Frequently Asked Questions

Section 1

General FAQ

In 1977, in the Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142 (now codified at section 1128 of the Act), Congress first mandated the exclusion of physicians and other practitioners convicted of program-related crimes from participation in Medicare and Medicaid. This was followed in 1981 with the enactment of the Civil Monetary Penalties Law (CMPL), Public Law 97-35 (codified at section 1128A of the Act), to further address health care fraud and abuse. The CMPL authorizes the Department and OIG to impose CMPs, assessments, and program exclusions against any person that submits false or fraudulent or certain other types of improper claims for Medicare or Medicaid payment. Claims submitted by an excluded person for items or services furnished during the person’s exclusion violate the CMPL.

To enhance OIG’s ability to protect the Medicare and Medicaid programs and beneficiaries, the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93, expanded and revised OIG’s administrative sanction authorities by, among other things, establishing certain additional mandatory and discretionary exclusions for various types of misconduct. The enactment of the Health Insurance Portability and Accountability Act (HIPAA), Public Law 104-191, in 1996 and the Balanced Budget Act (BBA) of 1997, Public Law 105-33, further expanded OIG’s sanction authorities. These statutes extended the application and scope of the current CMP and exclusion authorities beyond programs funded by the Department to all “Federal health care programs.” BBA also authorized a new CMP authority to be imposed against health care providers or entities that employ or enter into contracts with an excluded person to provide items or services for which payment may be made under a Federal health care program.

Since the publication of the 1999 Bulletin, various statutory amendments have strengthened and expanded OIG’s authority to exclude individuals and entities from the Federal health care programs. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care Education Reconciliation Act of 2010 (ACA), expanded OIG’s exclusion waiver authority. The ACA also modified and expanded OIG’s permissive exclusion authorities and amended the CMPL by adding a new provision that subjects an excluded person to liability if the person orders or prescribes an item or a service while excluded and knows or should know that a claim for the item or service may be made to a Federal health care program. For more information, please go to http://oig.hhs.gov/exclusions/background.asp

As a Medicare, Medicaid, or Tricare provider – applicable payees including physicians, employees, and even vendors must be routinely crosschecked against the OIG List of Excluded Individuals and Entities. Billing under these programs while associated with excluded parties can result in compounded civil monetary penalties.

Providers and contracting entities have an affirmative responsibility to routinely verify the exclusion status of individuals and entities and maintain a record.

Violations and Civil Monetary Penalty (CMP) amounts of the OIG LEIE fall under the False Claims Act (FCA). Details of CMP assessment include:

  • Fines for each item or service furnished by the excluded individual or entity.
  • An assessment of up to three times the amount claimed (the amount paid to the health care organization by the government program going back as many as 6 years).
  • Government Funded Program exclusion

CMPs are codified and adjusted for inflation annually. The latest adjustments can be referenced at 45 CFR § 102.3 as well as
45 CFR § 1003.210.

The Venops exclusion screening process is straightforward:

  1. An encrypted spreadsheet uploaded from your Venops dashboard provides an “exclusion screening template” with the individuals and entities you want to screen.
  2. Venops accurately crosschecks your list against a direct-source exclusions database of every applicable exclusion/sanction authority.
  3. Complete exclusion clearance investigations are included. A complete exclusion screening record is created and maintained on your dashboard to show there are no excluded parties affiliated with your organization.
  4. Our software instantly identifies all possible exclusion matches by name and source. The Venops knowledge base provides a concise guide to easily clear any possible matches found. This option is best for smaller covered entities with a staff that doesn’t change very often.
  5. Venops access includes monthly Autopilot screening. The Venops system remembers every name previously screened and re-checks each of them automatically against the new updated exclusions database. This provides you with an updated, current exclusion report every month without fail.

This is a statement we hear often enough to address it in our FAQ. Yes – exclusion screening still applies. This is why:

The OIG mandate not only includes exclusion screening to identify excluded parties, but also the requirement to maintain an appropriate record. Your records of routine screening will do much to prove due diligence during any audits that occur – and Venops covers this need with both membership options offered.

Take a closer look by clicking the “Memberships” button above to see a graph showing a side-by-side comparison for each membership level. No registration required.

There are multiple exclusion and sanction lists tracked by Venops. While the federal OIG LEIE and GSA SAM are the most recognized, the majority of states have additional provider sanction lists that are also commonly screened. 

Additional exclusion and sanction authorities are also included with Venops screening, such as OFAC, Tricare, and the CMS Opt Out affidavits. Review a full list of exclusion and sanction authorities tracked by Venops by clicking the Memberships tab above.

Venops is known in the healthcare industry as a reliable steward of sensitive information critical for carrying out compliance services, and trust is our most cherished principle. Venops uses industry standard encryption with SOC 2 elements to protect the data shared for services fulfillment. Additional protocols are in place to further reduce risk.
Section 2

CMS Open Payments FAQ

Also known as the Sunshine Act, Open Payments is a national disclosure program that promotes a more transparent and accountable health care system by making the financial relationships between applicable manufacturers and group purchasing organizations (GPOs) and health care providers (physicians and teaching hospitals) available to the public.
Physicians, hospitals, life-science manufacturers in general, and group purchasing organizations are applicable for Open Payments. Beginning next year in 2021, payment data for additional provider types will be collected for an inaugural year of reporting set for 2022. More information is available on this topic in the Venops Knowledge Base, accessible by our members.

The law requires CMS to collect and display information reported by applicable manufacturers and group purchasing organizations (GPOs) about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Between the time of data collection and public release, registered physicians and teaching hospitals can review and, if needed, dispute payments reported about them. Data is then displayed on the public Open Payments website.

CMS Open Payments data is published every year to reflect a full 12-month calendar year. That data is always published in June of the following calendar year. For example, the Open Payments data submitted for the 2018 calendar year was published on June 30, 2019.

All applicable manufacturers (life-science manufacturers in general) and group purchasing organizations have to report any payments or other transfers of value to physicians and to teaching hospitals.

States and CMS have worked closely to ensure compliance with the health insurance accountability and consumer protections in federal law. The vast majority of states are enforcing the Affordable Care Act health insurance market reforms. Some states lack the authority, the ability to enforce these provisions, or both. CMS has responsibility for enforcing these requirements in a state that is not enforcing the health insurance market reforms either through a collaborative arrangement with the state or by direct enforcement to ensure all residents of the state receive the protections of the Affordable Care Act.

A civil monetary penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported. The total amount of civil monetary penalties will not exceed $150,000.

Knowingly failing to submit payment information will result in a civil monetary penalty of not less than $10,000, but not more than $100,000, for each payment. The penalty will not exceed $1,000,000.

Combined, penalties may not exceed $1,150,000.

CMS open payments reports include the declared expenses and other third-party financial data for all physicians. 

Creating your Venops CMS OPR is very similar to generating your screening reports.

To begin – Venops connects directly with the CMS Open Payments physician profile database to organize and download the data for each report on-demand. Each report requires approximately five minutes to be available for review.

For a Venops member the process of creating each report is simple:

Download the appropriate template from your Venops dashboard and enter the name(s) for the provider(s) you want to include.
Securely upload the template from your Venops dashboard.
Your steps for creating this report are done. In minutes you will be able to download your report from the Venops dashboard.

Section 3

Exclusion Screening FAQ

In short – yes. Verifying the clearance of associations with excluded parties is a required regulatory compliance item. Enforcement is overseen and carried out by HHS OIG.

As explained by HHS, “OIG has the authority to exclude individuals and entities from Federally funded health care programs pursuant to section 1128 of the Social Security Act (Act) (and from Medicare and State health care programs under section 1156 of the Act) and maintains a list of all currently excluded individuals and entities called the List of Excluded Individuals/Entities (LEIE).”

The industry standard for exclusion screening is that it should be carried out on a monthly basis. This supports updates to the LEIE and other exclusion/sanction authorities that occur monthly (or more often). As a result, Venops fully supports and conducts monthly exclusion screening to minimize the liability for CMPs.

