When was AO 21-06 posted?
What is preferred hospital?
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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.
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 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.
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 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.
Advisory Opinions (AOs) | CMS
Section 1877(g)(6) of the Social Security Act (the Act) requires that CMS issue certain written advisory opinions. These opinions provide guidance on whether a physician's referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship are prohibited under the Medicare program by section 1877 of ...
Frequently Asked Questions About Advisory Opinions
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.
All Advisory Opinions - Office of Inspector General, U.S. Department of ...
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, would provide a premium credit of $100 off the next renewal premium to ...
Requesting an OIG Advisory Opinion | AAEM - American Academy of ...
Office. American Academy of Emergency Medicine 555 East Wells Street, Suite 1100 Milwaukee, WI 53202-3823 USA Tel: (800) 884-2236 or (414) 276-7390
HHS Advisory Opinions | HHS.gov
The Office of the General Counsel (“OGC”), at the sole discretion of the General Counsel, may issue Advisory Opinions either (i) in response to requests by the public soliciting the views of the General Counsel on significant legal issues or (ii) sua sponte to clarify the Department’s legal position on a critical issue. The OGC Advisory Opinions represent the then current views of the ...
Hall Render - OIG Issues New Guidance Regarding Big-Box Store Gift ...
On December 23, 2020, the Department of Health and Human Services Office of Inspector General (the “OIG”) issued Advisory Opinion No. 20-08 (the “Advisory Opinion”) addressing the use of gift cards to incentivize patients to utilize health care services. While gift cards themselves are not a new topic for the OIG in the area of beneficiary inducement, the OIG takes a position in the ...
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 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.
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 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 .
How to reduce fraud and abuse exposure?
In addition to taking steps to transition beneficiaries to other programs, pharmaceutical manufacturer PAPs can reduce their fraud and abuse exposure by taking one or more of the following steps: (i) Adjusting financial need criteria to reflect the lower drug costs incurred by Part D enrollees ( i .e., liability for premiums and cost-sharing amounts only, instead of the total cost of the drugs); (ii) where possible , subsidizing other drugs in the same class as the manufacturer's products covered by the PAP if a beneficiary's physician prescribes an alternate product; and (iii) checking CMS eligibility files, to the extent available , on a reasonably regular basis to determine whether PAP patients have enrolled in Part D and should be transitioned to other assistance programs. Occasional, inadvertent cost-sharing subsidies provided to a Part D enrollee should not be problematic ( 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). Notwithstanding a pharmaceutical manufacturer's compliance with the foregoing, the Government will take enforcement action in cases where there is evidence of unlawful intent.
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 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 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.
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.
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.
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.
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.
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.
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
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, ...
