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| >American Health Lawyers Association Pharmaceutical and
Device Law Institute March 15, 2005 Baltimore Marriott Waterfront Hotel
Baltimore, MD
Links for ASG MMA Part D >http://www.lbjlib.utexas.edu/johnson/archives.hom/speeches.hom/650730.asp >http://www.cms.hhs.gov/about/history/bushsignMMA2003.asp http://www.cms.hhs.gov/medicarereform/pdbma/general.asp >http://www.cms.hhs.gov/medicarereform/mma-t1t2-calendar.pdf >http://www.hsadecisions.org/Default.asp >http://www.hsainsider.com/ >http://www.opm.gov/hsa/chart.asp >http://www.medplanaccess.com/hsa/overview.htm >http://www.cms.hhs.gov/opendoor/092004/TrOOP93004.pdf >Internal Revenue Bulletin: 2004-15 April 12, 2004 Rev. Rul. 2004-38 Table of Contents ISSUE FACTS LAW AND ANALYSIS HOLDINGS DRAFTING INFORMATION Health Savings Accounts (HSAs). This ruling provides that if an individual is covered by both a high deductible health plan (HDHP) that does not cover prescription drugs and by a separate prescription drug plan (or rider) that provides benefits before the minimum annual deductible of the HDHP has been satisfied, that individual is not an eligible individual under section 223(c)(1)(A) of the Code and may not make contributions to a Health Savings Account. >Internal Revenue Bulletin: 2004-15 April 12, 2004 Notice 2004-23 Health Savings Accounts—Preventive Care PURPOSE BACKGROUND PREVENTIVE CARE SAFE HARBOR INTERACTION WITH STATE LAW HEALTH CARE REQUIREMENTS COMMENTS REQUESTED DRAFTING INFORMATION PURPOSE This notice provides a safe harbor for preventive care benefits allowed to be provided by a high deductible health plan (HDHP) without satisfying the minimum deductible under section 223(c)(2) of the Internal Revenue Code. >Internal Revenue Bulletin: 2004-22 June 1, 2004 Rev. Rul. 2004-45 Table of Contents ISSUE FACTS LAW AND ANALYSIS HOLDINGS Drafting Information Health Savings Account (HSA) - interaction with other health arrangements. This ruling addresses the interaction between Health Savings Accounts (HSAs), health flexible spending arrangements (health FSAs), and health reimbursement arrangements (HRAs). ISSUE In the situations described below, may an individual make contributions to a Health Savings Account (HSA) under section 223 of the Internal Revenue Code if the individual is covered by a high deductible health plan (HDHP) and also covered by a health flexible spending arrangement (health FSA) or a health reimbursement arrangement (HRA)? >Administrative, Procedural, and Miscellaneous Section 223: Health Savings Accounts Rev. Proc. 2004-22 SECTION 1. PURPOSE This revenue procedure provides transition relief from Revenue Ruling 2004-38 for determining an “eligible individual” under section 223 who may make contributions to a Health Savings Account (HSA). The transition relief covers the months before January 1, 2006, in the case of an individual who is covered by both a high deductible health plan (HDHP) and by a separate plan or rider that provides prescription drug benefits before the minimum annual deductible of the HDHP is satisfied. > IRS 2004 Form 8889•••• Health Savings Accounts (HSAs) >IRS 2004 Instructions for Form 8889 •••• Health Savings Accounts (HSAs) >IRS Publication 969 (2004) Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2004 Returns Table of Contents Publication 969 - Introductory Material What's New Reminder Introduction Publication 969 - Main Contents Health Savings Accounts (HSAs) Qualifying for an HSA Contributions to an HSA Distributions From an HSA Balance in an HSA Death of HSA Holder Filing Form 8889 Employer Participation Medical Savings Accounts (MSAs) Archer MSAs Contributions to an MSA Distributions From an MSA Balance in an MSA Death of the Archer MSA Holder Filing Form 8853 Employer Participation Medicare Advantage MSAs Flexible Spending Arrangements (FSAs) Qualifying for an FSA Contributions to an FSA Distributions From an FSA Balance in an FSA Employer Participation Health Reimbursement Arrangements (HRAs) Qualifying for an HRA Contributions to an HRA Distributions From an HRA Balance in an HRA Employer Participation >Federal Register: January 28, 2005 (Volume 70, Number 18)] [Rules and Regulations] [Page 4193-4585] Copied February 18, 2005 from the Federal Register Online in .htm format >CMS Web Site for Medicare Modernization Act Prescription Drug Benefit / Medicare Advantage Programs Rules & More >Kaiser Family Foundation Resources on the Medicare Prescription Drug Benefit >ePrescribing Proposed Rule February 4, 2005 >http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php?p_cat_lvl2=167 >CMS Q&A as of February 18, 2005 >Comments of David Brailer, MD, Ph.D., National Coordinator for Health Information Technology, on February 17, 2005 in Dallas regarding >NHII BENEFICIARY PROTECTIONS FOR QUALIFIED PRESCRIPTION DRUG COVERAGE SEC. 1860D-4. [42 U.S.C. 1395w-104] (a) DISSEMINATION OF INFORMATION.