Full Answer
What does the OIG say about Paps?
In numerous prior advisory opinions, the OIG has approved charitable programs that can help financially needy beneficiaries with health care expenses. In 2005, the OIG issued additional guidance in a special advisory bulletin that considered fraud and abuse concerns associated with PAPs.
What is an advisory opinion from OIG?
HHS-OIG issues advisory opinions about the application of certain fraud and abuse enforcement authorities to the requesting party’s existing or proposed business arrangements. Regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial.
When did the OIG issue the supplemental special advisory bulletin?
On May 30, 2014, the OIG issued a supplemental special advisory bulletin regarding Independent Charity Patient Assistance Programs, which updated the 2005 special advisory bulletin.
What is the purpose of the advisory opinion process?
One purpose of the advisory opinion process is to provide meaningful advice on the application of the anti-kickback statute and other OIG sanction statutes in specific factual situations. Please note, however, that advisory opinions are binding and may legally be relied upon only by the requestor.
What is PAP in Medicare?
Who is the Inspector General of HHS?
Can pharmaceutical companies make donations to PAPs?
Can OIG prevent Medicare from helping uninsured patients?
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About this website
What is an OIG advisory opinion?
An Office of Inspector General (OIG) advisory opinion is a legal opinion issued by OIG to one or more requesting parties about the application of the OIG's fraud and abuse authorities to the party's existing or proposed business arrangement.
How do I get an OIG advisory opinion?
Submit a request Advisory opinion requests must be submitted in PDF format to [email protected]. Although not required, we encourage requestors to use the OIG Advisory Opinion Request Template to prepare advisory opinion requests.
What does OIG stand for?
DHS Office of Inspector GeneralDHS Office of Inspector General (OIG) is an independent and objective audit, inspection, and investigative body. While part of the Department of Homeland Security, the OIG is also independent of the Department.
Can federal courts issue advisory opinions?
Federal courts cannot issue advisory opinions because of the Constitution's case-or-controversy requirement. State courts are not subject to the Constitution's case or controversy requirement and are therefore free to issue advisory opinions so long as their state constitutions allow.
What is AKS in healthcare?
The federal Anti-Kickback Statute (AKS) (See 42 U.S.C. § 1320a-7b.) is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of business reimbursable by federal health care programs.
How does OIG investigate?
OIG initiates investigations based on information received from a variety of sources, including: OIG's fraud, waste and abuse hotline; Departmental, GAO, and DOJ referrals; Congressional requests; and referrals from OSC regarding whistleblower disclosures.
What is the role of the OIG in the healthcare industry?
Since its 1976 establishment, the Office of Inspector General (OIG) has been at the forefront of the Nation's efforts to fight waste, fraud and abuse and to improving the efficiency of Medicare, Medicaid and more than 100 other Department of Health & Human Services (HHS) programs.
What are the 3 statutory goals of an OIG?
We have three clear goals: Fight fraud, waste, and abuse. Promote quality, safety, and value in HHS programs and for HHS beneficiaries. Advance excellence and innovation.
What is an advisory opinion in law?
An advisory opinion is an interpretation of the law as it applies to a set of facts provided in writing by the individual requesting the opinion. The purpose of an advisory opinion is to provide guidance to an official or employee before the official or employee engages in an action that may be prohibited.
What are the Anti Kickback safe harbors?
Anti-Kickback Laws and Safe Harbor Regulations The safe harbor regulations define payment and business practices that will not be considered kickbacks, bribes, or rebates that unlawfully induce payment by Medicare or Medicaid programs.
New Special Advisory Bulletin Provides Additional Guidance on ...
A Supplemental Special Advisory Bulletin on patient assistance programs (PAPs) run by independent charities was released today by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services.
HHS OIG Approves Narrowly-Tailored Patient Assistance Program
On Jan. 15, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion No. 20-02 which addresses whether a pharmaceutical manufacturer providing financial assistance to patients constitutes grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A(a)(5) of the ...
Compliance Guidance | Office of Inspector General | Government ...
Compliance Guidance. OIG has developed a series of voluntary compliance program guidance documents directed at various segments of the health care industry, such as hospitals, nursing homes, third-party billers, and durable medical equipment suppliers, to encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements.
