Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Proposed Rules 43607 

information about the proposed 

significant new use rules, please see the 

information provided in the direct final 

action, with the same title, that is 

located in the ‘‘Rules and Regulations’’ 

section of this issue of the Federal 

Register. 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: August 20, 2018. 

Jeffery T. Morris, 

Director, Office of Pollution Prevention and 

Toxics. 

[FR Doc. 2018–18528 Filed 8–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2017–0464; FRL–9982–25] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for 19 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). The chemical substances are 

subject to Orders issued by EPA 

pursuant to section 5(e) of TSCA. This 

action would require persons who 

intend to manufacture (defined by 

statute to include import) or process any 

of these 19 chemical substances for an 

activity that is designated as a 

significant new use by these rules to 

notify EPA at least 90 days before 

commencing that activity. The required 

notification initiates EPA’s evaluation of 

the intended use within the applicable 

review period. Persons may not 

commence manufacture or processing 

for the significant new use until EPA 

has conducted a review of the notice, 

made an appropriate determination on 

the notice, and has taken such actions 

as are required with that determination. 

In addition to this Notice of Proposed 

Rulemaking, EPA is issuing the action 

as a direct final rule elsewhere in this 

issue of the Federal Register. 

DATES: Comments must be received on 

or before September 26, 2018. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2017–0464, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: In 

addition to this Notice of Proposed 

Rulemaking, EPA is issuing the action 

as a direct final rule elsewhere in this 

issue of the Federal Register. For further 

information about the proposed 

significant new use rules, please see the 

information provided in the direct final 

action, with the same title, that is 

located in the ‘‘Rules and Regulations’’ 

section of this issue of the Federal 

Register. 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: August 17, 2018. 

Jeffery T. Morris, 

Director, Office of Pollution Prevention and 

Toxics. 

[FR Doc. 2018–18606 Filed 8–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Parts 1001 and 1003 

RIN 0936–AA10 

Medicare and State Health Care 

Programs: Fraud and Abuse; Request 

for Information Regarding the AntiKickback Statute and Beneficiary 

Inducements CMP 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

seeks input from the public on how to 

address any regulatory provisions that 

may act as barriers to coordinated care 

or value-based care. 

DATES: Comment Date: To ensure 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

October 26, 2018. 

ADDRESSES: In commenting, refer to file 

code OIG–0803–N. Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (fax) 

transmission. However, you may submit 

comments in one of three ways (no 

duplicates, please): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular, express, or overnight 

mail. You may send written comments 

to the following address: Susan 

Edwards, Office of Inspector General, 

Department of Health and Human 

Services, Attention: OIG–0803–N, Room 

5513, Cohen Building, 330 

Independence Avenue SW, Washington, 

DC 20201. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver your written comments 

by hand or courier before the close of 

the comment period to: Susan Edwards, 

Office of Inspector General, Department 

of Health and Human Services, 

Attention: OIG–0803–N, Room 5513, 

Cohen Building, 330 Independence 

Avenue SW, Washington, DC 20201. 

Because access to the interior of the 

Cohen Building is not readily available 

to persons without Federal Government 

identification, commenters are 

encouraged to schedule their delivery 

with one of our staff members at (202) 

619–0335. 


amozie on DSK3GDR082PROD with PROPOSALS1
43608 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Proposed Rules 

1H.R. Rep. No. 100–85, Pt. 2, at 27 (1987). 

2See section 1128A(i)(6) of the Act. 

3See id.; 42 CFR 1003.110. 

4See, e.g., Solicitation of New Safe Harbors and 

Special Fraud Alerts, 82 FR 61,229 (Dec. 27, 2017), 

available at https://www.gpo.gov/fdsys/pkg/FR2017-12-27/pdf/2017-27117.pdf; OIG, Semiannual 

Report to Congress, April 1, 2017–September 30, 

2017, available at https://oig.hhs.gov/reports-andpublications/archives/semiannual/2017/sar-fall2017.pdf. 

