reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Enforcement Procedures › Section 910.042 - Hearing Procedure

Current through Register 1525, July 5, 2024
(A) Prior to the
				imposition of any Administrative Sanction, the affected research institution is
				entitled to an adjudicatory hearing governed by the procedures of M.G.L. c. 30A
				and
				801 CMR 1.00
et
				seq
. A research institution which has received an Agency Notice of
				Action may, within 30 days of receipt of such Notice, file with the
				Commissioner a request for an adjudicatory hearing.
(B) A research institution requesting an
				adjudicatory hearing shall file, within 21 days of such request, its answer to
				the Agency Notice of Action. Such answer shall include full, direct and
				specific answers to each claim set forth in the Agency Notice of Action
				admitting, denying or explaining material facts, as well as all affirmative
				defenses relied upon.
(C) An
				adjudicatory hearing shall be scheduled with reasonable promptness after the
				filing of a request for such proceeding by a research institution. Notice of
				the date of an adjudicatory hearing shall be served upon the research
				institution no less than 15 days prior to the date set for the
				hearing.
(D) The Commissioner or a
				hearing officer designated by the Commissioner shall conduct an adjudicatory
				hearing. The Commissioner or hearing officer shall make all decisions regarding
				procedural matters which may arise in the course of the hearing.
(E) Adjudicatory hearings shall be recorded
				by electronic or stenographic means.
(F) After an adjudicatory hearing, the
				Commissioner shall issue a final decision and shall provide the reasons
				therefor. The Commissioner may decline to issue, revoke, not renew, modify,
				suspend, make probationary, or otherwise limit a license as he/she deems
				appropriate.
(G) The Commissioner
				shall make or cause to be made a record of each adjudicatory hearing. The
				record may contain the following items and other papers or documents which the
				Commissioner or hearing officer has specifically designated be made part of the
				record.
(1) All papers filed and served in
				connection with the proceeding;
(2)
				All documents or other data received in evidence at the hearing;
(3) A transcript of the hearing, if one has
				been prepared;
(4) Interlocutory
				orders of the Commissioner or hearing officer and the final decision of the
				Commissioner, including a statement of reasons.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Facilities and Operating Standards › Section 910.100 - Facilities, General

Current through Register 1525, July 5, 2024
(A)
Structural Strength
. Indoor and outdoor housing
				facilities for dogs or cats shall be structurally sound and shall be maintained
				in good repair, to protect the animals from injury, to contain the animals, and
				to restrict the entrance of other animals.
(B)
Water and Electric
				Power
. Reliable and adequate electric power, if required to comply
				with other provisions of
				105 CMR 910.000, and
				adequate potable water shall be available.
(C)
Storage
.
				Supplies of food and bedding shall be properly stored in facilities which
				adequately protect such supplies against infestation or contamination by
				vermin. Refrigeration shall be provided for supplies of perishable
				food.
(D)
Waste
				Disposa
l. Provisions shall be made for the prompt removal and
				disposal of animal and food wastes, bedding, dead animals, and debris. Disposal
				facilities shall be so provided and operated as to minimize vermin infestation,
				odors, and disease hazards.
(E)
Washrooms and Sinks
. Facilities, such as washrooms,
				basins, or sinks, shall be provided to maintain cleanliness among animal
				caretakers.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Facilities and Operating Standards › Section 910.101 - Facilities, Indoor

Current through Register 1525, July 5, 2024
(A)
Heating
. Indoor housing facilities for dogs or cats
				shall be sufficiently heated when necessary to protect the dogs or cats from
				cold, and to provide for their health and comfort. In usual circumstances the
				ambient temperature shall not be allowed to fall below 55°F. for dogs and
				cats.
(B)
Ventilation
. Indoor housing facilities for dogs or
				cats shall be adequately ventilated to provide for the health and comfort of
				the animals at all times. Such facilities shall be provided with fresh air
				either by means of windows, doors, vents, or air conditioning and shall be
				ventilated so as to minimize drafts, odors, and moisture condensation.
				Auxiliary ventilation, such as exhaust fans and vents or air conditioning,
				shall be provided when the ambient temperature is 80°F. or
				higher.
(C)
Lighting
. Indoor housing facilities for dogs or cats
				shall have ample light by natural or artificial means, or both, of good quality
				and well distributed. Such lighting shall provide uniformly distributed
				illumination of sufficient light intensity to permit routine inspection and
				cleaning during the entire working period. Primary enclosures shall be so
				placed as to protect the dogs or cats from excessive illumination.
(D)
Interior
				Surfaces
. The interior building surfaces of indoor housing
				facilities shall be constructed and maintained so that they are substantially
				impervious to moisture and may be readily sanitized.
(E)
Drainage
. A
				suitable method shall be provided to rapidly eliminate excess water from indoor
				housing facilities. If drains are used, they shall be properly constructed and
				kept in good repair to avoid foul odors therefrom. If closed drainage systems
				are used, they shall be equipped with traps.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Facilities and Operating Standards › Section 910.102 - Facilities, Outdoor

