MEDICINE AND LAW COMMITTEE

TIPSExpress
Medicine and Law Statutory and Regulatory Updates
from the Tort Trial & Insurance Practice Section

Attorneys practicing in the field of medicine and law face the overwhelming task of keeping current with daily changes in the law. To help attorneys manage the vast amount of information, the TIPS Medicine and Law Committee is pleased to introduce a free, archived and searchable legal database featuring entries in reverse chronological order that relate to newly enacted federal statutes, proposed federal legislation, and new or proposed federal regulations. Our partner, Quicklaw America, http://www.quicklawamerica.com, works closely with us to provide these legal news items which include a headline, a brief summary of the relevant legal event, and citation to the public law or page of the Federal Register or Congressional Record.  Direct questions, comments, or suggestions to braun@newnorth.net.

Back Issues of Legal News can be found at:   http://www.qlamerica.com/legalnews/legalnews.html

REGULATIONS

Retrieve regulations from http://www.access.gpo.gov/su_docs/aces/aces140.html
The searchable database covers Federal Register volumes 60, 61, 62, 63, and 64 (years 1995-99).

HHS PROPOSES WHISTLEBLOWER PROTECTION REGS
65 FR 70830, Nov. 28, 2000.

The Department of Health and Human Services is proposing regulations to protect persons who make a good faith allegation that a covered institution or one of its members engaged in or failed to respond adequately to an allegation of research misconduct and persons who cooperate in good faith with an investigation of research misconduct.

HEALTH PLAN DEFINITION CORRECTED
65 FR 70506, Nov. 24, 2000, correcting 45 CFR Sec. 61.3.

The Department of Health and Human Services has corrected the definition of "health plan" in national health care fraud and abuse data collection regulations.

HEALTH INSURANCE ELECTRONIC TRANSACTION REGS CORRECTED
65 FR 70507, Nov. 24, 2000, correcting 45 CFR Parts 160 and 162.

The Department of Health and Human Services has corrected technical errors in its health insurance reform electronic transactions standards regulations.

SBA ISSUES NEW SIZE STANDARDS FOR HEALTH CARE INDUSTRIES
65 FR 69432, Nov. 17, 2000, amending 13 CFR Part 121.

The Small Business Administration has adopted new size standards for health care industries to more appropriately define the size of businesses eligible for federal small business assistance programs.

The Food and Drug Administration has announced an information-collection concerning over-the-counter test sample collection systems for drug abuse testing and requests comments.

The Department of Health and Human Services has issued regulations updating the prospective payment system for hospital outpatient services furnished to Medicare beneficiaries.

The Department of Veterans Affairs has amended medical regulations to permit lower payments to non-VA public or private hospitals or physicians for inpatient or outpatient care for eligible VA beneficiaries based on negotiated contracts rather than the current payment system based on Medicare methodology.

The National Institutes of Health is amending regulations to add conditions under which traineeship awards may be terminated and to revise the authorities for the awards.

The Health Care Financing Administration is proposing the establishment of a prospective payment system for Medicare payment of inpatient hospital services provided by a rehabilitation hospital or by a rehabilitation unit of a hospital to replace the reasonable cost-based payment system under which the rehabilitation hospitals and rehabilitation units are currently paid.

The Department of Veterans Affairs has amended its medical regulations concerning reasonable charges for care provided for nonservice-connected disabilities incurred under various circumstances including for which the veteran is entitled to care under a health plan contract.

The Health Care Financing Administration has issued a final rule with comment period to make changes affecting Medicare Part B payments including alteration of resource-based practice expense relative value units, geographic practice cost indices and resource-based malpractice RVU’s and announces the CY 2001 Medicare physician fee schedule conversion factor.

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HCFA PROPOSES CHANGE IN APPLICATION OF MEDICAID FEDERAL FINANCIAL PARTICIPATION LIMIT
65 FR 64919, Oct. 31, 2000, affecting 42 CFR Part 435.

The Health Care Financing Administration is proposing amendment to the regulations governing the application of Federal Financial Participation (FFP) limits to ease the current regulatory interpretation that limits must be applied before States use less restrictive income methodologies than those used by related cash assistance programs in determining eligibility for Medicaid.

The Food and Drug Administration is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products.

The Department of Defense has issued regulations for the implementation of the TRICARE dental program allowing dental insurance to eligible dependents of certain members of the armed forces.

The Health Resources and Services Administration has proposed a more flexible compliance standard for health care facilities receiving assistance that principally serve nonpaying patient populations.

The Health Care Financing Administration has eliminated the requirements and references to the Cardiac Pacemaker Registry in its regulations as a repeal of duplicative and unnecessary medical device reporting in compliance with legislation.

The Food and Drug Administration has amended the menstrual tampon labeling regulation to add the term ``ultra'' absorbency for tampons and proposes an amendment to change the current labeling term "junior" to "light".

The Federal Trade Commission is proposing a study to investigate how generic drug competition has developed in light of certain recent laws governing entry of generic drug products into the market and seeks comment on such an investigation

The Federal Trade Commission has reopened and extended the comment period to the regulations to implement the Comprehensive Smokeless Tobacco Health Education Act of 1986

FDA ENVIRONMENTAL IMPACT AMENDMENTS CONFIRMED
65 FR 60359, Oct. 11, 2000, 21 CFR Part 25.

The Health Care Financing Administration has issued a final rule establishing additional standards to qualify as a Medicare supplier of durable medical equipment, prosthetics, orthotics and supplies.

The Health Care Financing Administration has proposed to modify Medicaid upper payment limits for inpatient hospital services, outpatient hospital services, nursing facility services, intermediate care facility services for the mentally retarded, and clinic services.

FDA RECLASSIFIES ENDOSSEOUS DENTAL IMPLANT ACCESSORIES
65 FR 60098, Oct. 10, 2000, 21 CFR Part 872.

The Food and Drug Administration has reclassified the manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools and laboratory pieces used for fabrication of dental prosthetics and other manually powered endosseous dental implant accessories from class I to class II based on new information.

ELIGIBILITY FOR HABILITATION SERVICES EXPANDED UNDER MEDICAID
65 FR 60105, Oct. 10, 2000, 42 CFR Parts 440 and 441.

The Health Care Financing Administration has issued a final rule with comment period expanding State flexibility to provide prevocational, educational and supported employment services under the Medicaid home and community-based services waiver provisions and deleting the eligibility prerequisites of prior institutionalization for services.

PRESCRIPTION DRUG INFORMATION PROVIDED TO PATIENTS NATIONAL SURVEY INFORMATION COLLECTION ANNOUNCED BY FDA
65 FR 59849, Oct. 6, 2000.

The Food and Drug Administration has announced an information collection concerning the proposed collection of information on a national tracking survey, conducted every 2 years, of prescription drug information received by patients.

BLOOD AND BLOOD COMPONENTS MANUFACTURING PRACTICES AND REGS INFORMATION COLLECTION ANNOUNCED BY FDA
65 FR 59851, Oct. 6, 2000.

The Food and Drug Administration has announced an information collection concerning current good manufacturing practices and related regulations for blood and blood components.

FDA UPDATES DIETARY SUPPLEMENT HEALTH CLAIMS AND LABELING STATEMENTS ENFORCEMENT STRATEGY
65 FR 59855, Oct. 6, 2000.

The Food and Drug Administration has updated its strategy to implement the recent court decision, Pearson v. Shalala, including an enforcement strategy for dietary supplement health claims that do not meet the "significant scientific agreement" standard of evidence and also changes in the process that will be used for reconsidering the four Pearson health claims and for responding to future petitions for dietary supplement health claims.

MEDICARE+CHOICE REGS CORRECTED
65 FR 59748, Oct. 6, 2000, amending 42 CFR Part 422.

The Health Care Financing Administration issued final regulations implementing the Medicare+Choice program (65 FR 40169, June 29, 2000, amending 42 CFR Parts 417 and 422) and now corrects those regulations regarding deeming status.

HOSPITAL OUTPATIENT SERVICES PROSPECTIVE PAYMENT REGS DELAY NOTICE CORRECTED
65 FR 59748, Oct. 6, 2000, affecting 42 CFR Parts 412, 413 and 489.

