reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › RECORDS › Section 5.52 - Contents of records

Current through Register Vol. 54, No. 28, July 13, 2024
Each clinical laboratory shall have a readily available
					 record indicating the daily accession of specimens containing the following
					 information:
(1) The laboratory number
				  identifying the specimen.
(2) The
				  identification of the person from whom the specimen was taken. Specimens
				  received by mail shall be accompanied by the name and address of the patient
				  from whom the specimen was taken.
(3) The name and address of the licensed
				  practitioner of the healing arts or other authorized person or clinical
				  laboratory who submitted the specimen. Hospitals may follow their normal
				  procedures associated with requests and records.
(4) The date and hour the specimen was
				  collected by the licensed practitioner or other authorized person.
(5) The date and hour the specimen was
				  received in the laboratory and date test was completed.
(6) The condition of the specimen when
				  received that is, broken, leaked, hemolyzed, turbid, satisfactory and so
				  forth.
(7) The analysis
				  performed.
(8) The result of the
				  laboratory test.
(9) The date a
				  required report was sent to the Department, under §§
										27.2-27.4 and
				  27.22, or other agencies in
				  accordance with other statutes or provisions.
(10) The charges issued to the patient or his
				  authorized agent for the laboratory services performed.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › QUALITY CONTROL AND PROFICIENCY TESTING › Section 5.61 - Quality control

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Quality
				  control procedures in chemistry, microbiology, hematology and other laboratory
				  specialties shall be those approved by the Department.
(b) A degree of accuracy, specificity and
				  precision satisfactory to the Department shall be shown in quality control
				  records at all times.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › QUALITY CONTROL AND PROFICIENCY TESTING › Section 5.62 - Results of proficiency tests

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				  Results of proficiency tests shall be maintained in the acceptable ranges
				  statistically determined for each evaluation. Failure of a laboratory to
				  satisfactorily perform in a proficiency test may be cause for revocation of
				  approval of the specific tests involved.
(b) If a permit is revoked or limited for
				  reasons of unsatisfactory performance, reinstatement of approval shall require
				  demonstration of proficiency over a testing period, not to exceed 6
				  months.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › ETHICAL PRACTICE › Section 5.71 - Restrictions on solicitation

Current through Register Vol. 54, No. 28, July 13, 2024
No employe or representative of a laboratory, either
					 personally or through an agent, may solicit referral of specimens to his or any
					 other laboratory in a manner which offers or implies an offer of rebates to
					 persons submitting specimens or other feesplitting inducements. This applies to
					 contents of fee schedules, billing methods or personal solicitation. No person
					 involved in the submission of specimens may receive payment or other inducement
					 by the laboratory or its representative.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › ETHICAL PRACTICE › Section 5.72 - List of tests and fee schedules

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No
				  blanket contract fee service may be made. Per specimen cost may vary with
				  volume, but the fee schedule shall be clearly stated, and offered equally to
				  all persons using the services of the laboratory. Except for cost adjustments
				  due to volume, only a single fee schedule shall be maintained and applied by a
				  licensed laboratory.
(b) A copy of
				  each list of tests and each fee schedule issued by a laboratory shall be placed
				  on file with the Department prior to issuance, and changes in the schedules
				  filed within 10 days of issuance. The record of fees shall include individual
				  fees, contract fees and special volume prices.
(c) It shall be an unethical practice for a
				  laboratory not to follow the practices in §
										5.48 (relating to disclosure of
				  charges).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › ETHICAL PRACTICE › Section 5.73 - Advertisements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Advertisements
				  shall be reviewed by the Department and approved prior to publication. Failure
				  of the Department to respond within 10 days after receipt of a submission shall
				  constitute an approval. Advertising is permissible in official media if it is
				  of an ethical nature and does not contain misleading statements or claims of
				  unusual superiority. Personal solicitation by an owner or his agent shall be
				  considered as advertising within the meaning of this section. No laboratory may
				  advertise services which are not performed on its own premises. Advertising to
				  the general public is not permitted.
(b) A laboratory requesting a permit shall
				  submit with its application copies of all advertising, telephone listings,
				  letterheads, cards and the like.
(c) Laboratories presently operating under
				  permit shall also submit copies of the advertising, telephone listing and the
				  like to the Department prior to publication.
(d) Signs of a descriptive character designed
				  to identify the laboratory premises or access thereto are permissible except
				  when their content, size or location is unethical or when they constitute a
				  form of advertising of clinical laboratory procedures to the lay
				  public.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EXEMPTIONS › Section 5.82 - Research laboratories

