Department of Health

Hearings:

Unless otherwise noted, the administrative proceedings specified below occur in Harrisburg, are conducted under the General Rules of Administrative Practice and Procedure (GRAPP) (1 Pa. Code §§ 31.1-35.251) and are governed by Chapter 5 of the Administrative Agency Law, 2 Pa.C.S. §§ 501-508. Also, unless otherwise noted, the adjudications and orders resulting from those proceedings are appealable to the Commonwealth Court pursuant to 42 Pa.C.S. § 763(a). General administrative proceedings not unique to DOH, such as a proceeding initiated by protesting the award of a contract, are not listed.

Abortion Facilities

• DOH, through its Bureau of Community Program. Licensure and Certification or the Bureau of Facility Licensure and Certification, may pursue action under the Abortion-Control Act (18 Pa.C.S. §§ 3201-3220) to deny a registration or revoke a registration of a facility to provide abortions pursuant to 28 Pa. Code § 29,.43. These Bureaus may also take action under the Medical Care Availability and Reduction of Error Act (MCARE Act) to revoke a registration of a facility to provide abortions pursuant to 40 P.S. § 1303.313(f), and may pursue an administrative penalty of $1,000/day under 40 P.S. § 1303.305(g) against a facility that does not timely pay an assessment fee levied under Chapter 3 of the MCARE Act.
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings are conducted before a hearing officer who issues a proposed report under 1 Pa. Code § 35.202.
  
  
• The facility/applicant or the relevant bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Controlled Substances, Drugs, Devices, and Cosmetics

Manufactures, Dealers and Retailers

• All persons or entities who manufacture, distribute, or sell for retail, controlled substances, drugs, devices, or cosmetics must register with DOH under the Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §§ 780-101 --- 780-144).
  
  
• DOH, through its Bureau of Community Program Licensure and Certification, may pursue action to deny a registration or suspend a registration pursuant to 35 P.S. § 780-106.
  
  
• To initiate administrative proceedings an order to show cause would be issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under 1 Pa. Code § 35.202.
  
  
• The registrant/applicant or the Bureau could appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head would then issue an adjudication and order.

Embargo

• A drug, device, or cosmetic can be subject to an embargo if there is probable cause to believe it is adulterated, misbranded or contraband. 35 P.S. § 780-127(a).
  
  
• The item shall be properly tagged and then an embargo citation and order to show cause accompanied by a notice of rights and responsibilities is to be served upon the claimant or owner of the item. 35 P.S. § 780-127(a) and (b).
  
  
• A hearing is conducted by a hearing examiner appointed by the Secretary of Health, with the approval of the Governor, under 35 P.S. § 780-130.
  
  
• The hearing officer issues an adjudication and order which may order that the item be destroyed at the expense of the claimant, or be properly labeled and processed by the claimant after costs, fees and expenses have been paid and a sufficient bond obtained. 35 P.S. § 780-127(c) and (d).

Drug and Alcohol Facilities

• DOH, through the Bureau of Community Program Licensure and Certification, Division of Drug and Alcohol Program Licensure, can refuse to issue a license or revoke a license for violation of the applicable requirements for licensure. 62 P.S. § 1026.
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings are held before a hearing officer. who certifies the record to the agency head. The agency head then issues an adjudication and order.

Emergency Medical Services

EMS Personnel

Certification/Recognition

• DOH pursues disciplinary action through its Bureau of Emergency Medical Services against emergency medical services (EMS) personnel who are certified or recognized by DOH under the Emergency Medical Services Act (EMS Act) (35 P.S. §§ 6921-6938). It does this under 35 P.S. § 6931(j.1). It may likewise conduct a hearing on a person's application to become certified or recognized as an EMS provider. This action is also initiated under 35 P.S. § 6931(j.l), however it may also address whether the applicant satisfies basic criteria for certification or recognition in 35 P.S. § 6931.
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities.
  
  
• Hearing are conducted before a hearing officer who issues a proposed report under 1 Pa. Code § 35.202.
  
  
• The EMS provider/applicant or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Medical Command Authorization

• Paramedics and prehospital registered nurses who have their medical command privileges denied or revoked by an advanced life support medical director may appeal that decision to the medical director of a regional EMS council, and the provider or the ALS service medical director may appeal that decision to DOH. See 35 P.S. § 6931(d)(2)(iv) and (e.1)(4).
  
  
• Hearings would be conducted before the Commonwealth Emergency Medical Director if necessary after the record before the regional EMS medical director is certified to the Commonwealth Emergency Medical Director. The Commonwealth Emergency Medical Director then issues a proposed report under 1 Pa. Code § 35.202.
  
