licensure
or Certification and, if applicable, have corrected all cited deficiencies without
de-licensure or de-certification being imposed;
2. documentation of any enforcement action against the individual or entity and, if
applicable, evidence that the individual or entity has corrected all cited deficiencies
without revocation of licensure or certification;
3. whether such individual or entity has been convicted of Medicare or Medicaid fraud;
4. whether such individual or entity has any judgments or settled any Medicare or
Medicaid false claims cases;
5. whether such individual or entity has been terminated from a Medicare program or
Medicaid program for any reason; and
6. any other information or documentation requested by EOAI.
(b) A copy of the conversion approval from the DPH, if an Applicant seeks to convert all
or part of a premises licensed as a Long-Term Care Facility to an Assisted Living Residence
or if an Applicant seeks to add Assisted Living Residences to existing premises licensed as
a Long-Term Care Facility;
(c) An operating plan which shall include, at a minimum, the following information:
1. The number of single and double occupancy Units for which Certification is sought,
the number of single and double occupancy Units designated as Special Care Units, and
the number of Residents per Unit; The location of Units and Special Care Units, common
spaces, and egresses by floor;
2. The fee structure for lodging, meals and services, and any optional services, including
Basic Health Services;
3. The type, extent, daily availability, and cost of services to be offered, including
optional services, such as Basic Health Services, in a format that allows Residents to
understand their anticipated weekly or monthly costs; the arrangements for providing
such services, including third-party contracts, and linkages with hospital and nursing
facilities;
4. A Plan for Self-Administered Medication Management (SAMM) for Residents,
including, but not limited to, assistance with as-necessary medication (PRN) when part
of the SAMM, and, if offered, Limited Medication Administration;
5. A means for Residents to communicate urgent or emergency needs, and a plan to
provide timely assistance to them;
6. Policies and procedures for the maintenance and operation of an automated external
defibrillator (AED);
7. The number of staff to be employed in the operation of the Assisted Living Residence
and their minimum qualifications and responsibilities;
8. A copy of the Residency Agreement and any disclosures that will be used by the
Assisted Living Residence. The Residency Agreement must clearly describe the rights
and responsibilities of the Resident and Sponsor, and comply with all requirements of
M.G.L. c. 19D and 651 CMR 12.00;
9. A copy of all required current building, fire safety, and locally approved state sanitary
code certificates and permits;
10. Procedures to notify a Resident and their Legal or Resident Representative, as
appropriate, that the Assisted Living Residence is no longer an appropriate environment
for the Resident. Such notice shall describe the changes in the Resident's service needs
that justify such a finding, explain when those changes occurred, and describe how the
Resident's needs can no longer be satisfied;
11. Procedures to ensure the advance and timely notification, of at least 60 calendar
days, to a Resident and their Legal or Resident Representative, as appropriate, of any new
fees or changes to existing fees, unless the Resident is assessed as needing additional
services to ensure their health and safety more immediately. The Residence must
establish and maintain written policies and procedures for how it handles urgent service
needs and communicates fee changes, if any, with the Resident and their Legal or
Resident Representative, as appropriate;
12. A copy of all policies and procedures related to the design and operation of a Special
Care Residence or Residences required under 651 CMR 12.04(5);
13. A copy of the quality improvement and assurance program required under 651 CMR
12.04(11);
14. A copy of the disaster and emergency preparedness plan required under 651 CMR
12.04(12);
15. A copy of the communicable disease control plan required under 651 CMR
12.04(13);
16. A copy of the Controlled Substances policies and procedures required by 651 CMR
12.04(15);
17. A statement citing the beginning and ending dates of the Residence's fiscal year;
18. Policies and procedures designed to ensure a safe environment for all Residents;
19. If the Residence accepts Residents who require the use a Lift Device, the policies
and procedures regarding the training of Clinical Professionals and Personal Care Staff
about all aspects of a program for safe and appropriate operation of any Lift Device used
for lifting a Resident assessed to require such assistance to ensure the safe transfer of
Residents;
20.
