Federal Register: June 4, 1998 (Volume 63, Number 107)NoticesPage 30499-30506From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr04jn98-76

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

HCFA-9152-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances--Third Quarter 1997

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

FOR FURTHER INFORMATION CONTACT: Bridget Wilhite, (410) 786-5248 (For Medicare instruction information). Betty Stanton, (410) 786-3247 (For Medicaid instruction information). Sharon Hippler, (410) 786-4633 (For Food and Drug Administration- approved investigational device exemption information). Pamela Gulliver, (410) 786-4659 (For all other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Health Care Financing Administration (HCFA) is responsible for administering the Medicare and Medicaid programs, which pay for health care and related services for 38 million Medicare beneficiaries and 36 million Medicaid recipients. Administration of these programs involves (1) providing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public, and (2) effective communications with regional offices, State governments, State Medicaid Agencies, State Survey Agencies, various providers of health care, fiscal intermediaries and carriers that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted the Secretary under sections 1102, 1871, and 1902 and related provisions of the Social Security Act (the Act) and also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

Section 1871(c)(1) of the Act requires that we publish in the Federal Register at least every 3 months a list of all Medicare manual instructions, interpretive rules, and guidelines of general applicability not issued as regulations. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the 3-month time frame. Since the publication of our quarterly listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid issuances to our quarterly listings. Accordingly, we list in this notice Medicaid issuances and Medicaid substantive and interpretive regulations published during July through September 1997.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of all manual issuances, memoranda, substantive and interpretive regulations, or Food and Drug Administration-approved investigational device exemptions published during the timeframe to determine whether any are of particular interest. We expect it to be used in concert with previously published notices. Most notably, those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the notice published March 31, 1993 (58 FR 16837), and those desiring information on the Medicare Coverage Issues Manual may wish to review the August 21, 1989 publication (54 FR 34555).

To aid the reader, we have organized and divided this current listing into five addenda. Addendum I lists the publication dates of the most recent quarterly listings of program issuances.

Addendum II identifies previous Federal Register documents that contain a description of all previously published HCFA Medicare and Medicaid manuals and memoranda.

Addendum III of this notice lists, for each of our manuals or Program Memoranda, a HCFA transmittal number unique to that instruction and its subject matter. A transmittal may consist of a single instruction or many. Often it is necessary to use information in a transmittal in conjunction with information currently in the manuals.

Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the date published, the Federal Register citation, the parts of the Code of Federal Regulations (CFR) that have changed (if applicable), the agency file code number, the title of the regulation, the ending date of the comment period (if applicable), and the effective date (if applicable).

On September 19, 1995, we published a final rule (60 FR 48417) establishing in regulations at 42 CFR 405.201 et seq. that certain devices with an investigational device exemption approved by the Food and Drug Administration and certain services related to those devices may be covered under Medicare. It is HCFA's practice to announce in this quarterly notice all investigational device exemption categorizations, using the investigational device exemption numbers the Food and Drug Administration assigns. Addendum V includes listings of the Food and Drug Administration-approved investigational device exemption numbers that have been approved or revised during the quarter covered by

[Page 30500]this notice. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B, and identified by the investigational device exemption number).

III. How To Obtain Listed Material

A. Manuals

An individual or organization interested in routinely receiving any manual and revisions to it may purchase a subscription to that manual. Those wishing to subscribe should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, all manuals are available at the following Internet address: http//www.hcfa.gov/pubforms/progman.htm.

B. Regulations and Notices

Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.

The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http:// www.access.gpo.gov/su__docs/, by using local WAIS client software, or by telnet to swais.access.gpo.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

C. Rulings

We publish Rulings on an infrequent basis. Interested individuals can obtain copies from the nearest HCFA Regional Office or review them at the nearest regional depository library. We have, on occasion, published Rulings in the Federal Register. In addition, Rulings, beginning with those released in 1995, are available online, through the HCFA Home Page. The Internet address is http://www.hcfa.gov/regs/ rulings.htm.

