The Basics of Health Care Facilities Licensure in Pennsylvania
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1 The Basics of Health Care Facilities Licensure in Pennsylvania Victoria Heller Johnson, Esq. March 13, Fox Rothschild
2 Role of Licensure Oversight Mechanism Ensure services are provided by properly trained and supervised individuals acting within the scope of practice Ensure facilities are safe, sanitary, properly staffed, equipped and maintained Ensure life safety and physical plant requirements are met
3 Role of Licensure Gatekeeper Function: restrict unauthorized practice State Police Power : supervision and enforcement A pre-requisite for Medicare, Medicaid, payors, accrediting agencies and others Can affect whether, how, what and when the facility gets paid
4 State Function Licensure is a creature of state law and varies from state to state! Requirements Terminology Cross jurisdictional issues Not a one size fits all!
5 PA Legal Framework Statutes Adopted by legislature Create the various state licensing agencies Basic licensure rules/req ts Marching Orders for Rules The Framework Regulations Adopted by the various licensing agencies Implement the framework created by statute The Specifics Other Guidance Bulletins Licensing Reference Manuals
6 The Key Players For Now Department of State/BPOA Practitioner and Pharmacy Licensing Department of Health Department of Human Services Department of Drug and Alcohol Programs Department of Aging Department of Insurance
7 The Key Players Change Coming Soon? Department of Health and Human Services Gov. Wolf s January 2017 budget proposal proposed to consolidate DOH, DHS, DDAP and Aging As of Feb 2018, this plan had been dropped, primarily due to concerns re: consolidation of DDAP Feb 24, 2018 Memorandum from the Legislature advises of plan to introduce a legislative package that would, among other things, combine DOH and DHS into DHHS
8 BPOA Bureau of Professional and Occupational Affairs Division of the Department of State Provides admin and legal support to 29 professional and occupational licensing Boards and commissions Protects the public from fraudulent and unethical practitioners Professionals range from Physicians and Cosmetologists to Accountants and Funeral Directors Lookup a license:
9 BPOA Disciplinary actions are public record The Professional Compliance Office administers formal complaint and investigation process Legal Office determines if investigation needed Bureau of Enforcement and Investigation investigates Order to Show Cause from a Prosecuting Attorney After a hearing, adverse actions can be appealed to a Commonwealth Court
10 Where to Look for BPOA Licensees Start with the Governing Statute e.g., The Pharmacy Act Consult Regulations under 49 Pa. Code Check the Board s website
11 General Licensure Matters for BPOA Licensees Don t forget to notify the Board of: Name Changes Address/Practice Location Changes Changes of Ownership/Control Remember to notify Medicare, Medicaid, NPI, DEA, payors and others too!
12 Disciplinary Action for BPOA Licensees Censure or public reprimand Fines Suspension Limitation of License Submit to Care/Treatment by a physician Revocation Injunction against unlicensed practice
13 Department of Health Division of Acute and Ambulatory Care (DAAC) Conducts state licensure, Medicare certification and complaint investigations for: General and special hospitals ASFs Abortion facilities
14 Department of Health Division of Home Health Conducts state licensure and complaint investigations for: Birth centers Home Health Agencies (HHAs) Home Care Agencies & Registries Hospices Pediatric Extended Care Facilities
15 Department of Health Division of Home Health Conducts Medicare certification and complaint investigations for: CORFs Kidney Dialysis (ESRD) Centers Outpatient Speech, PT, & OT Clinics RHCs [CMS determines if the RHC is in a MUA] Oversight of Drugs, Devices and Cosmetics PA Drug, Device and Cosmetic Program PA Hearing Aid Registration Program
16 Department of Health Division of Nursing Care Facilities Conducts state licensure, Medicare certification and complaint investigations for nursing facilities (a/k/a LTCFs and SNFs)
17 Department of Health Division of Intermediate Care Facilities Contracted state survey agency for CMS Conducts federal Medicare/Medicaid certification and complaint investigations for: ICFs/IIDs ICFs/ORCs PRTFs (Medicaid only) CMHCs
18 Department of Health Division of Safety Inspection Review construction plans/designs for compliance with the Life Safety Code (CMS) and State Guidelines for Hospitals, ASFs and LTCNFs Detailed plan review process Conducts inspections May also require L&I or local approvals
19 Department of Health Bureau of Labs Division of Laboratory Improvement Issues PA Clinical Lab Permits Implements CLIA On-site inspections, proficiency assessment and personnel training
20 Department of Health Bureau of Emergency Medical Services Licenses EMS Agencies including QRS, BLS, ALS, CCT and Air Ambulance Services Credentials pre-hospital providers in PA
21 Department of Health Issues permits for medical marijuana growers/processors No more than 25 initially; 5 can be dispensaries also Issues permits for medical marijuana dispensaries No more than 50 initially; each up to 3 locations Permits distributed among 6 geographic regions of the State Applications not currently being accepted