The Department of Health and Human Services has corrected its notice that delayed until August the effective date of regulations implementing a prospective payment system for hospital outpatient services furnished to Medicare beneficiaries.

FDA REVOKES FOOD LABELING HEALTH CLAIMS REGS
65 FR 58917, Oct. 3, 2000, amending 21 CFR Part 101.

The Food and Drug Administration has revoked its regulations codifying the agency’s decision not to authorize the use of health claims for four substance-disease relationships in labeling of foods, including dietary supplements: dietary supplements and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and certain folate intake and neural tube defects.

The Department of Health and Human Services had issued regulations   (65 FR 18433, Apr. 7, 2000) implementing a prospective payment system for hospital outpatient services furnished to Medicare beneficiaries and now delays the effective date of these regulations until January 10, 2001.

The Department of Health and Human Services has noticed a new system of records for the Workplace Violence Prevention Team and proposes new routine uses for the system including disclosures to law enforcement and the Department of Justice to enhance the administration of health, safety and prevention programs.

The Agency for Healthcare Research and Quality (AHRQ) has proposed an annual panel survey of U.S. households to collect information on a variety of measures related to health status, health insurance coverage, health care use and expenditures, and sources of payment for health services.  Comment on this information-collection is requested.

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SEC ADVISORY COMMITTEE ON MARKET INFORMATION ESTABLISHMENT
65 FR 58135, Sept. 27, 2000.

The Pension Benefit Guarantee Corporation is seeking to extend its information collection on the termination of single employer plans and missing participants.

IMPLANTED MECHANICAL/HYDRAULIC URINARY CONTINENCE DEVICE PMA AND PDP REGS ISSUED
65 FR 57726, Sept. 26, 2000, 26 CFR Part 1. The Food and Drug Administration has issued a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/ hydraulic urinary continence device.

NURSE VISA INFORMATION COLLECTION APPROVED BY OMB
65 FR 57092, Sept. 21, 2000, 20 CFR Part 655. The Employment and Training Administration and the Employment Standards Administration of the Labor Department has announced the approval of an information collection by the Office of Management and Budget concerning attestations by facilities seeking to employ aliens as registered nurses in health professional shortage areas on a temporary basis under H-1C visas

FDA LABELING REQUIREMENTS FOR SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS INTENDED FOR HUMAN USE PROPOSED
65 FR 56511, Sept. 19, 2000. The Food and Drug Administration (FDA) is proposing to require that all systemic antibacterial drug products intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains.

FSIS RECALL INFORMATION SHARING PROTECTION FROM MANDATORY FOIA DISCLOSURE PROPOSED
65 FR 56749, Sept. 19, 2000, affecting 9 CFR Part 390. The Food Safety and Inspection Service, USDA has proposed regulations to permit recall information sharing with state and other federal government agencies and protect certain proprietary information from mandatory Freedom of Information Act disclosure to facilitate cooperation and improve public health protection.

STERILITY REQUIREMENTS FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL INHALATION INFORMATION COLLECTION SOUGHT
65 FR 56314, Sept. 18, 2000. The Food and Drug Administration is requesting comment on the proposed collection of information concerning sterility requirements for aqueous- based drug products for oral inhalation.

NASS EXPANDS APPROVAL SOUGHT FOR NATIONAL CHILDHOOD AGRICULTURAL INJURY INFORMATION COLLECTION TO INCLUDE OCCUPATIONAL HEALTH SURVEY OF MINORITY FARM OPERATORS
65 FR 56291, Sept. 18, 2000. National Agricultural Statistics Service (NASS) seeks approval for an information collection for the National Childhood Agricultural Injury And Occupational Health Survey Of Minority Farm Operators.

COMMERCIAL SPACE TRANSPORTATION FINANCIAL RESPONSIBILITY REQUIREMENTS FOR LICENSED REENTRY ACTIVITIES ADOPTED
65 FR 56669, Sept. 19, 2000, adding 14 CFR Part 450. The Federal Aviation Administration has issued procedures for demonstrating compliance with requirements for reentry activities and risk allocation.

FDA GUIDANCE DOCUMENT PROCEDURES ISSUED
65 FR 56468, Sept. 19, 2000, amending 21 CFR Parts 7, 10, 14, 19, 25, 101, 107, 110, 114, 170, 310, 312, 314, 316, 500, 514, 601, 803, 814, and 860. The Food and drug Administration has adopted regulations to specify policies and procedures for the development, issuance and use of guidance documents.

AMBULANCE FEE PAYMENT SCHEDULE UNDER MEDICARE PROPOSED
65 FR 54988, Sept. 12, 2000, affecting 42 CFR Parts 410 and 414. The Health Care Financing Administration has proposed a fee schedule for payment of ambulance services under the Medicare program to replace current systems and revise physician certification requirements for non- emergencies.

LEAD-BASED PAINT HAZARD EVALUATION AND REDUCTION ACTIVITIES TRANSITION ASSISTANCE ANNOUNCED
65 FR 54858, Sept. 11, 2000. The Department of Housing and Urban Development described transition assistance available to service providers for the implementation of the new requirements for notification, evaluation and reduction of lead- based paint hazards in federally owned residential property and housing receiving federal assistance.

FOOD LABEL HEALTH CLAIMS FOR PLANT STEROL/STANOL ESTERS AUTHORIZED
65 FR 54685, Sept. 8, 2000, amending 21 CFR Part 101. The Food and Drug Administration authorized the use on food labels of health claims linking reduced risk of coronary heart disease with plant sterol/stanol esters.

STATE AGENCIES AND CHARITABLE INSTITUTIONS ALLOWED PARTIAL OR TOTAL TORT IMMUNITY IN NASA CONTRACTS
65 FR 54439, Sept. 8, 2000, amending 48 CFR parts 1828 and 1852. The proposed rule amending the National Aeronautics and Space Administration FAR regulations allowing State agency and charitable institutions on NASA contracts partial or total tort immunity published April 25, 2000 (65 FR 24170-24171) was finalized without change.

NATIONAL INTEREST WAIVERS FOR SECOND PREFERENCE EMPLOYMENT-BASED IMMIGRANT PHYSICIANS AUTHORIZED
The Immigration and Naturalization Service has issued an interim rule establishing and explaining procedures to obtain a waiver of the job offer requirement for immigrant physicians serving in medically underserved areas or at Department Of Veterans Affairs facilities. 65 FR 53889, Sept. 6, 2000, amending 8 CFR parts 204 and 245.

CHILD RESISTANT PACKAGING FOR FORMER PRESCRIPTION DRUGS PROPOSED
The Consumer Product Safety Commission is proposing to require child-resistant packaging on over-the-counter drugs that contain active ingredients previously available only in prescription drugs. 65 FR 52679, Aug. 30, 2000.

PHARMACEUTICALS PRODUCTION EMISSION STANDARDS ISSUED
The Environmental Protection Agency has issued emission standards for hazardous air pollutants for pharmaceuticals production. 65 FR 52587, Aug. 29, 2000 amending 40 CFR Part 63.

STEM CELL RESEARCH GUIDELINES ISSUED
The National Institutes of Health have issued guidelines for research using human pluripotent stem cells. 65 FR 51976, Aug. 25, 2000.

VA CHANGES VOCATIONAL REHAB SUBSISTENCE ALLOWANCE RATES
The Department of Veterans Affairs has amended its regulations concerning vocational rehabilitation basic subsistence allowance rates. 65 FR 51763, Aug. 25, 2000, amending 38 CFR Part 21.

MEAT AND POULTRY PREPARATION SUBSTANCE REGS AMENDED
The Food and Drug Administration has amended regulations to permit efficient review of petitions to use a food ingredient or radiation source in or on meat or poultry products. 65 FR 51758, Aug. 25, 2000, amending 21 CFR Parts 71, 170, and 171.

NURSE VISA REGS ISSUED
The Labor Department has issued regulations concerning attestations by facilities seeking to employ aliens as registered nurses in health professional shortage areas on a temporary basis under H-1C visas. 65 FR 51137, Aug. 22, 2000, amending 20 CFR Part 655.

