Health Law & Medicine Links (Law Page): Tom Mayo's Home Page

Law Page

► Health Law
► Federal Regulatory
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► Tort Reform
► Patient Safety
► Bioethics

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► Health Policy, Statistics
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► Journals

► Medical Reference
► Medical Humanities
► Universities, Hospitals & Physician Directories
► Miscellaneous

Health Law

Starting places: American Health Lawyers Association | Cornell's LII site for health law | Boston Univ. School of Public Health - Law Dep't Links Page | New England School of Law/Tufts partnership page | Ed Richards' Public Health Law Site | St. Louis University's Health Law Links | University of Houston's Health Pathfinder | State Bar of Texas Health Law Section | SCIRUS (excellent science-oriented search engine from Reed Elsevier) | University of Houston Health Law Center's Supplemental Materials on Health Law | AMA Managed Care Contracting page
Other: ABA Health Law Section - Links Page | ABA Commission on Legal Problems of the Elderly: State Health Decisions Legislative Update 2000 | AMA's Legal Issues for Physicians | ACLU's "Year in Civil Liberties -- 1999": health & medicine | American Society of Law, Medicine & Ethics (index to journals) | CDC's "The Legal Basis of Public Health" | Medical Staff Information Supersite | Medicare Compliance Alert (requires subscription) | Web Resource Page for Health Care Law Course @ SMU Law | Web Resource Page for Bioethics Course @ SMU Law | SMU Health Law Association

Federal Regulatory

Antitrust: DOJ/FTC "Statements of Antitrust Enforcement Policy in Health Care" | DOJ/FTC "Horizontal Merger Guidelines" (1997 rev.) | DOJ/FTC Draft "Antitrust Guidelines for Collaborations Among Competitors" |
- Federal Trade Comm'n: Federal Trade Comm'n
- Dep't of Justice: U.S. Dep't of Justice Antitrust Div. - DOJ Press Release re: Allocation of Business Between FTC & DOJ (March 2, 2002) (memorandum: HTML / PDF) - (What's New) (DOJ Public Documents/Health Care Pages) (Summary of Health Cases) (Health Care Task Force (recent enforcement actions) (Health Care Business Review Letters (summaries)) (Business Review Letters - Full Text) - Statement of Antitrust Enforcement Policy in Health Care (jointly with FTC)
Children's Health: DHHS SCHIP page - DHHS/Office of the Assistant Secretary for Planning and Evaluation's (ASPE) SCHIP Evaluation Website - DHHS/ASPE's Office of Health Policy's Children's Health Issues page | See also AAP's SCHIP page

Civil rights: DHHS's Office for Civil Rights | NIH Office of Research on Minority Health | DHHS Initiative to Eliminate Racial and Ethnic Disparities in Health

Compliance:

Consumer protection: FTC's health-related "Dot.Con" info page

Controlled substances: Drug Enforcement Agency | 21 U.S.C. ch. 13 | 21 C.F.R.

Disabilities & managed care: DHHS' Assistant Secretary for Planning and Evaluation

Drugs & devices:

U.S. DHHS: Food & Drug Administration

Laws FDA enforces

FDA Modernization Act of 1997: Backgrounder & Overview (see also CDRH's page below)

Title 21 C.F.R.

Federal Register notices

Current Dockets

News (incl. press releases) and Publications

MedWatch: The FDA Safety Information and Adverse Event Reporting System

Information for Health Professionals (portal to FDA pages of interest)

FDA News for Health Professionals (published in JAMA)

"'Off-Label' and Investigational Use of Marketed Drugs, Biologics, and Medical Devices" (Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update)

See also Food & Drug Law Institute - Update Magazine

Clinical Trials:

Clinical Trials and Human Subject Protection

FDA Information Sheets: Guidance for IRBs and Clinical Investigators

CDER's Information for Clinical Investigators

PhRMA Principles for Conduct of Clinical Trials and Communication of Trials Results (June 20, 2002)

Devices:

Center for Devices and Radiological Health (CDRH)

Current Good Manufacturing Practices (CGMP) - Final Rule (Oct. 7, 1996) (PDF)

Guidance documents

Device Advice

CDRH Regulatory Manuals

Investigational Device Exemptions Manual (HTML) (PDF)

Premarket Approval Manual (HTML) (PDF)

Content of a 510(k) - Device Advice

"The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance" (March 20, 1998)

CDRH's "FDA Modernization Act of 1997" page

CDRH's "Reuse of Single-Use Devices" page

Computers & Devices: Computer- and Software-Related Documents

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (Jan. 11, 2002) (PDF)

Guidance for Off-the-Shelf Software Use in Medical Devices; Final (Sept. 9, 1999) (PDF)