For information on viewing public 

comments, please see the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Susan Edwards, (202) 708–9845. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. Comments received 

in a timely manner will also be available 

for public inspection as they are 

received at the Office of Inspector 

General, Department of Health and 

Human Services, Cohen Building, 330 

Independence Avenue SW, Washington, 

DC 20201, Monday through Friday, from 

10 a.m. to 5 p.m. To schedule an 

appointment to view public comments, 

phone (202) 619–0335. 

I. Introduction 

The Department of Health and Human 

Services (HHS) is working to transform 

the health care system into one that 

better pays for value. Care coordination 

is a key aspect of systems that deliver 

value. Removing unnecessary 

government obstacles to care 

coordination is a key priority for HHS. 

To help accelerate the transformation to 

a value-based system that includes care 

coordination, HHS has launched a 

Regulatory Sprint to Coordinated Care, 

led by the Deputy Secretary. This 

‘‘Regulatory Sprint’’ is focused on 

identifying regulatory provisions that 

may act as barriers to coordinated care, 

assessing whether those regulatory 

provisions are unnecessary obstacles to 

coordinated care, and issuing guidance 

or revising regulations to address such 

obstacles and, as appropriate, to 

encourage and incentivize coordinated 

care while protecting against harms 

caused by fraud and abuse. 

The Office of Inspector General (OIG) 

seeks to identify ways in which it might 

modify or add new safe harbors to the 

anti-kickback statute and exceptions to 

the beneficiary inducements civil 

monetary penalty (CMP) definition of 

‘‘remuneration’’ in order to foster 

arrangements that would promote care 

coordination and advance the delivery 

of value-based care, while also 

protecting against harms caused by 

fraud and abuse. Through internal 

discussion and with the benefit of facts 

and information received from external 

stakeholders, OIG has identified the 

broad reach of the anti-kickback statute 

and beneficiary inducements CMP as a 

potential impediment to beneficial 

arrangements that would advance 

coordinated care. To inform our efforts, 

we welcome public comment on the 

safe harbors to the anti-kickback statute 

and the exceptions to the beneficiary 

inducements CMP definition of 

‘‘remuneration’’ as they relate to the 

goals of the Regulatory Sprint outlined 

above. In particular, we welcome 

comments in response to the questions 

presented in this Request for 

Information (RFI). 

II. Background 

Section 1128B(b) of the Social 

Security Act (the Act), the Federal antikickback statute, provides criminal 

penalties for individuals or entities that 

knowingly and willfully offer, pay, 

solicit, or receive remuneration to 

induce or reward the referral of business 

reimbursable under Federal health care 

programs, as defined in section 1128B(f) 

of the Act. The law endeavors to protect 

patients and the Federal health care 

programs from fraud and abuse by 

curtailing the corrupting influence of 

remuneration on health care decisions; 

however, because the statute is broadly 

written, when it was enacted there was 

concern that some relatively innocuous 

and potentially beneficial arrangements 

were technically covered by the statute 

and therefore were subject to criminal 

prosecution. 

In response to this concern, Congress 

passed section 14 of the Medicare and 

Medicaid Patient and Program 

Protection Act of 1987, which required 

HHS to set forth ‘‘safe harbors’’ to the 

anti-kickback statute. Specifically, 

section 1128B(b)(3)(E) of the Act 

protects from the anti-kickback statute 

‘‘any payment practice specified by the 

Secretary in regulations promulgated 

pursuant to section 14(a) of the 

Medicare and Medicaid Patient and 

Program Protection Act of 1987.’’ In 

giving HHS the authority to protect 

certain arrangements and payment 

practices under the anti-kickback 

statute, Congress intended the safe 

harbors to be evolving rules that would 

be updated periodically to reflect 

changing business practices and 

technologies in the health care 

industry.1

Health care providers and others may 

voluntarily comply with safe harbors in 

an effort to ensure that their business 

practices will not be subject to criminal 

prosecution under the anti-kickback 

statute, the imposition of civil monetary 

penalties (CMPs) under section 

1128A(a)(7) of the Act, program 

exclusion under section 1128(b)(7) of 

the Act, and liability under the False 

Claims Act (31 U.S.C. 3729–33). Since 

finalizing the first safe harbors in 1991, 

OIG has continued to engage the 

industry on the application of the 

Federal anti-kickback statute and 

development of safe harbors. 