22 Department of Health The PA Medical Marijuana Act [35 P.S ] Signed into law April 17, 2016 Creates PA s Medical Marijuana Program 17 specified serious medical conditions Temporary Regs at 28 Pa Code Chapters 1131, 1141, 1151, 1161, 1181, 1191 Regs good for two years from date of adoption
23 Department of Health The Health Care Facilities Act [35 P.S a et seq] General and special hospitals ASFs Long-Term Care Nursing Facilities Birth Centers Home Health Care Agencies Home Care Agencies/Registries Hospices Abortion Facilities Cancer Treatment Centers eventually? DOH may add new categories
24 Department of Health House Bill 1190 (Act 60 of 2013), effective January 1, 2014 Allows the DOH to grant deemed status licensure to hospitals accredited by 1 of 4 approved national accreditation organizations. Accredited hospitals can opt to be exempt from routine DOH licensure renewal surveys. Extended the licensure term from 2 years to 3 years for all hospitals. Does not apply to hospital psych units or psych hospitals
25 Department of Health Separate licenses within a single facility are required for: Home health Home care Hospice LTCFs/SNFs Mental health services (DHS) Pharmacy (SBofP) Drug and Alcohol (DDAP)
26 Department of Health 28 Pa Code Chapter 51 - General Licensure Regulations: Applicable to all DOH facilities licensed under The Health Care Facilities Act Notification requirements Civil rights compliance Exceptions process Restrictions on certain services (e.g., PET, cardiac cath) Sanctions
27 Department of Health 28 Pa Code Chapter 51 Reasons to Notify DOH: Adding new services or beds cannot provide until approved and/or surveyed Ceasing services or reducing beds Renovations Noncompliance with licensure requirements Reportable Events
28 Department of Health 28 Pa Code Chapter 51 Reasons to Notify DOH: Changes of name Changes of controlling interest Changes of ownership or management 5% or more of stock or equity Change in responsible person
29 Department of Health Penalties for Violations include: Plan of Correction (most common) Suspension Revocation or Non-renewal Provisional or limited license Limitation/Suspension of Admissions Penalties of up to $500/day
30 Department of Health 28 Pa Code Chapter 53 Applicable to all DOH facilities licensed under The Health Care Facilities Act (and physician practices) Photo identification badge requirements
31 Department of Health Regulations at 28 Pa. Code (in addition to Chapters 51 and 53) Clinical Labs Chapter 5 Hospitals - Chapters LTCFs (SNFs) Chapters Birth Centers Chapter 501 ASFs Chapters Home Health Chapter 601 Home Care Chapter 611
32 Department of Health Other Implementing Statutes Clinical Labs Blood Banks Abortion Facilities Pediatric Extended Care Facilities Ambulance and EMS Providers Hearing Aid Fitters and Sellers Medical Marijuana Organizations Growers/Processors and Dispensaries
33 DDAP Licenses Drug and Alcohol Treatment Facilities Inpatient Non-Hosp Inpatient Psych Hosp Residential Short-term detox Transitional living facilities Partial hospitalization Outpatient Approve Narcotic Treatment Programs (NTPs) Additional federal approvals (DEA, CSAT/SAMHSA) Formerly the Division of Drug and Alcohol Programs of the DOH spun out in 2012
34 Department of Human Services Office of Mental Health and Substance Abuse Services (OMHSAS) Private psych hospitals Partial hospitals PRS facilities Outpatient psych clinics CRRS homes LTSRs
35 Department of Human Services Office of Developmental Programs (ODP) Adult training facilities Vocational facilities Community homes for IIDs Family living homes Office of Children, Youth & Families (OCYF) Child Residential and Day Treatment Facilities
36 Department of Human Services Bureau of Human Services Licensing (BHSL) Personal Care Homes Assisted Living Residences
37 Department of Human Services Most facilities and agencies subject to licensure or approval under Articles IX and X of the Public Welfare Code
38 Department of Human Services Other implementing statutes The Mental Health and Intellectual Disability Act of 1966 [50 P.S et seq] The Mental Health Procedures Act [50 P.S et seq]
39 Department of Human Services 55 Pa Code Chapter 20 provides general licensing rules and requirements for most DHS licensees Notification requirements Civil rights compliance Inspections (both announced and unannounced) Types of licenses (regular, provisional) Conditions for denial, nonrenewal or revocation Appealable Decisions License called a certificate of compliance
40 Department of Human Services 55 Pa Code Chapter 20 Reasons to Notify DHS: Before: Changes in legal entity, name, location, or profit/nonprofit status New application required After: Change in responsible person Note: stock transfers do not count for licensing (they do for Medicaid)
41 Department of Aging Adult Day Service Centers Domiciliary Care Homes
42 Continuing Care Retirement Communities CCRCs offer a tiered hybrid approach, with some combo of: independent living personal care residence assisted living residence skilled nursing care home care
43 Continuing Care Retirement Communities Licensed by: PA Department of Insurance PA DHS PA DOH
44 Federal Interplay Some providers are required to meet additional licensure-like requirements under federal law State agencies often act as contracted survey agencies for Medicare and Medicaid State licensure status may impact provider-based status
45 Federal Interplay Medicare Conditions of Participation Part A Conditions for Coverage Part B Some have survey requirements Medicaid/PA Medical Assistance (OMAP)
46 Victoria Heller Johnson
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