Covered Entities (those who are regulated by the rule):

1) A health plan

2) A health care clearinghouse

3) "A health care provider who transmits any health information in electroni form in connection with a transaction covered by this subchapter"

 

Designated Record Set (what patients can have access to)

Designated Record Set means:

(1) A group of records maintained by or for a covered entity that is:

(i) The medical records and billing records about individuals maintained by or for a covered health care provider;

(ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or

(iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals.

(2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.

 

Disclosure

Disclosure means the release, transfer, provision of access to, or divulging in any other manner of information outside the entity holding the information.

 

Health Care Operations

Health care operations means any of the following activities of the covered entity to the extent that the activites are related to covered functions, and any of the following activities of an organized helath care arrangement in which the covered entity participates:

1) Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities; population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives; and related functions that do not include treatment;

2) Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, conducting treaining programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities;

3) Underwriting, premium rating, and other activities relating to the creation,k renewal or replacement of a contract of helath insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care (including stop-loss insurance and excess of loss insurance), provided that the requirements of §164.514(g) are met, if applicable;

(4) Conducting or arranging for medical review, legal services, and auditing function, including fraud and abuse detection and compliance programs;

(5) Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating the entity, including formulary development and administration, development or improvement of methods of payment or coverage policies; and

(6)Business management and general administrative activites of the entity, including, but not limited to:

(i) Management activites relating to implementation of and compliance with the requirements of this subchapter;

(ii) Customer service, including the provision of data analyses for policy holders, plan sponsors, or other customers, provided that protected health information is not disclosed to such policy holder, plan sponsor, or customer.

(iii) Resolution of internal grievances;

(iv) Due diligence in connection with the sale or transfer of assets to a potential successor in interest, if the potential successor in interest is a covered entity or, following completion of the sale or transfer, will become a covered entity; and

(v) Consistent with the applicable requirements of §164.514, creating deidentified health information, fundraising for the benefit of the covered entity, and marketing for which an individual authorization is not required as described in §164.514(e)(2).

Individually Identifiable Health Information

 

Individually identifiable health information is information that is a subset of health information, including demographic information collected form an individual, and

 

(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

 

(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual, and

 

(i) That identifies the individual; or

 

(ii) With respect to which there is a reasonble basis to believe the information can be used to identify the individual.

 

Payment

(1) The activities undertaken by:

(i) A health plan to obtain premiums or to determine or fulfill its responsibility for coverage and provision of benefits under the health plan; or

(ii) A covered helath care provider or health plan to obtain or provide reimbursement for the provision of health care; and

(2) The activities in paragraph (1) of this definition relate to the individual to whom health care is provided and include, but are not limited to:

(i) Determination of eligibility or coverage (including coordination of benefits or the determination of cost sharing amounts), and adjudication or subrogation of health benefit claims;

(ii) Risk adjusting amounts due based on enrollee health status and demographic characteristics;

(iii) Billing, claims management, collection activities, obtaining payment under a contract for reinsurance (including stop-loss insurance and excess of loss insurance), and related health care data processing;

(iv) Review of health care services with respect to medical necessity, coverage under a health plan, apropriateness of care, or justification of charges;

(v) Utilization review activites, including precertification and preauthorization of services, concurrent and retrospective review of services; and

(vi) Disclosure to consumer reporting agencies of any of the following protected health information relating to collection of premiums or reimbursement:

(A) Name and address;

(B) Date of birth

(C) Social Security Number

(D) Payment history

(E) Account number; and

(F) Name and address of the health care provider and/or health plan

 

Protected health information

Protected health information means individually identifiable health information:

(1) Except as provided in paragraph (2) of this definition, that is:

(i) Transmitted by electronic media;

(ii) Maintained in any medium described in the definition of electronic media at §164.103 of this subchapter; or

(iii) Transmitted or maintained in any other form or medium

(2) Protected health information excludes individually identifiable health information in:

(i) Education records coverd by the Family Educational Right and Privacy Act, as mended, 20 U.S.C. 1232g; and

(ii) Records described at 20 U.S.C. 1232g(a)(4)(B)(iv)

 

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge

 

Treatment

Treatment means the provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of helath care by a health care provider with a third party; consultation between health care providers relating to a patient; or the referral of a patient for helath care from one health care provider to another.

 

Use

Use means, with respect ot individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within an entity that maintains such information

 

Permitted Disclosures without Patient Consent (National Priority Activities)

§164.512:

Uses and disclosures for which an authorization or opportunity to agree or object is not required.