Current through Register Vol. 54, No. 28, July 13, 2024
Laboratories operated solely for research and teaching, and
					 conducting analyses, the results of which are not used for clinical
					 application, are exempt from the provisions of this chapter.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EXEMPTIONS › Section 5.83 - Laboratories outside the Commonwealth

Current through Register Vol. 54, No. 28, July 13, 2024
A laboratory located outside the Commonwealth may solicit
					 and receive specimens originating within the Commonwealth if it has a currently
					 valid license issued under the provisions of section 353 of the Clinical
					 Laboratory Improvement Act of 1967 (42 U.S.C.A. §
											263), and
					 applicable regulations and, it complies with all regulations which exceed or
					 differ from those of the Federal statute.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › DENIAL, SUSPENSION, REVOCATION OF PERMITS › Section 5.91 - Failure to maintain standards

Current through Register Vol. 54, No. 28, July 13, 2024
A permit shall be denied to a laboratory applying for same
					 and a permit shall be suspended or revoked in the case of laboratories already
					 operating, for failure to maintain proper standards of accuracy, for unethical
					 practice, unethical advertising, or for any other cause deemed adequate by the
					 Department, including failure to render required reports within the reasonable
					 time limits set.
This section cited in 28 Pa. Code §
												125.1 (relating to clinical and
						anatomical pathology services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › DENIAL, SUSPENSION, REVOCATION OF PERMITS › Section 5.92 - Change of director or change of location

Current through Register Vol. 54, No. 28, July 13, 2024
Permits shall become void upon change of director and also
					 upon removal of the laboratory to other quarters.
This section cited in 28 Pa. Code §
												125.1 (relating to clinical and
						anatomical pathology services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › DENIAL, SUSPENSION, REVOCATION OF PERMITS › Section 5.93 - Revocation of permit

Current through Register Vol. 54, No. 28, July 13, 2024
The following are prima facie reasons for the revocation of
					 a permit:
(1) Dishonest reporting or
				  consistent error based on faulty techniques.
(2) Permitting unauthorized persons to
				  perform the technical procedures or to sign reports.
(3) Proof that a holder of a permit has made
				  false statements on his application for a permit.
(4) The advertising of clinical laboratory
				  procedures to the lay public in magazines, newspapers, directories, circulars,
				  signs and the like.
(5) Knowingly
				  accepting an assignment for a clinical laboratory test or a specimen from and
				  the rendering of a report thereon to a person, other than the patient, not
				  authorized to submit the specimen or assignment.
(6) The adjudication of insanity or mental
				  illness involving personnel responsible for the direction of the
				  laboratory.
(7) Violations of
				  another provisions of this chapter, or of the statutes under which they are
				  adopted.
This section cited in 28 Pa. Code §
												125.1 (relating to clinical and
						anatomical pathology services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › DENIAL, SUSPENSION, REVOCATION OF PERMITS › Section 5.94 - Hearings and appeals

Current through Register Vol. 54, No. 28, July 13, 2024
If a license is denied or revoked, the applicant or holder
					 of the license is entitled to the rights of hearings and appeals provided for
					 in the Clinical Laboratory Act (35 P. S. §§
											2151-2165) and other provisions of statutes
					 related to
					 2
					 Pa.C.S. §§
											501-508 and
					 701-704 (relating to
					 practice and procedure of Commonwealth agencies and judicial review of
					 Commonwealth agency action) and the Pa.R.C.P.
This section cited in 28 Pa. Code §
												125.1 (relating to clinical and
						anatomical pathology services).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EQUIPMENT TO DETERMINE BLOOD ALCOHOL CONTENT UNDER THE VEHICLE CODE AND THE FISH AND BOAT CODE › Section 5.101 - Purpose

Current through Register Vol. 54, No. 28, July 13, 2024
The purpose of §§
										5.101-5.104 (relating to equipment to
					 determine blood alcohol content under the Vehicle Code and the Fish and Boat
					 Code) is to satisfy the requirements of
					 75 Pa.C.S. §
											1547(c) and
					 (k) and
					 30 Pa.C.S. § 5125(c)
					 and (k) (relating to chemical testing to determine amount of alcohol or
					 controlled substance).
The provisions of this §
												5.101 issued under the Fish and
						Boat Code,
						30 Pa.C.S. §
													5125.
This section cited in 58 Pa. Code §
												51.51 (relating to chemical
						tests); and 58 Pa. Code §
												131.5 (relating to chemical
						tests).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EQUIPMENT TO DETERMINE BLOOD ALCOHOL CONTENT UNDER THE VEHICLE CODE AND THE FISH AND BOAT CODE › Section 5.102 - Equipment and methods for laboratory analysis of breath samples