Policies and procedures regarding which staff are trained and certified in
cardiopulmonary resuscitation (CPR), and the use of an automated external defibrillator
(AED);
21. Policies and procedures for when cardiopulmonary resuscitation (CPR) will be
performed on a Resident and when an automated external defibrillator will be used on
a Resident;
22.
Policies and procedures regarding the storage and usage of naloxone and
epinephrine;
23. Policies and procedures regarding the proper use, administration, and maintenance
of oxygen, including safety protocols;
24. Policies and procedures regarding smoking on the Residence's premises and in the
Residents' Units;
25. Emergency response procedures for all Residents; and
26. Other information EOAI deems necessary.
(d)
Applications for Certification renewal must also include a statement that the data
required by 651 CMR 12.04(14), information documenting all substantial changes to the
operating plan prior to the effective date, and all other information required by EOAI, have
been submitted.
(3) Application for Certification of Basic Health Services.
(a) Any Residence may apply to EOAI for Certification to provide Basic Health Services.
No Residence shall offer or provide Basic Health Services without first being certified by
EOAI to provide Basic Health Services.
(b) An Application to provide Basic Health Services shall be made on forms and in the
manner prescribed by EOAI.
(c) An Application to be certified to provide Basic Health Services shall be submitted to
EOAI at least 90 days prior to the date the Applicant plans to commence the provision of
Basic Health Services.
(d) In support of the Application for Certification, each Applicant shall provide a detailed
operating plan for the provision of Basic Health Services that includes, at a minimum:
1. a proposed administrative and operational structure to ensure the safe and effective
provision of Basic Health Services and meet the needs of its Residents; and
2. a compliance plan to meet the requirements established under M.G.L. c. 19D and
651 CMR 12.00, which shall include, but not be limited to:
a. staff qualifications, and initial and ongoing training and competencies;
b. effective policies and procedures to ensure the availability of adequate supplies
necessary for the provision of Basic Health Services and the safe administration and
secure storage of medications;
c. a process to determine whether the location where Basic Health Services will be
provided is medically appropriate and to identify the space, equipment, and supplies
necessary to provide such services in an effective and private manner;
d. an organizational chart that details the roles and responsibilities of staff providing
Basic Health Services, including designating the management or clinical lead charged
with the creation, ongoing review and approval of all policies and procedures for
each component of Basic Health Services;
e. policies and procedures for the provision of each component of Basic Health
Services provided by the Residence;
f. standards for Resident assessment and evaluation to determine whether it is
appropriate for the Residence to initiate or continue the provision of Basic Health
Services to a Resident;
g. policies and procedures regarding the routine communication with the Resident's
Licensed Independent Provider;
h. emergency response procedures for Residents receiving Basic Health Services;
i. procedures to ensure continuity of care for Residents receiving Basic Health
Services who move-in or move-out of the Residence; and
j.
the role, membership, and authority of an internal quality assurance and
performance improvement committee. The internal quality assurance and
performance improvement committee must develop and implement key quality
indicators and implement key quality indicators as described or defined by EOAI.
(4) Review of Applications. The EOAI shall not review an Application for Certification unless:
(a) The Application includes all information required by EOAI;
(b) The Application includes all required attachments and statements that are required for
the Certification; and
(c) The Applicant has paid all required Application fees and any outstanding fines issued
in accordance with M.G.L. c. 19D and 651 CMR 12.00.
(5) Evaluation of Application. The EOAI shall not approve an Application for Certification
unless:
(a) The Secretary or a designee has conducted a compliance review of the Assisted Living
Residence as set forth in 651 CMR 12.09 and has reasonably determined that the premises
meets the requirements of M.G.L. c. 19D and is in compliance with 651 CMR 12.00; and
(b) The Secretary or a designee has conducted a review of the Applicant and has reasonably
determined that the Applicant meets the requirements of M.G.L. c. 19D and is in compliance
with 651 CMR 12.00.