Current through Register 1525, July 5, 2024
(A)
Shelter from sunlight
. When sunlight is likely to
				cause overheating or discomfort, sufficient shade shall be provided to allow
				all dogs and cats kept outdoors to protect themselves from the direct rays of
				the sun.
(B)
Shelter
				from rain or snow
. Dogs and cats kept outdoors shall be provided
				with access to shelter to allow them to remain dry during rain or
				snow.
(C)
Shelter from
				cold weather
. Shelter shall be provided for all dogs and cats kept
				outdoors when the atmospheric temperature falls below 55°F. Sufficient
				clean bedding material or other means of protection from the weather elements
				shall be provided for all dogs and cats.
(D)
Drainage
. A
				suitable method shall be provided to rapidly eliminate excess water.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Facilities and Operating Standards › Section 910.103 - Primary Enclosure

Current through Register 1525, July 5, 2024
All primary enclosures for dogs and cats shall conform to the
				  following requirements:
(A)
General
.
(1)
				Requirements for primary enclosures for dogs and cats. Primary enclosures shall
				be structurally sound, maintained in good repair to protect the dogs and cats
				from injury and provide for their health and comfort, to contain them, and to
				keep predators out.
(2) Primary
				enclosures shall be constructed and maintained so as to enable the dogs and
				cats to remain dry and clean.
(3)
				Primary enclosures shall be constructed and maintained so that the dogs and
				cats contained therein have convenient access to clean food and water as
				required in
				105 CMR 910.000.
(4) The floors of the primary enclosures
				shall be constructed so as to protect the dogs' and cats' feet and legs from
				injury.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.130 - Feeding

Current through Register 1525, July 5, 2024
(A) Dogs and cats shall be fed at least once
				each day except that more frequent feedings may be needed in special
				circumstances where nutritional supplement is required
(e.g.,
pregnancy and lactation). The food shall be free from contamination, wholesome,
				palatable, and of sufficient quantity and nutritive value to meet the normal
				daily requirements for the condition and size of the dog or cat.
(B) Food receptacles shall be accessible to
				all dogs or cats and shall be located so as to minimize contamination by
				excreta. Feeding pans shall be durable and kept clean and they must be
				constructed of material that is non-toxic and not rusted or corroded. The food
				receptacles shall be sanitized at least once every two weeks. Disposable food
				receptacles may be used but must be discarded after each feeding. Self-feeders
				may be used for the feeding of dry food, and they shall be sanitized regularly
				to prevent molding, deterioration, or caking of feed.
(C) If potable water is not accessible to the
				dogs and cats at all times, it shall be offered to such animals at least twice
				daily for periods of not less than one hour, except as might otherwise be
				required to provide adequate veterinary care. Watering receptacles shall be
				kept clean and shall be sanitized at least once every two weeks and be
				constructed of non-toxic materials that are not rusted or corroded.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.131 - Sanitation

Current through Register 1525, July 5, 2024
(A)
Cleaning of primary
				enclosures
. Excreta shall be removed from primary enclosures as
				often as necessary but not less than once a day to prevent contamination of the
				dogs or cats contained therein and to reduce disease hazards and odors. When a
				hosing or flushing method is used for cleaning a primary enclosure commonly
				known as a cage, any dog or cat contained therein shall be removed from such
				enclosure before the cleaning process, and shall be returned only after the
				cage is dry. Adequate measures shall be taken to protect the animals in other
				such enclosures from being contaminated with water and other wastes.
(B)
Sanitization of primary
				enclosures
.
(1) Prior to the
				introduction of unconditioned dogs or cats into primary enclosures previously
				occupied, such enclosures shall be sanitized in the manner provided in 105 CMR
				910.131(B)(3).
(2) Primary
				enclosures for dogs or cats shall be sanitized often enough to prevent
				accumulation of debris or excreta, or a disease hazard. Provided, however, that
				such enclosures shall be sanitized at least once every two weeks in the manner
				provided in 105 CMR 910.131(B)(3).
(3) Cages, rooms and hard-surfaced pens or
				runs shall be sanitized by washing them with hot water (180°F) and soap or
				detergent as in a mechanical cage washer, or by washing all soiled surfaces
				with a detergent solution followed by a safe and effective disinfectant, or by
				cleaning all soiled surfaces with live steam. Pens or runs using gravel, sand,
				or dirt shall be sanitized by removing the soiled gravel, sand, or dirt and
				replacing it as necessary.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.132 - Employees