D. HCFA's Compact Disk-Read Only Memory (CD-ROM)

Our laws, regulations, and manuals are also available on CD-ROM, which may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD- ROM disk:

<bullet> Titles XI, XVIII, and XIX of the Act.

<bullet> HCFA-related regulations.

<bullet> HCFA manuals and monthly revisions.

<bullet> HCFA program memoranda.

The titles of the Compilation of the Social Security Laws are current as of January 1, 1995. The remaining portions of CD-ROM are updated on a monthly basis.

Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re- visit this issue in the near future, and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.

Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1400 designated libraries throughout the United States. Interested parties may examine the documents at any one of the FDLs. Some may have arrangements to transfer material to a local library not designated as an FDL. To locate the nearest FDL, contact any library.

In addition, individuals may contact regional depository libraries, which receive and retain at least one copy of most Federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. Superintendent of Documents numbers for each HCFA publication are shown in Addendum III, along with the HCFA publication and transmittal numbers. To help FDLs locate the instruction, use the Superintendent of Documents number, plus the HCFA transmittal number. For example, to find the Home Health Agency Manual, (HCFA Pub. 11) transmittal entitled ``Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices,'' use the Superintendent of Documents No. HE 22.8/5 and the HCFA transmittal number 283.

V. General Information

It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. Copies can be purchased or reviewed as noted above.

Questions concerning Medicare items in Addendum III may be addressed to Bridget Wilhite, Office of Communications and Operations Support, Division of Regulations and Issuances, Health Care Financing Administration, Telephone (410) 786-5248.

Questions concerning Medicaid items in Addendum III may be addressed to Betty Stanton, Center for Medicaid State Operations, Policy Coordination and Planning Group, Health Care Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244- 1850, Telephone (410) 786-3247.

Questions concerning Food and Drug Administration-approved investigational device exemptions may be addressed to Sharon Hippler, Office of Clinical Standards and Quality, Coverage Analysis Group, Health Care Financing Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.

Questions concerning all other information may be addressed to Pamela Gulliver, Office of Communications and

[Page 30501]Operations Support, Division of Regulations and Issuances, Health Care Financing Administration, C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4659.

(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare-- Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program)

Dated: May 5, 1998. Pamela J. Gentry, Director, Office of Communications and Operations Support.

Addendum I

This addendum lists the publication dates of the most recent quarterly listings of program issuances.

December 18, 1996 (61 FR 66676) April 21, 1997 (62 FR 19328) May 12, 1997 (62 FR 25957) November 3, 1997 (62 FR 59358) November 21, 1997 (62 FR 62325)

Addendum II--Description of Manuals, Memoranda, and HCFA Rulings

An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the Medicare Coverage Issues Manual was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468.

Addendum III--Medicare and Medicaid Manual Instructions July 1997 Through September 1997

Trans.

Manual/Subject/Publication No,

Intermediary Manual

Part 1--Fiscal Administration

(HCFA Pub. 13-1)

(Superintendent of Documents No. HE 22.8/6-3)

128......................... <bullet> Coordination of Medicare and Complementary Insurance Programs.

Coordination of Medicare With the Federal Grants in Aid Program (Medicaid).

Intermediary Manual

Part 3--Claims Process

(HCFA Pub. 13-3)

(Superintendent of Documents No. HE 22.8/6)

1715........................ <bullet> Self-Administered Drug

Administered In An Emergency Situation. 1716........................ <bullet> Mammography Screening.

1717........................ <bullet> HCPCS for Hospital Outpatient

Radiology Services and Other Diagnostic Procedures.

1718........................ <bullet> Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices and Surgical Dressings.

1719........................ <bullet> CFA Common Procedure Coding System.

1720........................ <bullet> Completing Quarterly Report on Provider Enrollment.

1721........................ <bullet> Laboratory Tests for

Hemodialysis, Intermittent Peritoneal

Dialysis, Continuous Cycling Peritoneal Dialysis and Hemofiltration.

Laboratory Tests.