Section 1128A(a)(5) of the Act, the 

beneficiary inducements CMP, provides 

for the imposition of CMPs against any 

person who offers or transfers 

remuneration to a Medicare or State 

health care program beneficiary that the 

benefactor knows or should know is 

likely to influence the beneficiary’s 

selection of a particular provider, 

practitioner, or supplier of any item or 

service for which payment may be 

made, in whole or in part, by Medicare 

or a State health care program. In the 

same administrative proceedings in 

which it may seek to impose CMPs 

against a person, OIG may seek to 

exclude such person from the Federal 

health care programs. For purposes of 

section 1128A(a)(5) of the Act, the 

statute defines ‘‘remuneration’’ to 

include, without limitation, waivers of 

co-payments and deductible amounts 

(or any part thereof) and transfers of 

items or services for free or for other 

than fair market value.2 The statute and 

associated regulations contain a limited 

number of exceptions.3

OIG is mindful of the impact of 

delivery system and payment reform on 

Federal health care programs and the 

changing relationships between 

providers, suppliers, and other entities 

in delivering higher quality, better 

coordinated care; enhancing value; and 

improving the overall health of patients. 

We have received several suggestions 

for new safe harbors and proposed 

modifications to existing safe harbors 

that may promote care coordination and 

reduce regulatory impediments to valuebased arrangements, including in 

response to our annual ‘‘Solicitation of 

New Safe Harbors and Special Fraud 

Alerts.’’ 4

We continue to consider how to 

balance additional flexibility for 

industry stakeholders to provide 


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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Proposed Rules 43609 

5Medicare Program; Request for Information 

Regarding the Physician Self-Referral Law, 83 FR 

29,524 (June 25, 2018), available at https://

www.gpo.gov/fdsys/pkg/FR-2018-06-25/pdf/2018- 

13529.pdf. 

efficient, well-coordinated, patientcentered care with protections against 

the harms caused by fraud and abuse. 

We are requesting additional 

information in this RFI to help inform 

our efforts. We are particularly 

interested in thoughts on topics that 

include, but are not limited to: (i) The 

structure of arrangements between 

parties that participate in alternative 

payment models or other novel financial 

arrangements designed to promote care 

coordination and value; (ii) the need for 

new or revised safe harbors and 

exceptions to the definition of 

‘‘remuneration’’ under the beneficiary 

inducements CMP to promote beneficial 

care coordination, patient engagement, 

and value-based arrangements; and (iii) 

terminology related to alternative 

payment models, value-based 

arrangements, and care coordination. 

We are interested in any special 

considerations for rural providers and 

others serving underserved populations, 

including American Indian and Alaska 

Native communities. 

Where relevant, we intend to review 

comments submitted in response to the 

Medicare Program; Request for 

Information Regarding the Physician 

Self-Referral Law, RIN 0938–AT64, 

issued by the Centers for Medicare & 

Medicaid Services (CMS).5 However, 

given the volume of questions included 

in that RFI and OIG’s separate, and 

different, authorities, we urge 

individuals and entities to resubmit any 

relevant comments to this RFI to ensure 

they are considered by OIG. We look 

forward to receiving input in response 

to this RFI. 

III. Request for Information 

We welcome public input on any or 

all of the topics identified below. 

Respondents are not required to address 

every issue or respond to every question 

discussed in this RFI to have their 

responses considered. 

1. Promoting Care Coordination and 

Value-Based Care 

A. Please tell us about potential 

arrangements that the industry is 

interested in pursuing, such as care 

coordination, value-based arrangements, 

alternative payment models, 

arrangements involving innovative 

technology, and other novel financial 

arrangements that may implicate the 

anti-kickback statute or beneficiary 

inducements CMP. For example, we are 

interested in better understanding the 

structure and terms of the arrangement 

(e.g., categories/types of parties; how 

risk is allocated among parties; financial 

relationships involving potential referral 

sources and seekers created by the 

arrangement; and types of items and 

services provided by the arrangement). 

We are also interested in understanding 

how the arrangement promotes care 

coordination or value-based care and 

how the arrangement prevents potential 

harms, such as increased costs, 

inappropriate utilization, poor quality of 

care, and distorted decision making. 

