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78124 Federal Register / Vol. 65, No.

241 / Thursday, December 14, 2000 / Proposed Rules

to prevent loss of propeller control because propeller. Such failure could lead to loss of problem, you must do the following, unless

of hardening or blocking of the control cable, airplane control. already accomplished:

which could result in the inability to control (d) What actions must I accomplish to

propeller pitch and inability to feather the address this problem? To address this

Actions Compliance Procedures

Install a thermal protection sleee on the pro­ Within the next 100 hours time-in-service (TIS) Do this installation following the ACCOM­
peller control cable. after the effective date of this AD or within PLISHMENT INSTRUCTIONS of Socata
the next 3 calendar months after the effec­ Service Bulletin SB 70–084, dated Sep­
tive date of this AD, whichever occurs first, tember 2000, and the applicable mainte­
unless already done. nance manual.

(e) Can I comply with this AD in any other Issued in Kansas City, Missouri, on Washington, DC, on Monday through
way? You may use an alternative method of December 7, 2000. Friday of each week from 8:00 a.m. to
compliance or adjust the compliance time if: Larry E. Werth, 4:30 p.m.
(1) Your alternative method of compliance Acting Manager, Small Airplane Directorate, FOR FURTHER INFORMATION CONTACT: Joel
provides an equivalent level of safety; and Aircraft Certification Service. Schaer, (202) 619–0089, OIG
(2) The Manager, Small Airplane [FR Doc. 00–31892 Filed 12–13–00; 8:45 am] Regulations Officer.
Directorate, approves your alternative. Send
your request through an FAA Principal
Maintenance Inspector, who may add I. Background
comments and then send it to the Manager,
Small Airplane Directorate. DEPARTMENT OF HEALTH AND A. The OIG Safe Harbor Provisions
Note 1: This AD applies to each airplane HUMAN SERVICES Section 1128B(b) of the Social
identified in paragraph (a) of this AD,
Office of Inspector General Security Act (the Act) (42 U.S.C. 1320a–
regardless of whether it has been modified, 7b(b)) provides criminal penalties for
altered, or repaired in the area subject to the individuals or entities that knowingly
requirements of this AD. For airplanes that 42 CFR Part 1001
and willfully offer, pay, solicit or
have been modified, altered, or repaired so receive remuneration in order to induce
that the performance of the requirements of
Solicitation of New Safe Harbors and
Special Fraud Alerts business reimbursed under the Federal
this AD is affected, the owner/operator must or State health care programs. The
request approval for an alternative method of AGENCY: Office of Inspector General offense is classified as a felony, and is
compliance in accordance with paragraph (e) (OIG), HHS. punishable by fines of up to $25,000
of this AD. The request should include an
ACTION: Notice of intent to develop and imprisonment for up to 5 years. The
assessment of the effect of the modification,
alteration, or repair on the unsafe condition
regulations. OIG may also impose administrative
addressed by this AD; and, if you have not sanctions or exclude violators from the
SUMMARY: In accordance with section
eliminated the unsafe condition, specific Federal or State health care programs.
205 of the Health Insurance Portability The types of remuneration covered