MEDICARE PROSPECTIVE PAYMENT AMENDMENTS PROPOSED
The Health Care Financing Administration is proposing to revise the criteria related to provider-based status requirements for hospitals excluded from the hospital inpatient prospective payment system. 65 FR 47706, Aug. 3, 2000.

CHEMICAL RELEASE INFO REGS ISSUED
The Justice Department and the Environmental Protection Agency have issued regulations relating to access to information concerning potential consequences of accidental chemical releases. 65 FR 48107, Aug. 4, 2000, adding 40 CFR Part 1400.

DOT PROPOSES ACCESSIBILITY GUIDELINES
The Department of Transportation is proposing to adopt accessibility guidelines under the Americans with Disabilities Act. 65 FR 68444, Aug. 8, 2000.

FDA RECLASSIFIES LITHOTRIPTER
The Food and Drug Administration has reclassified the exracorporeal shock wave lithotripter, used to fragment kidney and ureteral stones, to class II (special controls). 65 FR 48609, Aug. 9, 2000, adding 21 CFR Sec. 876.5990.

TRICARE RETIREE DENTAL REGS ISSUED
The Defense Department has amended regulations concerning the TRICARE Retiree Dental Program. 65 FR 48911, Aug. 10, 2000, amending 32 CFR Sec. 199.22.

SOCIAL SECURITY DISABILITY AMENDMENTS PROPOSED
The Social Security Administration is proposing various amendments to its regulations concerning disability benefits and supplemental security income. 65 FR 49208, Aug. 11, 2000.

TRICARE RETIREE DENTAL REGS AMENDED
The Defense Department has amended its regulations to allow additional benefits under the retiree dental insurance plan for Uniformed Services retirees and their family members that may be comparable to those under the Dependents Dental Program. 65 FR 49491, Aug. 14, 2000, affecting 32 CFR Part 199.

HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATOR REGS ISSUED
The Environmental Protection Agency has issued regulations concerning emission guidelines for hospital/medical/infectious waste incinerators located in states and Indian country without effective state or tribal plans. 65 FR 49869, Aug. 15, 2000, affecting 40 CFR Part 62.

CENTERS FOR DISEASE CONTROL GET QUARANTINE AUTHORITY
The Department of Health and Human Services has transferred from the Food and Drug Administration to the Centers for Disease Control authority for interstate quarantine over persons. 65 FR 49906, Aug. 16, 2000, amending 21 CFR Part 1240 and adding 42 CFR Part 70.

HEALTH ADMINISTRATIVE DATA STANDARDS ISSUED
The Department of Health and Human Services has issued regulations concerning standards for electronic transactions and the use of such standards by health plans, health care clearinghouses, and certain health care providers. 65 FR 50311, Aug. 17, 2000, adding 45 CFR Parts 160 and 162.

MEDICARE COVERAGE CRITERIA MEETING ANNOUNCED
The Health Care Financing Administration will conduct a town hall meeting in Baltimore on the last day of August, to discuss criteria for Medicare national coverage decisions. 65 FR 50171, Aug. 17, 2000.

SOCIAL SECURITY DISABILITY MENTAL DISORDER AND BRAIN INJURY REGS AMENDED
The Social Security Administration has amended its regulations concerning evaluation of mental impairments and disorders and traumatic brain injury. 65 R 50745, Aug. 21, 2000, amending 20 CFR Parts 404 and 416.

NRC REVISES POLICY STATEMENT ON MEDICAL USE OF BYPRODUCT MATERIAL
The Nuclear Regulatory Commission has revised its policy statement on the medical use of byproduct material. 65 FR 47654, Aug. 3, 2000.

MEDICARE TRANSITIONAL PASS-THROUGH PAYMENT REGS AMENDED
The Health Care Financing Administration has amended regulations concerning Medicare prospective payment system transitional pass-throughs for new devices, drugs, and biologicals. 65 FR 47670, Aug. 3, 2000, amending 42 CFR Parts 413 and 419.

Indian Gaming Environmental, Health, And Safety Regs Proposed
The National Indian Gaming Commission is proposing regulations to provide for adequate protection of the environment, public health, and safety under the Indian Gaming Regulatory Act. 65 FR 45558, July 24, 2000.

Hospice Prescription Fax Regs Issued
The Drug Enforcement Administration has clarified that narcotic prescriptions for certain hospice patients may be transmitted by facsimile even if the patients reside at home. 65 FR 45712, July 25, 2000, amending 21 CFR Sec. 1306.11.

Terminally Ill Veteran Accelerated Benefit Regs Proposed
The Department of Veterans Affairs is proposing regulations concerning the payment of accelerated benefits to terminally ill persons in the Servicemembers' Group Life Insurance and Veterans' Group Life Insurance programs. 65 FR 44999, July 20, 2000.

Tricare Regs Amended
The Defense Department has implemented legislation requiring a nonavailability-of-health-care statement for a beneficiary not enrolled in TRICARE Prime for TRICARE cost-share of certain maternity care services. 65 FR 45288, July 21, 2000, amending 32 CFR Sec. 199.4.

Federal Employees Health Benefits Pre-Tax Premium Regs Issued
The Office of Personnel Management has issued regulations to enable employees to pay Federal Employees Health Benefits with pre-tax dollars. 65 FR 44644, July 19, 2000, amending 5 CFR Part 890 and adding 5 CFR Part 892.

Medicare Part B Payment Amendments Proposed
The Health Care Financing Administration is proposing amendments relating to Medicare Part B payment. 65 FR 44176, July 17, 2000.

Wireless Medical Telemetry Regs Issued
The Federal Communications Commission has issued regulations for a Wireless Medical Telemetry Service that allows life-critical equipment to operate on an interference-protected basis. 65 FR 43995, July 17, 2000, affecting 47 CFR Parts 1, 2, 15, 90, and 95.

Veterans Adjudication Regs Amended
The Department of Veterans Affairs has amended its adjudication regulations to reflect changes made by the Veterans Millenium Health Care and Benefits Act. 65 FR 43699, July 14, 2000, amending 38 CFR Part 3.

FDA Amends Definition Of Court Decisions
The Food and Drug Administration has amended its definition of court decisions for the purpose of calculating certain time periods. 65 FR 43233, July 13, 2000, amending 21 CFR Sec. 314.107.

Social Security Acquiescence Ruling Rescinded
The Social Security Administration has rescinded Social Security Acquiescence Ruling 87-4(8), concerning what constitutes substantial gainful activity for purposes of entitlement to disability benefits. 65 FR 42793, July 11, 2000.

Applicability Of State Insurance Law To Church Plans Clarified
Recent ERISA amendments are designed to clarify the applicability of state insurance law to church welfare plans. Pub. L. 106-244, July 10, 2000, 114 Stat. 499.

Social Security Disability Regs Amended
The Social Security Administration has amended its disability regulations concerning the trial work period, the disability insurance reentitlement period, and the determination of whether work is substantial gainful activity. 65 FR 42771, July 11, 2000, amending 20 CFR Parts 404 and 416.

Social Security Penalty Regs Issued
The Social Security Administration has issued regulations concerning penalties for false or misleading statements or material omissions. 65 FR 42283, July 10, 2000, amending 20 CFR Parts 404 and 426.

Champus Bonus Payment Regs Issued
The Defense Department has issued regulations concerning bonus payments in medically underserved areas under the CHAMPUS program. 65 FR 41002, July 3, 2000, amending 32 CFR Sec. 199.14.

Abortion "Gag Rule" Revoked
The Office of Population Affairs has revoked the rule (previously suspended) that restricted family planning grantees from providing abortion-related information. 65 FR 41269, July 3, 2000, amending 42 CFR Part 59.

Home Health Agencies Medicare Prospective Payment System Regs Issued
The Health Care Financing Administration has issued regulations concerning the Medicare prospective payment system for home health agencies. 65 FR 41127, July 3, 2000, affecting 42 CFR Parts 409-484.

Obstetric Data Analyzer Regs Issued
The Food and Drug Administration has issued regulations requiring a premarket approval application or notice of completion of product development protocol for the obstetric data analyzer. 65 FR 41330, July 5, 2000revising 21 CFR Sec. 884.2050.

