An Introduction to Health Care: Agencies, Laws and Regulations

Transcription

1 An Introduction to Health Care: Agencies, Laws and Regulations Association of Corporate Counsel December 5, 2017 Lawrence W. Vernaglia Partner & Chair, Health Care Industry Team Foley & Lardner LLP Boston, Mass. USA Ginger Appleberry Vice President & Associate General Counsel Caris Life Sciences

2 Goals View of the landscape for health care and life science. Understand the State and Federal regulatory framework for health care and life science. Identify relevant primary and secondary source material lawyers need to access.

3 Federalism in Health Care State Law: Licensure (health departments/dph) Certificate of Need Practitioner Licensure (Board of Registration) Attorney General oversight Medicaid programs Insurance Department

4 Federalism in Health Care Federal Law: Medicare & Medicaid DHHS/OIG/CMS FDA DEA, DOJ FTC

5 The Medicare Program Key agencies and departments: U.S. Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Medicare Administrative Contractors Office of the Inspector General (OIG)

6 The Medicare Program Administrative Appeals 5 levels: Level 1: Redetermination by the company that handles claims for Medicare Level 2: Reconsideration by a Qualified Independent Contractor (QIC) Level 3: Hearing before an Administrative Law Judge (ALJ) Level 4: Review by the Medicare Appeals Council Level 5: Judicial review by a federal district court

7 The Medicare Program Statutes: 42 USC d-8, hhh. Title XVIII of the Social Security Act (SSA). Legislative History including Congressional Record, Committee Reports and Conference Reports. CMS Resources: Regulations 42 CFR. Federal Register Commentary.

8 The Medicare Program Primary Source Information (cont.) CMS Manuals: Paper Based Manuals continuing utility. Provider Reimbursement Manual State Medicaid Manual Historic References Internet Only Manuals - more on these later. Communication Vehicles: Program Transmittals Manual Instruction Updates One-Time Notifications (CMS Pub ) Recurring Update Notifications (CMS Pub )

9 The Medicare Program Issues Related to Internet Only Manuals (cont.) Most commonly used manuals for reimbursement questions include: Medicare Claims Processing Manual, CMS Pub (MCPM). Much of what was in old Carriers and Intermediaries manuals. Subdivided by different topics (some provider-specific, others general). Medicare Benefit Policy Manual, CMS Pub (MBPM). Considerable overlap with MCPM.

10 The Medicare Program Issues Related to Internet Only Manuals (cont.) Medicare National Coverage Determinations Manual (NCD), CMS Pub Medicare Program Integrity Manual (PIM), CMS Pub State Operations Manual (SOM), CMS Pub

11 The Medicare Program Primary Source Information (cont.) CMS Forms and Instructions. Different purposes, e.g.: CMS Form(s) 855 CMS Form 1500 & 1450 (UB 04) CMS Form 2567 CMS Form 2552 and 339 Forms are more important than many realize: Certifications What information is actually required Instructions matter! Use the official list when possible:

12 The Medicare Program Primary Source Information (cont.) Medicare Coverage Database: National Coverage Determination Process Local Coverage Determinations Local policy articles National coverage analyses, coding analyses for labs, Medicare coverage guidance documents CMS Issuances: CMS Coding Guidance MLN Matters (formerly MedLearn) Summaries & Overviews FAQs often narrow; can be right on point The search field for FAQs works.

13 The Medicare Program Primary Source Information (cont.) OIG Issuances: Regulations Fraud Alerts Compliance Guidance Advisory Opinions Audit Reports Settlement and CIA Agreements OIG Work Plan Remember the OIG is not CMS.