(c) EOAI may, in its discretion, deny Certification to any Applicant who had an ownership
interest in an entity licensed under M.G.L. c. 111, a licensed medical provider, or a home
health agency certified under Title XVIII of the Social Security Act, as amended, that:
1. has been the subject to a patient care receivership action;
2. has ceased to operate such an entity as a result of, or has otherwise been subject to:
a. suspension or revocation of license or certification;
b. receivership; or
c. a settlement agreement arising from suspension or revocation of a license or
certification;
3. has a settlement agreement in lieu of or as a result of receivership;
4. has been the subject of a delicensure action or involuntary termination of participation
in either the Medical Assistance program or the Medicare program;
5. has been the subject of a substantiated case of patient abuse or neglect involving
material failure to provide adequate protection or services for a Resident in order to
prevent such abuse or neglect; or
6. has over the course of its operation been cited for repeated, serious or willful
violations of rules and regulations governing the operation of said entity that indicate a
disregard for resident safety and an inability to responsibly operate an Assisted Living
Residence.
(6) Certification.
(a)
After reviewing and evaluating an Application for Certification or renewal of
Certification, if EOAI determines that all required regulatory requirements are met, EOAI
will issue a Certification.
(b) The Certification shall indicate whether the Residence is certified to provide Basic
Health Services.
(c) Each Certification shall be for a term of two years and include a date of expiration.
(d) Each Certification shall be valid only in the possession of the Residence and the Sponsor
to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary
or involuntary.
(e) No Certification shall be valid for any building premises other than those for which the
Certification was originally issued.
(f) Every Assisted Living Residence Certificate must be displayed in a conspicuous place
in the Residence and on the Residence's website.
(g) The Certification of a Sponsor to operate an Assisted Living Residence shall be returned
by registered mail to EOAI immediately upon:
1. Revocation of or refusal to renew the Certification;
2. Transfer of ownership;
3. Change of the Sponsor's or Residence's name; or
4. Closure or other termination of the Residence's operations.
(7) Certification of Basic Health Services.
(a) EOAI will review the submitted Application for Basic Health Services Certification and
conduct a compliance review of the Residence as set forth in 651 CMR 12.09.
(b) Upon making a determination that the Residence is in compliance with the requirements
of M.G.L. c. 19D and 651 CMR 12.00, the Residence shall be approved by EOAI to provide
Basic Health Services and a Certification will be issued.
(c) A Residence certified to provide Basic Health Services shall pay a fee to EOAI in
accordance with 651 CMR 12.03(8).
(d) Once approved and certified to provide Basic Health Services by EOAI, a Residence
must notify Residents of the availability of such services for eligible Residents prior to
initiating the provision of such services.
(e) EOAI shall make available electronic copies of the required components of Basic Health
Services operating plans on its website.
(8)
Certification Fee and Basic Health Services Annual Fee. Upon receiving notice of
Certification, a Sponsor shall forward within ten days to EOAI a Certification fee set by the
Secretary of Administration and Finance pursuant to M.G.L. c. 7, § 3B, based on the number of
Units certified on the date of its most recent Application. In the event that the Applicant or
Sponsor of an Assisted Living Residence alters the Residence by the addition or removal of
Units, a fee adjustment may be made by EOAI. No fee for initial certification or certification
renewal shall be due from anyAssisted Living Residence created under the HUD Assisted Living
Conversion Program. If the Residence is certified to provide Basic Health Services, the
Residence shall forward within ten days of the certification, or within ten days of the anniversary
of said certification as applicable, an annual Basic Health Services fee set by the Secretary of
Administration and Finance pursuant to M.G.L. c. 7, § 3B. Failure to pay any of the fees
required by 651 CMR 12.03 within the ten-dayperiod shall result in a finding of non-compliance
by EOAI under 651 CMR 12.09.
(9) Renewal Certification Procedures.
(a) The Application for renewal of a Certification shall be filed on a form provided by
EOAI, include an Application fee as set by the Secretary for Administration and Finance and
follow the procedures set forth in 651 CMR 12.03.
(b) If the Application for renewal of a Certification is filed and date-stamped at EOAI at
least 30 days before the stated expiration date of the Certification, the Certification shall not
expire until EOAI notifies the Sponsor that the Application for renewal has been denied.