To Index

Communicable Diseases Advisory Council Established
The Secretary of Health and Human Services has established the Communicable Diseases Advisory Council to provide advice on communicable diseases, regulations, and related matters. 65 FR 40667, June 30, 2000.

SSI Benefits Denied To Certain Persons
The Social Security Administration has issued regulations implementing legislation denying Supplemental Security Income benefits to certain fugitives and probation and parole violators. 65 FR 40492, June 30, 2000, amending 20 CFR Part 416.

Hospital Outpatient Services Prospective Payment Regs Delayed
The Department of Health and Human Services has delayed until August the effective date of regulations implementing a prospective payment system for hospital outpatient services furnished to Medicare beneficiaries. 65 FR 40535, June 30, 2000, affecting 42 CFR Parts 409-1003.

Medicare+Choice Deeming Authority Applications To Be Accepted
The Health Care Financing Administration will soon begin to accept applications from private accrediting organizations who seek Medicare+Choice deeming authority. 65 FR 40112, June 29, 2000.

Veterans' Health Care Per Diem Regs Proposed
The Department of Veterans Affairs is proposing a mechanism for paying per diem to state homes providing adult day health care to eligible veterans. 65 FR 39835, June 28, 2000.

Medicare+Choice Regs Issued
The Health Care Financing Administration has issued final regulations implementing the Medicare+Choice program. 65 FR 40169, June 29, 2000, amending 42 CFR Parts 417 and 422.

Tricare Automatic Enrollment Regs Issued
The Defense Department has issued regulations providing for automatic enrollment of certain family members of enlisted personnel in the TRICARE Prime health care program. 65 FR 39804, June 28, 2000, amending 32 CFR Sec. 199.17.

Rehabilitation Act Amendment Regs Proposed
The Department of Education is proposing regulations concerning special demonstration programs, to implement changes to the Rehabilitation Act. 65 FR 39252, June 23, 2000.

Home Health Prospective Payment System Meeting Announced
The Health Care Financing Administration has announced a public meeting to provide information on the home health prospective payment system final rule. 65 FR 39314, June 26, 2000.

Vocational Rehabilitative Services Amendments Proposed
The Office of Special Education and Rehabilitative Services is proposing to revise its Vocational Rehabilitation Services Program regulations to redefine the term "employment outcome" to include only those outcomes in which an individual with a disability works in an integrated setting. 65 FR 39492, June 26, 2000.

Social Security Conference Regs Proposed
The Social Security Administration is proposing regulations concerning prehearing and posthearing conferences. 65 FR 38796, June 22, 2000.

FDA Classifies Upper Airway Obstruction Relief Devices
The Food and Drug Administration has classified devices to relieve upper airway obstruction into class II (special controls). 65 FR 39098, June 23, 2000, amending 21 CFR Sec. 868.5115.

JUNE 21, 2000
Draft guidance on Adverse Reactions Section of Labeling for Prescription Drugs
The Food & Drug Administration announced the availability of draft guidance for industry entitled "Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics". See 65 Fed. Reg. 38,563 (June 21, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000621c.html>. This guidance represents the first in a series of guidance documents on the content and format of individual labeling sections. Copies of this draft guidance are available at <http://www.fda.gov/cder/guidance/index.htm> or <http://www.fda.gov/cber/guidelines.htm>.

JUNE 21, 2000
FDA Amends Final Monograph for OTC Ophthalmic Drug Products
The Food & Drug Administration (FDA) is amending the monograph for over-the-counter (OTC) ophthalmic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). See 65 Fed. Reg. 38,426 (June 21, 2000), affecting21 C.F.R. Part 349, <http://www.access.gpo.gov/su_docs/fedreg/a000621c.html>. The amendment adds a new warning and revises an existing warning for ophthalmic vasoconstrictor drug products.

JUNE 20, 2000
Social Security Acquiescence Ruling: Haddock v. Apfel and the Use of Vocational Expert Testimony
The Social Security Administration (SSA) issued an Acquiescence Ruling for Haddock v. Apfel, 196 F.3d 1084 (10th Cir. 1999) concerning the use of vocational expert testimony and the Dictionary of Occupational Titles. The agency intends to clarify the regulations at issue in Haddock, 20 C.F.R. 404.1566 and 416.966. See 65 Fed. Reg. 38,312 (June 20, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000620c.html>. A Social Security Acquiescence Ruling explains how SSA applies a U.S. Court of Appeals holding in a decision that the agency determines conflicts with its interpretation of a Social Security Act provision.

Over-The-Counter Drug Label Reg Compliance Dates Extended
The Food and Drug Administration has partially extended the compliance dates for its rule requiring standardization of labeling of over-the-counter drug products. 65 FR 38191, June 20, 2000.

JUNE 19, 2000
HCFA Corrects Children’s Health Insurance Allotment Regulations
The Health Care Financing Administration (HCFA) issues a correction to regulations concerning allotments and payments to states under the State Children’s Health Insurance Program. See 65 Fed. Reg. 38,027 (June 19, 2000), affecting 45 C.F.R. Parts 447 and 457, http://www.access.gpo.gov/su_docs/fedreg/a000619c.html.
Locate the State Children’s Health Insurance Program regulations at 65 Fed. Reg. 33,615 (May 24, 2000), affecting 42 C.F.R. Parts 447 and 457 and 45 C.F.R. Parts 92 and 95, <http://www.access.gpo.gov/su_docs/fedreg/a000624c.html>.

JUNE 19, 2000
Medicare+Choice Final Rule
On June 19, 2000, the Health Care Financing Administration (HCFA) released the final rule governing the operations of health plans participating in the Medicare+Choice program. This document, <http://www.hcfa.gov/regs/mplusc/default.htm>, is on display at the Office of the Federal Register as of June 19, 2000, and will be published on June 29, 2000.
HCFA released its Medicare+Choice Contract Year 2001 Package on June 8, 2000. Read the contract package at <http://www.hcfa.gov/medicare/2001pkg.htm>.

JUNE 16, 2000
Report of Altered System of Records by HCFA
In accordance with the requirements of the Privacy Act of 1974, 5 U.S.C. §552a, the Health Care Financing Administration (HCFA) announced that it is correcting information provided in twenty HCFA systems of records. The Privacy Act allows HCFA to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a "routine use." The agency is deleting published routine uses and replacing them with revised routine uses. See 65 Fed. Reg. 37,792 (June 16, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000616c.html>.

JUNE 15, 2000
HCFA Extends Comment Period on Medicare Coverage Decision Standards
The Health Care Financing Administration (HCFA) announced that it would extend the comment period on its intention to publish a proposed rule regarding the criteria HCFA would use to make national Medicare coverage decisions. The original intention to publish set a comment period ending on June 15, 2000. See 65 Fed. Reg. 31,124 (May 16, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000516c.html>. The extension sets the new deadline at July 17, 2000. See 65 Fed. Reg. 37,507 (June 15, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000615c.html>.

JUNE 14, 2000
DHHS and NIH Exempt System of Records from Privacy Act Requirements
NIH in collaboration with the Department of Health & Human Services is exempting a system of records, "Administration: Investigative Records" (09-25-0213), from certain requirements of the Privacy Act of 1974 to protect records compiled in the course of an inquiry and/or investigation and to protect the identity of confidential sources who furnish information. See 65 Fed. Reg. 37, 288 (June 14, 2000), affecting, 45 C.F.R. Part 5b, http://www.access.gpo.gov/su_docs/fedreg/a000614c.html.

Comments Sought On Growth Impairment Disability Listings
The Social Security Administration is seeking comments on how to revise its growth impairment listings used in evaluating disability claims. 65 FR 37321, June 14, 2000.

JUNE 13, 2000
Medical Device Classification
The Food & Drug Administration is classifying the subcutaneous, implanted, intravascular (IV) infusion port and catheter, and the percutaneous, implanted, long-term IV catheter intended for repeated vascular access into Class II (special controls). This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. See 65 Fed. Reg. 37,041 (June 14, 2000), affecting, 21 C.F.R. Part 880, <http://www.access.gpo.gov/su_docs/fedreg/a000613c.html>.