Current through Register 1525, July 5, 2024
A sufficient number of trained employees shall be utilized to
				  maintain the prescribed level of husbandry practices set forth in this subpart.
				  Such practices shall be under the supervision of an animal caretaker who has a
				  background in animal husbandry or care.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.133 - Classification and Separation

Current through Register 1525, July 5, 2024
Dogs or cats housed in the same primary enclosure shall be
				  maintained in compatible groups, with the following additional
				  restrictions:
(A) Females in season
				(estrus) shall not be housed in the same primary enclosure with males, except
				for breeding purposes.
(B) Any dog
				or cat exhibiting a vicious disposition shall be housed individually in a
				primary enclosure or in a manner which will not be a threat to other animals.
				Muzzles shall not be used as a primary method for restraining such
				animals.
(C) Puppies or kittens
				shall not be housed in the same primary enclosure with adult dogs or cats other
				than their dams, except when permanently maintained in breeding
				colonies.
(D) Dogs shall not be
				housed in the same primary enclosure with cats, nor shall dogs or cats be
				housed in the same primary enclosure with any other species of
				animals.
(E) Dogs or cats under
				quarantine or treatment for a communicable disease shall be separated from
				other dogs or cats and other susceptible species of animals in such a manner as
				to minimize dissemination of such disease.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.135 - Transportation

Current through Register 1525, July 5, 2024
When dogs or cats are transported between two facilities of a
				  research institution or from one research institution to another, the licensee
				  shall assure that dogs or cats are receiving sufficient air for normal
				  breathing, that their ambient temperatures are within the prescribed limits,
				  that all other applicable standards are being complied with, and that dogs or
				  cats in obvious physical distress are provided needed veterinary care as soon
				  as possible.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.200 - Compliance with Standards

Current through Register 1525, July 5, 2024
(A) Each research
				institution shall comply in all respects with the standards set forth in
				105 CMR 910.000 for the
				humane handling, care, treatment, and transportation of dogs and cats;
				provided, that research involving the use of dogs or cats that, due to
				experimental design, does not conform to regulations or standards promulgated
				by the Commissioner must be approved, prior to the conduct thereof, by the
				institutional animal research committee and/or the attending veterinarian of
				the licensee. The approval must be in writing and must be placed on file at the
				institution, subject to inspection by the Commissioner or his designee. In
				granting approval to research projects which do not conform to these standards,
				the animal care committee and/or the attending veterinarian shall abide by the
				"Guidelines for the Care and Use of Laboratory Animals" published by the
				National Institutes of Health as follows:
(1)
				The research must be such as to yield fruitful results for the good of society
				and not random or unnecessary in nature.
(2) The experiment must be based on knowledge
				of the disease or problem under study and so designed that the anticipated
				results will justify its performance.
(3) Statistical analysis, mathematical
				models, or in vitro biological systems must be used when appropriate to
				replace, reduce or complement animal experiments and to reduce numbers of
				animals used.
(4) The experiment
				must be conducted so as to avoid all unnecessary suffering and injury to the
				animal.
(5) The scientist in charge
				of the experiment must terminate it whenever he/she believes that its
				continuation may result in unnecessary injury or suffering to the
				animals.
(6) Care of animals must
				be such as to minimize discomfort and the consequences of any disability
				resulting from the experimentation, in accordance with acceptable practices in
				veterinary medicine.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.201 - Appointment of Responsible Individual

Current through Register 1525, July 5, 2024
Each research institution shall appoint either an individual
				  or a committee authorized by the institution to supervise its compliance with
				  105 CMR 910.000 and to act
				  as a liaison between the institution and the Commissioner or his/her designated
				  agents on matters relating to the care and treatment of research
				  animals.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 910.000 - Licensure Of Research Institutions Using Dogs Or Cats In Research And Education › Animal Health and Husbandry Standards › Section 910.210 - Severability

Current through Register 1525, July 5, 2024
Any section, subsection, paragraph, or provision of
				  105 CMR 910.000 declared
				  illegal or unconstitutional by a court of competent jurisdiction is severable
				  from
				  105 CMR
				  910.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.001 - Statutory Authority and Purpose

Current through Register 1525, July 5, 2024
105 CMR 920.000 is
				promulgated under authority of M.G.L. c. 111, § 69I; c. 111, § 69E;
				c. 111, § 62I and c. 122, § 1. They are adopted to establish a
				uniform schedule of assessments for medical services rendered to needy patients
				at state hospitals who lack health insurance, who are not eligible for public
				assistance, and who are therefore required to make direct payments to the
				hospital to pay for health care.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.002 - Scope and Application

Current through Register 1525, July 5, 2024
The assessment schedule and the method of computing "adjusted
				income" set forth in these regulations shall be followed and applied in the
				case of every inpatient and/or outpatient in the Massachusetts Hospital School,
				Lemuel Shattuck Hospital, Rutland Heights Hospital, Lakeville Hospital, the
				Western Massachusetts Hospital and Tewksbury Hospital who must make direct
				payments to the hospital to pay for his health care in whole or in
				part.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.004 - Eligibility

Current through Register 1525, July 5, 2024
Any patient (inpatient or outpatient) who must make direct
				payments to the hospital to pay for his health care is eligible for an
				assessment in accordance with the schedule set forth herein.
(A) Patients who are eligible for and
			 actually do receive Medicaid, Medicare or other third party coverage are not
			 eligible for an assessment to the extent that the third party coverage is
			 actually received.
(1) Patients who seek an
			 assessment must apply for third party coverage whenever it appears that they
			 are able to receive it. Failure to apply may result in denial of an
			 assessment.
(2) Hospital personnel
			 shall assist patients in applying for third party coverage whenever
			 necessary.
(3) Patients who by
			 themselves or by financially responsible persons knowingly and intentionally
			 withhold information lawfully requested pursuant to
			 105 CMR 920.000 may be
			 charged the full rate for medical services rendered to them
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.005 - Method of Determining the Patient's Assessment

Current through Register 1525, July 5, 2024
The following steps shall be taken in order to determine the
				patient's assessment:
(A) The "Low
			 Budget of Family of Four" published by the U.S. Department of Labor Statistics
			 for Boston for the most current period available shall be used as a starting
			 figure.
(1) This figure shall be multiplied by
			 .92 to remove the medical care factor in this budget.
(2) The figure resulting from the calculation
			 performed under CMR 920.005(A)(1) above shall be multiplied by the following
			 factors depending upon the number of persons in the family
(a)
Number in Family
Factor
0
.04
1
.04
2
.05
3
.07
4
.08
5
.09
6
.11
7+
Add .01 or each additional family member.
(b) The
			 figure resulting from this calculation represents the low monthly budget for a
			 family of one, two, three,
etc.
persons.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.006 - Annual Maximum Assessments and Minimum Assessments

Current through Register 1525, July 5, 2024
(A) Notwithstanding the foregoing provisions,
			 no eligible direct pay patient shall be required to pay more for his health
			 care during the prospective fiscal year than an amount calculated in accordance
			 with the schedule set forth below:
(1) The
			 maximum yearly figure shall be determined by multiplying the family's adjusted
			 yearly income by the following percentages:
Family Size
Percentage of Income
0
65.2*
1
15.0
2
12.5
3
10.0
4
7.5
5
5.0
6+
5.0
(2)
Example
: The maximum yearly charge for a family of
			 four persons with an adjusted family income of
13,500.00
will be computed as follows:
$13,500x7.5 = $1,013
(a) Even though this family's monthly
			 assessment is $205 (which when multiplied by 12 equals $2,460), the maximum
			 they can be assessed over a 12-month period is $1,013.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.007 - Application and Determination Procedures

Current through Register 1525, July 5, 2024
(A)
			 The superintendent of each hospital shall appoint an employee or employees to
			 inform direct pay patients about the availability of an assessment, to
			 distribute, monitor and evaluate the applications and to make the calculations
			 and determinations required under these regulations.
(1) Such hospital personnel shall inform
			 patients or prospective patients, either personally or in writing of the
			 availability of an assessment, shall answer questions about the program that
			 patients may have, shall deliver application forms to all direct pay patients,
			 and shall accept and process all applications submitted.
(2) The application form to be used by all
			 hospitals is incorporated herein as exhibit B.
-----------------------------------------------------------------------------------------------------
* 65.2% consists of 50.2% which as stated in
				105 CMR
				920.005(B), a family of "0"
				does not have housing and food expenses. 15.% is the adjustment factor or
				percentage of income for a family of "0" if the individual had housing and food
				expenses. These two percentages summed together equals 65.2%.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.008 - Appeal from Computation of Adjusted Income and or Determination of Assessment

