E-Health and Medical Billing Requirements

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1 Brochure More information from Telemedicine and E-Health Law. Description: The use of the Internet and high-tech communications in health care has led to new approaches to medical treatment-and to challenging legal questions. Telemedicine and E-Health Law has the answers that health care providers, hospitals, pharmaceutical companies, insurers and their legal counsel need as medicine enters a new era. Its comprehensive scope includes everything from the licensing issues raised by physicians providing medical services electronically across state lines to the HIPAA privacy issues raised by the sharing of electronic patient consultations and health records across computer networks. What should you know about regulation by the FDA, FTC, Medicare and state attorneys general when advertising or selling pharmaceuticals on the Web? When do Medicare and Medicaid requirements (including reimbursement and fraud and abuse provisions) apply to e-health transactions? What unique malpractice and other liabilities are associated with telemedical practice? This important book includes chapters on these topics, as well as on tax, antitrust, intellectual property, and other aspects of e-health-all packed with expert advice that will help you steer clear of difficulties. Telemedicine and E-Health Law the ideal guide for anyone involved in this growing and important field. Contents: CHAPTER 1 Telemedicine: Legal and Regulatory Issues Introduction Regulation of Telemedicine [1] Defining the Practice of Telemedicine [2] Licensure Requirements [2] Credentialing Corporate Practice of Medicine Prohibitions Telemedical Malpractice Liability [1] Procedural Issues [2] Providing Health Law Information v. Practicing Medicine [3] The Practice of Telemedicine [4] Telemedicine Equipment [5] Risk Reduction CHAPTER 2 Establishing and Operating Health Care Web Sites, Apps and Social Media Networks Introduction Contracting for Design and Development, Hosting and Generation of Information Content [1] Contractual Issues and Questions [2] Design and Development Agreements [3] Hosting of Site/App/Network [4] Information Content Terms of Use [1] BrowseWrap Contracts: Formation, Amendment and Termination [2] Content, Services, and Software Provided by Site/App/Network Providers and Third Parties [3] Advertisements [4] Hypertext Links [5] Interstate and International Aspects of Internet Communications [6] Credentials and Competence, Content and Conduct of Visitors and Users [7] Privacy and Related Matters [8] Security [9] Liability Management [10] General Administrative Provisions Regulatory Compliance in the Context of Web Sites, Apps and Social Media Networks [1] Background [2] September 2009 Notice of Public Hearing and Request for Comments [3] FDA Rulemaking Versus FDA Guidance Issuance

2 Limitations of Liability CHAPTER 3 Regulation of the Promotion and Sale of Drugs, Medical Devices, and Dietary Supplements on the Internet Introduction Online Advertising and Promotion of Health-Related Products [1] Prescription Drugs and Restricted Medical Devices [2] Over-the-Counter (OTC) Drugs and Unrestricted Medical Devices [3] Dietary Supplements Online Sale of Health-Related Products [1] Online Non-Pharmacy Sales of Drugs and Medical Devices [2] Online Pharmacy Sales of Prescription Drugs/Devices [3] Cooperative Enforcement Against Online Sellers Conclusion CHAPTER 4 Intellectual Property and E-Health Sites Introduction Copyright [1] Copyright Protection in the United States [2] Overview of United States Copyright Law [3] International Copyright Protection [4] Licensing Content on the Internet Rights of Privacy and Publicity [1] Common-Law Right of Privacy [2] Right of Publicity Trademarks and Service Marks [1] Trademark Protection in the United States [2] International Trademark Protection [3] Trademark Licensing Trade Secrets [1] The Uniform Trade Secrets Act [2] Common Law Trade Secret Protection [3] Overlap with Other Forms of Protection [4] Methods, Practices and Policies for Trade Secret Protection for E-Health Activities Patents [1] Utility Patent Protection in the United States [2] Design Patents [3] Design Patents May Be Applicable to E-Commerce, Including Icons and Other Subject Matter [4] Emerging Issues Unique or Related to E-Health [5] Patent Protection Outside the United States Importance to E-Health CHAPTER 5 Legal Aspects of Electronic Health Records (EHRs): Guidelines for Implementing EHRs Initial Considerations [1] Introduction to EHRs and Relevant Laws [2] Fraud and Abuse Issues (Anti-Kickback and Self-Referral Laws) Implementation of an EHR System [1] Evaluating an EHR Software License Agreement [2] Medical Record and Electronic Signature Requirements [3] Privacy Issues [4] Genetic Information Nondiscrimination Act [5] Security Issues: HIPAA Security Rule [6] Security Issues: The HITECH Act [7] Integrity Issues Health Information Networks (HINS) [1] Federal Government Efforts to Build a National HIN [2] State Government Efforts to Build HINs [3] Regional and Private Initiatives to Build HINs [4] Participating in a HIN: Issues to Consider EHRS as Business and Legal Records [1] The Legal EHR