— ...(e) ELECTRONIC PRESCRIPTION PROGRAM.— (1) APPLICATION OF STANDARDS.—As of such date as the Secretary may specify, but not later than 1 year after the date of promulgation of final standards under paragraph (4)(D), prescriptions and other information described in paragraph (2)(A) for covered part D drugs prescribed for part D eligible individuals that are transmitted electronically shall be transmitted only in accordance with such standards under an electronic prescription drug program that meets the requirements of paragraph (2). (2) PROGRAM REQUIREMENTS.—Consistent with uniform standards established under paragraph (3)— (A) PROVISION OF INFORMATION TO PRESCRIBING HEALTH CARE PROFESSIONAL AND DISPENSING PHARMACIES AND PHARMACISTS.—An electronic prescription drug program shall provide for the electronic transmittal to the prescribing health care professional and to the dispensing pharmacy and pharmacist of the prescription and information on eligibility and benefits (including the drugs included in the applicable formulary, any tiered formulary structure, and any requirements for prior authorization) and of the following information with respect to the prescribing and dispensing of a covered part D drug: (i) Information on the drug being prescribed or dispensed and other drugs listed on the medication history, including information on drug-drug interactions, warnings or cautions, and, when indicated, dosage adjustments. (ii) Information on the availability of lower cost, therapeutically appropriate alternatives (if any) for the drug prescribed. (B) APPLICATION TO MEDICAL HISTORY INFORMATION.—Effective on and after such date as the Secretary specifies and after the establishment of appropriate standards to carry out this subparagraph, the program shall provide for the electronic transmittal in a manner similar to the manner under subparagraph (A) of information that relates to the medical history concerning the individual and related to a covered part D drug being prescribed or dispensed, upon request of the professional or pharmacist involved. (C) LIMITATIONS.—Information shall only be disclosed under subparagraph (A) or (B) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (D) TIMING.—To the extent feasible, the information exchanged under this paragraph shall be on an interactive, real-time basis. (3) Standards.— (A) IN GENERAL.—The Secretary shall provide consistent with this subsection for the promulgation of uniform standards relating to the requirements for electronic prescription drug programs under paragraph (2). (B) OBJECTIVES.—Such standards shall be consistent with the objectives of improving— (i) patient safety; (ii) the quality of care provided to patients; and (iii) efficiencies, including cost savings, in the delivery of care. (C) DESIGN CRITERIA.—Such standards shall— (i) be designed so that, to the extent practicable, the standards do not impose an undue administrative burden on prescribing health care professionals and dispensing pharmacies and pharmacists; (ii) be compatible with standards established under part C of title XI, standards established under subsection (b)(2)(B)(i), and with general health information technology standards; and (iii) be designed so that they permit electronic exchange of drug labeling and drug listing information maintained by the Food and Drug Administration and the National Library of Medicine. (D) PERMITTING USE OF APPROPRIATE MESSAGING.—Such standards shall allow for the messaging of information only if it relates to the appropriate prescribing of drugs, including quality assurance measures and systems referred to in subsection (c)(1)(B). (E) PERMITTING PATIENT DESIGNATION OF DISPENSING PHARMACY.— (i) IN GENERAL.—Consistent with clause (ii), such standards shall permit a part D eligible individual to designate a particular pharmacy to dispense a prescribed drug. (ii) NO CHANGE IN BENEFITS.