14 The Medicare Program Primary Source Information (cont.) Federal Court Case Law (sometimes state courts too) Administrative Decisions PRRB/Administrator ALJ/DAB/Medicare Appeals Council Decisions Medicare Geographic Classification Review Board Carrier/Intermediary/MAC Issuances LCDs, LMRPs Provider Bulletins Manuals, Billing Guides, Fact Sheets

15 The Medicare Program Primary Source Information (cont.) Coding Guides: AMA Current Procedural Terminology (CPT) Professional Edition International Disease Classification (ICD)-9-CM Reference Book for Hospitals and Physicians AMA CPT Assistant 2008 HCPCS Level II Expert Reference Book AHA Coding Clinic, UB-92 Code Editor and CD-Rom, Current Procedural Coding Expert and Coders Desk Reference for ICD-9-CM Procedures Accreditation Organization Manuals (i.e., TJC)

16 Researching Specific Medicare Related Issues Other State and other Federal materials you might not think of: Individual licensure regs MD, NP, CNS, DPM, PA, etc. May contain fraud and abuse, billing, scope of practice, supervision, and corporate practice limitations. Facility licensure hospitals, SNFs, residential care, ASCs, etc. Federal and state drug control laws Federal laws are administered by Drug Enforcement Administration. Insurance and managed care. State health planning/certificate of Need laws. CoN approvals may contain reimbursement, charity care, or other restrictions.

17 Medicare Program Secondary Source Materials AHLA Materials: AHLA s Health Law Archive All Program Papers All Journal of Health Law Issues All Health Lawyers Non-Dues Publications All Health Lawyers Weekly articles 2001-present All Health Law Digest articles 1995-present All Life Sciences and Health Law Daily briefings 2007-present All Practice Group newsletters, member briefings, toolkits and teleconference recordings 2007-present All Health Lawyers News 1997-present AHLA publications Federal Healthcare Laws & Regulations and Medicare Law AHLA Health Law Documents and AHLA Web Links Discussion List postings

18 Medicare Program Secondary Source Materials (cont.) Other professional associations Healthcare Financial Management Association (HFMA) Health Care Compliance Association (HCCA) American Hospital Association American Medical Association American Medical Group Association (AMGA) Trade publications, e.g.: Medical Economics Modern Healthcare Bureau of National Affairs Report on Medicare Compliance The Boston Health Law Reporter a particularly excellent reference! Millions of other web-based resources, many of questionable utility and accuracy.

19 Medicare Program Background Information and Source Materials Commerce Clearing House (CCH) Medicare and Medicaid Guide MediRegs Regulation and Reimbursement Suite Medicare Part B Desk Reference for Physicians, CPT Expert (Ingenix)

20 The Medicaid Program Key agencies and departments: U.S. Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) State Medicaid Agencies (e.g., MediCal, MassHealth)

21 The Medicaid Program Primary Source Materials Statutes 42 USC 1396a to 1396v, (d)(8). Title XIX of the Social Security Act (SSA). State Statutes. State Statutes generally include Medicaid Fraud Statutes. Legislative History including Congressional Records, Committee Reports and Conference Reports. Many states do not report legislative history. Governor s signing statements.

22 The Medicaid Program Primary Source Materials (cont.) Regulations 42 C.F.R. Parts 430 to 457, 483, 491, 493, 498 and State Regulations: Many state regs are not on-line. Need to secure paper copies from agencies and retain date of receipt. State regs sometimes expire don t assume the old regs are not used as guidance. State Medicaid Plans See MediRegs (fixed fee on-line database) Manuals Federal/State.

23 The Medicaid Program Primary Source Materials (cont.) Informal issuances Forms and instructions Case law Carrier issuances

24 The Medicaid Program Secondary Source Materials Much less available. Similar to the Medicare secondary sources: AHLA Program Materials BNA Publications CCH Westlaw/Lexis We get Lois law on a fixed fee Mediregs also

25 Topics for Review FDA Structural Overview What is regulated? Product Classification Approval Overview Pre-Market Requirements Enforcement 2 5

