CHAPTER
He-W 900 OTHER PROGRAMS ADMINISTERED BY
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART
He-W 910 EXPANDED HEALTH CARE COVERAGE
FOR CERTAIN LOW-INCOME CHILDREN
He-W
910.01 Purpose. To describe eligibility requirements and
services provided through the State Children’s Health Insurance Program
(SCHIP).
Source. #6925, eff 1-1-99; amd by #7666, eff 4-1-02;
ss by #8227, eff 1-1-05
He-W
910.02 Definitions.
(a) “Consolidated Omnibus Budget Reconciliation
Act (COBRA)” means public law 99-272, enacted in 1986, that allows the
continuation of group health coverage that otherwise would be terminated.
(b) “Co-payment” means an amount paid by a
recipient to a NH healthy kids-silver program provider.
(c) “Cost-sharing” means co-payments and premiums
as described in He-W 910.05 and 910.06.
(d) “Formulary” means a list of Federal Food and
Drug Administration-approved brand name and generic medications that has been
developed by the insurance provider contracted by Healthy Kids Corporation.
(e) “Healthy Kids Corporation, Inc. (Healthy Kids
Corp.)” means a non-profit corporation established pursuant to RSA 126:H and
doing business in the state of
(f) “Healthy kids-silver” means a medical
assistance benefits package for children over the age of one and under the age
of 19 whose family income is greater than 185%, but less than or equal to 300%,
of the federal Poverty Income Guidelines as published annually in the Federal Register
by the Secretary of the U.S. Department of Health and Human Services.
(g) “Premium” means a fixed monthly amount
determined by the department of health and human services (DHHS) and paid by a recipient
when required as a condition of eligibility.
(h) “Provider” means an entity or individual who
furnishes health care services or supplies to Healthy Kids Silver recipients
under an agreement with Healthy Kids Corp., and is licensed or certified pursuant
to applicable state law to provide such services and supplies
(i) “Recipient” means an individual who is
eligible for and receiving medical assistance under the program entitled
Healthy Kids-Silver.
(j) “Services” means medical care or a medical
product for which payment is made by the Healthy Kids-Silver program.
(k) “Subscriber parent” means the person in whose
name the insurance policy has been issued and under which the dependent child
receives health coverage.
(l) “Title XXI Program” means the joint
federal-state program described in Title XXI of the Social Security Act and
administered in New Hampshire by (DHHS) in cooperation with Healthy Kids Corp.
under the program entitled healthy kids-silver.
(m) “Utilization review and control” means the
monitoring of NH Title XXI program services pursuant to 42 CFR 456.
Source. #6925, eff 1-1-99; ss by #8227, eff 1-1-05
He-W
910.03 Program Administration. The department of health and human services
shall:
(a) Develop and administer the federal State Plan
for the operation of the Title XXI program, pursuant to applicable federal
statutes and regulations and in accordance with RSA 161:2 and RSA 167;
(b) Provide basic, comprehensive medical
assistance under Healthy Kids-Silver to all recipients eligible pursuant to
He-W 641.07 to the extent required by Section 2103 the Social Security Act as
enacted by P.L. 105-33 and amended by P.L. 105-100; and
(c) Enter into a cooperative contractual
partnership with Healthy Kids Corp. under which a comprehensive health benefits
insurance plan will be made available by Healthy Kids Corp. to all eligible
Healthy Kids-Silver recipients to meet the requirements of He-W 910.02(b).
Source. #6925, eff 1-1-99; ss by #7804, eff 1-1-03;
ss by #8227, eff 1-1-05
He-W 910.04
Eligibility.
(a) For purposes of determining income
eligibility for medical coverage for healthy kids-silver applicants, changes in
the poverty level guidelines shall apply the first day of the second month
following the annual publication of the poverty income guidelines in the
Federal Register.
(b) Resources shall not be counted when
determining eligibility for healthy kids-silver.
(c) Applicants for healthy kids-silver medical
coverage shall not be eligible if they currently have other health insurance
coverage;
(d) Applicants for healthy kids-silver medical coverage
shall not be eligible if they were covered under another health insurance
program within the 6 consecutive months prior to the date of application
unless:
(1)
Their health insurance was terminated due to involuntary loss of
employment by the subscriber parent;
(2)
Their health insurance was terminated due to voluntary loss of
employment by the subscriber parent, and the loss occurred for one of the
following good cause reasons:
a.
Discrimination by an employer based on age, race, sex, color, physical
or mental disability, religious belief, national origin, or political beliefs;
b.
Work demands or conditions that render continued employment
unreasonable, including but not limited to, employment in which the degree of
risk to health or safety is unreasonable or employment yielding weekly earnings
of less than the state or federal hourly minimum wage;
c.
Resignation by a subscriber parent that is recognized by the employer as
retirement;
d.
Employment which becomes or is revealed to be unsuitable following
acceptance of such employment, including, but not limited to, employment which
the parent is physically or mentally unfit to perform, or employment in which
the distance from the parent's home to the place of employment is more than a 2
hour round trip;
e.