  
• The EMS provider or the ALS service medical director may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Ambulance Services

• DOH pursues disciplinary action through the Bureau against ambulance services that are licensed by DOH under the EMS Act. It does this under 35 P.S. § 6932(1). It may likewise conduct a hearing on an applicant's application to become licensed as an ambulance service. This action is also initiated under 35 P.S. § 6932(1), however it may also address whether the applicant satisfies basic criteria for licensure in 35 P.S. § 6932(h).
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities:
  
  
• Hearing are conducted before a hearing officer who issues a proposed report under 1 Pa. Code § 35.202.
  
  
• The ambulance service/applicant or the Bureau of EMS may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Accreditations

Continuing Education Sponsors

• Persons seeking to become sponsors of EMS continuing education courses can be denied accreditation as a sponsor under 28 Pa. Code § 1003.30. Likewise a sponsor of continuing education courses can be denied renewal of accreditation under 28 Pa. Code § 1003.30.
  
  
• To initiate administrative proceedings an order to show cause would be issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under I Pa. Code § 35.202.
  
  
• The continuing education sponsor/applicant or the Bureau could appeal the proposed report to the agency head by filing a brief on exceptions pursuant to I Pa. Code §§ 35.211-35.213. The agency head would then issue an adjudication and order.

Educational Institutes

• Institutes seeking accreditation as EMS institutes can be denied accreditation under 35 P.S. § 6931(a)(1) and 28 Pa. Code §§ 1011.1-1011.3. Likewise an EMS institute can be denied renewal of accreditation under 28 Pa. Code §§ 1011.1-1011.3.
  
  
• To initiate administrative proceedings an order to show cause would be issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under 1 Pa. Code § 3 5.202.
  
  
• The EMS institute/applicant or the Bureau could appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head would then issue an adjudication and order.

Medical Command Facilities

• Hospitals seeking recognition of a hospital unit as a medical command facility can be denied recognition pursuant to 35 P.S. § 69310)(4) and 28 Pa. Code §§ 1009.1-1009.2, and the definition of "medical command facility" in 35 P.S. § 6923. Likewise renewal of medical command facility recognition can be denied pursuant to 28 Pa. Code §§ 1009.1-1009.2.
  
  
• Preliminary recognition decisions are made by the Bureau.
  
  
• Appeals of the Bureau's decisions may be made by the medical command facility/applicant pursuant to 1 Pa. Code § 35.20.
  
  
• Hearings would be conducted before a hearing office who would certify the record to the agency head. The agency head would then issue an adjudication and order.

Head Injury Program

• DOH, through the Bureau of Family Health, administers a Head Injury Program (HIP) through which persons who receive a head injury caused by trauma may be covered for medical, rehabilitation and attendant care services when all alternative financial resources have been exhausted. 35 P.S. § 6923. An applicant for enrollment into HIP who is denied enrollment or a HIP client who receives a decision discharging the client from HIP, or who receives a disapproval of a rehabilitation service plan, or is directed to pay for HIP services due to the availability of financial resources, may file a request for reconsideration and, upon receiving an adverse decision, may file an appeal to the agency head.
  
  
• Hearings would be conducted before a hearing office who would certify the record to the agency head. The agency head would then issue an adjudication and order.

Health Care Facilities

• DOH, through the Bureau of Quality Assurance, under the Health Care Facilities Act (35 P.S. §§448.101-448.904b), can deny, suspend or revoke a license or issue a civil monetary penalty to a health care facility pursuant to 35 P.S. § 448.802a et seq.
  
  
• This applies to hospitals, long term care nursing facilities, ambulatory surgical facilities, hospices, home health care agencies, home care agencies and registries, birth centers and cancer treatment centers.
  
  
• DOH issues an order imposing a sanction. The health care facility/applicant can then file an appeal and answer to that order.
  
  
• Hearings are held before the Health Policy Board pursuant to 71 P.S. § 532(n). The Board uses the GRAPP as supplemented by its own rules of practice and procedure at 37 Pa. Code § 197.1 et seq. The Health Policy Board issues the adjudication and order.

Hearing Aid Fitters and Dealers

• DOH, through its Bureau of Community Program Licensure and Certification, under the Hearing Aid Sales Registration Act (35 P.S. §§ 6700-101 - 6700-802), can deny, suspend, or revoke a hearing aid fitter's or dealer's registration pursuant to 35 P.S. § 6700-601 and 28 Pa. Code § 25.215.
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities.
  
  
• An applicant who is preliminarily denied registration may request a hearing before the Secretary under 35 P.S. § 6700-602.
  