Current through Register 1525, July 5, 2024
A patient who is aggrieved by a computation of adjusted income
				or by a determination of reduced charge assessment or by the denial of free
				care shall have the right to appeal to an intra-hospital committee composed of
				the superintendent of the hospital, a member of the social service department
				and three other persons appointed by the superintendent.
(A) The patient shall receive written notice
			 of this appeal right along with the written determination of assessment, (or
			 denial of assessment) required by
			 105 CMR
			 920.007(D). The notice shall
			 briefly outline the appeal procedure set forth herein.
(B) The patient shall submit a written
			 statement to the committee explaining his disagreement with the determination.
			 He shall include any other written documentation that he believes to be
			 relevant.
(C) The patient shall not
			 be granted a hearing before this committee unless he requests the opportunity
			 to appear personally or through a representative.
(D) The Committee may, considering all
			 available evidence, make a determination of reduced charge assessment, using
			 either the methods set forth in
			 105 CMR
			 920.005 and
			 105 CMR
			 920.006, and/or any other relevant factors
			 relating to ability to pay.
(E) If
			 the Committee upholds the initial determination made with respect to the
			 patient, no further appeals shall be granted.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.009 - Relationship to the Regulations Requiring a Minimum Level of Uncompensated Medical Services

Current through Register 1525, July 5, 2024
Lakeville Hospital, and Massachusetts Hospital School are
				subject to the Regulations Requiring a Minimum Level of Uncompensated Medical
				Services in Massachusetts. Said regulations shall prevail over the instant
				regulations in the event of conflict with the instant
				regulations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 920.000 - Establishing A Uniform Schedule Of Assessments For Direct Pay Patients At The Department Of Public Health Hospitals › Section 920.010 - Financial Information Form

Current through Register 1525, July 5, 2024
EXHIBIT A
Adj.
Annual Income
In Family
0
1
2
3
4
5
6
7 +
Under 2000
30
30
30
30
30
30
30
30
2000 To 2999
30
30
30
30
30
30
30
30
3000 To 3999
83
30
30
30
30
30
30
30
4000 To 4999
166
30
30
30
30
30
30
30
5000 To 5999
249
30
30
30
30
30
30
30
6000 To 6999
333
82
30
30
30
30
30
30
7000 To 7999
416
165
50
30
30
30
30
30
8000 To 8999
449
248
133
30
30
30
30
30
9000 To 9999
583
332
217
30
30
30
30
30
10000 To 10999
666
415
300
70
30
30
30
30
110000 To 11999
749
498
383
38
30
30
30
30
12000 To 12999
833
582
467
237
122
30
30
30
13000 To 13999
916
665
550
320
205
90
30
30
14000 To 14999
999
748
633
403
288
173
30
30
15000 To 15999
1083
832
717
487
372
257
30
30
16000 To 16099
1166
832
800
570
455
340
110
30
17000 To 17999
1249
998
883
653
338
423
193
78
18000 To 18999
1333
1082
967
737
622
507
277
162
19999 To 19999
1416
1165
1050
820
705
590
360
245
20000 To 20999
1499
1248
1133
903
788
673
443
328
21999 To 22999
1583
1332
1217
987
872
757
527
412
23000 To 23999
1749
1498
1383
1153
1038
923
693
578
24000 To 24999
1833
1582
1467
1237
1122
1007
777
662
25000 To 25999
1916
1665
1550
1320
1205
1090
860
745
Add *83.00 for each additional $1,000
+83
+83
+83
+83
+83
+83
+83
+83
EXHIBIT B
HUMAN SERVICES FINANCIAL INFORMATION FORM
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Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.001 - Purpose

Current through Register 1525, July 5, 2024
105 CMR
				960.000 is set forth for the purpose of interpreting
				and implementing M.G.L. c.111L, Biotechnology, as enacted under Chapter 27 of
				the Acts of 2005, An Act Enhancing Regenerative Medicine in the
				Commonwealth.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.002 - Regulatory Authority

Current through Register 1525, July 5, 2024
105 CMR
				960.000 is adopted under the authority of M.G.L.
				c.111, s.3 and M.G.L. c.111L.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.005 - Creation of Human Embryos for Research

Current through Register 1525, July 5, 2024
(A)
			 No person shall knowingly create an embryo or pre-implantation embryo by the
			 method of fertilization with the sole intent of donating the embryo for
			 research.
(B) Pre-implantation
			 embryos may be created by somatic cell nuclear transfer, parthenogenesis or
			 other asexual means for research purposes.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.006 - Purchase, Sale, Transfer, Receipt and Donation of Embryos, Human Gametes or Cadaveric Tissue