Acceptance by the subscriber parent of enrollment of at least half-time
in any:
1.
Employment training program;
2.
School approved by the State Board of Education as carried out under the
rulemaking authority of RSA 21-N:9 and defined in RSA 189:24-25 and RSA 194:23;
or
3.
Institution of higher education accredited by a secondary,
post-secondary or vocational training and education commission;
f.
Leaving a job in order to accept a bona-fide job offer, which, because
of subsequent circumstances beyond the control of the applicant, is withdrawn
or results in employment that does not allow the employee to enroll the
employee's dependent children under the employer's health plan;
g.
Leaving a job because of circumstances beyond the control of the parent
which render continued employment impracticable, including but not limited to:
1.
Lack of transportation or child care;
2.
Illness, incapacity or disability of the parent; or
3.
Illness, incapacity or disability of another household member serious
enough to require the presence in the home of the parent and net loss of cash
income;
(3)
Changing employment to an employer who does not offer the employee's
dependent children to become enrolled under the employer’s health plan;
(4)
Death of the subscriber parent;
(5)
Discontinuation of coverage to all employees by the employer;
(6)
Discontinuation of COBRA benefits after 18 months for job termination;
(7) Discontinuation
of COBRA benefits 24 months after the death of the subscriber parent;
(8)
The subscriber parent met other good cause reasons prior to accepting
COBRA coverage;
(9)
The insurer closes its operation in
(10)
An involuntary reduction in work hours that no longer allows the
employee's dependent children to be enrolled under the employer's health plan;
(11)
The subscriber parent experiences loss of coverage or an inability to
use current coverage due to family/domestic violence pursuant to Section
408(a)(7)(c)(iii) of the Social Security Act as amended;
(12) A
temporary insurance policy has ended and:
a. The
dependent children were not enrolled in a group or non-group health plan during
the previous 6 months; or
b. The
subscriber parent would not have met good cause reasons prior to accepting
temporary coverage; or
(13)
The subscriber parent leaves employment to become the primary caregiver
of their dependent children who are 5 years of age or under.
(14) The
health insurance was terminate by a non-custodial parent subscriber where the
loss of insurance was beyond the control of the custodial parent.
Source. #6925, eff 1-1-99; ss by #7804, eff 1-1-03; ss
by #8227, eff 1-1-05
He-W
910.05 Cost Sharing.
(a) Premium cost sharing for the healthy
kids-silver program shall be calculated pursuant to Section 2103(e)(3)(B) of
the Social Security Act.
(b) Healthy Kids Corp. shall:
(1) Educate families of recipients about cost
sharing requirements and limits;
(2) Monitor premium cost sharing via its own
accounting system;
(3) Monitor medical and dental co-payments on a
quarterly basis via a cost sharing report generated by the health and dental
providers;
(4) Notify in writing families who meet or exceed
the 5% limit to cease cost sharing for the remainder of the 12 month
eligibility period;
(5) Notify insurers in writing of those families who
meet or exceed the 5% limit to cease cost sharing for the remainder of the 12
month eligibility period; and
(6) In the case of overpayment on the part of a
family, either provide credit against future premiums or reimburse the family
the amount in excess of the 5% limit.
Source. #6925, eff 1-1-99; ss by #8227, eff 1-1-05
He-W 910.06 Premiums.
(a) A fixed monthly premium shall be paid by healthy kids-silver enrollees to the
Healthy Kids Corp. as follows:
(1)
When the family income is greater than 185% and equal to or less than
250% of the federal poverty level, as determined in He-W 910.03, the premium
shall be $32.00 per child per month with a maximum monthly premium payment not
to exceed $128.00 per family per month;
(2)
When the family income is greater than 250% and equal to or less than
300% of the federal poverty level, as determined in He-W 910.03, the premium
shall be $54.00 per child per month with a maximum monthly premium payment not
to exceed $162.00 per family per month;
(3)
Payment of the premium shall be due by the last day of the month prior
to the beginning of the coverage month; and
(4)
Healthy Kids Corp. shall collect, process, and monitor the payment of
premiums.
(b) Non-payment of a premium for 60 consecutive
days, without good cause as described in (e) below, shall result in the
following:
(1)
Recipient eligibility for healthy kids-silver shall be terminated on the
last day of the month in which the 60-day period ends;
(2)
The payment due date shall be counted as day one of the 60-day period;
and
(3)
Reapplication for healthy kids-silver shall not be allowed for a period
of 3 consecutive months beginning with the first day eligibility was
terminated.
(c) Non-payment of a premium without good cause
shall not apply to pregnant recipients until the 61st postpartum day.
(d) Healthy Kids Corp. shall notify DHHS when a
recipient’s premium has not been paid for 60 consecutive days, except when good
cause exists in accordance with (e) below.
(e) Good cause for non-payment of premiums shall
exist when Healthy Kids Corp. determines that one of the following criteria are
met:
(1)
The recipient’s family experienced a temporary or unexpected loss of
income which prevents the family from paying the premium; or
(2)
The recipient’s family incurred an unexpected expense that prevents the
family from paying the premium.