1722........................ <bullet> HCPCS Codes for Diagnostic Services and Medical Services (Correction to Transmittal Number 1719, dated July 1997).

1723........................ <bullet> Claims Processing Timeliness.

1724........................ <bullet> HCPCS Codes for Diagnostic Services and Medical Services--Correction to Transmittal Number 1722, Dated August 1997.

1725........................ <bullet> Mammography Screening.

Focused Medical Review.

Focused Medical Review Activity Report. 1726........................ <bullet> Review of Form HCFA-1450 for Inpatient and Outpatient Bills.

Provider Electronic Billing File and Record Formats.

Alphabetic Listing of Data Elements.

Intermediary Manual.

Part 4--Audit Procedures

(HCFA Pub. 13-4)

(Superintendent of Documents No. HE 22.8/6-4)

33.......................... <bullet> Home Office Uniform Desk Review.

Carriers Manual

Part 1--Fiscal Administration (HCFA Pub. 14-1)

(Superintendent of Documents No. HE 22.8/7-2)

122......................... <bullet> Coordination of Medicare and Complementary Insurance Programs.

<bullet> Coordination of Medicare With the Federal Grants in Aid Program (Medicaid).

Carriers Manual

Part 2--Claims Process (HCFA Pub. 14-2)

(Superintendent of Documents No. HE 22.8/7-3)

136......................... <bullet> Functional Standards for Claims Processing Operations.

[Page 30502]

Carriers Manual

Part 3--Claims Process

(HCFA Pub. 14-3)

(Superintendent of Documents No. HE 22.8/7)

1573........................ <bullet> Evidence of Medical Necessity for Durable Medical Equipment.

General Claims Processing Requirements. Billing Requirements.

Simplified Roster Bills.

Health Insurance Maintenance Organization Processing Requirements.

Speciality Code/Place of Service

Processing Requirements.

Suppression of EOMBs.

Billing Requirements for Global Surgeries. Claims Review for Global Surgeries. Payment for Return Trips to the Operating Room for Treatment of Complications. EOMB and Remittance Messages.

Payment for Eyeglasses, Contact Lenses, and Related Services.

Interpretation of Diagnostic Tests. 1574........................ <bullet> Identifying a Screening

Mammography Claim.

1575........................ <bullet> Claims Processing Terminology. Handling Incomplete or Invalid Claims.

Conditional Data Element Requirements.

Data Element Requirements Matrix.

Data Element Requirements.

Incomplete or Invalid Claims.

1576........................ <bullet> Exception to Sec. 7560 A and B When Physician, Other Practitioner, or Supplier Is Excluded From Participation in Medicare Program.

Authority to Exclude Practitioners, Providers, and Suppliers of Services.

1577........................ <bullet> Evidence of Medicaid Necessity for Durable Medical Equipment (Correction to Transmittal Number 1573, dated July 1997).

1578........................ <bullet> Assistant at Surgery Services. Purchased Diagnostic Tests.

Inpatient Dialysis On Same Date As

Evaluation and Management.

Consultations.

Threshold Times For Codes 99354 and 99355. 1579........................ <bullet> Services Eligible for HPSA Bonus Payments.

Remittance Messages.

1580........................ <bullet> Doctor of Medicine and

Osteopathy.

Carriers Manual

Part 4--Professional Relations

(HCFA Pub. 14-4)

(Superintendent of Documents No. HE 22.8/7-4)

14.......................... <bullet> Patient and Insured Information. Provider of Service or Supplier

Information.

Place of Service Codes and Definitions.

Program Memorandum

Intermediaries (HCFA Pub. 60A)

(Superintendent of Documents No. HE 22.8/6-5)

A-97-5...................... <bullet> Application of Medicare

Reasonable Cost Reimbursement Principles to Rural Health Clinics.

A-97-6...................... <bullet> Extension of Due Date for Filing Form HCFA-2540-96 and Form HCFA-1728-94 Cost Reports.