1) Uses and disclosures required by law

2) Uses and disclosures for public health activities

3) Disclosures about victims of abuse, neglect or domestic violence

4) Uses and disclosures for health oversight activities

5) Disclosures for judicial and administrative proceedings

6) Disclosures for law enforcement purposes

7)Uses and dislosures about decedents

8) Uses and disclosures for cadaveric organ, eye or tissue donation pruposes

9) Uses and disclosures for research purposes

10) Uses and disclosures to avert a serious threat to health or safety

11) Uses and disclosures for specialized government functions

12) Disclosures for workers compensation

Health Care Provider

"a provider of services (as defined in section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider of medical or health services (as defined in section 1861(s) of the Act, 42 U.S.C. 1395x(s)), and any other person or organization who furnishes, bills, or is paid for health care in the normal course of business."

 

42 U.S.C. 1395x(u) [section 1861(u)]:

(u) Provider of services

 

The term"provider of services" means a hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, or, for purposes of section 1395f(g) and section 1395n(e) of this title, a fund.

42 U.S.C. 1395x(u) [section 1861(s)]:

(s) Medical and other health services

The term "medical and other health services" means any of the following items or services:

1) physicians' services;

2)

(A) services and supplies (including drugs and biologicals which cannot, as dertermined in accordance with regulations, be self-administered) furnished as an incident to a physicians' services rendered to outpatients and partial hospitalization services incident to such services;

(B)hospital services (including drugs and biologicals which cannot, as determined in accordance with regulations, be self-administered) incident to physicians' services rendered to outpatients and partial hospitalization services incident to such services;

 

(C) diagnostic services which are --

 

(i) furnished to an individual as an outpatient by a hospital or by others under arrangements with them made by a hospital, and

 

(ii) ordinarily furnished by such hospital (or by others under such arrangements) to its outpatinets for the purpose of diagnostic study;

 

(D) outpatient physical therapy services and outpatient occupational therapy services;

 

(E) rural health clinic services and Federally qualified health center services;

 

(F) home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies;

 

(G) antigens (subject to quantity limitations prescribed in regulations by the Secretary) prepared by a physician, as defined in subsection (r)(1) of this section, for a particular patient, including antigens so prepared which are forwarded to another qualified person (including) a rural health clinic) for administration to such patient, from time to time, by or under the supervision of another such physician;

 

(H)

 

(i) services furnished pursuant to a contract under section 1395mm of this title to a member of an eligible organization by a physician assistant or by a nurse practitioner (as defined in subsection (aa)(5) of this section) and such services and supplies furnished as an incident to his [sic] service to such a member as wouldotherwise be covered under this part if furnished by a physician or as an incident to a physician's services; and

 

(ii) services furnished pursuant to a risk-sharing contract under section 1395mm(g) of this title to a member of an eligible organization by a clinical psychologist (as defined in subsection (hh)(2) of this section), and such services and supplies furnished as an incident to such clinical psychologist's services or clinical social worker's services to such a member as would otherwise be coverd under this part if furnished by a physician or as an incident to a physician's service;

 

(I) blood clotting factors, for hemophilia patients competent to use such factors to control bleeding without medical or other supervision, and items related to the administration of such factors, subject to utilization controls deemed necessary by the Secretary for the efficient use of such factors;

 

(J) prescription drugs used in immunosuppressive therapy furnished, to an individual who receives an organ transplant for which payment is made under this subchapter, but only in the case of drugs furnished--

 

(i) before 1995, within 12 month after the date of the transplant procedure,

 

(ii) during 1995, within 18 month after the date of the transplant procedure,

 

(iii) during 1996, within 24 month after the date of the transplant procedure,

 

(iv) during 1997, within 30 month after the date of the transplant procedure, and

 

(v) during any year after 1997, within 36 month after the date of the transplant procedure;

 

(K)

 

(i) services which would be physicians' services if furnished by a physician (as defined in subsection (r)(1) of this section) and which are performed by a physician assistant (as defined in subsection (aa)(5) of this section) under the supervision of a physician (as so defined and which the physician assistant is legally authorized to perform by the State in which the services are performed, and such services and supplies furnished as incident to such services as would be covered under subparagraph (A) if furnished incident to a physician's professional service; and[sic] but only if no facility or other provider charges or is paid any amounts with respect to the furnishing of such services, [and]

 

(ii) services which would be physicians' services if furnished by a physician (as defined is subsection (r)(1) of this section) and which are performed by a nurse practitioner or clinical nurse specialist (as defined in subsection (aa0(5) of this section) working in collaboration (as defined is subsection (aa)(6) of this section) with a physician (as defined in subsection (r)(1) of this section) which the nurse practitioner or clinical nurse specialist is legally authorized to perform by the State in which the services are performed, and such services and supplies furnished as an incident to such services as would be coverd under subparagraph (A) if furnished incident to a physician's professional service, but only if no facility or other provider charges or is paid any amounts with respect to the furnishing of such services.