Current through Register Vol. 54, No. 28, July 13, 2024
Only equipment and methods approved by the Department may
					 be used for the laboratory analysis of breath samples. Laboratories performing
					 these analyses shall be licensed and specifically approved for blood alcohol
					 analysis in accordance with §§
										5.50 and
					 5.103 (relating to approval to
					 provide special analytical services; and blood tests for blood alcohol
					 content).
The provisions of this §
												5.102 issued under section 2102 of
						The Administrative Code of 1929 (71 P. S. §
													532); and the Vehicle Code,
						75 Pa.C.S. §
													1547(c).
This section cited in 28 Pa. Code §
												5.101 (relating to purpose); 58
						Pa. Code §
												51.51 (relating to chemical
						tests); and 58 Pa. Code §
												131.5 (relating to chemical
						tests).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EQUIPMENT TO DETERMINE BLOOD ALCOHOL CONTENT UNDER THE VEHICLE CODE AND THE FISH AND BOAT CODE › Section 5.103 - Blood tests for blood alcohol content

Current through Register Vol. 54, No. 28, July 13, 2024
Equipment used for blood analysis to determine the amount
					 of alcohol in a person's blood which performs the analysis by means of gas
					 chromatography, enzymatic procedures, distillation procedures or diffusion
					 procedures is approved by the Department provided that:
(1) The equipment is located within a
				  clinical laboratory currently licensed by the Department.
(2) The particular brand or model of
				  equipment used and a reagent or procedures relating thereto have not been
				  prohibited by specific notification of the Department under §
										5.46 (relating to reagents and
				  equipment).
(3) A clinical
				  laboratory performing blood analyses with the equipment has in effect an
				  approval to provide the special analytical services under §
										5.50 (relating to approval to
				  provide special analytical services).
This section cited in 28 Pa. Code §
												5.101 (relating to purpose); 28
						Pa. Code §
												5.102 (relating to equipment and
						methods for laboratory analysis of breath samples); 58 Pa. Code §
												51.51 (relating to chemical
						tests); and 58 Pa. Code §
												131.5 (relating to chemical
						tests).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › EQUIPMENT TO DETERMINE BLOOD ALCOHOL CONTENT UNDER THE VEHICLE CODE AND THE FISH AND BOAT CODE › Section 5.104 - Prearrest breath tests for blood alcohol content

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Equipment approval
				  requirements.
(1) The Department
				  will approve prearrest breath testing devices for use by police officers in
				  conducting preliminary alcohol determinations on persons suspected of driving
				  while under the influence of alcohol. Until performance standards for prearrest
				  breath testing devices are promulgated by regulation, manufacturers who desire
				  interim approval of their devices shall file the following information with the
				  Department:
(i) A complete description of the
				  device, including its principle of operation.
(ii) An operator's manual for the
				  device.
(iii) A maintenance and
				  repair manual for the device, if applicable, including diagrams and lists of
				  component parts.
(iv) Performance
				  data derived from studies conducted by or for the manufacturer to support
				  claims relating to the reliability of the device.
(v) The names and addresses of law
				  enforcement agencies in this Commonwealth who have purchased the device.
				  Manufacturers shall provide to the Department, on an annual basis, the names
				  and addresses of new purchasers to whom the devices are sold.
(vi) A list and complete description,
				  including applicable manuals, for breath simulators or other accessories
				  intended for use with the prearrest breath testing device.
(vii) A list of authorized distributors and
				  service representatives for the prearrest breath testing device.
(viii) The data and results of reviews or
				  studies conducted by other State or Federal agencies, including certification
				  or approval, if available.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 6 - DRUGS WHICH MAY BE USED BY CERTAIN OPTOMETRISTS › Section 6.1 - Approved drugs

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Administration and prescription of pharmaceutical agents
.
				Optometrists who are certified to prescribe and administer pharmaceutical
				agents for therapeutic purposes under section
				4.1 of the Optometric Practice and
				Licensure Act (35 P. S. §
										244.4a), may prescribe and administer the
				drugs listed in subsection (b) in their practice of optometry under the
				following conditions:
(1) The drugs shall be
				approved by the Food and Drug Administration (FDA).
(2) Over-the-counter medications (per FDA
				listing) are fully authorized.
(3)
				An optometrist may not administer any drug parenterally.
(4) The treatment undertaken by an
				optometrist under this section:
(i) May not
				continue beyond 6 weeks from the initiation of treatment unless the prescribing
				optometrist documents consultation with a licensed physician.
(ii) May not include beta-blockers or
				steroids.
(iii) May not be
				prescribed for systemic conditions except as an adjunctive therapy and shall be
				limited to the anterior eye structures (and adnexa).
(5) An optometrist may not treat
				glaucoma.
(6) An optometrist may
				not prescribe or administer a Schedule I or II controlled substance.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 7 - PRIMARY HEALTH CENTERS UNDER THE HEALTH CARE SERVICES MALPRACTICE ACT › Section 7.1 - Statutory coverage