Computerized Systems Used in Clinical Trials (April 1, 1999) (PDF)

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final (May 29, 1998) (PDF)

Meeting Summary: Computer-Aided Diagnosis Workshop (Jan. 26, 1996)

Computerized Devices/Processes Guidance - Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes (May 1, 1992) (PDF)

Blue Book Memo: Review of 510(k)s for Computer Controlled Medical Devices -- 510(k) Memorandum #K91-1 (Aug. 29, 1991)

FDA Policy For The Regulation Of Computer Products (DRAFT) (Nov. 13, 1989) (PDF)

Glossary of Computerized System and Software Development Terminology

See also: Lee H. Monsein - Primer on Medical Device Regulation

Drugs:

Center for Drug Evaluation & Research (CDER)

CDER Handbook (a useful guide to the drug approval process)

CDER's Information for Clinical Investigators

Overview of Drug Approval Application Process

New Drug Application Approval Process (schematic)

Abbreviated New Drug Application (ANDA) Process for Generic Drugs

IND Application Approval Process (schematic)

From Test Tube to Patient: Improving Health Through Human Drugs (Sept. 1999 ed.) (PDF)

Comprehensive List of Guidance Documents (PDF)

The Orange Book (searchable list of approved drug products with therapeutic equivalence evaluations)

U.S. FDA's mifepristone (RU-486) information page

Pediatric Drugs: Pediatric Medicine page

Marketing Practices:

HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers (April 2003) (PDF)

PhRMA Code on Interactions with Healthcare Professionals

PhRMA Principles for Conduct of Clinical Trials and Communication of Trials Results (June 20, 2002)

Biologics:

Center for Biologics Evaluation & Research (CBER)

CBER Reading Room (approval information, enforcement actions, healthcare letters, information sheets, rules, etc.)

CBER Guidance/Guidelines/Points to Consider

CBER Tissue Action Plan -- Documents
EMTALA:
- Statute:
  - EMTALA statute (Office of Code Revision Counsel)
  - Cornell's LII version (has easy update feature)
- Rules: 42 C.F.R.
  - Final rule (68 Fed. Reg. 53222 (
    Sept. 9, 2003)) (PDF) (TXT)
    