B. Please identify what, if any, 

additional or modified safe harbors to 

the anti-kickback statute or exceptions 

to the definition of ‘‘remuneration’’ 

under the beneficiary inducements CMP 

may be necessary to protect such 

arrangements and any key provisions 

that should be included in the 

additional or modified safe harbor or 

exception. Existing safe harbors and 

exceptions of particular relevance to 

coordinated care include, for example, 

those related to personal services and 

management contracts, electronic health 

record arrangements, warranties, 

transportation, and promoting access to 

care. Suggested new safe harbors or 

exceptions might address care 

coordination services arrangements or 

arrangements promoting the use of 

innovative technology. In particular, 

please describe what conditions would 

be appropriate to include in a safe 

harbor or exception to protect against 

fraud and abuse in the context of such 

arrangements, including what, if any, 

disclosures should be required by such 

safe harbors or exceptions. 

C. Please explain how ‘‘value’’ could 

be defined and used in a safe harbor or 

exception such that OIG could evaluate 

‘‘value’’ within an arrangement to 

determine compliance with the safe 

harbor or exception. 

D. In the context of health care 

delivery reform, payment reform, and 

the anti-kickback statute, please share 

thoughts on definitions for critical 

terminology such as: 

i. Alternative payment model 

ii. Care coordination services 

iii. Care coordinator 

iv. Clinical integration 

v. Coordinated care 

vi. Financial integration 

vii. Gainsharing 

viii. Health system 

ix. Integrated care model 

x. Integrated delivery system 

xi. Incentive payments 

xii. Outcomes-based care 

xiii. Risk 

xiv. Risk-sharing 

xv. Value-based care 

xvi. Value-based arrangement 

E. Are there opportunities where OIG 

could clarify its position through 

guidance as opposed to regulation? For 

example, would a law enforcement 

policy statement offer sufficient 

protection in some instances? If so, 

please elaborate. 

2. Beneficiary Engagement 

A. Beneficiary Incentives 

i. Please provide feedback regarding 

the types of incentives providers, 

suppliers, and others are interested in 

providing to beneficiaries, how 

providing such incentives would 

contribute to or improve quality of care, 

care coordination, and patient 

engagement, including adherence to 

care plans, and whether the types of 

providers, suppliers, or other entities 

that furnish the incentives matter from 

an effectiveness and program integrity 

perspective. Please be as specific as 

possible. Additional areas of interest 

include: 

a. What, if any, restrictions should 

OIG place on the sources, types, or 

frequency of beneficiary incentives that 

could be provided to reduce the risk of 

fraud and abuse? 

b. Examples of beneficiary incentive 

arrangements that are appropriate and 

effective. 

c. Should beneficiary incentives 

connected to medication adherence and 

medication management be treated 

differently than other types of 

beneficiary incentives? If so, how and 

why? 

d. What, if any, disclosures should 

OIG require the offeror to make to 

beneficiaries regarding an incentive 

(e.g., the source of the incentive)? 

ii. Please identify (and provide 

citations to) any recent studies assessing 

the positive or negative effects of 

beneficiary incentives on patient care or 

patient engagement. 

iii. In the context of beneficiary 

incentives, please identify any risks or 

benefits from the following types of 

potential remuneration, as well as any 

safeguards to mitigate risks, and 

describe how these terms should be 

defined for purposes of any rulemaking 

related to coordinated care or valuebased arrangements: 

a. Cash equivalent 

b. Gift card 

c. In-kind items and services 

d. Nonmonetary remuneration 

iv. To promote care coordination and 

value-based care, should OIG amend its 

‘‘Office of Inspector General Policy 

Statement Regarding Gifts of Nominal 

Value To Medicare and Medicaid 


amozie on DSK3GDR082PROD with PROPOSALS1
43610 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Proposed Rules 

6OIG, Office of Inspector General Policy 

Statement Regarding Gifts of Nominal Value To 

Medicare and Medicaid Beneficiaries (Dec. 7, 2016), 

available at https://oig.hhs.gov/fraud/docs/ 

alertsandbulletins/OIG-Policy-Statement-Gifts-ofNominal-Value.pdf. 