3 [2] Release of EHR Information for Purposes of Litigation [3] E-Discovery [4] Security Breach Notification [5] Patient Safety Act Standardization of Electronic Health Records [1] State Initiatives for Standardization of Electronic Health Records [2] Private Initiatives [3] Federal Initiatives CHAPTER 6 Privacy of Electronic Health Information Basic Concepts of Privacy, Confidentiality and Security [1] Privacy as an Individual's Right To Be Left Alone [2] Privacy of Personal Health Information [3] Protections for Personal Health Information in an Electronic Age [4] Striking a Balance: Protecting the Privacy of Electronic Health Information Without Hindering the Advancement of Medical Research and Other Activities for the Public Good Health Insurance Portability and Accountability Act of 1996 [1] HIPAA Administrative Simplification Regulations [2] HIPAA Privacy Regulations [3] Information Covered Under the Privacy Regulations [4] Entities Covered Under or Affected by the Privacy Regulations [5] Permitted or Required Uses or Disclosures [6] Compliance and Enforcement A Health Information Technology for Economic and Clinical Health Act (2009) [1] Business Associates [2] Limitations on Sales and Disclosure of PHI [3] Individual Rights [4] Increased Enforcement and Penalties Other Federal Restrictions [1] Federal Privacy Act of 1974 [2] Gramm-Leach-Bliley Act [3] Children's Online Privacy Protection Act [4] Federal Substance Abuse Record Confidentiality Rules [5] Electronic Communications Privacy Act [6] Other Federal Privacy Laws State Law: Health Information Privacy [1] Examples of State Statutes [2] Additional State Privacy Protections [3] Mandatory Disclosures Under State Law International Restrictions The European Union Directive on Data Protection [1] Prohibitions on Transfer of Personal Data [2] Transfers of Health-Related Information [3] Data Protection Authorities and Tribunals [4] Principles for Protecting Personal Data [5] Protection of Data Outside of the EU Community [6] The EU-U.S. Safe Harbor Self-Regulation for Health Internet Websites [1] The American Accreditation Health Care Commission ( URAC ) Accreditation Program [2] Health Internet Ethics ( Hi-Ethics ) Principles for Offering Internet Health Services to Customers [3] TRUSTe Privacy Seal of Approval [4] Health of the Net (HON) Foundation HONcode Seal of Approval [5] Internet Health Coalition ehealth Code of Ethics Application of Privacy Restrictions to Telemedicine CHAPTER 7 E-Health and Antitrust Introduction The Antitrust Laws [1] Governing Principles [2] Types of Conduct Prohibited [3] Exemptions and Immunities [4] Remedies and Enforcement