26 FDA Organization 2 6

27 FDA Headquarters: Five Program Centers Based on Product 1. CBER: Center for Biologics Evaluation and Research (products derived from human, plant, animal or micro-organism sources) 2. CDER: Center for Drug Evaluation and Research (safety and effectiveness of prescription, OTC and generic drugs) 3. CDRH: Center for Devices and Radiological Health (safety and effectiveness of medical devices, protect consumers from radiation) 4. CFSAN: Center for Food Safety and Applied Nutrition (domestic and foreign food supply except meat, poultry and some egg products; also regulates cosmetics) 5. CVM: Center for Veterinary Medicine (safety and effectiveness of animal drugs, food additives, feed ingredients, and animal devices) 2 7

28 What types of products does the FDA regulate? Allergy Therapies Animal Drugs and Food LASIK Aquaculture Mammography Facilities Bioengineered Food Medical Devices Biologics Microwave Ovens Blood Mobile Phones Breast Implants Nanotechnology Products Cell Phones Orphan Products (drugs and devices) Combination Products Sunlamps Cosmetics Tattoos Dietary Supplements Tissue for Transplantation Drugs Vaccines Food Whole-Body CT Scans Gene Therapy Xenotransplantation Infant Formula Lasers 2 8

29 Definitions Drug: an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body of man or other animals. Biologic: any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. Medical device: an instrument, apparatus, implement, machine, contrivance, implant in vitro reagent or other similar or related article including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man, or intended to affect the structure or any function of the body of man, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 2 9

30 Product Classification Basics Each product type has a different regulatory process for classification and approval Typically fit into the FDA Program Centers, but emerging technologies challenge these predetermined boundaries FDA goal is public health-oriented 3 0

31 Drugs Drugs must be safe and effective for labeled conditions New drugs: prove this through clinical trials Generic drugs: prove similarity to new drugs OTC drugs: Must meet requirements for safety and effectiveness in their class 3 1

32 Devices Medical device must be either: substantially equivalent to marketed devices or be shown to be safe and effective 3 2

33 In Vitro Diagnostic Devices Sub-category of "Device" CDRH OVID Chemical reagents Biological reagents (proteins, antibodies, etc) Computer-based, software systems (analyzers, laboratory management) 21 CFR

34 Combination Products Product Jurisdiction must be determined before regulatory pathway can be established (21 CFR 3) Primary Mode of Action (PMOA)? Office of Combination Products Assign jurisdiction Resolve Center disputes Ensure consistent application of rules 3 4

35 Combination Products A product comprised of two or more regulated components that are combined or mixed and produced as a single entity. May be regulated by CDER and/or CBER and/or CDRH Jurisdiction based on product s primary mode of action Responsibility assigned according to several intercenter agreements Where jurisdiction is not clear, sponsor may request designation 3 5

36 Why Classify Early? Classification provides the Regulatory Pathway (identification of applicable requirements) Submissions/Approvals Cost and Time Pre-market requirements Interaction with Intellectual property strategy? Impacts Commercialization Strategy 3 6

37 Regulation of New Products Basic Rule: No product can be used on humans, commercially distributed or marked unless FDA rules are met. This could mean an actual approval OR may mean that standards are met (depends on classification risk) FDA enforcement regarding foreign companies increasing Marketing Approval Federal Food, Drug and Cosmetic Act requires approval or clearance of most drugs and medical devices New drug application (NDA) Abbreviated new drug application (ANDA) Premarket approval application (PMA) 510(k) notification 3 7

38 Basic Approvals and Standards Devices Investigational Device Exemption (IDE) = reasonably safe to use a significant-risk medical device on human subjects Pre - Market Notification (510(k)) = substantially equivalent to marketed device (PREDICATE) Pre - Market Approval (PMA) = safe and effective for labeled use and indications 3 8

39 Investigational New Drug Applications Submitted to FDA with information about the new drug Previous clinical studies, e.g., in other countries Non-clinical data, i.e., laboratory and animal Proposed Clinical protocol Chemistry, manufacturing and control (CMC) Investigation information May begin clinical study if FDA does not respond with questions within 30 days of receipt 3 9