7CMS, Fraud and Abuse Waivers for Select CMS 

Models and Programs, available at https://

www.cms.gov/Medicare/Fraud-and-Abuse/Physicia

nSelfReferral/Fraud-and-Abuse-Waivers.html. 

8The Pioneer ACO model began in 2012, and the 

final performance year concluded on December 31, 

2016. 

9Bipartisan Budget Act of 2018, Public Law 115– 

123, 115th Cong. (2018) (enacted). 

10 Id. 

Beneficiaries’’ 6 to increase ‘‘nominal 

value’’ from no more than $15 per item 

or $75 in the aggregate per patient on an 

annual basis? If so, why? Please provide 

data or other support for any suggested 

changes in the dollar amounts. Also, 

please provide input on whether OIG 

should have a similar policy under the 

anti-kickback statute and, if so, how 

such policy would contribute to care 

coordination or value-based care. 

B. Cost-Sharing Obligations 

i. We are interested in input about 

how relieving or eliminating beneficiary 

cost-sharing obligations might improve 

care delivery, enhance value-based 

arrangements, and promote quality of 

care. Please describe any patient care 

scenarios in which cost-sharing 

obligations are particularly problematic. 

ii. Please describe the financial 

impact on providers, suppliers, and 

other entities, as well as the fraud and 

abuse risks, if cost-sharing amounts 

could be waived (i.e., the amount owed 

is not paid) by participants in a care 

coordination or value-based 

arrangement. What, if any, concerns 

arise if cost-sharing obligations could be 

subsidized by providers, suppliers, or 

other entities in a care delivery 

arrangement? 

iii. Please describe any risks to 

beneficiaries and Federal health care 

programs from the reduction or 

elimination of cost-sharing obligations. 

iv. Please describe any suggested 

protections or safeguards that OIG 

should incorporate if we were to create 

a safe harbor for certain beneficiary costsharing waiver or subsidy arrangements. 

3. Other Related Topics of Interest 

A. Current Fraud and Abuse Waivers 

i. Please provide feedback on the 

current waivers developed for the 

purposes of testing models by the Center 

for Medicare and Medicaid Innovation 

(Innovation Center) and carrying out the 

Medicare Shared Savings Program 

(MSSP).7 Feedback from parties who are 

using or who are eligible to use those 

waivers would be helpful as we 

consider the issues raised in this RFI. 

For example, we are interested in the 

following: 

a. How, if at all, have stakeholders 

found compliance with the waiver 

conditions challenging? Please be as 

specific as possible. 

b. Are any waiver requirements 

particularly burdensome, such that they 

impede the goals of the models, 

initiatives, or programs? If so, please 

specify which waiver requirements and 

why they impede the goals of the model, 

initiative, or program. 

c. What waiver structures or 

conditions, if any, work well? Should 

OIG consider any waiver structures or 

conditions for any future safe harbors or 

exceptions related to care coordination 

and value-based care (including 

beneficiary incentives to promote 

patient engagement)? Please be as 

specific as possible and provide reasons. 

d. One of the key safeguards to 

mitigate the risk of fraud or abuse from 

arrangements protected by the preparticipation and participation waivers 

developed pursuant to the MSSP, the 

Next Generation ACO Model’s 

participation waiver, and the Pioneer 

ACO Model’s participation waiver 8 is 

the involvement of the accountable care 

organization’s (ACO’s) governing body 

in the authorization of each 

arrangement. We are interested in 

feedback on how the ACO governing 

body concept is working, and whether 

and if so how, it could be applied to safe 

harbors or exceptions for alternative 

payment models and coordinated care 

arrangements. 

e. We invite specific feedback 

regarding the pros and cons of fraud and 

abuse protections (e.g., waivers or safe 

harbors) that are uniform across 

different types of CMS-sponsored 

models, initiatives, and programs. 

B. Cybersecurity-Related Items and 

Services 

i. We are aware of interest in donating 

or subsidizing cybersecurity-related 

items and services to providers and 

others with whom they share 

information. We are interested in 

information about the types of 

cybersecurity-related items or services 

that entities wish to donate or subsidize, 

and how existing fraud and abuse laws 

may pose barriers to such arrangements. 