Current through Register 1525, July 5, 2024
(A) No person shall
			 knowingly and for valuable consideration, purchase, sell, transfer or otherwise
			 obtain embryos, human gametes or cadaveric tissue for research
			 purposes.
(B) Persons may bank or
			 donate their gametes for personal future use and may donate their gametes to
			 another person or may donate their gametes for research.
(C) Persons from whose cells a
			 pre-implantation embryo has originated or will originate may donate such
			 pre-implantation embryo or cells to another person for research:
(1) In the absence of valuable
			 consideration;
(2) After the
			 fulfillment of the requirements of informed consent;
(3) Provided that the pre-implantation
			 embryo, if created by the method of fertilization, was not knowingly created
			 with the sole intent of donating the resultant embryo for research;
			 and
(4) Provided that the recipient
			 of the pre-implantation embryo shall use the extant or resultant
			 pre-implantation embryo in biomedical research and shall not transfer the
			 pre-implantation embryo to a uterus or uterine-like environment or nurture the
			 pre-implantation embryo beyond 14 days of development.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.007 - Prohibition on Human Reproductive Cloning

Current through Register 1525, July 5, 2024
(A)
			 Human reproductive cloning is prohibited. No person shall knowingly attempt,
			 engage in, or assist in human reproductive cloning.
(B) No person shall knowingly purchase, sell,
			 transfer or otherwise obtain human embryonic, gametic or cadaveric tissue for
			 the purpose of human reproductive cloning.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.008 - In Vitro Fertilization for Reproductive Purposes

Current through Register 1525, July 5, 2024
(A) The provisions of these regulations do
			 not prohibit the use of in vitro fertilization for reproductive
			 purposes.
(B) A physician or other
			 health care provider who provides a patient with in vitro fertilization therapy
			 shall provide the patient with timely, relevant and appropriate information
			 sufficient to allow that patient to make an informed and voluntary choice
			 regarding the disposition of any pre-implantation embryos or gametes remaining
			 following treatment.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.009 - Penalties

Current through Register 1525, July 5, 2024
(A) A person who is found to have knowingly
			 violated sections 960.005(A) or 960.006(A) shall be punished by imprisonment in
			 a jail or house of correction for not less than one year nor more than two
			 years or by imprisonment in the state prison for not more than five years or by
			 a fine of not more than $100,000.
(B) A person who is found to have knowingly
			 violated shall be punished by imprisonment in a jail or house of correction for
			 not less than five years nor more than ten years or by imprisonment in the
			 state prison for not more than ten years or by a fine of not more than
			 $1,000,000. In addition to such penalty, and at the discretion of the court, a
			 person who is found to have knowingly violated this section and derives a
			 personal financial profit from such violation may be ordered to pay all or part
			 of any such profits to the commonwealth as damages.
(C) Complaints regarding violators shall be
			 referred to the Office of the Attorney General.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.001 - Purpose

Current through Register 1525, July 5, 2024
105 CMR 970.000 implements
				M.G.L. c. 111N, Pharmaceutical and Medical Device Manufacturer Conduct.
				105 CMR 970.000 is intended
				to benefit patients, enhance the practice of medicine, and ensure that the
				relationship between pharmaceutical or medical device manufacturers and health
				care practitioners not interfere with the independent judgment of health care
				practitioners. Pursuant to M.G.L. c. 111N,
				105 CMR 970.000 seeks to
				accomplish these objectives without compromising companies' legitimate
				confidentiality interests in protecting trade secrets and other intellectual
				property rights associated with genuine medical research, clinical trials, and
				the discovery of new treatments and medical devices.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.002 - Regulatory Authority

Current through Register 1525, July 5, 2024
105 CMR 970.000 is adopted
				under the authority of M.G.L. c. 111, § 3 and M.G.L. c.
				111N.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.003 - Citation

Current through Register 1525, July 5, 2024
105 CMR 970.000 shall be
				known, and may be cited, as
The Pharmaceutical and Medical Device
				Manufacturer Code of Conduct
or the
Marketing Code of
				Conduct
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.005 - General Requirements