Current through Register Vol. 54, No. 28, July 13, 2024
The Department of Health will consider, for purposes of the
				  Health Care Services Malpractice Act (40 P. S. §§
										1301.101-__1301.1006) (hereinafter, the act)
				  and for no other purpose, that any Commonwealth community-based, nonprofit
				  corporation meets the statutory description of a primary health center as
				  defined in the act if the corporation provides preventive, diagnostic,
				  therapeutic, and basic emergency health services by licensed practitioners who
				  are employes of the corporation or under contract to the corporation to
				  patients who are usually ambulatory and who may require any of a variety of
				  medical or health related services and if the corporation makes application to
				  the Department in the manner provided in this chapter and demonstrates
				  compliance with §
									7.2 (relating to minimum
				  standards).
This section cited in 28 Pa. Code §
											7.2 (relating to minimum
					 standards).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 7 - PRIMARY HEALTH CENTERS UNDER THE HEALTH CARE SERVICES MALPRACTICE ACT › Section 7.2 - Minimum standards

Current through Register Vol. 54, No. 28, July 13, 2024
The following minimum standards shall be maintained under
				  §
									7.1 (relating to statutory
				  coverage):
(1) There is a governing
				authority legally responsible for the conduct of the center, a majority of the
				membership of which are residents of the area served by the center, are
				potential users of the service and are not employed by and do not have any
				other financial interest in the operation of the center.
(2) The center is managed by a specifically
				designated person responsible for operating the center in accordance with
				policies clearly enunciated by the Board of Directors of the
				corporation.
(3) Clear, precise,
				and complete financial records and other business records, such as Board
				meeting minutes, are kept in accordance with generally accepted accounting and
				business procedures.
(4) Clear,
				precise, and complete medical records are kept which include a record of a
				basic history and physical examination, a record of presenting complaints,
				laboratory studies, diagnoses, prescribed therapy, medications, progress and
				evaluation of the therapy prescribed, and summaries and evaluations of any and
				all specialized health services, including hospitalization, for which patients
				have been referred outside the center, and all entries in the records are dated
				and authenticated.
(5) When
				appropriate specialized services are not available at the primary health
				center, the patient is provided with a choice of referral to qualified
				specialists to whom the medical records of the patient are made available. If
				the primary health center is part of a closed panel group practice making its
				services available through a prepayment mechanism, such as a health maintenance
				organization, nothing in this paragraph shall be interpreted to obligate that
				organization to pay for specialist services if and when a patient chooses to be
				referred outside the panel.
(6)
				Patients are accorded an opportunity to have their own medical records
				explained to them by an appropriate health care professional as designated by a
				physician and qualified by training and skill to accurately interpret the
				records and counsel patients.
(7)
				The facilities in which the services are rendered are safe, sanitary, and
				adequately equipped.
(8) There is
				an organized medical or professional staff responsible for maintaining accepted
				standards of medical, surgical, or health-related care and for requiring staff
				members to participate in recognized continuing education programs.
This section cited in 28 Pa. Code §
											7.1 (relating to statutory
					 coverage); and 28 Pa. Code §
											7.3 (relating to documentation to
					 be submitted).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 7 - PRIMARY HEALTH CENTERS UNDER THE HEALTH CARE SERVICES MALPRACTICE ACT › Section 7.3 - Documentation to be submitted

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				Department of Health will request that the following documentation of adherence
				to the standards be submitted to the Department of Health:
(1) A statement that the corporation meets
				the eight standards prescribed in §
										7.2 (relating to minimum
				standards) for a facility to qualify as a primary health center as defined in
				the act.
(2) A copy of the
				certificate of incorporation and bylaws along with a list of members of the
				Board of Directors identified by home address and principal
				occupation.
(3) The name and
				address of the person designated by the Board of Directors to manage the
				operation of the center with a copy of the Board resolution designating such
				person to perform this function.
(4) A sample of the principal business forms
				and a brief description of the accounting system and business procedures
				used.
(5) A sample of a patient
				chart, demonstrating the form in which the medical records are kept.
(6) A description of referral procedures and
				an identification of principal referral resources.
(7) A description of method utilized to
				inform patients of contents of their medical records.
(8) A copy of Certificate of Safety for
				Public Occupancy and Safety of Elevators, if elevators are utilized, and
				Laboratory and Pharmacy Certificates, if such exist.
(9) A list of professional staff members with
				brief indications of professional qualifications, such as degrees.
(10) A brief description of the continuing
				education program in which the professional staff members participate and a
				brief description of other quality assurance measures utilized.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 7 - PRIMARY HEALTH CENTERS UNDER THE HEALTH CARE SERVICES MALPRACTICE ACT › Section 7.4 - Issuance of a certificate