JUNE 13, 2000
OPM Issues Final Rule on Sick Leave for Family Care Purposes
The Office of Personnel Management (OPM) issued final regulations expanding use of sick leave for family care purposes. See 65 Fed. Reg. 37,234 (June 13, 2000), affecting, 5 C.F.R. Part 630, <http://www.access.gpo.gov/su_docs/fedreg/a000613c.html>.

JUNE 12, 2000
Draft Compliance Program Guidance for Individual and Small Group Practices
On June 12, 2000, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG) published the official version of its draft compliance program guidance for physicians in solo or small group practices. See 65 Fed. Reg. 36,818 (June 12, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html>. The OIG hopes to publish final guidance in early fall 2000. Read an OIG press release on the subject at <http://www.hhs.gov/progorg/oig/medadv/cpgphynr.htm>. Interestingly, the draft guidance has a 45-day comment period. Previous draft guidances were issued with 30-day comment periods, but the OIG, in this instance, wanted to provide extra time for the physician community to review and comment on the guidance.

Aircraft Smoking Regs Issued
The Department of Transportation has issued regulations implementing recent legislation concerning smoking aboard aircraft. 65 FR 36771, 65 FR 36776, June 9, 2000, affecting 14 CFR Parts 121, 129, 135, and 252.

JUNE 8, 2000
EEOC Rescinds Portions of ADA Title I Interpretive Guidance Relating to Mitigating Measures
An Equal Employment Opportunity Commission (EEOC) final rule rescinds several sentences of the EEOC’s Interpretive Guidance on Title I of the Americans with Disabilities Act (ADA) that address mitigating measures used by persons with impairments. See 65 Fed. Reg. 36,327 (June 8, 2000), affecting, 29 C.F.R. Part 1630, http://www.access.gpo.gov/su_docs/fedreg/a000612c.html.
This action is necessary as a result of recent U.S. Supreme Court rulings in Sutton v. United Airlines, 119 S.Ct. 2139 (1999) (Stevens, J. and Breyer, J. dissenting), <http://supct.law.cornell.edu/supct/html/97-1943.ZS.html> or <http://laws.findlaw.com/US/000/97-1943.html>, and Murphy v. United Parcel Service, Inc., 119 S.Ct. 2133 (1999) (Stevens, J. and Breyer, J. dissenting), <http://supct.law.cornell.edu/supct/html/97-1992.ZS.html> or <http://laws.findlaw.com/US/000/97-1992.html>. In those cases, the U.S. Supreme Court held that the determination of whether an individual has an impairment that substantially limits a major life activity under the ADA must be made by considering any mitigating measures (such as medications or assistive devices) that the individual uses to eliminate or reduce the effects of an impairment.

JUNE 8, 2000
Medical Device Classification
The Food & Drug Administration (FDA) is classifying liquid chemical sterilants/high level disinfectants intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use into Class II (special controls), and general purpose disinfectants intended to process noncritical medical devices and equipment surfaces into Class I (general controls). The FDA is also exempting the general-purpose disinfectants from the premarket notification requirements. See 65 Fed. Reg. 36,324 (June 8, 2000), affecting, 21 C.F.R. Part 880, <http://www.access.gpo.gov/su_docs/fedreg/a000608c.html>.

JUNE 8, 2000
FDA Extends Effective Date for OTC Sunscreen Drug Products Final Monograph
The Food & Drug Administration (FDA) is extending to December 31, 2002, the effective date for the final monograph for over-the-counter (OTC) sunscreen drug products. In addition, the FDA is reopening the administrative record for the rulemaking of these products to allow for comment in response to a citizen petition requesting that the agency, among other things, initiate an administrative process to publish a comprehensive sunscreen final monograph that addresses formulation, labeling, and testing requirements for ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. See 65 Fed. Reg. 36, 319 (June 8, 2000), affecting, 21 C.F.R. Parts 310, 352, and 700, <http://www.access.gpo.gov/su_docs/fedreg/a000608c.html>.

JUNE 8, 2000
FEHB Program and DoD Demonstration Project
The Office of Personnel Management (OPM) established a demonstration project under which certain Medicare and other eligible Department of Defense (DoD) beneficiaries can enroll in health benefit plans in certain geographic areas under the Federal Employees Health Benefits (FEHB) Program. The project runs from January 1, 2000, through December 31, 2002. See 65 Fed. Reg. 36,383 (June 8, 2000), affecting, 48 C.F.R. Parts 1604, 1615, 1632, and 1652, <http://www.access.gpo.gov/su_docs/fedreg/a000608c.html>.

JUNE 7, 2000
Draft Compliance Program Guidance for Individual and Small Group Practices
On June 7, 2000, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG) released draft compliance program guidance to help physicians in solo or small group practices conduct voluntary compliance measures to prevent fraud and abuse in government health programs, including Medicare and Medicaid. Read the draft guidance at <http://www.hhs.gov/progorg/oig/modcomp/cpgphysiciandraft.htm> and an OIG press release on the subject at <http://www.hhs.gov/progorg/oig/medadv/cpgphynr.htm>. Visit the American Health Lawyers Association Web site for a summary of the draft guidance, <http://www.healthlawyers.org/ofnote_oigphyspracgddraft.htm>. The draft guidance is scheduled for publication in the Federal Register and will have a 45-day comment period. Previous draft guidances issued with 30-day comment periods, but the OIG wanted to provide extra time for the physician community to review and comment on the guidance. See 65 Fed. Reg. 36,818 (June 12, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or <http://www.access.gpo.gov/su_docs/fedreg/a000612c.html>.

Disability Review Process Changes To Be Tested
The Social Security Administration is conducting a test of the elimination of the requirement of a request for Appeals Council review in disability cases. 65 FR 36210, June 7, 2000.

JUNE 6, 2000
HCFA Delays Start of Outpatient PPS until August 1, 2000
According to a June 6, 2000, announcement on the Health Care Financing Administration (HCFA) Web site, <http://www.hcfa.gov/medicare/oppsmssg.htm>, the effective date of the new Hospital Outpatient Prospective Payment System published in the Federal Register on April 7, 2000, will be delayed for one month, from July 1 to August 1, 2000. See 65 Fed. Reg. 18,434 (Apr. 7, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html>.

JUNE 6, 2000
Systems of Records Deletions by HCFA
In accordance with the requirements of the Privacy Act of 1974, 5 U.S.C. §552a, the Health Care Financing Administration (HCFA) is deleting three systems of records from its inventory, including Medicare Enrollment Records Statistics (No. 09-70-0006), Health Insurance Enrollment Statistics - General Enrollment Period (No. 09-70-0007), and Medicare Beneficiary Correspondence Files (No. 09-70-0509). See 65 Fed. Reg. 35,948 (June 6, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000606c.html>.

JUNE 6, 2000
Documentation Guidelines for Evaluation & Management Services
On June 6, 2000, the Health Care Financing Administration (HCFA) announced a meeting to discuss the status of their work on revising the documentation guidelines for evaluation and management (E/M) services. The documentation guidelines provide the health care community with information regarding the proper use of E/M Current Procedural Terminology (CPT) codes. This meeting will present the results of efforts to simplify the guidelines, reduce the burden on physicians, and foster consistent and fair medical review. See 65 Fed. Reg. 35,947 (June 6, 2000), <http://www.access.gpo.gov/su_docs/fedreg/a000606c.html>.

State Vocational Rehab Services Regs Issued
The Office of Special Education and Rehabilitative Services has issued regulations concerning the State Vocational Rehabilitation Services program. 65 FR 35791, June 5, 2000, amending 34 CFR Part 361.

Health Care Fraud And Abuse Penalty Regs Corrected
The Department of Health and Human Services has corrected certain errors in its health care fraud and abuse civil money penalty regulations. 65 FR 35583, June 5, 2000, affecting 42 CFR Parts 1001, 1003, 1005, and 1006.

Defense Federal Employees Health Benefits Regs Issued
The Office of Personnel Management has issued regulations concerning a demonstration project under which certain Defense Department beneficiaries can enroll under the Federal Employees Health Benefits Program. 65 FR 35259, June 2, 2000, amending 5 CFR Part 890.

Vietnam Vets' Children Spina Bifida Regs Issued
The Department of Veterans Affairs has amended regulations concerning benefits for Vietnam veterans' children suffering from spina bifida. 65 FR 35280, June 2, 2000, affecting 38 CFR Parts 3, 17, and 21.