A-97-7...................... <bullet> Home Health Agency Requests to Intermediaries to Change Cost Center Allocation Sequence or Statistical Allocation Basis.

A-97-8...................... <bullet> Instructions to Implement the New Medicare Summary Notice.

A-97-9...................... <bullet> Hospital Outpatient Procedures: Medicare Changes Due to 1997 HCPCS Update--New Dermatology Codes

(Clarification).

A-97-10..................... <bullet> Change in Hospice Payment Rates. A-97-11..................... <bullet> Hospice Provisions Enacted by the Balanced Budget Act of 1997.

A-97-12..................... <bullet> Medicare Home Health Benefit--The Balanced Budget Act of 1997 Clarification of Part-Time or Intermittent Skilled Nursing Care.

A-97-13..................... <bullet> FY 1998 Prospective Payment System, TEFRA Hospital and Other Bill

Processing Changes.

A-97-14..................... <bullet> Hospital Outpatient Procedures: Billing for Contrast Material

(Clarification).

Program Memorandum

Carriers

(HCFA Pub. 60B)

(Superintendent of Documents No. HE 22.8/6-5)

B-97-2...................... <bullet> Changes to Correct Coding Edits, Version 4.0.

B-97-3...................... <bullet> Instructions for CLIA Compliance for Part B Laboratory Claims Submitted to Carriers.

B-97-4...................... <bullet> Instructions for CLIA Compliance for Part B Laboratory Claims Submitted to Carriers-- Correction to Transmittal Number B-97-3, dated September 1997. B-97-5...................... <bullet> Update of Rates and Wage Index for Ambulatory Surgical Center Payments Effective October 1, 1997.

[Page 30503]

Program Memorandum

Intermediaries/Carriers

(HCFA Pub. 60A/B)

(Superintendent of Documents No. HE 22.8/6-5)

AB-97-10.................... <bullet> Claims for Separately Billable End Stage Renal Disease Laboratory Services Performed by Certified

Independent Dialysis Facilities.

AB-97-11.................... <bullet> Counting of Non-Medicare Home

Health Visits and the Reporting of the Associated Costs in Determining the Average Cost Per Visit for Home Health Services.

AB-97-12.................... <bullet> New Implementation Date for Hematocrit Levels for Erythropoietin.

AB-97-13.................... <bullet> Extension of the Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End Stage Renal Disease Who are Covered by Group Health Plans.

AB-97-14.................... <bullet> Extension of the Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End Stage Renal Disease Who are Covered by Group Health Plans (GHP)-- Correction to Program Memorandum Number AB-97-13, dated September 1997.

AB-97-15.................... <bullet> Update to the Hospice Wage Index. AB-97-16.................... <bullet> Balanced Budget Act of 1997, P.L. 105-33 (H.R. 2015)--Home Health Payment Provisions.

AB-97-17.................... <bullet> New Panels Approved by Common

Procedural Terminology--Clarification of Program Memorandum AB-97-5.

AB-97-18.................... <bullet> Balanced Budget Act of 1997, P.L. 105-33 (H.R.)-Home Health Payment

Provisions.

State Operations Manual

Provider Certification

(HCFA Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

283......................... <bullet> Interpretive Guidelines and Survey Procedures.

Peer Review Organization Manual

(HCFA Pub. 19)

(Superintendent of Documents No. HE 22.8/8-15)

64.......................... <bullet> Opportunity to Discuss.

Authority.

Scope of Review.

Complaints That Do Not Meet Statutory Requirements.

Referrals.

Review Process.

Hospital Manual

(HCFA Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

716......................... <bullet> Self-Administered Drug

Administered In An Emergency Situation. 717......................... <bullet> Billing for Mammography

Screening.

718......................... <bullet> HCPCS for Hospital Outpatient

Radiology Services and Other Diagnostic Procedures.

719......................... <bullet> Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices, and Surgical Dressings.

720......................... <bullet> HCFA Common Procedure Coding System.

721......................... <bullet> HCPCS Codes for Diagnostic Services and Medical Services.