actions you propose to address it. and Accountability Act (HIPAA) of specifically include kickbacks, bribes,
(f) Where can I get information about any 1996, this annual notice solicits
already-approved alternative methods of
and rebates, whether made directly or
proposals and recommendations for indirectly, overtly or covertly, or in cash
compliance? Contact Karl Schletzbaum, developing new and modifying existing
Aerospace Engineer, FAA, Small Airplane or in kind. In addition, prohibited
safe harbor provisions under the Federal conduct includes not only remuneration
Directorate, 901 Locust, Room 301, Kansas
and State health care programs’ anti- intended to induce referrals of patients,
City, Missouri 64016; telephone: (816) 329–
4146; facsimile: (816) 329–4090.
kickback statute, as well as developing but remuneration intended to induce
(g) What if I need to fly the airplane to new OIG Special Fraud Alerts. the arranging for or the purchasing,
another location to comply with this AD? The DATES: To assure consideration, public leasing or ordering of any good, facility,
FAA can issue a special flight permit under comments must be delivered to the service, or item paid for by Federal or
sections 21.197 and 21.199 of the Federal address provided below by no later than State health care programs.
Aviation Regulations (14 CFR 21.197 and 5 p.m. on February 12, 2001. Since the statute on its face is so
21.199) to operate your airplane to a location ADDRESSES: Please mail or deliver your broad, concern has been expressed for
where you can accomplish the requirements written comments to the following many years that some relatively
of this AD. address: Office of Inspector General, innocuous commercial arrangements are
(h) How do I get copies of the documents Department of Health and Human technically covered by the statute and
referenced in this AD? You may get copies of are, therefore, subject to criminal
Services, Attention: OIG–51–N, Room
the documents referenced in this AD from
5246, Cohen Building, 330 prosecution. As a response to the above
Independence Avenue, SW., concern, the Medicare and Medicaid
Support, Aerodrome Tarbes-Ossun-Lourdes,
BP 930—F65009 Tarbes Cedex, France; or the Washington, DC 20201. Patient and Program Protection Act of
Product Support Manager, SOCATA— We do not accept comments by 1987, section 14 of Public Law 100–93,
Groupe AEROSPATIALE, North Perry facsimile (FAX) transmission. In specifically required the development
Airport, 7501 Pembroke Road, Pembroke commenting, please refer to file code and promulgation of regulations, the so-
Pines, Florida 33023. You may look at these OIG–51–N. Comments received timely called ‘‘safe harbor’’ provisions,
documents at FAA, Central Region, Office of will be available for public inspection as designed to specify various payment
the Regional Counsel, 901 Locust, Room 506, they are received, generally beginning and business practices which, although
Kansas City, Missouri 64106. approximately 3 weeks after publication potentially capable of inducing referrals
Note 2: The subject of this AD is addressed of a document, in Room 5541 of the of business under the Federal and State
in French AD 2000–430(A), dated November Office of Inspector General at 330 health care programs, would not be
15, 2000. Independence Avenue, SW., treated as criminal offenses under the
Federal Register / Vol. 65, No. 241 / Thursday, December 14, 2000 / Proposed Rules 78125