Source. #6925, eff 1-1-99; ss by #8227, eff 1-1-05; ss by #8467, eff 10-29-05; ss by #9513, INTERIM, eff 7-18-09, EXPIRES: 1-14-10; ss by #9617, eff 1-15-10
He-W
910.07 Co-Payments.
(a) Recipients shall make co-payments as follows:
(1) A co-payment in the amount of $5.00 shall be
required for:
a. Physical therapy, occupational therapy or
speech therapy;
b. Early intervention services;
c. Hearing aids;
d. Routine vision and hearing exams; and
e. Eyewear;
(2) A co-payment in the amount of $10.00 shall be
required for:
a. Each covered provider office visit that does
not include a preventive health service;
b.
Mental health outpatient or office visits;
c.
Substance abuse outpatient or office visits; and
d.
Chiropractic office visits. and
(3) A co-payment in the amount of $50.00 shall be
required for each non-emergent or unauthorized outpatient emergency room visit.
(b) Co-payments shall not be required for:
(1) Preventive health services;
(2) Well baby provider office visits; and
(3) Dental check-ups, cleanings, x-rays and
fluoride treatments.
(c) Recipients shall make co-payments for
prescriptions as follows:
(1) A co-payment of $5.00 for each covered
formulary generic prescription drug dispensed;
(2) A co-payment of $15.00 for each covered formulary
brand name prescription drug dispensed when no generic equivalent is available;
(3)
A co-payment of $25.00 for each covered non-formulary brand name prescription
drug dispensed when no generic equivalent is available;
(4) A co-payment of $15.00 for each covered
formulary brand name prescription drug dispensed when the prescribing provider
indicates that the brand name drug is medically necessary when a generic
equivalent is available;
(5) A co-payment of $25.00 for each for each
covered non-formulary brand name prescription drug dispensed when the
prescribing provider documents that the brand name drug is medically necessary
when a generic equivalent is available; and
(6) A co-payment of $15.00 plus the difference in
cost between the generic drug and the covered brand name drug if the
recipient’s family opts for the brand name drug when a generic equivalent is
available.
Source. #6925, eff 1-1-99; ss by #8227, eff 1-1-05;
ss by #8467, eff 10-29-05
He-W 910.08
Covered Services.
(a)
Medical care and supplies shall be covered under Healthy Kids Silver
pursuant to Section 2103(a) of the Social Security Act.
(b)
Covered services shall include the following:
(1) Inpatient
hospital services;
(2)
Outpatient hospital services, including emergency services;
(3)
Physician services, including primary care services provided by advanced
registered nurse practitioners and physician assistants;
(4)
Surgical services;
(5)
Clinic services, including health center services and other ambulatory
health care services;
(6)
Care coordination provided as part of the role of the primary care
provider;
(7)
Prescription drugs as provided in He-P 910.07(c), including all FDA approved
prescriptive oral contraceptive medications;
(8)
Laboratory and radiological services;
(9)
Prenatal care and pre-pregnancy family planning services and supplies;
(10)
Inpatient mental health services, up to a maximum of 15 days per
calendar year, including services furnished in a state-operated mental
hospital, and including residential or other 24-hour therapeutically planned
structural services;
(11)
Outpatient mental health services, up to a maximum of 20 visits per
calendar year, including services furnished in a state-operated mental hospital
and community-based mental health services;
(12)
Durable medical equipment and other medically-related or remedial
devices, including eyeglasses and hearing aids;
(13)
Disposable medical supplies;
(14)
Home health visits, up to a maximum of 20 visits per calendar year;
(15)
Dental services, including, but not limited to, diagnostic and
preventive services, and sealants and fillings, which shall be covered at 100%
up to a maximum benefit of $600.00 per calendar year;
(16)
Physical therapy and occupational therapy, up to a maximum of 24 visits
per calendar year for physical therapy or for occupational therapy, or for a
combination of physical and occupational therapy;
(17)
Speech therapy, up to a maximum of 24 visits per calendar year;
(18)
Hospice care;
(19)
Chiropractic services;
(20)
Emergency transportation by ambulance;
(21)
Skilled nursing and rehabilitation facility services;
(22)
Inpatient substance abuse treatment services;
(23)
Outpatient substance abuse treatment services;
(24)
Preventive health services;
(25)
Vision services;
(26)
Hearing services; and
(27)
Any other service pursuant to Section 2103 of the Social Security Act.
Source. #6925, eff 1-1-99; ss by #8227, eff 1-1-05
He-W
910.09 Recovery of Medical Assistance
Provided.
(a) Acceptance of medical assistance under Title
XXI shall constitute assignment to DHHS of rights to recovery from any third
party in accordance with RSA 167:14-a.
(b) In all cases involving distribution of
recovery from a third party settlement, DHHS shall be considered a creditor.
(c) Recovery of medical assistance from liable
third parties shall be made in accordance with 42 CFR 433.139.