For example, we are interested in (i) the 

types of persons that would be parties 

to, or benefit from, such arrangements; 

(ii) whether any persons should be 

excluded from such arrangements; (iii) 

the particular types of items that would 

be involved in such arrangements (e.g., 

hardware, software, and other items); 

and (iv) the types of services that would 

be involved in such arrangements (e.g., 

testing services, training services, 

monitoring services, or repair or 

maintenance services). Other areas of 

interest include: 

a. How might such items or services 

reduce cybersecurity risks to the 

following: The donor, the recipient, 

patients, and other nonparties to the 

arrangement? 

b. Are there technical or legal barriers 

(besides the physician self-referral law 

and the anti-kickback statute) that could 

prevent or limit the arrangements? 

c. Are there any potential risks or 

unintended consequences to such 

arrangements (e.g., potential for fraud or 

abuse, information blocking, or anticompetitive practices) and, if so, how 

might these risks be mitigated? 

d. Are there any particular risks if 

HHS takes no action? 

C. ACO Beneficiary Incentive Program 

(Section 50341(b) of the Bipartisan 

Budget Act of 2018) 9

Section 50341(b) of the Bipartisan 

Budget Act of 2018, which added 

section 1128B(b)(3)(K) of the Act, states 

that ‘‘illegal remuneration’’ under the 

anti-kickback statute does not include 

‘‘. . . an incentive payment made to a 

Medicare fee-for-service beneficiary by 

an ACO under an ACO Beneficiary 

Incentive Program established under 

subsection (m) of section 1899, if the 

payment is made in accordance with the 

requirements of such subsection and 

meets such other conditions as the 

Secretary may establish.’’ 

i. For the purposes of implementing 

this new statutory exception through a 

safe harbor, what, if any, ‘‘other 

conditions’’ should this safe harbor 

include as protections or safeguards? 

Please provide supporting reasons. 

D. Telehealth (Section 50302(c) of the 

Bipartisan Budget Act of 2018) 10

Section 50302(c) of the Bipartisan 

Budget Act of 2018 creates a new 

exception to the definition of 

‘‘remuneration’’ in the beneficiary 

inducements CMP. This exception 

applies to ‘‘telehealth technologies’’ 

provided on or after January 1, 2019, by 

a provider of services or a renal dialysis 

facility to an individual with end-stage 

renal disease (ESRD) who is receiving 

home dialysis for which payment is 

being made under Medicare Part B. 

Under the statute, ‘‘telehealth 

technologies’’ is a term to be defined by 

the Secretary. The exception requires 

that (i) the telehealth technologies not 

be offered as part of any advertisement 


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or solicitation; (ii) the telehealth 

technologies must be provided for the 

purpose of furnishing telehealth 

services related to the patient’s ESRD; 

and (iii) the provision of the telehealth 

technologies must ‘‘meet[] any other 

requirements set forth in regulations 

promulgated by the Secretary.’’ 

i. For the purposes of this exception, 

please provide input on how ‘‘telehealth 

technologies’’ should be defined. Please 

provide examples of telehealth 

technologies that may be used to furnish 

telehealth services related to a 

beneficiary’s ESRD (e.g., technologies 

that address services on the Medicare 

telehealth list). Also, please indicate 

whether telehealth technologies should 

include services. If so, please explain, in 

detail, what services should be 

considered ‘‘telehealth technologies.’’ 

ii. For the purposes of this exception, 

should OIG include protections or 

safeguards as ‘‘any other requirements 

set forth in regulations promulgated by 

the Secretary?’’ If so, please explain 

what protections or safeguards and why. 

4. Intersection of Physician Self-Referral 

Law and Anti-Kickback Statute 

Please share any feedback regarding 

specific circumstances in which (i) 

exceptions to the physician self-referral 

law and safe harbors to the antikickback statute should align for 

purposes of the goals of this RFI; and (ii) 

exceptions to the physician self-referral 

law in furtherance of care coordination 

or value-based care should not have a 

corresponding safe harbor to the antikickback statute. 

Respondents are encouraged to 

provide complete but concise and 

organized responses, including any 

relevant data and specific examples. 

Respondents are not required to address 

every issue or respond to every question 

discussed in this RFI to have their 

responses considered. All responses 

will be considered, provided they 

contain information OIG can use to 

identify the commenter. 