  
• Hearings are conducted before a hearing officer who issues a proposed report under I Pa. Code § 35.202.
  
  
• The hearing aid fitter or dealer/applicant or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Clinical Laboratories

• DOH, through its Bureau of Laboratories, under The Clinical Laboratory Act (35 P.S. §§ 2151-2165), can pursue action to revoke a clinical laboratory permit under 35 P.S. § 2156, and may deny an application for a permit under 35 P.S, § 2160.
  
  
• An aggrieved person can request a hearing before the Secretary of Health under 35 P.S. § 2162 and 28 Pa. Code § 5.94.
  
  
• To initiate administrative proceedings an order to show cause would be issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under 1 Pa. Code § 35.202.
  
  
• The clinical laboratory/applicant or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Managed Care

DOH is to review complaint appeals filed by enrollees of managed care plans pursuant to Article XXI of the Insurance Company Law of 1921 (40 P.S. §§ 991.2101-991.2193), commonly referred to as "Act 68." Specifically, section 2142 provides an enrollee of a managed care plan 15 days to appeal a second level complaint decision of a managed care plan to either DOH or the Insurance Department, depending on which is the appropriate agency. (40 P.S. § 991.2142(a)).

• Section 2142 provides for the records from the first and second level complaint reviews held before the plan to be transferred to the appropriate department (40 P.S. § 991.2142(b)), and allows enrollees, managed care plans or health care providers to provide additional materials to DOH in its review of the case. (Id.)
  
  
• Hearings would be conducted before a hearing officer who would certify the record to the agency head.
  
  
• The agency head would then issue an adjudication and order.

Nurse Aides

• DOH, through its Bureau of Facility Licensure and Certification, Division of Nursing Care Facilities, can pursue action to enter a determination of abuse, neglect or misappropriation of resident property on the Pennsylvania Nurse Aide Registry. 42 C.F.R. § 483,156.
  
  
• To initiate administrative proceedings an order to show cause is issued accompanied by a notice of rights and responsibilities.
  
  
• The hearing must be held at a reasonable place and time convenient for the individual. 42 C.F.R, § 488.334(d)(2).
  
  
• Hearings are conducted before a hearing officer who issues a proposed report under 1 Pa. Code § 35.202.
  
  
• The nurse aide or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Public Bathing Places (Specifically, Public Swimming Establishments)

• All entities who operate a public swimming establishment must obtain a permit from DOH under 35 P.S. § 676.
  
  
• DOH, through action pursued by its Bureau of Community Health Systems, under the Public Bathing Law (35 P.S. §§ 672-680d), can deny, revoke or suspend a permit for reasons given in 35 P.S. §§ 676(d) and 680b, or may cause the swimming or bathing pool to be closed and drained pursuant to 35 P.S. § 679(b).
  
  
• Depending upon the reason action is taken, action may be taken by DOH by the issuance of an order subject to appeal or by the issuance of an order to show cause accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under 1 Pa. Code § 35.202.
  
  
• The permit holder/applicant or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Wholesale Prescription Drug Distributors

• DOH, through its Bureau of Community Program Licensure and Certification, under the Wholesale Prescription Drug Distributors License Act (63 P.S. §§ 391.1-391.15), can pursue action to refuse to issue or to suspend, revoke or limit a license as a wholesale prescription drug distributor under 63 P.S. § 391.9.
  
  
• The aggrieved party can request a hearing under 63 P.S. § 391.12.
  
  
• To initiate administrative proceedings an order to show cause would be issued accompanied by a notice of rights and responsibilities.
  
  
• Hearings would be conducted before a hearing officer who would issue a proposed report under 1 Pa. Code § 35.202.
  
  
• The licensee/applicant or the Bureau may appeal the proposed report to the agency head by filing a brief on exceptions pursuant to 1 Pa. Code §§ 35.211-35.213. The agency head will then issue an adjudication and order.

Women, Infants and Children Special Supplemental Food Program (WIC Program)

Applicant and Participant Appeals

• When a local WIC agency denies an application to become a WIC participant, places an applicant on a waiting list or removes a participant from the WIC Program the applicant or participant may appeal this adverse decision. 28 Pa. Code § 1111.2.
  
  
• When a local agency receives an applicant or participant appeal a hearing is scheduled under 28 Pa. Code § 1111.5.
  