JUNE 1, 2000
HCFA Rule Allows Law Enforcement Personnel Access to HIPDB Information
A Health Care Financing Administration (HCFA) final rule, effective immediately, exempts the Healthcare Integrity and Protection Data Bank (HIPDB) from certain provisions of the Privacy Act so that law enforcement officials can access database reports on adverse actions taken against healthcare providers, suppliers, and practitioners without notifying the entities that are the subject of the reports in order to avoid compromising law enforcement investigations. See 65 Fed. Reg. 34,986 (June 1, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or <http://www.access.gpo.gov/su_docs/fedreg/a000601c.html>.

JUNE 1, 2000
State Health Insurance Assistance Program
The Health Care Financing Administration (HCFA) interim final rule with comment period explains the terms and conditions that apply to grants to states for counseling and assistance to Medicare beneficiaries under the State Health Insurance Assistance Program. See 65 Fed. Reg. 34,983 (June 1, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html>.

Disability Evidence Regs Amended
The Social Security Administration has amended its disability regulations to expand the list of acceptable medical sources of evidence. 65 FR 34950, June 1, 2000, amending 20 CFR Parts 404 and 416.

Regs Issued On Clinical Trials Excluding Women
The Food and Drug Administration may now place a clinical hold on certain studies excluding women because of a risk of reproductive or developmental toxicity. 65 FR 34963, amending 21 CFR Sec. 312.42.

Medicare Grant Regs Issued
The Health Care Financing Administration has issued regulations concerning grants to states for counseling and assistance to Medicare beneficiaries. 65 FR 34983, June 1, 2000, amending 42 CFR Part 403.

Healthcare Integrity And Privacy Data Bank Privacy Act Exemptions Established
The Department of Health and Human Services has exempted the Healthcare Integrity and Protection Data Bank from certain Privacy Act provisions. 65 FR 34986, June 1, 2000, amending 5 CFR Sec. 5b.11.

To Index

NIH Clinical Trial Regs Proposed
The Department of Defense is proposing to modify the general prohibition against CHAMPUS cost-sharing of unproven drugs, devices, and medical treatments or procedures by allowing a waiver for certain clinical trials sponsored or approved by the National Institutes of Health. 65 FR 34627, May 31, 2000.

High Tricare Reimbursement Regs Proposed
The Defense Department is proposing regulations allowing higher than normal health care provider reimbursements under the TRICARE program in certain circumstances. 65 FR 34423, May 30, 2000.

Hemophilia Relief Fund Regs Issued
The Health Resources and Services Administration has issued regulations under the Ricky Ray Hemophilia Relief Fund Program. 65 FR 34859, May 31, 2000, adding 42 CFR Part 130.

MAY 22, 2000
Interpretive Guidelines for Patients’ Rights under Medicare Hospital Conditions of Participation
The Health Care Financing Administration (HCFA) posted its interpretive guidance for Hospital Conditions of Participation (CoP) for Patients’ Rights on its Web site, <http://www.hcfa.gov/quality/4b2.htm>. For questions and answers on the guidance, visit http://www.hcfa.gov/quality/4b1.htm.
On July 2, 1999, HCFA issued an interim final rule with comment introducing new patients’ rights conditions of participation that hospitals must meet in order to be approved for, or continue participation in, the Medicare and Medicaid programs. The interim final rule remains effective until HCFA publishes a final rule. See 64 Fed. Reg. 36,070 (July 2, 1999), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or <http://www.access.gpo.gov/su_docs/fedreg/a990702c.html>.

Oral Inhalation Drug Regs Issued
The Food and Drug Administration has issued regulations to require that aqueous-based drug products for oral inhalation be manufactured sterile. 65 FR 34082, May 26, 2000, affecting 21 CFR Part 200.

Fruit And Vegetable Irradiation Regs Proposed
The Animal and Plant Health Inspection Service is proposing regulations concerning use of irradiation as a phytosanitary treatment for fruits and vegetables imported into the United States. 65 FR 34113, affecting 7 CFR Parts 305 and 319.

Aircraft Defibrillator Regs Proposed
The Federal Aviation Administration is proposing that air carrier operators carry automated external defibrillators on large, passenger-carrying aircraft and also augment currently required emergency medical kits. 65 FR 33720, May 24, 2000.

Children's Health Insurance Allotment Regs Issued
The Health Care Financing Administration has issued regulations concerning allotments and payments to states under the State Children's Health Insurance Program. 65 FR 33615, May 24, 2000, affecting 42 CFR Parts 447 and 457 and 45 CFR Parts 92 and 95.

Ambulance Restocking Safe Harbor Regs Proposed
The Department of Health and Human Services is proposing a safe harbor to protect certain arrangements involving hospitals that replenish drugs and medical supplies used by ambulance providers when transporting emergency patients to the hospitals. 65 FR 32060, May 22, 2000.

Down Syndrome Disability Reg Issued
The Social Security Administration has added a listing to evaluate non-mosaic Down syndrome in adults for disability claim purposes. 65 FR 31800, May 19, 2000, amending 20 CFR Part 404.

Premarket Approval Required For Female Condom
The Food and Drug Administration has classified the female condom as requiring premarket approval. 65 FR 31454, May 18, 2000, adding 21 CFR Sec. 884.5330.

Comments Solicited On Medicare Coverage Decision Criteria
The Health Care Financing Administration is soliciting comments on criteria to be used in making Medicare coverage decisions. 65 FR 31124, May 16, 2000.

Social Security Disability Obesity Ruling Issued
The Social Security Administration has issued a ruling on the evaluation of disability claims involving obesity. 65 FR 31039, May 15, 2000.

FDA Proposes Environmental Impact Amendments
The Food and Drug Administration is proposing to amend its regulations on environmental impact considerations. 65 FR 30366, May 11, 2000.

Ground Water Regs Proposed
The Environmental Protection Agency is proposing regulations to reduce public health risk associated with the consumption of waterborne pathogens from fecal contamination for people served by ground water sources. 65 FR 30194, May 10, 2000.

Federal Employee Long-Term Care Insurance Proposed
A bill has been reported in the House to make long-term care insurance available to current and retired federal employees and members of the uniformed services. Congressional Record, May 8, 2000, page H2654.

Railroad Retirement Board Proposes To Accept Nurse Practitioner Statements
The Railroad Retirement Board is proposing to permit a nurse practitioner to execute a statement of sickness. 65 FR 26161, May 5, 2000.

Medicare Inpatient Prospective Payment Amendments Proposed
The Health Care Financing Administration is proposing to revise the Medicare hospital inpatient prospective payment system for operating costs. 65 FR 26282, May 5, 2000.

Medicare Fraud Dialysis Safe Harbor Rules Proposed
The Department of Health and Human Services is proposing a civil sanction safe harbor to provide protection for independent dialysis facilities that pay certain Medicare premiums for financially needy beneficiaries with end-stage renal disease. 65 FR 25460, May 2, 2000.

Medicare Expense Survey Regs Issued
The Health Care Financing Administration has established criteria for submitting supplemental practice expense survey data for use in determining payments under the physician fee schedule. 65 FR 25664, May 3, 2000, amending 42 CFR Sec. 414.22.

Medicare Fraud Dialysis Safe Harbor Rules Proposed
The Department of Health and Human Services is proposing a civil sanction safe harbor to provide protection for independent dialysis facilities that pay certain Medicare premiums for financially needy beneficiaries with end-stage renal disease. 65 FR 25460, May 2, 2000.

Medicare Expense Survey Regs Issued
The Health Care Financing Administration has established criteria for submitting supplemental practice expense survey data for use in determining payments under the physician fee schedule. 65 FR 25664, May 3, 2000, amending 42 CFR Sec. 414.22.

To Index

Medicare Upgraded Durable Medical Equipment Payment Amendments Proposed
The Health Care Financing Administration is proposing to permit Medicare suppliers to furnish upgraded durable medical equipment on an assignment basis. 65 FR 24666, Apr. 27, 2000.