From OIG HHS:

“Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties (CMP)… To avoid CMP liability, health care entities need to routinely check the LEIE to ensure that new hires and current employees are not on the excluded list.”

As a Medicare, Medicaid, or Tricare provider – applicable payees including physicians, employees, and even vendors must be crosschecked against the OIG List of Excluded Individuals and Entities. Billing under these programs while associated with excluded parties can result in compounded civil monetary penalties.

Early on, Venops adopted a comprehensive approach to track all applicable exclusion and sanction authorities in addition to the List of Excluded Individuals and Entities (LEIE). Since then, it has become the industry standard. Why? The need for monthly screening arises not only from staffing changes, but also from the dynamic nature of the exclusion and sanction authorities themselves. Many of them change monthly – some weekly – and those authorities are monitored in real time by Venops.

Providers and contracting entities have an affirmative responsibility to routinely verify the exclusion status of individuals and entities and maintain a record.

Violations and Civil Monetary Penalty (CMP) amounts of the OIG LEIE fall under the False Claims Act (FCA). Details of CMP assessment include:

  • Fines for each item or service furnished by the excluded individual or entity.
  • An assessment of up to three times the amount claimed (the amount paid to the health care organization by the government program going back as many as 6 years).
  • Government Funded Program exclusion

CMPs are codified and adjusted for inflation annually (typically in November). The latest adjustments can be referenced at 45 CFR § 102.3 as well as
45 CFR § 1003.210.

Venops mitigates compliance risk with automated exclusion screening through all applicable exclusion and sanction lists.

There are multiple exclusion and sanction lists tracked by Venops. While the federal OIG LEIE and GSA SAM are the most recognized exclusion lists, the majority of states have additional exclusion lists that should be tracked every month. Additional exclusion and sanction authorities are also included with Venops screening, such as the lists for OFAC, Tricare, and CMS Opt Out affidavits. A full list of exclusion authorities tracked by Venops can be found in our knowledge base – available to our members.

The Venops exclusion screening process is straightforward:

  1. An encrypted upload from your Venops dashboard provides an “exclusion screening template” with the individuals and entities you want to screen.
  2. Venops accurately crosschecks your list against a direct-source exclusions database of every applicable exclusion/sanction authority.
  3. Complete exclusion clearance investigations are included with a premium membership. A complete exclusion screening record is created to show there are no excluded parties affiliated with your organization.
  4. Our free model instantly identifies all possible exclusion matches by name and source. The Venops knowledge base provides a concise guide to easily clear any possible matches found.
  5. Premium and basic free memberships both include unlimited exclusion screening.
  6. Premium membership includes Autopilot™ monthly screening. The Venops system remembers every name previously screened and re-checks each of them automatically against the new updated exclusions database. This provides you with an updated, current exclusion report every month without fail.
At Venops we recognize that after you upload your first list of staff, providers, and vendors you may not have any changes from month to month. In response to this, we created Autopilot™ screening. Autopilot™ will remember every name included on your most recent exclusion report to screen everything through the updated exclusions database every month. This is an automated process that requires nothing from your office to occur.
The primary federal government exclusion and sanction authorities utilitze SSN and DOB for objective identification of individuals while the states use other variable information in most cases. Venops uses professional identity verification and background check tools for exclusion screening which require sensitive information. Venops not only identifies possible exclusions – it also verifies or disproves their exclusion status for you. To do that, Venops needs the identifying information used for that particular exclusion/sanction source wherever possible.

This is a statement we hear often enough to address it in our FAQ. Yes – exclusion screening still applies. This is why:

The OIG mandate not only includes exclusion screening to identify excluded parties, but also the requirement to maintain an appropriate record. Your records of routine screening will do much to prove due diligence during any audits that occur – and Venops covers this need with both membership options offered.

Take a closer look by clicking the “Memberships” button above to see a graph showing a side-by-side comparison for each membership level. No registration required.