Pharmaceutical Manufacturer Patient Assistance Program Information | CMS
Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.
What is PAP in Medicare?
As explained in the Bulletin, arrangements through which a pharmaceutical manufacturer would use a PAP it operates or controls to subsidize its own products that will be payable by Medicare Part D present a heightened risk of fraud and abuse .
Who is the Inspector General of HHS?
202-619-0088. Washington, DC – HHS Inspector General Daniel R. Levinson today released a Special Advisory Bulletin providing guidance on the application of OIG fraud and abuse laws to patient assistance programs (PAPs) that offer assistance in obtaining outpatient prescription drugs to financially needy Medicare beneficiaries who enroll in ...
Can pharmaceutical companies make donations to PAPs?
For example, the Bulletin, reflecting long-standing OIG guidance, makes clear that pharma ceutical manufacturers can make cash donations to bona fide independent charity PAPs that are not affiliated with a manufacturer and operate without regard to donor interests, providing appropriate safeguards exist. These programs are typically operated by patient advocacy and support organizations.
Can OIG prevent Medicare from helping uninsured patients?
Finally, the Bulletin makes clear that nothing in any OIG laws or regulations prevents pharmaceutical manufacturers or others from helping uninsured patients and Medicare beneficiaries who have not enrolled in Part D with their outpatient prescription drugs.
When was AO 21-06 posted?
AO 21-06 was posted on June 29, 2021. Regarding a spinal implant manufacturer’s proposal to offer its products to hospitals at a reduced price if the hospitals agree to assume certain duties related to the products. AO 21-05 was posted on May 20, 2021. Regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health ...
What is preferred hospital?
Regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, ...
What is OIG opinion 20-02?
On Jan. 15, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion No. 20-02 which addresses whether a pharmaceutical manufacturer providing financial assistance to patients constitutes grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A (a) (5) of the Social Security Act (the Act), the exclusion authority at section 1128 (b) (7) of the Act or the civil monetary penalty provision at section 1128A (a) (7) of the Act. These sections relate to the commission of acts described in section 1128B (b) of the Act, the federal anti-kickback statute.
What is an eligible patient?
Eligible patients are patients who have been prescribed the drug for an FDA-approved indication and have a household income that does not exceed 600 percent of the federal poverty level, who live more than two hours driving distance or 100 miles from the nearest center accepting patients and who have no insurance for non-emergency medical travel. The requestor offers the arrangement to eligible patients regardless of their provider or insurance status. To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
What is a drug infusion requestor?
Under the arrangement, the requestor assists eligible patients, between the ages of 18-25 years old, and up to two caregivers with travel, lodging, meals and certain out-of-pocket expenses they incur during and after the patient’s drug infusion. For patients 26 and older, the requestor provides the same support for a patient and one caregiver. The requestor does not provide assistance with patient travel or expenses associated with initial patient consultations, leukapheresis or follow-up visits beyond the post-infusion monitoring required by the drug’s prescribing information. The requestor does not authorize lodging under the arrangement to a patient treated by a center when the requestor has knowledge that the patient is eligible to receive lodging from the center, and such lodging is available for that patient’s use. The requestor also certified that it does not advertise the arrangement. Patients do not learn about, or become eligible for, the arrangement until they have been diagnosed with the appropriate disease and are prescribed treatment with the drug. Under the arrangement, the requestor provides reimbursement for gas and tolls or arranges for transportation via bus, rail, rental car or air travel for a patient and caregiver (s) to and from the closest center accepting patients using a third-party travel vendor.
How long does a patient have to be monitored after an infusion?
Patients receive assistance for four weeks post-infusion; however, if the patient’s physician determines that it is medically necessary to monitor the patient for risks of negative outcomes for longer than four weeks , the requestor provides assistance for the duration of monitoring deemed necessary by the physician.
Can the OIG impose administrative sanctions?
The OIG advised that it will not impose administrative sanctions under the above-listed sections of the Act for the specific scenario described but noted that similar circumstances could create prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of federal health care program business were present.
Does a requestor authorize lodging under an arrangement?
The requestor does not authorize lodging under the arrangement to a patient treated by a center when the requestor has knowledge that the patient is eligible to receive lodging from the center, and such lodging is available for that patient’s use. The requestor also certified that it does not advertise the arrangement.
Do you have to agree to reimburse for a health care arrangement?
To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
When did OIG issue advisory opinion 20-05?
On September 18, 2020, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 20-05. In this unfavorable Advisory Opinion, OIG declined to approve a pharmaceutical manufacturer’s proposal to provide cost-sharing assistance directly to Medicare beneficiaries who are prescribed the manufacturer’s drugs.
What is OIG 20-05?
OIG Advisory Opinion 20-05 represents another shot across the bow from the government to pharmaceutical manufacturers that attempt to subsidize federal health care program beneficiaries’ cost-sharing obligations for the manufacturers’ own drug products. This Advisory Opinion comes on the heels of recent federal enforcement activity surrounding pharmaceutical manufacturers’ involvement in patient assistance programs run by purportedly independent foundations. In those enforcement actions, the U.S. Department of Justice alleged that a number of pharmaceutical manufacturers violated the federal False Claims Act, 31 U.S.C. § 3729 et seq., by unlawfully paying the Medicare copayments for their own products through purportedly independent nonprofit charitable foundations that the manufacturers used as conduits. [1] The Department of Justice’s position on financial assistance provided directly to Medicare beneficiaries by pharmaceutical manufacturers is clear: such conduct not only violates the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (b), but also undermines the Medicare program’s copayment structure, which Congress intended to serve as a check against the prices manufacturers can charge for their drugs.
Is OIG advisory opinion binding?
Although OIG Advisory Opinions are not binding on any individual or entity other than the requestor, they provide valuable insights into OIG’s interpretation of the law. Health care providers that provide financial assistance directly to federal health care program beneficiaries for the providers’ own items or services may wish to re-evaluate ...
Does OIG require remuneration?
OIG did acknowledge that the manufacturer’s proposed arrangement would not involve remuneration to prescribers, and that a critical prerequisite to a beneficiary’s purchase of the medication is the treating physician’s decision to prescribe (or not prescribe) the medication.
What is OIG guidance?
OIG periodically develops and issues guidance, including Special Advisory Bulletins, to alert and inform the health care industry about potential problems or areas of special interest. This Federal Register notice sets forth the recently issued OIG Special Advisory Bulletin addressing patient assistance programs for Medicare Part D enrollees.
Why is it important for PAPs to provide free drugs outside of Part D?
In addition, to promote quality of care, we believe it would be important for PAPs that provide free drugs outside the Part D benefit to coordinate effectively with Part D plans so that the plans can undertake appropriate drug utilization review and medication therapy management program activities .
What are the issues with PAPs?
Analytically, pharmaceutical manufacturer PAPs raise two main issues in connection with the Part D program: (i) Whether subsidies they provide can count toward a Part D enrollee's true out-of-pocket costs (known as the TrOOP); and (ii) whether the subsidies implicate the Federal anti-kickback statute. [ 7]
Do PAPs have to disenroll Medicare?
PAPs need not disenroll all Medicare beneficiaries from their existing PAPs to be compliant with the fraud and abuse laws. Enrollment in Part D is voluntary; therefore, existing PAPs may continue to provide free or reduced price outpatient prescription drugs to Medicare beneficiaries who have not yet enrolled in Part D. The Centers for Medicare & Medicaid Services (CMS) anticipates instituting procedures that will help PAPs determine if PAP clients have enrolled in Part D.
Can a pharmacy waive cost sharing?
Financial need-based waivers that meet these criteria have long been permitted. [ 4] However, a pharmacy has not waived a cost-sharing amount if the amount has been paid to the pharmacy, in cash or in kind, by a Start Printed Page 70625 third party (including, without limitation, a PAP).
Is PAP a part D subsidy?
Occasional, inadvertent cost-sharing subsidies provided by a pharmaceutical manufacturer PAP to a Part D enrollee should not be problematic under the anti-kickback statute ( e.g., where, despite due diligence, a pharmaceutical manufacturer PAP does not know and should not have known that a beneficiary has enrolled in Medicare Part D).
What is OIG access to care?
Access to Care: OIG interprets “promoting access to care” as “improving a particular beneficiary’s, or a defined beneficiary population’s, ability to obtain items and services payable by Medicare or a State health care program.” OIG explained that its interpretation encompasses providing the tools necessary for removing “socioeconomic, educational, geographic, mobility, or other barriers that could prevent patients from seeking care (including preventive care) or following through with a treatment plan.”
What is care OIG?
Care: OIG defines “ care” in “access to care” as “access to items and services that are payable by Medicare or a state health care program for the beneficiaries who receive them.” This means that the exception may not cover remuneration that encourages beneficiaries to access services that could promote general wellness, unless those services are covered by the individual’s Medicare or state health care program benefit. This “care” limitation may result in some incentives being permissible in some states but not others depending on the applicable Medicaid scope of benefits or differences between Medicare Advantage plan benefits.
What is the OIG regulation?
OIG’s new regulation interprets the changes made to the beneficiary inducement provisions of the CMP by the Affordable Care Act (ACA). The CMP prohibits offering “remuneration” to individuals eligible for federal health care program benefits that the offeror knows or should know are likely to influence beneficiaries’ selection of particular providers, practitioners or suppliers. The ACA added an exception to permit “certain remuneration that poses a low risk of harm and promotes access to care.”
Why does OIG endorse example 3?
OIG endorses Example (3) because “ [the item] is a tool that enables the patient to access the right drugs at the appropriate dosage and time” and, as such, may reduce errors associated with the patient misremembering or misunderstanding physicians’ instructions. Remember: cash or “cash equivalents” are unacceptable.
What is a safe zone for a physician?
Facilitating patient-physician communication or compliance with a treatment plan is a safe zone. The new rule favors remuneration that acts to improve patient-physician communication and the patient’s involvement in managing their care and health conditions, with the apparent goal of better health outcomes. OIG provides three examples: (1) a primary care group practice’s purchase of a subscription to a Web-based food and activity tracker that offers information about healthy lifestyles for its diabetic patients; (2) a hospital sending its patients home with inexpensive devices that record data (such as weight or other vitals) that is then transmitted to the hospital or primary care provider; and (3) providing patients with an item that dispenses medications at a certain time at the correct dosage.
When did the OIG release the AO?
In December 2016, the Office of Inspector General of the US Department of Health and Human Services (OIG) issued a final regulation implementing new “safe harbors” for certain patient incentive arrangements and programs, and released its first Advisory Opinion (AO) under the new regulation in March 2017.
How is health care becoming consumer driven?
With health care becoming more consumer-driven, many health care providers and health plans are wrestling with how to incentivize patients to participate in, and adhere to, health promotion programs and treatment plans. As payments are increasingly being tied to quality outcomes, a provider’s ability to effectively engage patients ...
When did the OIG issue its first opinion?
On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and... more
When was OIG advisory opinion rescinded?
On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare... more
What is OIG 20-02?
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical... more
When did OIG post a modification?
On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial... more
When did the OIG release the new guidance?
On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”... more
When was OIG 20-02 issued?
On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides... more
Who gave the green light to virtual care companies?
Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare... more
What is PAP in Medicare?
As explained in the Bulletin, arrangements through which a pharmaceutical manufacturer would use a PAP it operates or controls to subsidize its own products that will be payable by Medicare Part D present a heightened risk of fraud and abuse .
Who is the Inspector General of HHS?
202-619-0088. Washington, DC – HHS Inspector General Daniel R. Levinson today released a Special Advisory Bulletin providing guidance on the application of OIG fraud and abuse laws to patient assistance programs (PAPs) that offer assistance in obtaining outpatient prescription drugs to financially needy Medicare beneficiaries who enroll in ...
Can pharmaceutical companies make donations to PAPs?
For example, the Bulletin, reflecting long-standing OIG guidance, makes clear that pharma ceutical manufacturers can make cash donations to bona fide independent charity PAPs that are not affiliated with a manufacturer and operate without regard to donor interests, providing appropriate safeguards exist. These programs are typically operated by patient advocacy and support organizations.
Can OIG prevent Medicare from helping uninsured patients?
Finally, the Bulletin makes clear that nothing in any OIG laws or regulations prevents pharmaceutical manufacturers or others from helping uninsured patients and Medicare beneficiaries who have not enrolled in Part D with their outpatient prescription drugs.