—Clause (i) shall not be construed as affecting— (I) the access required to be provided to pharmacies by a prescription drug plan; or (II) the application of any differences in benefits or payments under such a plan based on the pharmacy dispensing a covered part D drug. (4) DEVELOPMENT, PROMULGATION, AND MODIFICATION OF STANDARDS.— (A) INITIAL STANDARDS.—Not later than September 1, 2005, the Secretary shall develop, adopt, recognize, or modify initial uniform standards relating to the requirements for electronic prescription drug programs described in paragraph (2) taking into consideration the recommendations (if any) from the National Committee on Vital and Health Statistics (as established under section 306(k) of the Public Health Service Act (42 U.S.C. 242k(k))) under subparagraph (B). (B) ROLE OF NCVHS.—The National Committee on Vital and Health Statistics shall develop recommendations for uniform standards relating to such requirements in consultation with the following: (i) Standard setting organizations (as defined in section 1171(8)) (ii) Practicing physicians. (iii) Hospitals. (iv) Pharmacies. (v) Practicing pharmacists. (vi) Pharmacy benefit managers. (vii) State boards of pharmacy. (viii) State boards of medicine. (ix) Experts on electronic prescribing. (x) Other appropriate Federal agencies. (C) PILOT PROJECT TO TEST INITIAL STANDARDS.— (i) IN GENERAL.—During the 1-year period that begins on January 1, 2006, the Secretary shall conduct a pilot project to test the initial standards developed under subparagraph (A) prior to the promulgation of the final uniform standards under subparagraph (D) in order to provide for the efficient implementation of the requirements described in paragraph (2). (ii) EXCEPTION.—Pilot testing of standards is not required under clause (i) where there already is adequate industry experience with such standards, as determined by the Secretary after consultation with effected standard setting organizations and industry users. (iii) VOLUNTARY PARTICIPATION OF PHYSICIANS AND PHARMACIES.—In order to conduct the pilot project under clause (i), the Secretary shall enter into agreements with physicians, physician groups, pharmacies, hospitals, PDP sponsors, MA organizations, and other appropriate entities under which health care professionals electronically transmit prescriptions to dispensing pharmacies and pharmacists in accordance with such standards. (iv) EVALUATION AND REPORT.— (I) EVALUATION.—The Secretary shall conduct an evaluation of the pilot project conducted under clause (i). (II) REPORT TO CONGRESS.—Not later than April 1, 2007, the Secretary shall submit to Congress a report on the evaluation conducted under subclause (I). (D) FINAL STANDARDS.—Based upon the evaluation of the pilot project under subparagraph (C)(iv)(I) and not later than April 1, 2008, the Secretary shall promulgate uniform standards relating to the requirements described in paragraph (2). (5) RELATION TO STATE LAWS.—The standards promulgated under this subsection shall supersede any State law or regulation that— (A) is contrary to the standards or restricts the ability to carry out this part; and (B) pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered part D drugs under this part. (6) ESTABLISHMENT OF SAFE HARBOR.—The Secretary, in consultation with the Attorney General, shall promulgate regulations that provide for a safe harbor from sanctions under paragraphs (1) and (2) of section 1128B(b) and an exception to the prohibition under subsection (a)(1) of section 1877 with respect to the provision of nonmonetary remuneration (in the form of hardware, software, or information technology and training services) necessary and used solely to receive and transmit electronic prescription information in accordance with the standards promulgated under this subsection— (A) in the case of a hospital, by the hospital to members of its medical staff; (B) in the case of a group practice (as defined in section 1877(h)(4)), by the practice to prescribing health care professionals who are members of such practice; and (C) in the case of a PDP sponsor or MA organization, by the sponsor or organization to pharmacists and pharmacies participating in the network of such sponsor or organization, and to prescribing health care professionals.
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