722......................... <bullet> Billing for Mammography

Screening.

Home Health Agency Manual

(HCFA Pub. 11)

(Superintendent of Documents No. HE 22.8/5)

283......................... <bullet> Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices.

Skilled Nursing Facility Manual

(HCFA Pub. 12)

(Superintendent of Documents No. HE 22.8/3)

348......................... <bullet> Billing for Mammography

Screening.

349......................... <bullet> Billing for Durable Medical Equipment (DME), Orthotic/Prosthetic Devices, and Surgical Dressings.

350......................... <bullet> Billing for Mammography

Screening.

Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation Facility Manual

(HCFA Pub. 9)

(Superintendent of Documents No. HE 22.8/9)

130......................... <bullet> Billing for Durable Medical Equipment Orthotic/Prosthetic Devices, and Surgical Dressings.

Coverage Issues Manual

(HCFA Pub. 6)

(Superintendent of Documents No. HE 22.8/18)

102......................... <bullet> Hyperbaric Oxygen Therapy

[Page 30504]

Lung Volume Reduction Surgery (Reduction Pneumoplasty, Also Called Lung Shaving or Lung Contouring) Unilateral or Bilateral by Open or Thoracoscopic Approach for

Treatment of Emphysema or Chronic

Obstructive Pulmonary Disease.

Provider Reimbursement Manual--Part 1

(HCFA Pub. 15-1)

(Superintendent of Documents No. 22.8/4)

400......................... <bullet> Provider Requests Regarding Applicability of Cost Limits.

Request for Exemption From Skilled Nursing Facility Cost Limits.

Provider Reimbursement Manual--Part I

Chapter 27--Reimbursement for ESRD and Transplant Services (HCFA Pub. 15-1-27)

(Superintendent of Documents No. 22.8/4)

29.......................... <bullet> Allowable Compensation for Physician Owners and Medical Directors Allowable Compensation for Owners,

Administrators, and Assistant

Administrators.

Submission of Documentation.

Provider Reimbursement Manual--Part II

Provider Cost Reporting Forms and Instructions

(HCFA Pub. 15-II-A)

(Superintendent of Documents No. 22.8/4)

19.......................... <bullet> Electronic Submission of Cost

Reports.

Electronic Submission of Hospital Cost

Reports.

Electronic Submission of SNF and HHA Cost Reports.

Provider Reimbursement Manual--Part II

Provider Cost Reporting Forms and Instructions

(HCFA Pub. 15-II-A)

(Superintendent of Documents No. 22.8/4)

3........................... <bullet> Hospital and Hospital Health Care Complex Cost Report, Form HCFA-2552-96.

State Medicaid Manual--Part 2

State Organization and General Administration

(HCFA Pub. 45-2)

(Superintendent of Documents No. HE22.8/10)

89.......................... <bullet> Statistical Report on Medical

Care: Eligibles, Recipients, Payments, and Services (Form HCFA-2082).

Requirements for State Participation in the Medicaid Statistical Information System.

State Medicaid Manual--Part 3

Eligibility

(HCFA Pub. 45-3)

(Superintendent of Documents No. HE22.8/10)

68.......................... <bullet> Retroactive Medicaid Coverage.

State Medicaid Manual--Part 6

Payment for Services

(HCFA Pub. 45-6)

(Superintendent of Documents No. HE22.8/10)

34.......................... <bullet> Ingredient Prices Used by States to Establish Upper Limits for

Prescription Drugs.

Rural Health Clinic Manual and Federally

Qualified Health Centers Manual

(HCFA Pub. 27)

(Superintendent of Documents No. HE22.8/19:985)

27.......................... <bullet> Billing for Mammography Screening by Rural Health Clinics and Federally

Qualified Health Centers.

28.......................... <bullet> Billing for Mammography Screening by Rural Health Clinics and Federally

Qualified Health Centers.

Program Memorandum

State Survey Agencies

(HCFA Pub. 65)

97-1........................ <bullet> Policy Clarification: Home Health Agency Parent, Branch, and Subunit Criteria.