(c)
Term of Renewal Certification. EOAI will renew for a term of two years the
Certification of a Residence if EOAI determines that the Sponsor and the Residence meet the
requirements of M.G.L. c. 19D and 651 CMR 12.00.
(10) Change of Ownership.
(a) Any person or entity who intends to acquire a 5% or greater interest in an existing
Assisted Living Residence shall submit an Application for Certification to EOAI at least
30 days prior to the change of the ownership interest.
1. The Application for Certification shall include a statement on a form developed by
EOAI, signed and notarized bythe parties, regarding the anticipated change of ownership
of the Residence.
2. If EOAI receives these documents at least 30 days prior to the effective date of the
change of ownership, the new Applicant shall be considered to be deemed temporarily
certified from and after the date of the change of ownership, until such time as EOAI
approves or denies the Applicant's Application for Certification.
(b) Within five days after the Transfer of Ownership or change of ownership is completed:
1. The new Applicant must submit a signed and notarized statement confirming the
change of ownership or Transfer of Ownership is complete. The new Applicant must
notify all current Residents, Resident Representatives or Legal Representatives, if
applicable, and prospective Residents that the change of ownership or Transfer of
Ownership has occurred and that the Residence is awaiting EOAI's decision on the new
Sponsor's Application for Certification; and
2. The previous Sponsor must return its Assisted Living Residence Certificate to EOAI.
(c)
Any notice of hearing, order or decision that EOAI or the Secretary issues for a
Residence prior to a Transfer of Ownership or change of ownership shall be effective against
the former Sponsor prior to such change of ownership of Transfer of Ownership and, where
appropriate, the new Sponsor, following such change of ownership or Transfer of Ownership
unless said notice, order or decision is modified or dismissed by EOAI or by the Secretary.
(d) EOAI retains the discretion to conduct a full or partial compliance review in the event
of a Transfer of Ownership or a change of ownership.
(e)
Within 14 calendar days of EOAI approving the new Sponsor's Certification, the
Residence must provide written notice to all Residents, their Legal Representatives and
Resident Representatives (if applicable), and the Long-Term Care Ombudsman Program
confirming EOAI's approval and issuance of the new Certificate.
(f) The Residence must make ownership information available to all Residents, Legal
Representative and Resident Representatives (if applicable). The Residence must make
ownership information available to prospective Residents, upon request.
(11) Closure. In the event a Sponsor of an Assisted Living Residence elects to permanently
close or sell the Residence for anyreason, compliance with the following notification procedures
is required:
(a)
Resident Notice. A written notice must be received by the Residents, their Legal
Representatives, and their Resident Representatives (if applicable), at least 120 days prior
to the date on which the Sponsor intends to close or sell the Residence and cease operations
as an Assisted Living Residence. At a minimum, such notice shall include:
1. The date on which the Sponsor intends to close or sell the Residence and cease
operations as an Assisted Living Residence;
2. A description of the actions the Sponsor will take to assist the Residents in securing
comparable housing and services, if necessary;
3. A reference to the rights of the Residents that may be exercised under the
landlord/tenant laws established under M.G.L. c. 186 or M.G.L. c. 239; and
4. The contact information for the Long-Term Care Ombudsman Program.
(b) EOAI Notice. A written notice must be received by EOAI at least 120 days prior to the
date on which the Sponsor intends to close or sell the Residence and cease operations as an
Assisted Living Residence. Such notice shall include a copy of the Resident notice in
accordance with 651 CMR 12.03(11)(a), proof of notification of all affected Residents and
their Legal Representatives and Resident Representatives (as applicable), and the
identification of all Residents receiving additional services, including but not limited to,
Group Adult Foster Care.
(c) Long-Term Care Ombudsman Program Notice. A written notice must be received by
the Long-Term Care Ombudsman Program at least 120 days prior to the date on which the
Sponsor intends to close or sell the Residence and cease operations as an Assisted Living
Residence.
(12) Suspension of Certification. If EOAI suspends the Certification of an Assisted Living
Residence, the Sponsor shall display the notice of suspension in a prominent place in the
Residence, in place of the Certification, so long as the suspension is in effect.