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				Facilities seeking to qualify as primary health centers under the act shall
				submit the documentation required by §
									7.3 (relating to documentation to
				be submitted) to the Division of Primary Care Development, Department of
				Health, Post Office Box 90, Harrisburg, Pennsylvania 17108.
(b) Upon review and approval by the
				Department of Health of the required documentation, the Secretary will issue a
				certificate to the facility. The certificate will be effective for 2 years from
				date of issuance and may be renewed for successive 2-year periods upon review
				and approval by the Department of Health of the documentation required by
				§ 7.3. Whenever the Department intends to deny an application, the
				applicant will be notified and have the right to request, within 30 days, a
				hearing.
(c) For purposes of the
				act, the facility shall qualify as a "health care provider" from the date of
				issuance of the certificate. Notice of certification will be sent promptly to
				the Administrator for Arbitration Panels for Health Care and to the director of
				the Medical Professional Liability Catastrophe Loss Fund. Facilities which are
				certificated as "primary health centers" shall be required, in conformity with
				the act, to purchase and maintain a specific amount of malpractice
				insurance.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 8 - PRACTICE AND PROCEDURE › PRELIMINARY PROVISIONS › Section 8.1 - Applicability of general rules

Current through Register Vol. 54, No. 28, July 13, 2024
Under 1 Pa. Code 31.1 (relating to scope of part), 1 Pa.
					 Code Part II (relating to general rules of administrative practice and
					 procedure) is applicable to the activities of and proceedings before the
					 Department of Health, except as otherwise provided in this
					 title.
This section cited in 28 Pa. Code §
												205.4 (relating to building
						plans).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 8 - PRACTICE AND PROCEDURE › CAPITAL EXPENDITURES › Section 8.11 - Procedure for capital expenditure hearings under Federal law

Current through Register Vol. 54, No. 28, July 13, 2024
The rules of practice and procedure for fair hearings held
					 under section 1122 of the Social Security Act (42 U.S.C.A. §
											1320a-1) are found in §
										301.7 (relating to fair
					 hearing).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter C - COORDINATED CARE ORGANIZATIONS › APPLICATION PROCEDURES › Section 9.313 - Certification period

Current through Register Vol. 54, No. 28, July 13, 2024
A certification as a coordinated care organization will
						be valid for 2 years from the date of its issue, unless the certification is
						earlier suspended or revoked by the Department for reasons specified in section
						306(f.2)(4) of the Workers' Compensation Act (77 P. S. §
												531.1(f.2)(7)).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter C - COORDINATED CARE ORGANIZATIONS › FEES › Section 9.331 - Application fees

Current through Register Vol. 54, No. 28, July 13, 2024
The schedule of fees charged for applications relating to
						coordinated care organizations (CCOs) is as follows:
Application for certification as a CCO ... $1,500
Application for expansion of CCO service area ...
						$500
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter F - GENERAL › Section 9.601 - Applicability

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter
				  applies to managed care plans as defined by section 2102 of the act
				  (40
				  P. S. §
											991.2102) unless expressly
				  stated otherwise. Plans are advised to consult the regulations of the Insurance
				  Department on these topics. See 31 Pa. Code Chapters 154 and 301 (relating to
				  quality health care accountability and protection; and health maintenance
				  organizations) to ensure complete compliance with Commonwealth
				  requirements.
(b) An entity,
				  including an IDS, subcontracting with a managed care plan to provide services
				  to enrollees shall meet the requirements of Article XXI of the act, and
				  Subchapters H-L for services provided to those enrollees.
(c) This chapter does not apply to ancillary
				  service plans.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter F - GENERAL › Section 9.603 - Technical advisories