Social Security Administration Proposes Regs On Grants And Agreements
The Social Security Administration is proposing standards in the administration of grants and agreements with institutions of higher education, hospitals, other non-profit organizations, and commercial organizations. 65 FR 24768, Apr. 27, 2000.

Asbestos Worker Protection Regs Proposed
The Environmental Protection Agency is proposing to protect State and local government employees from the health risks of exposure to asbestos to the same extent as private sector workers. 65 FR 24606, Apr. 27, 2000.

Medical Device Tracking Amendments Proposed
The Food and Drug Administration is proposing amendments to its medical device tracking regulations to conform to statutory changes. 65 FR 24144, Apr. 25, 2000.

Health Care Fraud Penalty Regs Issued
The Department of Health and Human Services has issued amended regulations concerning health care program fraud and abuse civil money penalties. 65 FR 24400, Apr. 26, 2000, affecting 42 CFR Parts 1001, 1003, 1005, and 1006.

 Date Rape Drug Regs Issued
The Drug Enforcement Administration has issued regulations implementing the Date-Rape Drug Prohibition Act. 65 FR 21645, Apr. 24, 2000, amending 21 CFR Part 1310.

Railroad Unemployment Insurance Decision Finality Regs Proposed
The Railroad Retirement Board is proposing regulations concerning the finality of Railroad Unemployment Insurance Act decisions. 65 FR 21164, Apr. 20, 2000.

Medical Malpractice Reporting Rules To Be Proposed
The Health Resources and Services Administration will propose rules on National Practitioner Data Bank medical malpractice payments reporting requirements. 65 FR 20428, Apr. 17, 2000.

Railroad Retirement Disability Review Policy Changed
The Railroad Retirement Board is abolishing routine continuing disability reviews in medical improvement not expected cases. 65 FR 20371, Apr. 17, 2000, amending 20 CFR Sec. 220.186.

FDA Rules On Penile Inflatable Implant
The Food and Drug Administration is requiring the filing of a premarket approval application or a notice of completion of a product development protocol for the penile inflatable implant. 65 FR 19650, Apr. 12, 2000, amending 21 CFR Sec. 876.3350.

Drug Label Amendments Proposed
The Food and Drug Administration is proposing regulations to require the labels of prescription drugs to bear the statement "RX only" instead of the statement "Caution: Federal law prohibits dispensing without prescription" and to remove the requirement that certain habit-forming drugs bear the statement "Warning-May be habit forming." 65 FR 18934, Apr. 10, 2000.

Skilled Nursing Facility Prospective Payment Amendments Proposed
The Health Care Financing Administration is proposing amendments to the skilled nursing facility prospective payment system regulations, updating rates and changing the case-mix methodology. 65 FR 19188, Apr. 10, 2000.

Medigap Deduction Announced
The Health Care Financing Administration has announced that the Medigap high deductible options deductible for this year will be $1,350. 65 FR 18999, Apr. 10, 2000.

Medicare Sustainable Growth Rate Notice Issued
The Health Care Financing Administration has issued a notice concerning the Medicare sustainable growth rate. 65 FR 19000, Apr. 10, 2000.

 
Medicare Hospital Outpatient Prospective Payment Regs Issued
The Department of Health and Human Services has issued regulations implementing a prospective payment system for hospital outpatient services furnished to Medicare beneficiaries. 65 FR 18433, Apr. 7, 2000, affecting 42 CFR Parts 409-1003.

Social Security Disability Regs Amended
The Social Security Administration has amended its regulations concerning consideration of age and transferability of skills in disability proceedings. 65 FR 17994, Apr. 6, 2000, amending 20 CFR Parts 404 and 416.

FDA Issues Street Drug Alternative Guidance
The Food and Drug Administration has issued a guidance stating that it considers products promoted as alternatives to illicit street drugs to be illegal. 65 FR 17512, Apr. 3, 2000.

To Index

Electronic And Information Technology Accessibility Standards Proposed
The Architectural and Transportation Barriers Compliance Board is proposing accessibility standards for electronic and information technology under the Rehabilitation Act. 65 FR 17346, Mar. 31, 2000.

Mammography Facility State Certification Regs Proposed
The Food and Drug Administration is proposing regulations concerning state certification of mammography facilities. 65 FR 16847, Mar. 30, 2000.

FDA Revokes Tobacco Regs
The Food and Drug Administration has revoked its regulations concerning access and promotion of cigarettes and tobacco to children and adolescents, in light of a Supreme Court decision that the FDA lacks authority to regulate tobacco products. 65 FR 17135, Mar. 31, 2000, affecting 21 CFR Parts 801, 803, 807, 820, and 897.

Trust Fund To Combat Aids Proposed
A bill has been reported in the House to provide for negotiations for the creation of a trust fund to be administered by the International Bank for Reconstruction and Development to combat AIDS. Congressional Record, Mar. 28, 2000, pages H1475-76.

IRS Issues Cafeteria Plan Election Regs
The Internal Revenue Service has issued regulations clarifying the circumstances under which an employee benefit cafeteria plan election may be changed. 65 FR 15548, Mar. 23, 2000, amending 26 CFR Part 1.

Organ Procurement And Transplantation Network Regs Take Effect
The Department of Health and Human Services has announced that its Organ Procurement and Transplantation Network regulations have become effective. 65 FR 15252, Mar. 22, 2000, affecting 42 CFR Part 121.

Nursing Facilities Compliance Program Guidance Issued
The Department of Health and Human Services has issued a compliance program guidance for nursing facilities, to combat fraud and abuse. 65 FR 14289, Mar. 16, 2000.

Veterans' Benefits Appeal Regs Amended
The Department of Veterans Affairs has amended its appeals procedures to reflect recent legislation. 65 FR 14471, Mar. 17, 2000, amending 38 CFR Parts 19 and 20.

Paramedic Intercept Ambulance Service Regs Amended
The Health Care Financing Administration has amended is regulations concerning Medicare coverage of paramedic intercept ambulance services in rural communities. 65 FR 13911, Mar. 15, 2000, amending 42 CFR Parts 405 and 410.

 Organic Food Program Proposed
The Agricultural Marketing Service is proposing to establish a National Organic Program, to facilitate interstate commerce and marketing of fresh and processed food that is organically produced and to assure consumers that such products meet consistent, uniform standards. 65 FR 13512, Mar. 13, 2000.

Date-Rape Drug Regs Issued
The Drug Enforcement Administration has issued regulations concerning gamma-hydroxybutyric acid (the "date-rape drug"), implementing recent legislation. 65 FR 13235, Mar. 13, 2000, amending 21 CFR Parts 1301 and 1308.

Medicare Clinical Diagnostic Lab Services Regs Proposed
The Health Care Financing Administration is proposing national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B. 65 FR 13082, Mar. 10, 2000.

Social Security Disability Opinion Evidence Regs Amended
The Social Security Administration has amended its regulations to clarify how opinion evidence should be considered in disability cases. 65 FR 11866, Mar. 7, 2000, amending 20 CFR Parts 404 and 416.

FDA Regs On Communications With Officials Issued
The Food and Drug Administration has issued regulations concerning communications with state and foreign government officials. 65 FR 11881, Mar. 7, 2000, amending 21 CFR Part 20.

OSHA Issues Ergonomics Program Hearing Procedures
The Occupational Safety and Health Administration has issued hearing and post-hearing procedures for its proposed Ergonomics Program standard. 65 FR 11948, Mar. 7, 2000.

Healthcare Integrity And Protection Data Bank To Become Operational
The Department Of Health And Human Services has announced that the Healthcare Integrity and Protection Data Bank is about to become operational for purposes of requesting information. 65 FR 11589, Mar. 3, 2000.

Meeting Scheduled On Medicare+Choice Encounter Data
The Health Care Financing Administration will hold a public meeting on March 15 to provide Medicare+Choice organizations, providers, practitioners, and other interested parties an overview of data requirements for physician and hospital outpatient encounter data. 65 FR 10812, Feb. 29, 2000.

To Index

Social Security Ruling Issued On Fault In Providing Evidence
The Social Security Administration has issued a ruling concerning "similar fault" under legislation concerning fraud or similar fault in providing evidence. 65 FR 10140, Feb. 25, 2000.