40 Investigational New Drug Applications Typically involves 3 phases: Phase I - first in man; usually performed on healthy volunteers, designed to determine metabolic and pharmacologic actions, side effects associated with increasing doses Phase II - early controlled clinical trials; designed to obtain preliminary data on effectiveness of drug for particular indication and additional safety Phase III - expanded controlled and uncontrolled trials; additional effectiveness and safety information; enough data to extrapolate results to general population Phase IV - post marketing studies 4 0

41 Investigational New Drug Applications Typically involves 3 phases: Phase I - first in man; usually performed on healthy volunteers, designed to determine metabolic and pharmacologic actions, side effects associated with increasing doses Phase II - early controlled clinical trials; designed to obtain preliminary data on effectiveness of drug for particular indication and additional safety Phase III - expanded controlled and uncontrolled trials; additional effectiveness and safety information; enough data to extrapolate results to general population Phase IV - post marketing studies 4 1

42 Clinical Trial Basics Will results support an FDA submission? 21 C.F.R. Part 50 (Informed Consent), 21 C.F.R. Part 54 (Financial Disclosure of Investigators), 21 C.F.R. Part 56 ORB and research institutions), and 21 C.F.R. Parts 312 and 812 (Investigational New Drug and Investigational Device Exemptions). Will the trial be federally funded? 45 C.F.R. Part 46 (Protection of Human Subjects) 42 C.F.R. Part 50, subpart F (Promoting Objectivity in Research), and any specific grant agency requirements (NIH, CDC, SBIR, etc.) Both FDA support and federally funded? Must meet both requirements 4 2

43 Medical Devices FDA regulates medical device companies that manufacture, repackage, relabel import/export products Basic requirements Establishment registration Medical device listing 510(k) or PMA IDE for clinical studies Quality System (QS) regulation Labeling requirements Medical device reporting 4 3

44 Risk Based Classification, Level of Regulatory Control, & Submission Type 510(k) Exempt Class I Class II Class III Very Low Low (~782) Medium (~799) High (~119) General Controls (may or may not be GMP exempt) General Controls Premarket Notification or 510(k) Generally exempt from 510(k) General & Special Controls 510(k) Submission General & Special Controls Premarket Approval 4 4

45 510(k) Notification Is device substantially equivalent to a pre-1976 device or a post-1976 device that was found to be substantially equivalent to a pre-1976 device; Submit to FDA at least 90 days before introduction into commerce; Substantial equivalence means that the new device has the same intended use and the same technological characteristics as the predicate device; May require clinical data if intended use the same but different technological characteristics; Must be as safe and effective as predicate device and not raise different questions of safety and effectiveness; and Modifications to device may require new notification. 4 5

46 Investigational Device Exemption (IDE) Investigational Device Exemption (IDE) Significant risk device requires submission of IDE and approval of IDE before clinical trials can begin. Non-significant risk devices can be studied with approval of investigational review board (IRB). 4 6

47 Current Good Manufacturing Practices (cgmp) and Quality System Compliance Product NOT manufactured in compliance with GMP is deemed "adulterated;" Constantly changing and represent "customary Practice" or "state-of-the-art" in the industry; Critical in product development and major factor in FDA "approval" 4 7

48 Current Good Manufacturing Practices (cgmp) and Quality System Compliance Quality System is the mechanism to achieve cgmp Product changes are monitored and documented cgmp and QS compliance is the primary basis for FDA inspections and compliance enforcement

49 Adverse Event Reporting and Corrective Action Requirements All products have some form of adverse event Reporting Evaluate whether a report is indicated Evaluate role product played in event Involve product liability litigator to review narrative since reports are public Corrective Action v. Recall (upgrade unrelated to potential for harm v. potential for harm) 4 9

50 FDA Investigations and Enforcement Deficiencies resulting from an inspection, scheduled or surprise (often GMP or QS deficiencies) ("FDA 483") Product Recall Warning Letter and Response Civil Fine Criminal Investigation 5 0