Current through Register 1525, July 5, 2024
(1) By July 1,
			 2009, each pharmaceutical or medical device manufacturing company that employs
			 or contracts with a pharmaceutical or medical device manufacturer agent shall:
(a) adopt a marketing code of conduct in
			 compliance with the requirements of
			 105 CMR 970.000;
(b) adopt and submit to the Department a
			 description of a training program to provide regular training to appropriate
			 employees including, without limitation, all sales and marketing staff, on the
			 marketing code of conduct. The training program must:
1. ensure that all representatives who are
			 employed by or acting on behalf of the company and who visit health care
			 practitioners have sufficient knowledge of:
a.
			 the marketing code of conduct,
b.
			 general science, and
c.
			 product-specific information to provide accurate, up-to-date information,
			 consistent with state law and FDA requirements; and
2. provide for regular assessments of persons
			 who are employed by or acting on behalf of the companies to ensure that they
			 comply with the requirements of
			 105 CMR 970.000 and other
			 relevant company policies.
(c) certify to the Department to the best of
			 the company's knowledge, information and belief that it is in compliance with
			 105 CMR 970.000;
(d) adopt and submit to the Department
			 policies and procedures for investigating non-compliance with
			 105 CMR 970.000, taking
			 corrective action in response to noncompliance and reporting instances of
			 non-compliance to the appropriate state authorities; and
(e) submit to the Department the name, title,
			 address, telephone number and electronic mail address of the compliance officer
			 it has identified as responsible for certifying compliance with
			 105 CMR 970.000 and
			 implementing, monitoring, and enforcing the company's marketing code of
			 conduct.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.006 - Provision of Meals

Current through Register 1525, July 5, 2024
(1) Except as
			 otherwise provided in
			 105 CMR 970.000, no
			 pharmaceutical or medical device manufacturing company or its agent that
			 employs or contracts with a pharmaceutical or medical device manufacturer agent
			 may provide or pay for meals for health care practitioners that:
(a) are part of an entertainment or
			 recreational event;
(b) are offered
			 without an informational presentation made by a pharmaceutical or medical
			 device marketing agent or without such an agent being present; or
(c) are provided to a healthcare
			 practitioner's spouse or other guest.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.007 - CME, Third-party Scientific or Educational Conferences, or Professional Meetings

Current through Register 1525, July 5, 2024
(1) No
			 pharmaceutical or medical device manufacturing company that employs or
			 contracts with a pharmaceutical or medical device manufacturer agent may
			 provide:
(a) financial support for the costs
			 of travel, lodging, or other personal expenses of non-faculty health care
			 practitioners attending any CME event, third-party scientific or educational
			 conference, or professional meetings, either directly to the individuals
			 participating in the event or indirectly to the event's sponsor.
(b) funding to compensate for the time spent
			 by health care practitioners participating in any CME event, third-party
			 scientific or educational conferences, or professional meetings;
(c) payment for meals directly to a health
			 care practitioner at any CME event, third-party scientific or educational
			 conferences, or professional meetings, although a CME provider or conference or
			 meeting organizer may, at its own discretion, apply any financial support
			 provided by a pharmaceutical or medical device manufacturing company for the
			 event to provide meals for all participants.
(d) sponsorship or payment for CME, also
			 known as independent medical education, that does not meet the Standards For
			 Commercial Support as established by the Accreditation Council for Continuing
			 Medical Education (ACCME) or equivalent commercial support standards of the
			 relevant continuing education accrediting body, or that provides payment
			 directly to a health care practitioner.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.008 - Other Payments to Health Care Practitioners

Current through Register 1525, July 5, 2024
(1)
			 No pharmaceutical or medical device manufacturing company that employs or
			 contracts with a pharmaceutical or medical device manufacturer agent may
			 provide:
(a) entertainment or recreational
			 items of any value, including, but not limited to, tickets to the theater or
			 sporting events, concerts, sporting equipment, or leisure or vacation trips, to
			 any health care practitioner who is not a salaried employee of the
			 pharmaceutical or medical device manufacturing company;
(b) payments of any kind including cash or
			 cash equivalents, equity, "in kind" or tangible items including any
			 "complimentary" items such as pens, coffee mugs, gift cards,
etc
. to health care practitioners either directly or
			 indirectly, except as compensation for
bona fide
services;
(c) any grants,
			 scholarships, subsidies, supports, consulting contracts, or educational or
			 practice related items in exchange for prescribing, disbursing, or using
			 prescription drugs, biologics or medical devices or for a commitment to
			 continue prescribing, disbursing, or using prescription drugs, biologics or
			 medical devices;
(d) any other
			 payment or remuneration, in cash or in kind, directly or indirectly, including
			 any rebate or "kickback" that is prohibited under applicable federal or state
			 "fraud and abuse" laws or regulations including the federal "Anti-Kickback
			 Statute" (
			 42
			 U.S.C. 1320a-7b ) and equivalent
			 Massachusetts laws such as M.G.L. c. 118E, § 41 and M.G.L. c. 175H, §
			 3.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.009 - Reporting to the Department