Medicare/Medicaid

Sanction--Reinstatement Report

(HCFA Pub. 69)

97-7........................ <bullet> Report of Physicians/

Practitioners, Providers and/or Other

Health Care Suppliers Excluded/

Reinstated--May 1997.

[Page 30505]

97-8........................ <bullet> Report of Physicians/

Practitioners, Providers and/or Other

Health Care Suppliers Excluded/

Reinstated--June 1997.

97-9........................ <bullet> Report of Physicians/

Practitioners, Providers and/or Other

Health Care Suppliers Excluded/

Reinstated--July 1997.

97-10....................... <bullet> Report of Physicians/

Practitioners, Providers and/or Other

Health Care Suppliers Excluded/

Reinstated--August 1997.

Addendum IV.--Regulation Documents Published in the Federal Register

End of

Publication date FR Vol. 62, CFR part(s) File code*

Regulation title comment Effective page

period

date

07/01/97........ 35513-35516 ........... HSQ-243-N........... Medicare, Medicaid, ........... 07/01/97 and CLIA Programs;

Clinical Laboratory

Improvement

Amendments of 1988

Continuance of

Exemption of

Laboratories

Licensed by the

State of Washington.

07/01/97........ 35608-35634 ........... BPD-889-NC.......... Medicare Program;

09/02/97 07/01/97 Schedule of Limits

on Home Health

Agency Costs Per

Visit for Cost

Reporting Periods

Beginning on or

After July 1, 1997.

07/02/97........ 35824-35826 ........... HSQ-207-NC.......... Medicare Program;

09/02/97 07/02/97 Description of the

Health Care

Financing

Administration's

Evaluation

Methodology for the

Peer Review

Organization 5th

Scope of Work

Contracts.

07/16/97........ 38100-38107 ........... BPD-845-PN.......... Medicare Program;

09/15/97 07/16/97 Special Payment

Limits for Home

Oxygen.

07/17/97........ 38314-38315 ........... ORD-101-N........... New and Pending ........... 07/17/97 Demonstration

Project Proposals

Submitted Pursuant

to Section 1115(a)

of the Social

Security Act: May

1997.

07/29/97........

40568 ........... BPD-889-NC.......... Medicare Program; ........... 07/01/97 Schedule of Limits

on Home Health

Agency Costs Per

Visit for Cost

Reporting Periods

Beginning on or

After July 1, 1997;

CORRECTION.

08/08/97........ 42860-42883

418 BPD-820-F........... Medicare Program; ........... 10/01/97 Hospice Wage Index.

08/14/97........ 43541-43542 ........... ORD-102-N........... New and Pending ........... 08/14/97 Demonstration

Project Proposals

Submitted Pursuant

to Section 1115(a)

of the Social

Security Act: June

1997.

08/15/97........ 43657-43674 412 413 414 BPD-763-F........... Medicare Program; ........... 08/15/97 End-Stage Renal

Disease (ESRD)

Payment Exception

Requests and Organ

Procurement Costs.

08/18/97........ 43962-43963 400 405 410 BPD-884-CN.......... Medicare Program; ........... ........... 414

Revisions to

Payment Policies

Under the Physician

Fee Schedule, Other

Part B Payment

Policies, and

Establishment of

the Clinical

Psychologist Fee

Schedule for

Calendar Year 1998;

CORRECTION.

08/18/97........ 43931-43937 431 442 488 HSQ-139-F........... Medicare and

........... 09/17/97 489 498

Medicaid Programs;

Effective Dates of

Provider Agreements

and Supplier

Approvals.

08/20/97........

44221

488 HSQ-156-CN.......... Medicare and

........... 07/01/95 Medicaid Programs;

Survey,

Certification and

Enforcement of

Skilled Nursing

Facilities and

Nursing Facilities.

08/29/97........ 45815-45821 ........... HSQ-219-GNC......... CLIA Program; Fee

10/28/97 01/01/98 Schedule Revision.

08/29/97........