 

(L) certified nurse-midwife services;

 

(M) qualified psychologist services;

 

(N) clinical social worker services (as defined in subsection (hh)(2) of this section);

 

(O) erythropoietin for dialysis patients competent to use such drug without medical or other supervision with respect to the administration of such drug, subject to methods and standards established by the Secretary by regulation for the safe and effective use of such drug, and tiems related to the administration of such drug;

 

(Q) an oral drug (which is approved by the Federal Food and Drug Administration) prescribed for use as an anticancer chemotherapeutice agent for a given indication, and containing an active ingredient (or ingredients), which is the same indication and active ingredient (or ingredients) as a drug which the carrier determines would be covered pursuant to subparagraph (A) or (B) if the drug could not be self-administered;

 

(R) colorectal cancer screening tests (as defined in subsection (pp) of this section); and [sic]

 

(S) diabetes outpatient self-management training services (as defined in subsection (qq) of this section); and

 

(T) an oral drug (which is approved by the Federal Food and Drug Administration) prescribed for use as an acute anti-emetic used as part of an anticancer chemotherapeutic regimen if the drug is administered by a physician (or as prescribed by a physician)--

 

(i) for use immediately before, at, or within 48 hours after the time of the administration of the anticancer chemotherapeutice agent; and

 

(ii) as a full replacement for the anti-emetic therapy which would otherwise be administered intravenously [;]

 

 

(3) diagnostic X-ray tests (including tests under the supervision of a physician, furnished in a place of residence used as the patient's home, if the performance of such tests meets such conditions relating to health and safety as the Secretary may find necessary and including diagnostic mammography if conducted by a facility that haws a certificate (or provisional certificate) issued under section 354 of the Public Health SErvice Act [42 U.S.C. 263b]), diagnostic laboratory tests, and other diagnostic tests;

 

(4) X-ray, radium, and radioactive isotope therapy, including materials and services of technicians;

 

(5) surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations;

 

(6) durable medical equipment;

 

(7) ambulance service where the use of other methods of transportation is contraindicated by the individual's condition, but only to the extent provided in regulations;

 

(8) prosthetic devices (other than dental) which replace all or part of an internal body organ (including colostomy bags and supplies directly related to colostomy care), including replacement of such devices, and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens;

 

(9) leg, arm, back, and nectk braces, and artificial legs, arms and eyes, including replacements if required because of a change in the patient's physical condition;

 

(10)

(A) pneumococcal vaccine and its administration and, subject to section 4071(b) of the Omnibus Budget Reconciliation Act of 1987, influenza vaccine and its administration; and

 

(B) hepatitis B vaccine and its administration, furnished to an individual who is at high or intermediate risk or contracting hepatitis B (as determined by the Secretary under regulation);

 

(11) services of a certified registered nurse anesthetist (as defined in subsection (bb) of this section);

 

(12) subject to section 4072(e) of the Omnibus Budget Reconciliation Act of 1987, extra-depth shoes with inserts or custom molded shoes with inserts for an individual with diabetes, if --

 

(A) the physician who is managing the individual's diabetic condition

 

(i) documents that the individual has peripheral neuropathy with evidence of callus formation, a history of pre-ulcerative calluses, a history of previous ulceration, foot deformity, or previous amputation, or poor circulation, and

 

(ii) certifies that the individual needs such shoes under a comprehensive plan of care related to the individual's diabetice condition;

 

(B) the particular type of shoes are prescribed by a pdiatrist or other qualified physician (as established by the Secretary); and

 

(C) the shoes are fitted and furnished by a podiatyrist or other qualified individual (such as a pedorthist or orthotist, as established by the Secretary) who is not the physician described in subparagraph (A) (unless the Secretary finds that the physician is the only such qualified individual in the area);

 

(13) screening mammography (as defined in subsection (jj) of this section);

 

(14) screening pap smear and screening pelvic exam; and

 

(15) bone mass measurement (as defined in subsection (rr) of this section)

 

No diagnostic test performed in any laboratory, including a laboratory that is part of a rural health clinic, or a hosptial (which, for pruposes of this sentence, means an institution considered a hospital for purposes of section 1395f(d) of this title) whall be included within paragraph(3) unless such laboratory--

 

(16) if situated in any State in which State or applicable local law provides for licensing of establishments of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing establishment of this nature, as meeting the standards established for such licensing; and

 

(17)

 

(A) meets the certification requirements under section 353 of the Public Health Service Act [42 U.S.C. 263a] and

 

(B) meets such other conditions relating to the health and safety of individuals with respect to whom such tests are performed as the Secretary may find necessary.

 

There shall be excluded from the diagnostic services specified in paragraph (2)(C) any item or service (except services referred to in paragraph(1)) which would not be included under subsection (b) of this section if it were furnished to an inpatient of a hospital. None of the items and services referred to in the preceding paragraphs (other than paragraphs(1) and (2)(A)) of this subsection which are furnished to a patient of an institution which meets the definition of a hospital for purposes of section 1395f(d) of this title shall be included unless such other conditions are met as the Secretary may find necessary relating to health and safety of individuals with respect to whom such items and services are furnished.