    CMS Press Release on Final Rule (Aug. 29, 2003)
  - e-CFR provisions (updated daily and generally easier to access than the official version on NARA's site)
    - § 489.24
    - § 489.20 (see subsecs. l, m, q & r)
- Guidance, Interpretations, Resources, etc.
  - Medicare State Operations Manual, App. V – Interpretive Guidelines – Responsibilities of Medicare Participating Hospitals in Emergency Cases (Revision 1, May 21, 2004)
    - CMS' Interim Guidance Letter (Nov. 7, 2003)
    - CMS' Program Memoranda (June 13, 2002) re: on-call requirements and simultaneous on-call coverage (PDF) (if these links don't work, try CMS' Program Memo page)
    - HCFA's Investigative Procedures and Interpretive Guidelines (State Operations Manual, Appendix V (go to p. 118 of 313; interpretive guidelines start at p. 131) (pdf)
      - HCFA's Interpretive Guidelines (pdf) (private site - faster to load)
  - HCFA's Medicare Learning Center
    - EMTALA Q&A's (missing in action)
    - Interaction of ABNs and EMTALA FAQ
  - OIG's Survey of Hospital Emergency Departments and report on "The Enforcement Process" (both Jan 2001)
  - OIG's Special Advisory Bulletin (press release) , 64 Fed. Reg. 61353 (Nov. 10, 1999): text or PDF (slow to load)
- See also
  - EMTALA.com (excellent resource) (statute, regs, interpretations, etc.)
  - American College of Emergency Physicians: EMTALA page
  - American Academy of Emergency Medicine: EMTALA page
  - Frew Consulting Group
ERISA/Health Insurance Portability & Accountability Act/COBRA: HHS' Administrative Simplification Page (HIPAA privacy rules) | HIPAA Home Page (HCFA) | HIPAA Q&A (Dep't of Labor) (Nov 98 Supplement) | HIPAAComply (Beacon Partners) | Health Benefits under COBRA (Dep't of Labor) | HIPAA vs. COBRA (IRS Notice 98-12) | Dep't of Labor's ERISA Statute, Rules, Advisory Opinions page | Amicus briefs re: preemption of med-mal claims against HMOs and "complete preemption"
FBI: home page | "About the Health Care Fraud Unit" | Criminal Fraud Cases (summary) | "Health Care Fraud: National and Local Perspective on a Growing Trend" | Statement to Congress on Health Care Fraud (2000)
Genetics: The National Human Genome Research Institute (NIH) | NIH's information page on Certificates of Confidentiality | DOE's Human Genome Project Information page | GeneTests (from Nat'l Library of Medicine (NIH) and Maternal & Child Health Bureau (HRSA) | U.S. Patent & Trademark Office (press releases) | Notice of Utility Examination Guidelines for gene patents (Jan. 5, 2001, Fed. Reg.) | Nature's Genome Information Centre (includes great collection of news, ethics articles, useful links) | See also my Bioethics/Web Resources page for many more links
Government Accountability Office: reports | Health-related reports from 1997 - present
Health and Human Resources: homepage | employee directory | What's New | Press Releases and Fact Sheets
HIPAA Portability Final Rule: 69 Fed. Reg. 78719-99 (Dec. 30, 2004)
HIPAA Privacy Rules:
- HIPAA law (Pub. L. No. 104-191)
- Updated versions of 45 C.F.R. Parts 160 & 164
- HHS/OCR HIPAA resource page
  - HHS/OCR Final Rule page
- CMS' Administrative Simplification Page - Electronic Transactions & Code Sets
  - Educational Materials
    - HIPAA Administrative Simplification Information Series for Providers
    - Provider HIPAA Checklist
Human Subject Research: (extensive nongovernmental materials here)
- DHHS: Office for Human Research Protections (OHRP):
- National Institutes of Health:
  - MedlinePlus' intro to clinical trials - great place to start research
  - Office of Extramural Research - Office for Protection from Research Risks (OPRR)
    - NIH's Certificates of Confidentiality Kiosk (includes detailed background information, FAQs, and application information)
  - Human Subjects Protection page
Labor & employment: National Labor Relations Board (Decisions) (Weekly Summary) (Rules & Regulations) (Public Notices) | Occupational Safety & Health Administration (OSHA) (11/01 Enforcement Directive re: bloodborne pathogens)
Medical records, electronic files, etc.:
- HHS' "Administrative Simplification" website
- Health Information Retention Policies
  - AHIMA Practice Brief, updated June 1999, with federal standards (Chart 3) as well as AHIMA guidelines, accreditation-agency standards, and 50-state survey
  - DHHS OIG's Compliance Guidance Page (most compliance manuals have a document-retention standard)
Medicare/Medicaid
- Statutes: Laws & Regulations Portal Page (includes HCFA Rulings, Hearings & Appeals, Advisory Opinions) | Compilation of the Social Security Act (Medicare - Title. XVIII) (Medicaid - Title XIX) (General provisions - Title XI (including fraud and abuse) | CMS Quarterly Provider Update - listing of rules and instructions, listed by provider type | HHS Summary of Medicare/Medicaid Provisions of the Balanced Budget Act of 1997 | Ways and Means Committee: Green Book (searchable) (book format) | See also Medicare and Health Care Chartbook (Feb. 27, 1997) | Ways and Means Committee's Publications Page | Medicare Rights Center
- 2003 Reform Legislation
  - AHLA Teleconference Materials for Members
  - Law firm newsletters
    - Health Law Update: Congress Approves Medicare Prescription Drug and Modernization Act of 2003 - McDermott Will & Emery
      Health Law Update Vol. 20, No. 7
    - Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - Cozen O'Connor
    - The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - Reed Smith
    - The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - Baker & McKenzie
    - The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - Crowell & Moring (Arthur N. Lerner)