Meeting On Dietary Supplement Use During Pregnancy Announced
The Food and Drug Administration will hold a public meeting, scheduled for April 24, on safety issues associated with dietary supplement use during pregnancy. 65 FR 9230, Feb. 24, 2000.

Physician-Landlord Referral Fraud Alert Issued
The Department of Health and Human Services has issued a
Special Fraud Alert concerning rental of space in physicians' offices by persons or entities that provide health care items or services to patients that are referred by the physician-landlord. 65 FR 9274, Feb. 24, 2000.

Technical Amendments Made To Medicare Regs
The Health Care Financing Administration has removed references to the Lower of Cost or Charges carryover provision from its Medicare regulations. 65 FR 8660, Feb. 22, 2000, amending 42 CFR Part 413.

New Veterans Claim Review Procedures Proposed
The Department of Veterans Affairs is proposing to allow claimants to obtain de novo review at the Veterans Service Center level. 65 FR 8329, Feb. 18, 2000.

Regs Issued On Government Collection Of Health Care Costs From Third Parties
The Defense Department has amended its regulations concerning collection from third parties of health care service costs. 65 FR 7724, Feb. 16, 2000, amending 32 CFR Part 200.

Osha Settlement Process Pilot Program Extended
The Occupational Safety and Health Review Program has extended its mandatory settlement process pilot program. 65 FR 7434, Feb. 15, 2000, affecting 29 CFR Part 2200.

Prescription Drug Information
The Food and Drug Administration announced a public meeting (scheduled for Feb. 29, 2000) to discuss the findings of an interim study of the status of useful written   prescription drug information for patients. See 65 Fed. Reg. 7,022 (Feb. 11, 2000), http://www.access.gpo.gov/su_docs/aces/aces140.html or http://www.access.gpo.gov/su_docs/fedreg/a000211c.html (index of the Feb. 11, 2000, Federal Register).

Reuse of Single-Use Medical Devices
The Food and Drug Administration announced the availability of two draft guidance documents entitled "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme" ( <http://www.fda.gov/cdrh/ODE>) and "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" ( <http://www.fda.gov/cdrh/OC>) These draft guidance documents are neither final, nor are they in effect. See 65 Fed. Reg. 7, 027 (Feb. 11, 2000) (comments by March 3, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or <http://www.access.gpo.gov/su_docs/fedreg/a000211c.html> (index of the Feb. 11, 2000, Federal Register). Access documents at the Center for Devices and Radiological Health (CDRH) home page at <http://www.fda.gov/cdrh/reuse>.

MEWA Compliance with Healthcare Law Requirements
The Department of Labor Pension and Welfare Benefits Administration (PWBA) issued interim final rules describing reporting requirements, penalties and appeal procedures to ensure that administrators of multiple employer welfare arrangements (MEWAs) comply with healthcare law requirements. The rules require MEWA administrators to file a form with the Labor Secretary to determine compliance with the requirements of the Health Insurance Portability and Accountability Act, the Mental Health Parity Act, and the Newborns' and Mothers' Health Protection Act.  See 65 Fed. Reg. 7,181, 65 Fed. Reg. 7,191 and 65 Fed. Reg. 7,151 (Feb. 11, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or <http://www.access.gpo.gov/su_docs/fedreg/a000211c.html> (index of the Feb. 11, 2000, Federal Register).

Disability Listing Of Impairments Revised
The Social Security Administration has made technical revisions to the Listing of Impairments used for disability claims. 65 FR 6929, Feb. 11, 2000.

Medicare Ambulatory Surgery Rates Adjusted
The Health Care Financing Administration has adjusted for inflation the Medicare rates for ambulatory surgery center facility services. 65 FR 6380, Feb. 9, 2000.

 Penile Rigidity Implant Reclassified
The Food and Drug Administration has reclassified the penile rigidity implant from class III to class II, and identified a guidance document as being capable of providing reasonable assurance of the safety and effectiveness of the device. 65 FR 4881, Feb. 2, 2000, revising 21 CFR Sec. 876.3630.

To Index

Ambulance Fee Schedule
The Health Care Financing Administration announced a public meeting of the Negotiated Rulemaking Committee on the ambulance fee schedule. The meeting will take place on February 14, 2000. See 65 Fed. Reg. 4,545 (Jan. 28, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html>.

Veterans' Dependency And Indemnity Compensation Regs Issued
The Department of Veterans Affairs has concluded that certain statutory provisions authorize payment of dependency and indemnity compensation only in cases where the veteran had, during his lifetime, established a right to receive total service-connected disability compensation from VA for the period required by that statute or would have established such a right if not for clear and unmistakable error by VA. 65 FR 3388, Jan. 21, 2000, amending 38 CFR Part 3.

Medicare Disproportionate Share Hospital Adjustment Calculation
The Health Care Financing Administration issued an interim final rule with comment period that changes the Medicare disproportionate share hospital (DSH) adjustment calculation policy in reference to §1115 expansion waiver days. The rule details the criteria to use in calculating the Medicare DSH adjustment for hospitals for purposes of payment under the prospective payment system (PPS). HCFA revised the policy, effective with discharges occurring on or after January 20, 2000, to allow hospitals to include the patient days of all populations eligible for Title XIX matching payments in a state’s § 1115 waiver in calculating the hospital’s Medicare DSH adjustment. See 65 Fed. Reg. 3,136 (Jan. 20, 2000) (comments due by Mar. 20, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html>.

Hiv Testing Of Newborns Found Not Routine
The Department of Health and Human Services has determined that it has not become routine practice to test newborns for HIV infection. 65 FR 3368, Jan. 20, 2000.

FDA Issues Premarket Notification Regs
The Food and Drug Administration has issued regulations designating which class I devices are subject to premarket notification requirements. 65 FR 2296, Jan. 14, 2000, affecting 21 CFR Parts 862-892.

Tricare Claimcheck Appeals Regs Proposed
The Defense Department is proposing regulations under the Civilian Health and Medical Program of the Uniformed Services, concerning appeals from denials by TRICARE Claimcheck and similar software systems. 65 FR 2085, Jan. 13, 2000.

Dietary Supplement Statement Regs Issued
The Food and Drug Administration has issued regulations on statements concerning the effect of dietary supplements on the structure and function of the body. 65 FR 999, Jan. 6, 2000, amending 21 CFR Part 101.

Veterans' Nursing Home Care Per Diem Regs Issued
The Department of Veterans Affairs has issued regulations concerning the payment of per diem to state homes providing nursing home care to veterans. 65 FR 961, Jan. 6, 2000, affecting 38 CFR Parts 17, 51, and 58.

Clarifications to Privacy Rule
The Health Care Financing Administration clarified the Standards for Privacy of Individually Identifiable Health Information. See 65 Fed. Reg. 427 (Jan. 5, 2000), <http://www.access.gpo.gov/su_docs/aces/aces140.html> (searchable database of Federal Register volumes 60-65) or <http://www.access.gpo.gov/su_docs/fedreg/a000105c.html> (index of the Jan. 5, 2000 Federal Register).

Medicare Graduate Medical Education Consortia Demonstration Announced
The Health Care Finance Administration has announced the Medicare Graduate Medical Education (GME) Consortia demonstration, which will test how teaching hospitals and affiliated organizations respond to the incentive of shared direct GME payments. 65 FR 494, Jan. 5, 2000.

Medicare Lifestyle Modification Program Demonstration Expansion
The Health Care Financing Administration is soliciting proposals to expand the Medicare Lifestyle Modification Program Demonstration to one additional, national multi-site cardiovascular lifestyle modification program. 65 FR 495, Jan. 5, 2000.

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HIPAA Information Collection
The Department of Labor Pension and Welfare Benefits Administration (PWBA) is seeking comments on ongoing collections of information associated with requirements under the Health Insurance Portability and Accountability Act (HIPAA) in accordance with the Paperwork Reduction Act of 1995. See 64 Fed. Reg. 72,696 (Dec. 28, 1999), <http://www.access.gpo.gov/su_docs/aces/aces140.html> or link to the comment requests at <http://www.access.gpo.gov/su_docs/fedreg/a991228c.html>. The PWBA seeks comments on information collections relating to notice of special enrollment rights, notice of preex