Current through Register Vol. 54, No. 28, July 13, 2024
The Department may issue technical advisories to assist
					 plans in complying with the HMO Act, Article XXI and this chapter. The
					 technical advisories do not have the force of law or regulation, but will
					 provide guidance on the Department's interpretation of, and how a plan may
					 maintain compliance with, the HMO act, Article XXI and this chapter. Notice of
					 the availability of a technical advisory will be published in the
Pennsylvania Bulletin
.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter F - GENERAL › Section 9.604 - Plan reporting requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Annual reports.
A plan shall submit to the Department on or
				  before April 30 of each year, a detailed report of its activities during the
				  preceding calendar year. The plan shall submit the report in a format specified
				  by the Department in advance of the reporting date, and shall include, at a
				  minimum, the following information:
(1)
				  Enrollment data by product line-for example, commercial, Medicare and Medicaid
				  and by county.
(2) Utilization
				  statistics containing the following minimum data:
(i) The number of days of inpatient
				  hospitalization on a quarterly, year-to-date and annualized basis.
(ii) The average number of physician visits
				  per enrollee on a quarterly, year-to-date and annualized
				  basis.
(3) The number,
				  type, and disposition of all complaints and grievances filed with the plan or
				  subcontractors.
(4) A copy of the
				  current enrollee literature, including subscription agreements, enrollee
				  handbooks and any mass communications to enrollees concerning complaint and
				  grievance rights and procedures.
(5) A copy of the plan's current provider
				  directory.
(6) A statement of the
				  number of physicians leaving the plan and of the number of physicians joining
				  the plan.
(7) A listing of all IDS
				  arrangements and enrollment by each IDS.
(8) Copies of the currently utilized generic
				  or standard form health care provider contracts including copies of any
				  deviations from the standard contracts and reimbursement methodologies.
				  Reimbursement information submitted to the Department under this paragraph may
				  not be disclosed or produced for inspection or copying to a person other than
				  the Secretary or the Secretary's representatives, without the consent of the
				  plan which provided the information, unless otherwise ordered by a
				  court.
(9) A copy of the plan's
				  written description of its quality assurance program, a copy of the quality
				  assurance work plan, and a copy of the quality assurance report submitted to
				  the plan's Board of Directors.
(10)
				  A listing, including contacts, addresses and phone numbers, of all contracted
				  CREs that perform UR on behalf of the plan or a contracted IDS.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter F - GENERAL › Section 9.605 - Department investigations

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				  Department may investigate plans as necessary to determine compliance with Act
				  68, the PPO Act, the HMO Act and this chapter
(b) Investigation may include onsite
				  inspection of a plan's facilities and records, and may include onsite
				  inspection of the facilities and records of any IDS subcontractor.
(c) The Department or its agents will have
				  free access to all books, records, papers and documents that relate to the
				  business of the plan, other than financial business.
(d) The Department will have access to
				  medical records of plan enrollees for the purpose of determining the quality of
				  care, investigating complaints or grievances, enforcement, or other activities
				  relating to ensuring compliance with Article XXI, this chapter or other laws of
				  the Commonwealth.
(e) The
				  Department may request submission by the plan of a special report detailing any
				  aspect of its operations relating to the provision of health care services to
				  enrollees, provider contracting or credentialing, operation of the enrollee
				  complaint and grievance system, or quality assessment.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter F - GENERAL › Section 9.606 - Penalties and sanctions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) For
				  violations of Article XXI and this chapter, the Department may take one or more
				  of the following actions:
(1) Impose a civil
				  penalty of up to $5,000 per violation.
(2) Maintain an action in the name of the
				  Commonwealth for an injunction to prohibit the activity.
(3) Issue an order temporarily prohibiting
				  the plan from enrolling new members.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › GENERALLY › Section 9.621 - Applicability

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This subchapter
					 applies to corporations that propose to undertake to establish, maintain and
					 operate an HMO within this Commonwealth, with the exception of an HMO exempted
					 under sections 16 and 17(b) of the HMO Act (40 P. S. §§
												1566 and
					 1567(b)).
(b) This subchapter is intended to ensure
					 that HMOs certified by the Commonwealth offer increased competition and
					 consumer choices that serve to advance quality assurance, cost effectiveness
					 and access to health care services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › GENERALLY › Section 9.622 - Prohibition against uncertified HMOs

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A corporation may not, within this
					 Commonwealth, solicit enrollment of members, enroll members or deliver prepaid
					 basic health services, by or through an HMO, unless it has received a
					 certificate of authority from the Secretary and Commissioner to operate and
					 maintain the HMO.
(b) A foreign HMO
					 may not, within this Commonwealth, solicit enrollment of members, enroll
					 members or deliver prepaid basic health care services unless it has received a
					 certificate of authority from the Secretary and the Commissioner to operate and
					 maintain an HMO.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › GENERALLY › Section 9.623 - Preapplication development activities