anti-kickback statute (section 1128B(b) C. Section 205 of Public Law 104–191 Fraud Alerts beyond those summarized
of the Act; 42 U.S.C. 1320a–7b(b)) and Section 205 of Public Law 104–191 in the appendix to the OIG Semiannual
would not serve as a basis for a program requires the Department to develop and Report referenced above.
exclusion under section 1128(b)(7) of publish an annual notice in the Federal
the Act; 42 U.S.C. 1320a–7(b)(7). The Criteria for modifying and establishing
Register formally soliciting proposals safe harbor provisions
OIG safe harbor provisions have been for modifying existing safe harbors to
developed ‘‘to limit the reach of the the anti-kickback statute and for In accordance with the statute, we
statute somewhat by permitting certain developing new safe harbors and will consider a number of factors in
non-abusive arrangements, while Special Fraud Alerts. reviewing proposals for new or
encouraging beneficial and innocuous In developing safe harbors for a modified safe harbor provisions, such as
arrangements’’ (56 FR 35952, July 29, criminal statute, the OIG is compelled to the extent to which the proposals would
1991). Health care providers and others engage in a complete and thorough
effect an increase or decrease in—
may voluntarily seek to comply with review of the range of factual
these provisions so that they have the circumstances that may fall within the • Access to health care services;
assurance that their business practices proposed safe harbor subject area so as • The quality of care services;
are not subject to any enforcement to uncover all potential opportunities
• Patient freedom of choice among
action under the anti-kickback statute or for fraud and abuse. Only then can the
health care providers;
program exclusion authority. OIG determine, in consultation with the
Department of Justice, whether it can • Competition among health care
To date, the OIG has developed and
effectively develop regulatory providers;
codified in 42 CFR 1001.952 a total of
21 final safe harbors that describe limitations and controls that will permit • The cost to Federal health care
beneficial and innocuous arrangements programs;
practices that are sheltered from
within a subject area while, at the same
liability. The OIG is also currently
time, protecting the Federal health care • The potential overutilization of the
developing a final safe harbor rule health care services; and
programs and their beneficiaries from
addressing ambulance restocking
abusive practices. • The ability of health care facilities
II. Solicitation of Additional New to provide services in medically
B. OIG Special Fraud Alerts Recommendations and Proposals underserved areas or to medically
underserved populations.
In addition, the OIG has also In accordance with the requirements
periodically issued Special Fraud Alerts of section 205 of Public Law 104–191, In addition, we will also take into
to give continuing guidance to health the OIG is continuing to study safe consideration the existence (or
care providers with respect to practices harbor and Special Fraud Alert nonexistence) of any potential financial
the OIG regards as unlawful. These proposals submitted in response to the benefit to health care professionals or
Special Fraud Alerts serve to notify the annual solicitations. Some of those providers that may vary based on their
health care industry that the OIG has suggestions have been addressed in the decisions whether to (1) order a health
become aware of certain abusive safe harbor rulemakings published on care item or service, or (2) arrange for
practices that the OIG plans to pursue November 19, 1999 (64 FR 63504 and 64 a referral of health care items or services
and prosecute, or to bring civil and FR 63518) or are already under to a particular practitioner or provider.
administrative action, as appropriate. development. The OIG last published a
Federal Register solicitation notice for Criteria for Developing Special Fraud
The Special Fraud Alerts also serve as Alerts
a tool to encourage industry compliance developing new safe harbors and
by giving providers an opportunity to Special Fraud Alerts on December 10,
In determining whether to issue
examine their own practices. The OIG 1999 (64 FR 69217). The OIG received
additional Special Fraud Alerts, we will
Special Fraud Alerts are intended for 17 timely-filed responses from a cross-
section of organizations, associations also consider whether, and to what
extensive distribution directly to the extent, those practices that would be
health care provider community, as well and other interested parties. In response
to that and previously-issued Federal identified in new Special Fraud Alerts
as those charged with administering the may result in any of the consequences
Medicare and Medicaid programs. Register solicitation notices, a status
report of the public comments received set forth above, and the volume and
In developing these Special Fraud for new and modified safe harbors is set frequency of the conduct that would be
Alerts, the OIG has relied on a number forth in Appendix G to the OIG’s identified in these Special Fraud Alerts.
of sources and has consulted directly Semiannual Report covering the period A detailed explanation of
with experts in the subject field, April 1, 2000 through September, 30, justifications or empirical data
including those within the OIG, other 2000.2 OIG is currently taking the supporting the suggestion, and sent to
agencies of the Department, other recommendations listed in the appendix
Federal and State agencies, and those in the address indicated above, would
under advisement and is not seeking prove helpful in our considering and
the health care industry. To date, ten additional public comment on those
individual Special Fraud Alerts have drafting new or modified safe harbor
proposals at this time. Rather, this regulations and Special Fraud Alerts.
been issued by the OIG and notice seeks additional
subsequently reprinted in the Federal recommendations from affected Dated: December 7, 2000.
Register.1 provider, practitioner, supplier and June Gibbs Brown,
beneficiary representatives regarding the Inspector General.
1 See 59 FR 65372 (December 19, 1994); 60 FR
development of proposed or modified [FR Doc. 00–31808 Filed 12–13–00; 8:45 am]
40847 (August 10, 1995); 61 FR 30623 (June 17,
1996); 63 FR 20415 (April 24, 1998); and 64 FR safe harbor regulations and new Special BILLING CODE 4152–01–P
1813 (January 12, 1999). The OIG has also issued
three Special Advisory Bulletins—64 FR 37985 2 The OIG Semiannual Report can be accessed

(July 14, 1999); 64 FR 52791 (September 30, 1999); through the OIG web site at
and 64 FR 61353 (November 10, 1999). oig/semann/index.htm.