Please note: This is a request for 

information only. This RFI is issued 

solely for information and planning 

purposes; it does not constitute a 

Request for Proposal (RFP), application, 

proposal abstract, or quotation. This RFI 

does not commit the U.S. Government 

to contract for any supplies or services 

or make a grant award. Further, OIG is 

not seeking proposals through this RFI 

and will not accept unsolicited 

proposals. Respondents are advised that 

the U.S. Government will not pay for 

any information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. Not responding to this 

RFI does not preclude participation in 

any future procurement, if conducted. It 

is the responsibility of the potential 

responders to monitor this RFI 

announcement for additional 

information pertaining to this request. 

Please note that OIG will not respond to 

questions about the policy issues raised 

in this RFI. Contractor support 

personnel may be used to review RFI 

responses. 

Responses to this RFI are not offers 

and cannot be accepted by the U.S. 

Government to form a binding contract 

or issue a grant. Information obtained as 

a result of this RFI may be used by the 

U.S. Government for program planning 

on a nonattribution basis. Respondents 

should not include any information that 

might be considered proprietary or 

confidential. This RFI should not be 

construed as a commitment or 

authorization to incur costs for which 

reimbursement would be required or 

sought. All submissions become U.S. 

Government property and will not be 

returned. OIG may publicly post the 

comments received or a summary 

thereof. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

However, section III of this document 

does contain a general solicitation of 

comments in the form of a request for 

information. In accordance with the 

implementing regulations of the 

Paperwork Reduction Act (PRA), 

specifically 5 CFR 1320.3(h)(4), this 

general solicitation is exempt from the 

PRA. Facts or opinions submitted in 

response to general solicitations of 

comments from the public, published in 

the Federal Register or other 

publications, regardless of the form or 

format thereof, provided that no person 

is required to supply specific 

information pertaining to the 

commenter, other than that necessary 

for self-identification, as a condition of 

the agency’s full consideration, are not 

generally considered information 

subject to the PRA. Consequently, there 

is no need for review by the Office of 

Management and Budget under the 

authority of the PRA (44 U.S.C. 3501 et 

seq.). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, if we proceed with 

a subsequent document, we may 

respond to the comments in the 

preamble to that document. 

Dated: August 20, 2018. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. 2018–18519 Filed 8–24–18; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF THE INTERIOR 

Office of the Secretary 

43 CFR Part 11 

[Docket No. DOI–2018–0006; XXXD5198NI.

DS61600000.DNINR0000.000000.DX61604] 

RIN 1090–AB17 

Natural Resource Damages for 

Hazardous Substances 

AGENCY: Office of Restoration and 

Damage Assessment, Interior. 

ACTION: Advance notice of proposed 

rulemaking; request for public 

comment. 

SUMMARY: The Office of Restoration and 

Damage Assessment (ORDA) is seeking 

comments and suggestions from State, 

Tribal, and Federal natural resource cotrustees, other affected parties, and the 

interested public on whether revisions 

to the regulations for conducting natural 

resource damage assessments and 

restoration (NRDAR) for hazardous 

substance releases are needed, and if so, 

what specific revisions should be 

considered. 

DATES: We will accept comments 

through October 26, 2018. 

ADDRESSES: You may submit comments 

to ORDA on this ANPRM by any of the 

following methods. Please reference the 

Regulation Identifier Number (RIN) 

DOI–2018–0006 in your comments. 

• Electronically: Go to http://

www.regulations.gov. In the ‘‘Search’’ 

box enter ‘‘DOI–2018–0006.’’ Follow the 

instructions to submit public comments. 

We will post all comments. 

• Hand deliver or mail comments to 

the Office of Restoration and Damage 

Assessment, U.S. Department of the 

Interior, 1849 C Street Northwest, Mail 

Stop/Room 5538, Washington, DC 

20240. 

FOR FURTHER INFORMATION CONTACT: 

Steve Glomb, Director, Office of 

Restoration and Damage Assessment at 

(202) 208–4863 or email to steve_

glomb@ios.doi.gov. 


amozie on DSK3GDR082PROD with PROPOSALS1