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will, upon request, provide technical
						advice and assistance to persons proposing to develop an HMO, including review
						of health care services provider contracts to be used to establish and maintain
						an acceptable health care services provider network. A network is required for
						issuance of a certificate of authority.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › APPLICATION FOR CERTIFICATE OF AUTHORITY › Section 9.632 - HMO certificate of authority review by the Department

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The applicant shall submit a complete
					 application to both the Department and the Insurance Department.
(b) Upon receipt of a complete application
					 for a certificate of authority the Department will publish notification of
					 receipt in the
Pennsylvania Bulletin
. The Department will
					 accept public comments, suggestions or objections to the application for 30
					 days after publication. The Department may hold a public meeting concerning the
					 application, with appropriate notification to the applicant, and notice to the
					 public through publication of notice in the
Pennsylvania
					 Bulletin
.
(c) Within 45
					 days of receipt of the application, the Department will notify the applicant of
					 any additional information required to complete the application, and of any
					 part of the application which must be corrected by the applicant to demonstrate
					 compliance with the HMO Act or this chapter. A copy of requests for information
					 sent to the applicant will be sent to the Commissioner.
(d) The Department will review the completed
					 application for compliance with the HMO Act and this chapter. The application
					 will not be considered complete until the required information is provided to
					 the Department in writing, including evidence of a contracted and credentialed
					 provider network of sufficient capacity to serve the proposed number of
					 enrollees.
(e) The Department will
					 visit and inspect the site or proposed site of the applicant's facilities or
					 facilities of the applicant's contractors and its provider network, to
					 ascertain its capability to comply with the HMO Act, Act 68 and this
					 chapter.
(f) The Department will
					 complete its review within 90 days of submission of the completed
					 application.
(g) Within 90 days of
					 receipt of a completed application for a certificate of authority, the
					 Secretary and Commissioner will jointly take action as set forth in paragraph
					 (1) or (2). A disapproval of an application may be appealed in accordance with
					 2 Pa.C.S. (relating to administrative law and procedure).
(1) Approve the application and issue a
					 certificate of authority.
(2)
					 Disapprove the application and specify in writing the reasons for the
					 disapproval.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › APPLICATION FOR CERTIFICATE OF AUTHORITY › Section 9.633 - Location of HMO activities, staff and materials

Current through Register Vol. 54, No. 28, July 13, 2024
To demonstrate its ability to assure both availability
						and accessibility of adequate personnel and facilities to effectively provide
						or arrange for the provision of basic health services in a manner enhancing
						access, availability and continuity of care, the HMO shall meet the following
						minimum standards:
(1) The HMO shall
					 make available for review at a location within this Commonwealth, by the
					 Department or an agent of the Department, the books and records of the
					 corporation and the essential documents as the Department may require,
					 including signed provider contracts, credentialing files, complaint and
					 grievance files, committee meeting (quality assurance and credentialing)
					 minutes and hearing transcriptions. Documents need not be permanently
					 maintained in this Commonwealth but shall be made available within this
					 Commonwealth within 30 days, unless the Department determines for matters of
					 patient safety the documents must be provided within 2-business days.
(2) The HMO shall identify a physician to
					 serve as its medical director who is licensed in this Commonwealth and
					 qualified to perform the duties of a medical director. The medical director
					 shall be responsible for the following:
(i)
					 Oversight of the UR and quality assurance activities regarding coverage and
					 services provided to enrollees.
(ii) General coordination of the medical care
					 of the HMO.
(iii) Appropriate
					 professional staffing of the HMO's medical management operations.
(iv) Designing protocols for quality
					 assurance.
(v) Implementation of
					 quality assurance programs and continuing education requirments.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › APPLICATION FOR CERTIFICATE OF AUTHORITY › Section 9.634 - Delegation of HMO operations

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
					 HMO may contract with an individual, partnership, association, corporation or
					 organization for the performance of HMO operations. A contract for delegation
					 of HMO operations shall be filed with the Commissioner under section 1558(b) of
					 the HMO Act and may not in any way diminish the authority or responsibility of
					 the board of directors of the HMO, or the ability of the Department to monitor
					 quality of care and require prompt corrective action of the HMO when
					 necessary.
(b) An HMO shall
					 delegate medical management authority in accordance with §
											9.675 (relating to the delegation
					 of medical management).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › APPLICATION FOR CERTIFICATE OF AUTHORITY › Section 9.635 - Issuance of a certificate of authority to a foreign HMO