Current through Register 1525, July 5, 2024
(1) Beginning July
			 1, 2010, and annually on or before July 1st of each
			 year thereafter, every pharmaceutical or medical device manufacturing company
			 that employs or contracts with a pharmaceutical or medical device manufacturer
			 agent shall disclose to the Department the value, nature, purpose and
			 particular recipient of any fee, payment, subsidy or other economic benefit
			 with a value of at least $50, which the company provides, directly or through
			 its agents, to any covered recipient in connection with the company's sales and
			 marketing activities.
(2) Each
			 annual disclosure report shall be accompanied by a fee of $2,000. The first
			 annual payment of $2,000 shall be due to the Department on July 1, 2009. No
			 payment pursuant to 105 CMR 970.009(2) shall be required after July 1,
			 2012.
(3) Disclosures shall be made
			 for the previous calendar year using a standardized reporting format developed
			 by the Department. The first required disclosure report shall cover the period
			 from July 1, 2009 through December 31, 2009. Each annual disclosure report may
			 be submitted to the Department electronically.
(4) Pharmaceutical or medical device
			 manufacturing companies shall certify that to the best of the company's
			 knowledge, information and belief, that any report is true and
			 accurate.
(5) For the purposes of
			 computing the $50 threshold, fees, payments, subsidies and other economic
			 benefits relating to separate events or transactions shall be calculated on an
			 individual transactional basis and shall not be aggregated. Pharmaceutical or
			 medical device manufacturing companies shall not structure fees, payments,
			 subsidies or other economic benefits to health care practitioners to circumvent
			 the reporting requirements of M.G.L. c. 111N, § 6 and 105 CMR
			 970.009.
(6) Notwithstanding the
			 provisions of 105 CMR 970.009, no pharmaceutical or medical device
			 manufacturing company is required to disclose information to the Department
			 that has been disclosed to a federal agency pursuant to federal law and that is
			 then provided by the Secretary to the Department in annual reports.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.010 - Penalties

Current through Register 1525, July 5, 2024
(1) A person who knowingly and willfully
			 violates
			 105 CMR 970.000 shall be
			 punished by a fine of not more than $5,000 for each transaction, occurrence or
			 event.
(2) No pharmaceutical or
			 medical device manufacturing company, shall discharge, refuse to hire, refuse
			 to serve or in any manner retaliate or take any adverse action against any
			 employee, applicant, health care practitioner or covered recipient because such
			 employee, applicant, health care practitioner, or covered recipient takes or
			 has taken any action in furtherance of the enforcement of
			 105 CMR 970.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.011 - Enforcement

Current through Register 1525, July 5, 2024
(1) Fines pursuant to
			 105 CMR 970.000 shall be
			 issued by an authorized entity.
(2)
			 Ten days prior to the issuance of any fine pursuant to 105 CMR. 970.000, the
			 authorized entity shall provide notice and an informal opportunity to dispute
			 the issuance of the fine in person or by counsel or other representative as to
			 the proposed action.
(3) Notice
			 shall be provided by mail, postage prepaid, to the person's usual place of
			 business or, if unavailable, to the person's last known address.
(4) A person aggrieved by the issuance of a
			 fine by an authorized entity pursuant to
			 105 CMR 970.000 may seek
			 judicial review in the Superior Court.
(5) An authorized entity may file a civil
			 complaint in Superior Court following the failure of any person to pay a fine
			 issued by the authorized entity.
Code of Massachusetts Regulations › 106 CMR - DEPARTMENT OF TRANSITIONAL ASSISTANCE › Title 106 CMR 327.000 - Eligibility requirements for State Supplement Program (SSP) › Section 327.010 - Authority for State Supplement Program

Current through Register 1525, July 5, 2024
The Supplemental Security Income (SSI) program is administered
				by the Social Security Administration (SSA) to provide financial assistance to
				eligible aged, disabled and blind individuals. States have the option to
				provide additional assistance through the State Supplement Program (SSP).
				Massachusetts has opted to provide this additional assistance.
SSP is authorized under M.G.L. c. 6, § 131 and M.G.L. c.
				118A and applicable federal law pertaining to the SSI program and agreements
				with the Commissioner of Social Security.
106 CMR 327.000 is promulgated and implemented in accordance
				with M.G.L. c. 30A, and applicable General Laws of
				Massachusetts.