  
• The place of the hearing may not be further from the residence of the applicant or participant than the county seat of the county in which the applicant or participant resides. If the county seat is unsuitable due to the health of the applicant or participant, transportation problems, convenience of witnesses or for other legitimate reasons, an alternative place of hearing shall be a location convenient to the home of the applicant or participant. 28 The place of the hearing may not be further from the residence of the applicant or participant than the county seat of the county in which the applicant or participant resides. If the county seat is unsuitable due to the health of the applicant or participant, transportation problems, convenience of witnesses or for other legitimate reasons, an alternative place of hearing shall be a location convenient to the home of the applicant or participant. 28 Pa. Code § 1111.5.
  
  
• Hearings are conducted before a hearing officer who issues a decision in accordance with 28 Pa. Code § 1111.10.
  
  
• The applicant or participant may appeal the hearing officer's decision to the Secretary. 28 Pa. Code § 1111.11.
  
  
• The agency head will then issue an adjudication and order. 28 Pa. Code § 1111.13.

Store Appeals

• A store has the right to appeal an adverse action of the Division of WIC that affects the store's participation in the WIC Program as a WIC authorized store. Adverse actions include: (1) termination of authorization or reauthorization in accordance with 28 Pa. Code 1103.1(d), (2) denial of an application for authorization or reauthorization or, (3) refusal to accept an application for authorization or reauthorization. 28 Pa. Code § 1113.1.
  
  
• When the Division of WIC receives a store appeal a hearing is scheduled under 28 Pa. Code § 1113.2.
  
  
• Hearings are conducted before a hearing officer who issues an adjudication and order in accordance with 28 Pa. Code § 1113.3.

Complaint Appeal Hearings for Enrollees of Managed Care Plans

Glossary:

Complaint - A dispute or objection regarding a participating health care provider or the coverage, operations or management of a managed care plan, which has not been resolved by the managed care plan, and has been filed with the plan or with the Department of Health or the Insurance Department .

Enrollee or member - Any policyholder, subscriber, covered person or other individual who is entitled to receive health care services under a managed care plan. For purposes of the complaint process, the term also includes the parents of a minor enrollee, as well as designees or legal representatives who are entitled to authorize or act on behalf of an enrollee.

Gatekeeper PPO - Preferred provider organization requiring enrollee use of a gatekeeper from which an enrollee must receive referral or approval for covered health care services as a requirement for payment at the highest level of benefits.

HMO: Health maintenance organization - An organized system that combines the delivery and financing of health care and which provides basic health services to voluntarily enrolled members for a fixed prepaid fee.

Participating provider - Health care provider that has been credentialed by and contracts with the plan as a part of the plan's network to provide services to the plan's enrollees at the terms and conditions included in the contract.

PCP: Primary care provider - A health care provider who, within the scope of the providers practice, supervises, coordinates, prescribes or otherwise provides or proposes to provide health care services to an enrollee, initiates enrollee referral for specialist care, and maintains continuity of enrollee care.

Provider Network - The health care providers designated by a managed care plan to perform health care services.

WIC Food Store Hearings

Glossary:

Applicant - An individual applying to become a participant.

Authorization - The grant of authority to a store to serve as a WIC authorized store.

Clinic - A facility where applicants apply for and participants receive WIC Program services other than food benefits.

Compliance buy - A covert purchase at a WIC authorized store, with a WIC check, conducted to enable the Department to evaluate adherence by a WIC authorized store with this part governing the store's participation in the WIC Program.

Compliance investigation - A series of at least two compliance buys conducted at the same WIC authorized store.

Food prescription - A designation by a competent professional authority of allowable foods in specified quantities to meet a participant's nutritional needs based upon a determination of nutritional risk.

Local agency - A public or private nonprofit health or human service agency with which the Department contracts to provide WIC Program services for a specific geographic area.

Overcharge - A charge by a WIC authorized store to the WIC Program through redemption of a WIC check for an allowable food in excess of the store's shelf price for that food or in excess of the price charged a non-WIC participant for that food.

Overpayment - Payment to a WIC authorized store of a WIC check redeemed by the store in an amount in excess of the amount to which the store was entitled based upon the maximum allowable price of each allowable food authorized for purchase on the WIC check.

Participant - A pregnant woman, breast-feeding woman, postpartum woman, infant or child enrolled in the WIC Program.

Proxy - A person authorized by the local agency and the participant, or by the participant's parent or guardian if the participant is an infant or child, to pick up or use WIC checks to make purchases for that participant.

Reauthorization - The Department's renewal of authorization

WIC check - A negotiable instrument issued to participants to purchase allowable foods at WIC authorized stores.

Contact Person:

Angela Green
Equal Opportunity
Specialist 613 Health and Welfare Building
625 Forster Street
Harrisburg, PA 17120-0701
Telephone: (717) 346-2245
Fax: (717) 783-1915
E-mail:angreen@pa.gov