4 Potential Antitrust Issues in the E-Health Context [1] Competition Among the Venture Participants [2] Competition at the Network Level Case Studies [1] Scenario One: A Cooperatively-Formed Claims Processing Network [2] Scenario Two: An Independent Medical Products Procurement Exchange Conclusion CHAPTER 8 Reimbursement for Telemedicine Services Introduction [1] Overview [2] Reimbursement Coverage Considerations [3] Service Definition and Payment Amount [4] Obtaining Coverage Medicare [1] Background [2] Medicare Coverage of Telemedicine Medicaid [1] Background [2] Federal Statute and State Determinations [3] Medicaid Managed Care Programs [4] Current State Medicaid Telemedicine Programs [5] Future Developments Veterans Administration State Regulated Insurance Companies [1] Mandatory Coverage Laws [2] Discretion of Payers [3] Required State Insurance Department Filings [4] Checking Policy and Coverage Before Submitting Claims [5] Case Management Coverage Opportunities [6] Preferred Provider Organizations [7] Summary Health Maintenance Organizations ERISA Plans [1] State Regulation of ERISA Plans That Purchase Coverage From Commercial Insurers [2] Discretion of Self-Insured Plans [3] ERISA Plans Driven Both by Economic Concerns and Paternalism for Employees [4] Case Management and Exceptions [5] Summary Conclusion Appendix CHAPTER 9 Fraud and Abuse Introduction [1] Overview of Federal Fraud and Abuse Laws [2] Issues in Application to E-Health False Claims or False Statements [1] False Claims Against the Government [2] False Claims Against Private Entities Kickbacks and Financial Inducements for Referrals [1] Prohibition on Kickbacks [2] Regulatory Safe Harbors to the Anti-Kickback Statute [3] Penalties Under the Anti-Kickback Statute [4] Scope and Breadth of Anti-Kickback Statute Exclusion Remedies [1] Mandatory Exclusion [2] Discretionary Exclusion [3] Strategic Corporate Re-Structuring [4] Regular Screening of Employees for Exclusion Stark Act

5 [1] Violation and Penalties [2] Designated Health Care Services [3] Principal Exceptions [4] Exception for Electronic Prescribing and Electronic Health Records Arrangements [5] CMS Advisory Opinion Special Fraud Alerts [1] Joint Venture Arrangements [2] Routine Waiver of Part B Copayments and Deductibles [3] Hospital Incentives to Physicians [4] Prescription Drug Marketing Schemes [5] Clinical Laboratory Arrangements Proposed Use of Electronic Records for Fraud Detection OIG Advisory Opinions [1] Ophthalmologist/Optometrist Arrangement [2] Rural Telemedicine Network [3] Medical Alert Pagers [4] Telemedicine School Screening Program Potential E-Health Fraud and Abuse Issues [1] Integrated Delivery System/Joint Venture Issues [2] Provision of Electronic Medical Records Systems [3] Accountable Care Organizations [4] Provision of Equipment or Software to Facilitate E-Health Connections [5] Responsibility for Costs of E-Health Networks [6] Manufacturer Sponsored Web-Based Referral Services [7] False Claim Issues with Telemedicine [8] Fee Splitting/Inducements [9] GPOs and B2B Arrangements Conclusion Appendix CHAPTER 10 Taxes and Web Activities Introduction Unrelated Business Income Tax Basics [1] Purpose of Tax [2] Basic Tests For Taxability [3] Exclusions Sales/Merchandising Activities Web Site Activities [1] Corporate Sponsorship Rules [2] Specific Issues Exemption Issues [1] Lobbying Restrictions [2] Political Campaign Activity Restrictions [3] Joint Ventures [4] Electronic Health Record (EHR) Arrangements State Charitable Solicitation Statutes Conclusion Appendix Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) Privacy Regulations Index Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8,

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7 Page 1 of 2 Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to (from USA) or (from Rest of World). If you have any questions please visit Order Information Please verify that the product information is correct and select the format(s) you require. Product Name: Web Address: Office Code: Telemedicine and E-Health Law. SC Product Formats Please select the product formats and quantity you require: Online Access (1 Year Sub.) - Single User: Hard Copy and Online Access (1 Year Sub.) - Single User: Quantity USD 588 USD USD 57 Shipping/Handling * Shipping/Handling is only charged once per order. Contact Information Please enter all the information below in BLOCK CAPITALS Title: Mr Mrs Dr Miss Ms Prof First Name: Last Name: Address: * Job Title: Organisation: Address: City: Postal / Zip Code: Country: Phone Number: Fax Number: * Please refrain from using free accounts when ordering (e.g. Yahoo, Hotmail, AOL)

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