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A foreign HMO may be authorized by
					 issuance of a certificate of authority to operate or to do business in this
					 Commonwealth if the Department is satisfied that it is fully and legally
					 organized and approved and regulated under the laws of its state and that it
					 complies with the requirements for HMOs organized within and certified by the
					 Commonwealth. A foreign HMO shall submit a letter to the Department and a copy
					 of its approved application for licensure or certification on file with its
					 state of domicile.
(b) A foreign
					 HMO shall submit a completed Commonwealth application for a certificate of
					 authority in accordance with §§
											9.631 and
					 9.632 (relating to content of an
					 application for an HMO certificate of authority; and HMO certificate of
					 authority review by the Department) and the following:
(1) In lieu of the Commonwealth application,
					 a foreign HMO may submit to the Department and the Insurance Department a copy
					 of the application submitted and approved for certificate of authority or
					 licensure in another state with cross references to requirements contained in
					 the Commonwealth's application.
(2)
					 The foreign HMO shall provide, along with the out-of-State application,
					 documentation of any change or modification occurring since that certificate of
					 authority or license was approved.
(3) The foreign HMO shall otherwise affirm
					 that the information submitted to the Department remains current and accurate
					 at the time of submission.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › OPERATIONAL STANDARDS › Section 9.651 - HMO provision and coverage of basic health services to enrollees

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An HMO shall
					 maintain an adequate network of health care providers through which it provides
					 coverage for basic health services to enrollees as medically necessary and
					 appropriate without unreasonable limitations as to frequency and
					 cost.
(b) An HMO may exclude
					 coverage for services, except to the extent that a service is required to be
					 covered by State or Federal law.
(c) An HMO shall provide or arrange for the
					 provision of and cover the following basic health services as the HMO
					 determines to be medically necessary and appropriate according to its
					 definition of medical necessity:
(1)
					 Emergency services on a 24-hour-per-day, 7-day-per-week basis. The plan may not
					 require an enrollee, or a participating health care provider advising the
					 enrollee regarding the existence of an emergency, to utilize a participating
					 health care provider for emergency services, including ambulance services. See
					 §
												9.672 (relating to emergency
					 services).
(2) Outpatient
					 services.
(3) Inpatient services
					 for general acute care hospitalization for a minimum of 90 days per contract or
					 calendar year.
(4) Preventive
					 services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › OPERATIONAL STANDARDS › Section 9.652 - HMO provision of other than basic health services to enrollees

Current through Register Vol. 54, No. 28, July 13, 2024
An HMO may provide coverage for other than basic health
						services including dental services, vision care services, prescription drug
						services, durable medical equipment or other health care services,
						provided:
(1) The HMO establishes,
					 maintains and operates a network of participating health care providers
					 sufficient to provide reasonable access to and availability of the contracted
					 nonbasic health services to enrollees in accordance with §
											9.679 (relating to access
					 requirements in service areas).
(2)
					 The health care provider contracts it uses to contract with participating
					 providers meet the requirements of §
											9.722 (relating to plan and health
					 care provider contracts).
(3) The
					 provision of those health services is subject to the same complaint and
					 grievance procedures applicable to the provision of basic health
					 services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 9 - MANAGED CARE ORGANIZATIONS › Subchapter G - HMOS › OPERATIONAL STANDARDS › Section 9.653 - HMO provision of limited subnetworks to select enrollees

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An HMO that wants to offer benefit plans
					 based on limited subnetworks, that is, networks which include only selected
					 participating health care providers, shall request approval from the Department
					 to do so.
(b) The Department will
					 approve a request to offer limited subnetworks if the proposal meets the
					 following requirements:
(1) There is adequate
					 disclosure to potential enrollees and any current enrollees who would be
					 affected by a change to a limited subnetwork benefit package of the economic
					 penalties that apply when enrollees do not obtain health care services through
					 the limited subnetwork. Disclosure of the limitations in the number of the
					 HMO's participating providers must be consistent with the act and the
					 requirements of 31 Pa. Code §
												154.16 (relating to disclosure of
					 information).
(2) If a covered
					 service is not available within the limited subnetwork, the HMO shall provide
					 or arrange for the provision of the service at no additional out-of-pocket cost
					 to the enrollee, other than the routine copayments which would have been
					 applicable if the service had been provided within the limited
					 subnetwork.
(3) The limited
					 subnetwork meets the minimum healthcare provider standards in §
												9.679 (relating to access
					 requirements in service areas) and has an adequate number and distribution of
					 network providers to provide care which is available and accessible to
					 enrollees within a defined area.
(4) Enrollment is limited to enrollees within
					 a reasonable traveling distance to the limited participating subnetwork
					 providers.
(5) The limited
					 subnetwork meets the standards for adequate networks and accessibility in
					 § 9.679.