    - The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Its Impact on Hospitals - Gardner Carton & Douglas
- HHS & CMS (formerly HCFA):
  - U.S. Dep't of Health & Human Services (U.S. DHHS) | (employee directory) (Press Office) (News from HHS Agencies)
  - U.S. DHHS: Centers for Medicare and Medicaid Services (CMS) (formerly Health Care Financing Administration (HCFA)) (Press Releases)
    - Medicare and Medicaid Program Instructions (paper-based manuals, internet-only manuals, program transmittals, program memoranda)
    - CMS Quarterly Provider Update - listing of rules and instructions, listed by provider type
    - Conditions of Participation & Conditions for Coverage
    - Hospital Conditions of Participation for Patients' Rights - Interpretive Guidelines
    - HCFA Rulings of the Administrator
    - Index of Operational Policy Letters
    - HCFA Standing Committees
    - Practicing Physicians Advisory Council
    - Medicare Coverage Advisory Committee
    - Consumer Publications
    - Medicare Learning Network (physicians and other providers)
    - "Medicare & You/2003" (PDF)
      - Physician Edition/2002 (PDF) (physician-specific pages only)
    - "What Every Resident Needs to Know About the Medicare Program" (HCFA, 1999; 148 pp.) (PDF)
    - "MEDICARE RESIDENT & NEW PHYSICIAN GUIDE: Helping Health Care Professionals Navigate Medicare, 7th Edition – August 2003" (PDF)
    - Texas Medicaid in Perspective (2002) (PDF)
      - Texas Medicaid web site
  - See also Medicare Compliance Alert (requires subscription)
- Medicare Payment Systems: CMS web page with links to each type of provider
- Fraud & Abuse:
  - Statutes:
    - Stark (Cornell server)
      - 42 CFR Parts 411 (see §§ 411.350-.361) & 424.22
      - Stark II final rule, Phase 1: 66 Fed. Reg. 855 (Jan. 4, 2001) (pt. i, pt. ii, pt. iii (PDF)) - usually incredibly slow to load
      - Stark II final rule, Phase 2: 69 Fed. Reg. 16054 (March 26, 2004) (PDF)
    - Antikickback (Cornell server)
      - Safe Harbor Regs
      - 42 CFR § 1001.951
      - OIG resource page
  - "Medicare Fraud & Abuse" (2d ed., March 1999) (53 pp.) (PDF)
  - Regulatory pages: U.S. DHHS Office of Inspector General (OIG) (HHS OIG What's New) (proposed rules) (program exclusions) (searchable exclusions page) (see also Government Service Agency's excluded parties list (all agencies, all programs) & (Medical Staff Service's consolidated list of OIG exclusions) | OIG Fraud Prevention & Detection (letters, reports, statements, safe harbor regs & preambles) | OIG Advisory Opinions (illegal remuneration) | | HCFA/CMS Fraud Page | OIG Fraud Alerts, Special Fraud Alerts, Medicare Advisory Bulletins & Special Advisory Bulletins | Orange Book (nonmonetary recommendations for program improvements) | Guide to Clinical Preventative Services (2nd ed.) (a key to understanding part of the OIG's Civil Money Penalty authority) | OIG Compliance Program Guidance | Corporate Integrity Agreements (current list of entities subject to CIAs) | OIG Office of Evaluation & Inspections (procedure manuals, reports, etc.) (recent E&I reports) | HCFA Advisory Opinions (Stark) | Health Integrity and Protection Data Bank (Final rule (Federal Register) (CFR) (e-CFR))
    - Sec. Thompson's letter to AHA re: discounts for the uninsured
    - OIG/CMS Guidance re: discounts for the uninsured
- False Claims Act: Department of Justice (DOJ) (False Claims Act Guidance in Civil Health Care Matters (June 3, 1998)) (Review of June 3, 1998, Guidance on the Use of the False Claims Act in Civil Health Care Matters (Feb. 3, 1999)) | U.S. Attorneys' Manual (new 9-2.032 deals with prosecutions of attorneys (see Title 9 zip file)) | GAO Report (Aug. 1999) re: Implementation of FCA Guidelines (HTML) (PDF) | See also Fried Frank's False Claims Act page | False Claims Act and Qui Tam Quarterly Review
- Texas Medicaid Program: Medicaid Eligibility Handbook | Texas Department of Human Services' Medicaid page | Supplemental Medicare Program | Texas Health & Human Services' Children's Health Insurance Program (CHIP) page - DHHS SCHIP page - DHHS/Office of the Assistant Secretary for Planning and Evaluation's (ASPE) SCHIP Evaluation Website - DHHS/ASPE's Office of Health Policy's Children's Health Issues page
- Selected Medicaid Issues:
  - AHLA's Medicaid Guide: Medicaid Basics: A Question and Answer Guide about Eligibility, Coverage and Benefits (2006)
  - Medicaid Handbook: Kaiser Family Foundation (invaluable)
  - Medicaid Benefits: Kaiser Commission's 50-state survey
  - Estate Recovery and Third-party Recovery
    - From CMS: http://www.cms.hhs.gov/medicaid/estaterec.asp
    - Texas Health and Human Services briefing paper (Jan. 2004) and statement on a proposed rulemaking on the subject

National Practitioner Data Bank: National Practitioner Data Bank: Guidebook | Health Integrity and Protection Data Bank (Final rule) (Guidebook)

Patent: U.S. Patent & Trademark Office (press releases) | Notice of Utility Examination Guidelines for gene patents (Jan. 5, 2001, Fed. Reg.)

Policy: Agency for Health Care Research & Quality | The National Academies | Institute of Medicine

Practice guidelines: Agency for Healthcare Research & Quality: Guidelines | See also National Guideline Clearinghouse

Presidential commissions: President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry ( Patients Bill of Rights, e.g.) | National Bioethics Advisory Commission

Public health: Centers for Disease Control (Public Health Image File (CDC)) | CDC's Public Health Law Program | Institute of Medicine (part of the National Academies) | Reports of the U.S. Surgeon General | Non-governmental resources: Ed Richards' web page | WWW Virtual Library: Public Health (U.S.A.)
- Bioterrorism: