The OIG’s Past Stances on Patient Assistance Programs (PAP) 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.
Full Answer
What is OIG letter about hospital-physician incentive plans?
OIG letter regarding hospital-physician incentive plans for Medicare and Medicaid beneficiaries enrolled in managed care plans Gainsharing Arrangements and CMPs for Hospital Payments to Physicians to Reduce or Limit Services to Beneficiaries Solicitation of Comments on the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute
What is the OIG’s guidance on PAP fraud and abuse?
In 2005, the OIG issued additional guidance in a special advisory bulletin that considered fraud and abuse concerns associated with PAPs.
What does OIG advisory opinion 20-05 mean for drug manufacturers?
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.
What was the OIG report on the Affordable Care Act?
OIG concluded that the subsidy would present many of the traditional risks of fraud and abuse that the federal Anti-kickback Statute is designed to prevent, including increased costs to federal health care programs, beneficiary steering and anti-competitive effects, and interference with or skewing of clinical decision-making.
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 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.
What does OIG stand for in Medicare?
the Office of Inspector GeneralSince 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 OIG advisory opinions?
What is an 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.
How does OIG investigate?
The OIG reviews the information and makes an initial determination of what action is required. If an allegation appears to be credible, the OIG will generally take one of three actions: (1) initiate an investigation; (2) initiate an audit or inspection; or (3) refer the allegation to management or another agency.
What is the general purpose of the OIG Work Plan?
The Work Plan The OIG Work Plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond by OIG's Office of Audit Services and Office of Evaluation and Inspections.
What are government enforcement actions?
Criminal, civil or administrative legal actions relating to fraud and other alleged violations of law, initiated or investigated by OIG and its law enforcement partners.
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.
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 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.
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 does it mean to be on the OIG exclusion list?
An OIG Exclusion is a final administrative action by the Office of the Inspector General (OIG) that prohibits participation in any Federal Health Care Program. Exclusions are imposed because the individual or entity is found to pose unacceptable risks to patient safety and/or program fraud.
What are the 3 statutory goals of an OIG?
We have three clear goals: (1) fight fraud, waste, and abuse, (2) promote quality, safety, and value in HHS programs and for HHS beneficiaries, and (3) advance excellence and innovation.
What is OIG compliance?
OIG compliance programs provide oversight toward promoting ethical and lawful corporate conduct that focus on encouraging prevention, detection and resolution of occurrences of conduct that do not meet federal and state law, and a hospital or health system's business policies.
What is the difference between Sam and OIG?
The primary difference between the OIG LEIE and SAM.gov is that the LEIE only consists of exclusion actions taken by the HHS OIG while the SAM.gov exclusion database consists of debarment actions taken by various Federal agencies.
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 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.
What is the OIG opinion on Caring Voice?
The Office of Inspector General’s (OIG) advisory opinion protected Caring Voice Coalition from liability under the Anti-Kickback Statute for its work providing financially needy Medicare patients with premium and cost-sharing assistance. Drug companies are the primary donors to almost all charity patient assistance programs (PAPs), including Caring Voice Coalition, while some drug companies also create their own charity PAPs. The OIG’s 2006 opinion issued to Caring Voice Coalition was fact-specific, as are all advisory opinions, and in this case was predicated on commitments the charity made to implement certain safeguards regarding contributions from donors and grants to beneficiaries.
What is the OIG CIA?
The December 2017 OIG CIA was announced as part of a settlement between United Therapeutics and the Department of Justice (DOJ), which alleged that United Therapeutics induced patients to purchase its drugs by donating to charity PAPs over which it exerted some control.
What is the alleged violation of the OIG?
According to the OIG, the alleged violations “materially increased the risk that [the charity] served as a conduit for financial assistance from a [drug company] donor to a patient,” and thus increased the risk that the charity’s Medicare patients would be steered to that company’s federally reimbursable drugs.
Is Caring Voice Coalition offering financial assistance?
Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018.
Is United Therapeutics in the CIA?
Subsequent to entering the CIA with United Therapeutics, and on the same day Caring Voice Coalition announced it would not offer financial assistance in 2018, OIG released a letter it sent to a drug company trade group, dated January 4, 2018.
Who is the OIG?
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.
What happens if assistance is available only for the highest cost drugs?
If assistance is available only for the highest-cost drugs, patients may be steered to those pharmaceuticals rather than to equally effective, lower-cost alternatives . If, instead, assistance is available for a broader range of equally effective treatments, patients, and their prescribers, have greater freedom of choice.
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.
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.
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 the fraud and abuse risks associated with such assistance in light of unfavorable Advisory Opinion 20-05 and the current enforcement environment. Consequently, the principles discussed in this Advisory Opinion may have ramifications well beyond the pharmaceutical industry.
What is the OIG in PAP?
First, the OIG highlighted the autonomy of the charitable organization, the non-affiliation with any Donor, and the inability of any Donor to exert direct or indirect control or influence over the charitable organization or the Program. The requestor’s independent discretion to use donations was apparent in the facts discussed above, and the inability of Donors or their affiliates to influence the board of directors was adequately protected. Second, the OIG highlighted that under the requestor's PAP, patients must have selected their provider, practitioner, or supplier and have a treatment regimen in place prior to applying for benefits, and remain free to change them while receiving assistance. Further protection is found in the requestor certifying that it would not make referrals or recommendations to patients.
What are the protections afforded by the OIG?
First, eligibility decisions would be based solely on financial need, according to uniform standards applied consistently, without regard for the identity of the provider, practitioner, supplier, drug, device, referring party, or any Donor. Second, patients must have their provider, practitioner, or supplier, and their treatment plan, in place prior to applying for assistance (which the patient remains free to change while receiving assistance), and would receive support on a first-come, first-served basis. Eligibility decisions would not be based on whether the provider, practitioner, or supplier is a Donor, and the requestor would not make any referrals or recommendations or share Donor identities with patients. For these reasons, the OIG found the Program presented a low risk of fraud and abuse.
What is the OIG opinion 15-06?
In approving these disease funds, the OIG stressed the importance of the protection built into the arrangement, including the board of director independence from donors, strict limits on the involvement of donors and anyone related to them, the patients’ freedom of choice to switch providers and suppliers, and the requirement that patients select their providers and suppliers and have a treatment plan in place before applying to the PAP for assistance. Advisory Opinion 15-06 thus provides another concrete example of the type of PAP arrangement that the OIG is willing to approve.
What is the OIG's conclusion on donor contributions?
As to Donor contributions to the requestor, the OIG concluded that the design and administration of the Program presented minimal risk and would provide sufficient insulation to prevent assistance decisions being influenced by the Donors. The OIG based its analysis on four aspects of the arrangement that provide protection.
What is OIG advisory opinion?
Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a charitable organization’s proposal to provide financial assistance to individuals with chronic diseases by assisting with the costs of health insurance and drug and device therapies. In Advisory Opinion 15-06, the OIG drew upon its past guidance regarding patient assistance programs (PAPs) to approve an arrangement operated by a charity that involves disease funds under certain carefully defined parameters.
Can a requestor refer a patient to a physician?
The requestor would not refer patients or recommend or arrange for the use of any practitioner, provider, supplier, drug or device. Patients would use a benefit card at the patients' preferred pharmacy or device distributer if treatment is self-administered. Where treatment is physician-administered, the requestor would provide assistance directly to the patient’s physician or hospital, or directly to the patient (upon verification) if the physician or hospital does not accept third-party payments or the benefit card.
Do you have to change providers before applying for assistance?
Importantly, before applying for assistance, a patient must have selected a health provider, practitioner, or supplier, and have a treatment regimen in place, and the patient would remain free to change such providers, practitioners, or suppliers, or drug or device therapies, or insurance plans, at any time. Candidates would annually reapply for assistance and undergo an eligibility reassessment.
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 is cost sharing in PAP?
Cost-sharing subsidies offered by a pharmaceutical manufacturer PAP to the dispensing supplier differ in two important respects from a provider's or supplier's unadvertised, non-routine waiver of cost-sharing amounts based on a patient's financial need, which has long been permitted. First, the subsidies result in the dispensing supplier receiving full payment for the product and avoiding the risk of non-collection, thus providing the supplier with an economic incentive to favor the subsidized product and a disincentive to recommend a lower-cost alternative, such as a generic. In addition, the availability of PAP assistance is typically advertised and may influence a beneficiary's choice of product (through the prescribing physician acting on behalf of the beneficiary). Moreover, once a beneficiary is enrolled in a pharmaceutical manufacturer PAP, the beneficiary is effectively locked into using the pharmaceutical manufacturer's product, since the beneficiary risks losing financial assistance if he or she switches products, even if an equally effective, but less expensive, product would be in his or her best medical interests.
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.”
How does remuneration help patients?
In the first two examples, OIG notes that these forms of remuneration promote access to care by preparing both the patient and the physician for follow-up care. Example (1) “would help the patient understand and manage the interaction between lifestyle, disease, and prescribed treatment and create a record that would facilitate interactions with the physician for future care-planning.” Example (2) “increases the beneficiary’s ability to capture information necessary for follow-up care and to comply with the treatment plan.” Both examples facilitate patient-physician communication, as one equips the patient with resources that allow for informed decision-making and compliance, and the other offers the physician easier access to the information necessary for providing quality care. 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.
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.
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.
Who shifts the remuneration cost to the programs or claims the costs of the remuneration?
the provider shifts the remuneration’s cost to the programs or claims the costs of the remuneration on its cost report;
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.