Source. #7666, eff 4-1-02; ss by #8227, eff 1-1-05
He-W
910.10 Utilization Review and Control.
(a) DHHS shall monitor utilization review and control
in accordance with He-W 520.06.
(b) Healthy Kids Corp. shall be responsible for
utilization review activities by:
(1)
Performing the utilization reviews directly, or contracting with qualified
professional organizations for the performance of reviews; and
(2) Monitoring the results of reviews to ensure
appropriate corrective action has been taken.
Source. #8227, eff 1-1-05
PART He-W 950 COMPREHENSIVE HEALTH CARE INFORMATION SYSTEM
PROCEDURES FOR THE RELEASE OF CLAIMS DATA SETS FOR PUBLIC AND RESEARCH PURPOSES
He-W 950.01 Purpose. This chapter specifies the provisions for
release of health care claims data sets from the department of health and human
services to researchers and the public.
Source. #8600, eff
4-6-06
He-W 950.02 Scope. This chapter shall apply only to data
collected under RSA 420-G:11, II.
Source. #8600, eff
4-6-06
He-W 950.03 Definitions.
(a) “Carrier” means an insurance company
represented in the data set collected under RSA 420-G:11, II that is the
recipient of the claims.
(b) “Cell size” means the count of patients that
share a set of characteristics contained in a statistical table.
(c) “Charge” means the actual dollar amount
charged on the claim.
(d) “Clinical data” means the health care claims,
hospital and non-hospital health care facility data, and all other data collected
pursuant to the rules adopted relative to RSA 420-G:11, II.
(e) “Commissioner” means the commissioner of the
(f) “Comprehensive health care information
system” means a health care data repository developed to meet the intent of RSA
420-G:11-a and the components of the memorandum of understanding between the
New Hampshire department of health and human services and the New Hampshire
insurance department (NHID) required under RSA 420-G:11-a that relate to claims
data collected under RSA 420-G:11, II.
(g) “Confidential data” means individual or
collective data elements contained in the claims data set that:
(1) Have not been revealed previously to the general public; and
(2) Directly identify a patient.
(h) “Confidential research
data set” means a data set available for research, subject to the provisions in
He-W 950.07 below, which might:
(1) Be used in conjunction with patient supplied
identifiers, subject to the informed consent of the patients identified; or
(2) Contain insured group policy identifiers,
subject to the informed consent of the insurer groups identified.
(i) “Data set” means the collection of individual
data records, whether in electronic or manual files.
(j) “Department” means the
(k) “Direct patient identifiers” means:
(1) Names;
(2) Business names when that name would serve to
identify a patient;
(3) Postal address information other than town or
city, state, and 5-digit zip code;
(4) Specific latitude and longitude or other
geographic information that would be used to derive postal address;
(5) Telephone and fax numbers that identify a
patient;
(6) Electronic mail addresses that identify a
patient;
(7) Social security
numbers that identify a patient;
(8) Medical record numbers;
(9) Health plan beneficiary numbers;
(10) Certificate and license numbers that identify
a patient;
(11) Internet protocol (IP) addresses and uniform
resource locators (URL) that identify a business that would serve to identify a
patient;
(12) Biometric identifiers, including finger and
voice prints; and
(13) Personal photographic images.
(l) “Disclosure” means to communicate clinical
data to a person not already in possession of that information.
(m) “Encrypted identifier” means a code or other
means of record identification to allow patients to be tracked across the data
set without revealing their identity.
Encrypted identifiers are not direct identifiers.
(n) “Health care claims data” means information
consisting of or derived directly from member eligibility, medical claims,
pharmacy claims, or dental claims files submitted by health care claims
processors collected under RSA 420-G:11, II.
Health care claims data does not include analysis, reports, or studies
containing information from health care claims data sets, if those analyses,
reports or studies have already been released in response to another request
for information or as part of a general distribution of public information by
the department.
(o) “Health care facility” means a public or
private, proprietary or not-for-profit entity or institution providing health
services licensed under RSA 151:2 and facilities operating as community health
clinics.
(p) “Health care practitioner” means physicians
and all persons licensed or registered as a health care provider in the state
of
(1) Nurses;
(2) Podiatrists;
(3) Optometrists;
(4) Pharmacists;
(5) Chiropractors;
(6) Physical therapists;
(7) Dentists;
(8) Psychologists;
(9) Licensed clinical social workers;
(10)
Marriage and family therapists;
(11) Professional counselors; and
(12) Physicians’ assistants.
(q) “Indirect patient
identifier” means:
(1) All geographic subdivisions of New Hampshire or
any state or province, including census tracts, blocks, and block groups,
cities, towns, zip codes, and their equivalent geocodes, except county;
(2) Race;
(3) All elements of dates, except year, for dates
related to a patient, including birth date, admission date, discharge date,
date of death, and all ages over 89 and all elements of dates, including year, indicative of such age, except that such elements
may be aggregated into a single category of age 90 and older; and
(4) Group policy numbers.
(r) “Limited use research data set” means a data
set available for research, subject to provisions in He-W 950.06 below, from
which all direct patient identifiers have been encrypted in such a way as to
not allow direct identification, and the following additional modifications
have been made:
(1) Any data that directly identifies or would
lead to the indirect identification of health care practitioners performing
abortions are deemed confidential and shall not be released in the limited use
data set; and
(2) Insured group or policy numbers are
encrypted.
(s) “Patient” means any person in the data set
that is the subject of the activities of the claim performed by the health care
provider.
(t) “Payment” means the actual dollar amount paid
for a claim by a carrier.
(u) “Principal investigator” means the person in
charge of a project that makes use of limited use research or research health
care claims data sets. The principal investigator
is the custodian of the data and is responsible for the observance of all
conditions of use and for establishment and maintenance of security
arrangements to prevent unauthorized use.
(v) “Provided by law” means use and disclosure as
permitted or required by
(w) “Public use data set” means a data set which
contains no confidential data, and from which all known direct or indirect
identifiers about individual health care practitioners and employers or
purchaser groups which have been removed and contains the data elements
specified in He-W 950.04 below.
(x) “Release” means to make all or part of the
claims data set available for inspection and analysis to persons other than the
department and the NHID.
(y) “Statistical table” means single or
multivariate counts based on the information contained in a data set and which
does not include any direct identifiers.
Source. #8600, eff
4-6-06
He-W 950.04 Public Use
Data Sets.
(a) Public use data sets shall consist of the
following data sets:
(1) Medical claims
data sets; and
(2) Pharmacy claims data sets.
(b) Medical claims data sets shall contain the
following elements:
(1) Service event
primary key;
(2) Insurance
product type;
(3) Line counter;
(4) Member gender;
(5) Member age if
under 90, if 90 or over member age is aggregated into a single category of age
90 or older;
(6) Member county;
(7) Admission year;
(8) Admission hour;
(9) Admission type;
(10) Admission source;
(11) Length of stay;
(12) Discharge year;
(13) Discharge hour;
(14) Discharge member status;
(15) Whether service
provider entity type is person or group practice or non-person or group
practice;
(16) Service provider organization name;
(17) Service provider county;
(18) Type of bill;
(19) Health care facility type;
(20) Claim status;
(21) Admitting diagnosis;
(22) External cause of injury or poisoning code
(E-code);
(23) Principal diagnosis;
(24) Other diagnoses;
(25) Revenue code;
(26) Procedure codes;
(27) Length of service in days;
(28) Quantity;
(29) Charge amount;
(30) Paid amount;
(31) Fee for service prepaid equivalent amount for
capitated services;
(32) Co-pay amount;
(33) Co-insurance
amount;
(34) Deductible
amount; and
(35) Record type.
(c) Pharmacy
claims data set shall contain the following elements:
(1) Service event
primary key;
(2) Insurance
product type;
(3) Line counter;
(4) Member gender;
(5) Member age if
under 90, if 90 or over member age is aggregated into a single category of age
90 or older;
(6) Member county;
(7) Pharmacy county;
(8) Claim status;
(9) Drug code;
(10) Drug name;
(11) New
prescription;
(12) Generic drug indicator;
(13) Dispense as written code;
(14) Compound drug indicator;
(15) Year prescription filled;
(16) Quantity dispensed;
(17) Days supply;
(18) Charge amount;
(19) Paid amount;
(20) Ingredient cost or list price;
(21) Dispensing fee;
(22) Co-pay amount;
(23) Co-insurance
amount;
(24) Deductible amount; and
(25) Record type.
Source. #8600, eff
4-6-06
He-W 950.05 Release of Public Use Data Sets.
(a) Except as otherwise provided by law, upon
request the department shall release public use data sets.
Source. #8600, eff
4-6-06
He-W 950.06 Release
of Limited Use Health Care Claims Research Data Sets.
(a) Except as otherwise provided by law, the
department shall, upon consideration of the advice of the claims data release
advisory committee, release limited use health care claims research data sets
to requestors for the purposes of research under the following conditions:
(1) When the
requestor submits a written application developed by the department that
contains:
a. The principal investigator’s:
1. Name, address, and phone number;
2. Organizational affiliation;
3. Professional qualification; and
4. Name and phone number of principal
investigator's contact person, if any;
b. The names and qualifications of additional
research staff, if any, who will have access to the data;
c. A research protocol which contains:
1. A summary of background, purposes, and origin
of the research;
2. A statement of the health-related problem or
issue to be addressed by the research;
3. The research design and methodology,
including either the topics of exploratory research or the specific research
hypotheses to be tested;
4. The procedures that will be followed to
maintain the confidentiality of any data or copies of records provided to the
principal investigator; and
5. The intended research completion date; and
d. Information about the data set being
requested including:
1. The time period of the data requested;
2. The minimum needed specific data items or
fields of information required;
3. A justification for the need for potentially
indirect patient identifiers;
4. The minimum needed specificity of those data
items, including how the data should be recoded by the department to be less
specific;
5. The selection criteria for the minimum needed
data records required; and
6. Any special format or layout of data
requested by the principal investigator.
(2) When the
requestor and the principal investigator submit a signed data use agreement
that specifies that the requestor and the principal investigator shall:
a. Use the data for only the purpose specified
in the application;
b. Establish appropriate safeguards to protect
the confidentiality of the data and prevent unauthorized use of the data;
c. Not use or further disclose or sell the data
set or statistical tabulations derived from the data set to any person or
organization other than as described in the application and as permitted by the
data use agreement without the written consent of the department;
d. Not use or further disclose the information
as otherwise required by law;
e. Not seek to ascertain or disclose the
identity of patients, employer groups or purchaser groups revealed in the
limited use data set;
f. Not seek to ascertain or disclose any of the
information removed from the data or encrypted as specified in He-W 950.03(q)
above that specifies the exclusions from the limited use data set;
g. Not publish or make public the content of
cells that contain counts of patients in statistical tables in which the cell
size is more than 0 and less than 5;
h. Not publish or make public any information
that could be used to ascertain the identity of providers of abortion services;
i. Report to the department any use or
disclosure of the information, of which the principal investigator becomes
aware, that is contrary to the agreement;
k. Not release any
document deemed by the department which breach the conditions of the agreement;
l. Acknowledge the
department and the NHID as the source of the data in any and all public
reports, publications, or presentations generated by the requestor from these
data;
m. Specify that the
analyses, conclusions and recommendations drawn from such data are solely those
of the requestor and are not necessarily those of any agency of the State of
n. Retain the data
only for the period of time necessary to fulfill the requirements of the data
request;
o. Return the data
within 30 days of the scheduled completion date of the project or shall destroy
the data, so certifying by submitting a written notice to the department or
reapply for approval within 60 days of scheduled completion if the requestor
determines the end date of the project needs to be extended; and
p. Acknowledge that
failure to adhere to the data use agreement will be cause for immediate recall
by the department of the data, revocation of permission to use the data, and
application of any relevant criminal liability under
(b) The department shall establish a claims data
release advisory committee to provide non-binding advice and opinion on the
merit of applications for limited use data sets. The committee, selected by the commissioner,
shall consist of the following members:
(1) One member
representing carriers;
(2) One member
representing facilities;
(3) One member representing
health care practitioners;
(4) One member
representing the general public;
(5) One member
representing purchasers of health insurance;
(6) One member
representing health care researchers; and
(7) Two members of
the department.
(c) The commissioner shall sign the data use
agreement and release limited data sets when:
(1) The application
submitted is complete pursuant to (a)(1) and the requestor and principal investigator
have signed the data use agreement as specified in (a)(2) above;
(2) Procedures to
ensure the confidentiality of any patient and any confidential data are
documented;
(3) The
qualifications of the investigator and research staff are documented by:
a. Training and previous research, including
prior publications; and
b. An affiliation with a university, private
research organization, medical center, state agency, or other institution that
will provide sufficient research resources;
(4) The claims data
release advisory committee has been given 45 days after receipt of the
application to comment on the merits of the application to the department; and
(5) No other state
or federal law, or federal regulation prohibits release of the requested
information.
(d) If the commissioner declines to release the
limited use data sets, within 60 days of receipt of the application, the
department shall provide a written statement identifying the specific criteria
that are the basis for denial of the application.
(e) Studies taking longer than 2 years shall
require annual renewal.
(f) The requestor
shall comply with the conditions in the data use agreement as described in
(a)(2) above.
(g) In the event the department determines that
any report or publication referenced in (a)(2)j. above might lead to direct or
indirect identification of patients, employers or other group purchasers, the
department shall provide a written statement to the researcher stating
specifically the problematic sections in the publication. The requesting party shall modify the report
or publication prior to its release by fully addressing the problematic
sections. No cause other than direct or
indirect identification of patients, employers or other group purchasers shall be
given to prevent publication of information derived from the data.
(h) When multiple reports of a similar nature
will be created from the data, upon request the department shall waive the
requirement that any subsequent reports or publications be provided to the
department prior to release by the requesting party.
(i) Any draft reports or publications supplied to
the department shall be treated as confidential and shall not be released by
the department.
(j) The commissioner shall:
(1) Maintain records
of applications for, and releases of, limited use data sets and make them
available for public inspection;
(2) Maintain a
system for tracking the dates by which data sets must be returned or destroyed;
and
(3) Maintain records of the review of
publications, if applicable.
Source. #8600, eff
4-6-06
He-W 950.07 Release
of Confidential Health Care Claims Research Data Sets.
(a) Except as otherwise provided by law, the
department shall release, upon the approval of the privacy review committee,
confidential health care claims research data sets to requestors for the
purposes of research under the following conditions:
(1) When the
requestor submits a completed written application developed by the department
that contains the following:
a. The principal
investigator’s:
1. Name, address,
and phone number;
2. Organizational
affiliation;
3. Professional
qualification; and
4. Name and phone number
of principal investigator's contact person, if any;
b. The names and qualifications of additional
research staff, if any, who will have access to the data;
c. A research protocol which contains:
1. A summary of background, purposes, and origin
of the research;
2. A statement of the health-related problem or
issue to be addressed by the research;
3. The research hypothesis or hypotheses to be
tested or the specific statistical quantities or dependencies to be measured;
4. The research design and methodology which
shall include:
(i) A clear definition of exactly how the records
needed for the research will be selected and how the patients and or employer
groups who are the subject of the research are defined;
(ii) Method of data analysis;
(iii) The way in which the requested data will be
used;
(iv) The procedures for contacting any persons or
facilities named in records, if applicable; and
(v) The procedures to obtain informed consent
from the patients, employer groups or other group purchasers, if applicable.
5. The procedures that will be followed to
maintain the confidentiality of any data or copies of records provided to the
principal investigator; and
6. The intended research completion date.
d. Information about the data set being
requested including:
1. The time period of the data requested;
2. The minimum needed specific data items or
fields of information required;
3. The minimum needed specificity of those data
items;
4. The selection criteria for the minimum needed
data records required; and
5. Any special format or layout of data
requested by the principal investigator.
e. When the data set requested will be used in
conjunction with confidential patient data, the application shall include
written evidence of prior consent for its disclosure from the patients who are
the subject of the information; and
f. When the data set requested identifies
employer or group purchasers the application shall include written evidence of
prior consent for its disclosure from the employer or group purchasers that are
the subject of the information; and
(2) When the
requestor and principal investigator submit a signed data use agreement that
specifies that the requestor and the principal investigator shall:
a. Use the data for only the purpose specified
in the application;
b. Establish appropriate safeguards to protect
the confidentiality of the data and prevent unauthorized use of the data;
c. Not use or further disclose or sell the data
set or statistical tabulations derived from the data set to any person or
organization other than as described in the application and as permitted by the
data use agreement without the written consent of the department;
d. Not use or further disclose the information
as otherwise required by law;
e. Not seek to ascertain or disclose the
identity of patients or employers or other group purchasers revealed in the
data set for any purpose except as approved as part of the study;
f. Not publish or make public the content of
cells that contain counts of patients in statistical tables in which the cell
size is more than 0 and less than 5;
g. Not publish or make public any information
that could be used to ascertain the identity of providers of abortion services;
h. Report to the department any use or
disclosure of the information, of which the principal investigator becomes
aware, that is contrary to the agreement;
i. Provide the department with a preview copy of
a proposed release at least 15 days prior to publication or release of any
reports or publications containing information derived from the data set so
that the department can review the release and verify that the agreed upon
conditions have been applied;
j. Not release any document which is deemed by
the department to breach the conditions of the agreement;
k. Acknowledge the department and the NHID as
the source of the data in any and all public reports, publications, or
presentations generated by the requestor from these data;
l. Specify that the analyses, conclusions and
recommendations drawn from such data are solely those of the requestor and are
not necessarily those of any agency of the State of
m. Retain the data only for the period of time
necessary to fulfill the requirements of the data request;
n. Return the data within 30 days of the
scheduled completion date of the project or shall destroy the data, so certifying
by submitting a written notice to the department or reapply for approval within
60 days of scheduled completion if the requestor determines the end date of the
project needs to be extended; and
o. Acknowledge that failure to adhere to the
data use agreement will be cause for immediate recall by the department of the
data, revocation of permission to use the data, and application of any relevant
criminal liability under
(b) The commissioner shall sign the data use agreement
and release research data sets when:
(1) The application
submitted is complete pursuant to (a)(1) above and the requestor and principal
investigator have signed the data use agreement as specified in (a)(2) above;
(2) Procedures to
ensure the confidentiality of patients, employer groups, or other group
purchasers are documented;
(3) The study, if
carried out according to the application submitted, will be able to answer the
research hypothesis as stated in the application;
(4) There is no evidence
that the applicant is seeking the requested data for other purposes in addition
to research purposes;
(5) The applicant is
seeking only the data necessary to fulfill the specific requirements of the
research study;
(6) The
qualifications of the principal investigator and research staff are documented
by:
a. Training and previous research, including
prior publications in the proposed or related area; and
b. An affiliation with a university, private research
organization, medical center, state agency, or other institution that will
provide sufficient research resources;
(7) No other state
or federal law or federal regulation prohibits release of the requested
information; and
(8) Approval has
been obtained from the researcher’s affiliated Institutional Review Board
formed in accordance with 45 CFR 46, if the researcher intends to contact
patients in the study.
(c) The department shall establish a privacy
review committee:
(1) For the purposes
of reviewing research requests for confidential data;
(2) Which has 6
members with varying backgrounds to promote complete and adequate review of
health related research activities; and
(3) To be appointed as follows:
a. Three members shall
be appointed by the commissioner including one who will serve as chair of the
committee; and
b. Three members
shall be appointed by the commissioner of the NHID.
(d) The privacy review committee shall be able to
ascertain the acceptability of proposed research in terms of applicable law,
regulations, and standards of professional conduct and practice.
(e) The privacy review committee shall include
persons knowledgeable in the following areas:
(1) At least one
member whose primary concerns are in the area of health research activities;
(2) At least one
member whose primary concerns are in the area of providing health services;
(3) At least one
member whose primary concerns are in the area of providing health insurance;
and
(4) At least 2 members
who are not otherwise affiliated with either the department or the NHID and who
are not part of the immediate family of a person who is affiliated with either
the department or the NHID.
(f) No member of the privacy review committee
shall participate in initial or continuing review of any health-related
research project in which the member has a conflicting interest, except to
provide information requested by the committee.
(g) The committee shall invite individuals when
necessary to assist in the review of issues which require
expertise beyond or in addition to that possessed by the members of the
committee. These individuals shall only
offer advice and guidance and shall not participate in the decision as to
whether or not to approve the release of data for the purposes of
health-related research.
(h) The department shall use an existing review
committee or institutional review board if its membership conforms, or can be
modified as needed to conform to the membership specifications required by (f)
through (g) above.
(i) Studies taking longer than 2 years shall
require annual renewal.
(j) The requestor shall comply with the
conditions in the data use agreement as described in (a)(2) above.
(k) In the event the department determines that
any report or publication referenced in (a)(2)i. above, might lead to direct or
indirect identification of patients, employers or other group purchasers unless
approved as part of the study design, the department shall provide a written
statement to the researcher stating specifically the problematic sections in
the publication. The requesting party
shall modify the report or publication prior to its release by fully addressing
the problematic sections. No cause other
than direct or indirect identification of patients, employers or other group
purchasers shall be given to prevent publication of information derived from
the data.
(l) When multiple reports of a similar nature
will be created from the data, upon request the department shall waive the requirement
that any subsequent report or publication be provided to the department prior
to release by the requesting party.
(m) Any draft reports or publications reviewed by
the department shall be kept confidential and shall not be released by the
department.
(n) The commissioner shall:
(1) Maintain records
of applications for, and releases of, research data sets and make them
available for public inspection;
(2) Maintain a system
for tracking the dates by which data sets must be returned or destroyed; and
(3) Maintain records
of the preview of publications, if applicable.
Source. #8600, eff
4-6-06
He-W 950.08 Fees.
(a) Nothing in this section shall exempt any
requestor from paying fees otherwise established by law for obtaining copies of
the data sets.
(b) Such fees shall be based on the costs of
providing the copy in the format requested.
(c) The department shall provide the requestor
with a written description of the basis for the fee.
Source. #8600, eff
4-6-06
He-W 950.09 Exemption
from Rule.
(a) Release of the entire claims data set to the
NHID shall be made without restriction except that the NHID shall defer to the
department any release of data sets and shall not release data sets to other
parties, except as specified in the data collection rules, Ins 4000, and except for the public use data set in whole or part.
(b) The department and the NHID shall release data to their agents for
specific projects as needed.
(c) The departments shall ensure that contracts with their agents contain
signed agreements to maintain the confidentiality of the data, prevent
unauthorized re-release of the data sets, and prevent the agents from using the
data for their own benefit or advantage.
Source. #8600, eff
4-6-06
He-W 950.10 General Limitation.
(a) The Comprehensive
Health Care Information System shall not contain direct patient identifiers.
(b) Neither the
department nor any employee or agent shall receive, obtain, or otherwise possess
direct patient identifiers or supply them to others.
Source. #8600, eff
4-6-06
APPENDIX
|
RULE |
STATUTE |
|
|
|
|
He-W 910.01 |
Title XXI of the Social Security Act and 42 CFR 456; and Section 2110 of the Title XXI Act and 42 CFR 457.10 |
|
He-W 910.02 |
Title XXI of the Social Security Act and 42 CFR 456; and Section 2110 of the Title XXI Act and 42 CFR 457.10 |
|
He-W 910.03 |
RSA 161:2 and RSA 167; and Section 2103 of the Title XXI Act of the Social Security Act |
|
He-W 910.04 |
Section 2110 of the Title XXI Act and 42 CFR §457.310 |
|
He-W 910.05 |
Section 2103(e) (3) (B) of Title XXI of the Social Security Act |
|
He-W 910.06 |
RSA 126-A:5, IV, Section 2103(e) of Title XXI of the Social Security Act, and 42 U.S.C. 1397cc |
|
He-W910.07 |
RSA 126-A:5, IV, 42CFR 457.10, Section 2103(e) of Title XXI of the Social Security Act, and 42 U.S.C. 1397cc |
|
He-W 910.08 |
Sections 2103 (a) – (c) and 2110 (a) of Title XXI of the Social Security Act |
|
He-W 910.09 |
RSA 167:14-a and Section 2102 of Title XXI of the Social Security Act |
|
|
|
|
He-W 910.10 |
Sections 2102 (a) (4) and (7) of Title XXI of the Social Security Act |
|
He-W 950.01 - 950.06 |
RSA 420-G:11-a |
|
He-W 950.07 |
45 CFR 46 |
|
He-W 950.08 - 950.10 |
RSA 420-G:11-a |