Online Coupon Advertising Gets Thumbs Up From The OIG

On March 27, 2012 the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion No. 12-02.  The opinion stated that a proposed website that would display coupons and advertising from health care providers, suppliers, and other entities would not lead to administrative sanctions or civil monetary penalties under the federal anti-kickback statute or the prohibition against providing inducements to beneficiaries.
A corporation would operate the proposed website that would contract with providers, suppliers, and other health care entities who wish to provide coupons and advertisements on the website.  The coupons can offer discounts on services or items through either percentage or dollar-off amounts; however, the coupons cannot offer free services and any coupon must apply to the entire service cost, not just the patient’s cost-sharing obligation.  Any provider who wishes to pay a membership fee may post coupons on the website.  Additionally, health care providers and suppliers may choose to purchase advertising space on the website.
The OIG noted that the proposed arrangement involved two activities that could implicate the anti-kickback statute:  (i) selling advertising space on the website to health care providers and suppliers that may bill federal health care programs, and (ii) posting providers’ coupons for health care items or services.  The OIG further noted that the coupons could also implicate the civil monetary penalty provision prohibiting inducements to beneficiaries.
The OIG found the proposed website to have a permissibly low risk of fraud or abuse because:
• The website operator is not a healthcare provider or supplier.  Although one of the members is a practicing physician, his name would not appear anywhere on the website, nor would the site claim to be operated by a doctor or other healthcare provider or supplier.
• The payments from providers and advertisers to the operators would not depend on customers using the coupons.  Instead, the providers and advertisers would pay a set fee, consistent with fair market value in an arms-length transaction.  Thus, the fee would not take into account the volume or value of any referrals.
• The advertising could take the form of banner or pop-up advertisements on a publicly accessible website.  The website would not require customers to register, and any customer information voluntarily gathered would not be shared with providers or advertisers.
• The types of coupons decreases risk under the anti-kickback statute because they are not pre-paid coupons for services that might not be medically appropriate for the customer.  For example, a coupon could include 50% off of a mammogram or $100 off of a memmogram surgery, but could not be a coupon for a free mammogram or a Groupon-style prepaid coupon for a mammogram for $10 prepaid to the coupon service.  The latter two examples could cause a customer of the website to seek care they might not need because the service is either free or was paid for before consulting with the healthcare provider to determine whether the service is appropriate for the customer.
The OIG also noted that the advertising and coupons involved are similar to accurate and non-deceptive print advertising in general circulation media that does not typically raise concerns.
For more information regarding this OIG opinion or if you have questions regarding the anti-kickback statute please contact Laura Carlsen.

CMS Proposed Rule on Overpayments – A 10 Year Burden

CMS recently published its proposed rules on reporting and returning overpayments.  These rules are intended to implement the 60 day overpayment reporting requirement pursuant to the Affordable Care Act (the “ACA”).  The ACA created a new section 1128J(d) of the Social Security Act requiring a person who receives an overpayment to return and report the overpayment to HHS, the State, a carrier or a contractor and notify the recipient of the reason for the overpayment.  The statute requires that all  overpayments be refunded within 60 days after the date the overpayment was identified or the date of any corresponding cost report (as applicable), whichever is later.

The proposed regulations only relate to Medicare Parts A and B.  Medicaid, Medicare Advantage, Part D, and managed care organizations are not covered by the proposed rules; however, the 60 day shot clock noted in the statute still applies.

Reporting Overpayments

The proposed rules rename the current voluntary refund process the “self-reported overpayment refund process” (described more fully in the Medicare Financial Management Manual).  Providers will use voluntary refund forms currently on the websites of their Medicare contractors.  Reports of overpayments will require the inclusion of the following information:

1)      Name;

2)      TIN;

3)      How the error was discovered;

4)      The reason for the overpayment;

5)      The health insurance claim number, as appropriate;

6)      Date of service;

7)      Medicare claim control number, as appropriate;

8)      NPI;

9)      Description of the corrective action plan to ensure the error does not occur again;

10)   Whether the person has a corporate integrity plan with the OIG or is under the OIG Self-Disclosure Protocol;

11)   The timeframe and the total amount of the refund for the period during which the problem existed that caused the refund;

12)   If a statistical sample was used to determine the overpayment amount, a description of the statistically valid methodology used to determine the overpayment; and

13)   A refund in the amount of the overpayment.

Under the proposed rules, providers are required to report the overpayment within 60 days of identification and refund the overpayment within the same 60 day period.  Providers may request a refund extension through the extended repayment schedule.  A person has “identified” an overpayment if that person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment.  Providers who retain an overpayment after the 60 day deadline for reporting and returning the overpayment are liable under the False Claims Act.  Additionally, any person who knows of an overpayment and does not report and return the overpayment may be found liable for Civil Monetary Penalties and excluded from participation in federal health care programs.