45823 ........... OPL-016-N........... Medicare Program; ........... ........... September 22, 1997,

Meeting of the

Practicing

Physician Ad visory

Council.

08/29/97........ 45966-46140 400 409 410 BPD-878-FC.......... Medicare Program;

10/28/97 10/01/97 411 412 413

Changes to the

424 440 485

Hospital Inpatient

488 489 498

Prospective Payment

Systems and Fiscal

Year 1998 Rates.

09/04/97........ 46698-46707

416 BPD-831-P........... Medicare Program;

11/03/97 09/04/97 Adjustment in

Payment Amounts for

New Technology

Intraocular Lenses.

09/08/97........

47237

416 BPD-878-FC.......... Medicare Program;

Changes to the

Hospital Inpatient

Prospective Payment

Systems and Fiscal

Year 1998 Rates;

CORRECTION.

09/11/97........ 47896-47903

440 MB-071-F............ Medicaid Program; ........... 11/10/97 Coverage of

Personal Care

Services.

09/12/97........ 48098-48105 ........... MB-115-N............ State Children's ........... ........... Health Insurance

Program; Reserved

Allotments to

States for Fiscal

Year 1998; Enhanced

Federal Medical

Assistance

Percentages.

09/15/97........ 48292-48297 ........... MB-110-N............ Medicaid Program; ........... ........... Final Limitations

on Aggregate

Payments to

Disproportionate

Share Hospitals:

Federal Fiscal Year

1997.

[Page 30506]

09/17/97........ 48872-48873 ........... BPD-898-NC.......... Medicare and

11/17/97 ........... Medicaid Programs;

Announcement of

Additional

Applications From

Hospitals

Requesting Waivers

for Organ

Procurement Service

Area.

09/18/97........

49049 400 409 410 BPD-878-FC.......... Medicare Program; ........... ........... 411 412 413

Changes to the

424 440 485

Hospital Inpatient

488 489 498

Prospective Payment

Systems and Fiscal

Year 1998 Rates;

CORRECTION.

09/23/97........ 49649-49654 ........... OMC-029-N........... Medicare Program;

10/08/97 ........... Solvency Standards

for Provider-

Sponsored

Organizations;

Intent To Form

Negotiated

Rulemaking

Committee.

09/23/97........

49726

440 MB-071-F............ Medicaid Program; ........... ........... Coverage of

Personal Care

Services;

CORRECTION.

09/24/97........ 49937-49938

473 BPD-453-CN.......... Medicare Program; ........... 06/11/97 Medicare Appeals of

Individual Claims;

CORRECTION.

Categorization of Food and Drug Administration-Approved Investigational Device Exemptions

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. Also, under the new categorization process to assist HCFA, the Food and Drug Administration assigns each device with a Food and Drug Administration-approved investigational device exemption to one of two categories. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328).

The following information presents the device number, category (in this case, A), and criterion code.

G960082 A1 G970008 A4 G970044 A2 G970058 A2 G970069 A2 G970073 A2 G970088 A2 G970118 A2 G970121 A2 G970128 A1 G970131 A1 G970136 A2 G970147 A1 G970151 A2 G970169 A2 G970176 A2

The following information presents the device number, category (in this case, B), and criterion code.

G910187 B1 G960161 B4 G970014 B2 G970015 B4 G970024 B4 G970045 B4 G970081 B4 G970094 B3 G970096 B1 G970112 B2 G970116 B1 G970117 B4 G970122 B4 G970123 B4 G970129 B2 G970132 B3 G970133 B3 G970134 B4 G970135 B4 G970137 B4 G970138 B4 G970140 B1 G970141 B2 G970142 B1 G970149 B3 G970150 B1 G970157 B4 G970161 B4 G970168 B1 G970178 B2 G970179 B2 G970180 B4 G970183 B1 G970189 B4 G970191 B1 G970193 B2 G970194 B2

FR Doc. 98-14834Filed6-3-98; 8:45 amBILLING CODE 4120-01-P