Significantly, the proposed rules also set a lookback period of 10 years, meaning that if a provider identifies an overpayment within 10 years of the date the overpayment is received it will have to report and refund such overpayment.

SRDP and OIG Self-Disclosure Protocol

CMS attempts to reconcile these proposed regulations with the OIG Self-Disclosure Protocol and the new CMS Self-Referral Disclosure Protocol (“SRDP”) (which allows reports of Stark Law violations).  The reconciliation falls flat and creates confusion which will hopefully be remedied in the final rule.

The 60 day deadline for returning overpayments will be suspended if the OIG acknowledges receipt of submission to the OIG Self-Disclosure Protocol.  This suspension will last until a settlement agreement is entered, the person withdraws from the OIG Self-Disclosure Protocol, or the person is removed from the OIG Self-Disclosure Protocol.  Additionally, a person satisfies the reporting requirements listed above by making a disclosure under the OIG Self-Disclosure Protocol which results in a settlement agreement.

Similarly, the 60 day deadline for returning overpayments is suspended if CMS acknowledges receipt of a submission to the SRDP until such time as a settlement agreement is entered, a person withdraws from the SRDP, or the person is removed from the SRDP.  However, the reporting requirement described above is not tolled by submission to the SRDP.

Conclusion

Regardless of these proposed rules, providers must currently report and refund overpayments within 60 days per the ACA.  CMS has opened public comment on these proposed rules through April 16, 2012.  If you would like assistance on drafting comments or assistance with reporting an overpayment please contact Don Black or Elana Zana.

EHR Contracting Tip: Attestation for AIU

Now that most states have their Medicaid EHR Incentive Program in full swing we have gotten a glimpse of what they are requiring for attesting to “adopt, implement and upgrade” aka “AIU”.  As described in the CMS rules themselves, practices need to show that they have some skin in the game and have actually invested in an EHR product.  Many states are asking that an EP (or group practice) upload the actual EHR software contract (or a redacted version).  Some states (such as California) are requesting a signed vendor statement in lieu of the full contract.  

If you are a practice in the process of negotiating an EHR contract, you may want to consider including a provision in the contract specific to the AIU attestation requirements of the state your practice is in.  For example, requiring in the contract itself that the software vendor execute any documents required by the state to attest to AIU or that the vendor provide a letter acknowledging the practice’s EHR license (if such a letter is acceptable in your state). Similar provisions are recommended in situations where the practice is involved with a Stark donation arrangement or other type of third party contract. 

Setting expectations up front and creating a contractual obligation will help ensure that the software vendor or other third party contractor does not stand in the way of your practice receiving EHR incentive dollars.

For assistance in drafting and negotiating EHR software contracts or the Medicaid EHR Incentive Program in general please contact Elana Zana or Dave Schoolcraft.            

OIG Launches Series on Provider Compliance

In December, the Office of Inspector General (OIG) launched a webcast series on provider compliance. Currently there are six short (approximately five minutes) webcasts on topics such as fraud and abuse, the anti-kickback statutes and the physician self-referral law (aka the Stark law).    These webcasts provide a short overview of these important compliance laws.  The OIG also has sixteen webcast modules that go into further depth on fraud and abuse enforcement.  The OIG plans on posting additional webcasts on a weekly basis over the next few months.

To access the webcasts click here.  Slides and handouts are also available on the OIG compliance training website.

New OIG Advisory Opinion – Pediatric Hospital May Provide Housing, Meals, etc.

Yesterday, the OIG issued Advisory Opinion No. 11-16 regarding the provision by a pediatric hospital of housing, transportation, meals and other miscellaneous items to patients participating in clinical research protocols.  The OIG determined that while the arrangement could potentially generate prohibited remuneration under the anti-kickback statute, the OIG would not impose civil monetary penalties.

The decision noted that the hospital’s provision of these services was not intended to induce referrals of federal health care program business.  The purpose behind these services was to  enable the patients and families to seek treatment at the hospital.  The OIG identified factors that protected the provision of these services from the risk of fraud and abuse:

1.  The hospital was a not-for-profit institution which relied primarily on donations, and is reimbursed less than a quarter of its costs from federal health care programs.

2.  The nature of the services provided are not likely to induce self referral to the hospital considering that the hospital focuses on treatment for catastrophic diseases of children.

3.  The purpose of the services is to enable compliance with the research protocols and allow the hospital to more closely monitor its patients.

4. The lodging facilities are designed for infection control.

5.  The provision of meal assistance ensures that the patients and families are able to satisfy basic nutritional requirements.

6.  These services are not marketed to prospective patients, their families or referring physicians.

7.  There is a substantial public benefit from the specialized care and the research.

As with all of its opinions, the OIG clarifies that the opinion only applies to the requestor of the opinion.  If you have questions regarding this advisory opinion please contact Elana Zana.