Holland & Hart's Health Law Blog

OIG Issues Revised Self-Disclosure Protocol

April 18, 2013/in Fraud and Abuse

by Patricia (Pia) Dean, Holland & Hart LLP

On April 17, 2013, the Department of Health and Human Services Office of Inspector General released a revised provider self-disclosure protocol (SDP) that supersedes and replaces the 1998 Federal Register Notice and the Open Letters to Health Care Providers issued in 2006, 2008, and 2009. The SDP reaffirms the obligation on all members of the health care industry to take measures to detect and prevent fraudulent and abusive activities, and establishes new reporting requirements and guidance on calculating penalty multipliers.

Importance of Voluntary Self-Disclosure

The new SDP reaffirms the importance of self-disclosure, including OIG’s position that individual and entities that use the SDP and cooperate with OIG during the SDP process deserve to pay a lower multiplier on single damages than would normally be required. For the first time, the SDP states OIG’s general practice of requiring a minimum multiplier of 1.5 times the single damages, although the specific multiplier accepted may vary depending on the facts of each case.

CMS 60-Day Report and Repay Rule

The new protocol addresses CMS’s proposed 60-day “report and repay” rule. The Affordable Care Act generally requires that providers report and return Medicare or Medicaid overpayments within 60 days of the date the overpayment is first identified. Failure to report and repay within 60 days may create liability under the Civil Monetary Penalties Law (CMPL) and False Claims Act. CMS issued its proposed rule implementing the 60-day repayment obligation in February 2012. (77 FR 9179). The proposed rule would suspend the obligation to report overpayments when OIG acknowledges receipt of a submission on the SDP, provided the submission is timely made. In return for suspending the 60-day requirement, the new SDP states that OIG expects disclosing parties to disclose with a good-faith willingness to resolve all liability within the CMPL’s six-year statute of limitations. OIG has indicated it will provide additional guidance regarding the 60-day obligation and SDP process after CMS releases a final rule.

Eligibility Criteria and Guidance

The SDP provides greater guidance on how to investigate potentially fraudulent conduct, quantify damages, and report the conduct to OIG. According to the SDP, over the past 15 years, it has resolved over 800 disclosures, resulting in recoveries of more than $280 million to Federal health care programs. The SDP states that all health care providers, suppliers, or other individuals or entities that are subject to OIG’s civil monetary penalty authority are eligible to use the SDP. Accordingly, the SDP is not limited to any particular industry, medical specialty, or type of service. By way of example, the SDP states that a pharmaceutical or medical device manufacturer may use the SDP to disclose potential violations of the Federal anti-kickback statute (AKS) because such violations trigger CMP liability.

In addition, the new protocol delineates conduct that is not eligible for the SDP, including (1) matters that do not involve potential violations of Federal criminal, civil, or administrative law for which civil monetary penalties are authorized, such as one exclusively involving overpayments or errors, (2) requests for opinions from OIG regarding whether an actual or potential violation has occurred, and (3) disclosure of an arrangement that involves only liability under the physician self-referral law (Stark) without accompanying potential liability under the AKS for the same arrangement. Conduct that only involves Stark violations should be disclosed to CMS through CMS’s Self-Referral Disclosure Protocol.

Among other requirements, the SDP requires that the disclosing parties explicitly identify the laws that were potentially violated, and not just refer broadly to federal laws, rules and regulations. The SDP provides details for the content of all submissions as well as the specific requirements for conduct involving false billing, excluded persons, and the anti-kickback statute and physician self referral law.

The revised SDP is available here.

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

New OSHA Webpage for Health Care Clinicians

March 22, 2013/in OSHA, Workplace Safety

By Susan Woods

If you’ve ever struggled with how to handle a work-related health and safety issue, you are in luck. The Occupational Safety and Health Administration (OSHA) recently launched a webpage specifically designed to help clinicians address safety concerns and ensure a safe and healthy workplace.

Physicians, nurses, paramedics and other health care professionals encounter hazardous situations and exposures at work almost every day. Hospital administrators and medical office managers are left to untangle the web of regulatory and clinical issues to reduce, report and respond to those situations effectively. This new webpage can be a valuable resource to get you pertinent information quickly and easily.

One-Stop Resource for OSHA’s Medical and Occupational Health Information

OSHA’s new Clinician’s webpage gathers important information related to health care employers and their responsibility to develop and enforce health and safety standards and practices. Topics covered on the webpage include:

evaluating occupational exposures and injuries;
medical screening and surveillance;
legal and confidentiality requirements for medical records;
recordkeeping – the OSHA 300 log;
setting up a safe outpatient office; and
protocols for an occupational health practice.

In addition, the webpage offers quick links to OSHA standards on bloodborne pathogens, hazardous waste and emergency response, occupational noise exposure and respiratory protection. Additional information from governmental, academic, clinical and professional resources are included, such as a new educational resource on healthcare worker and patient safety from The Joint Commission, the Health Hazard Evaluation Program from the National Institute for Occupational Safety and Health (NIOSH) and toxicological profiles on substances from the Agency for Toxic Substances and Disease Registry (ATSDR).

You never know when a workplace safety question will come up so check out OSHA’s new webpage and bookmark it for future use.

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

May our group offer free screenings?

March 15, 2013/in Fraud and Abuse

by Kim Stanger, Holland & Hart LLP

As with other free or discounted items or services, offering free screenings can violate (1) the federal Anti-Kickback Statute (“AKS”) if one purpose of the free screening is induce referrals for items or services payable by federal healthcare programs (42 USC § 1320a-7b), and/or (2) the federal Civil Monetary Penalties Law (“CMP”) if the physician knows or should know that the free screening is likely to induce a federal program beneficiary to purchase items or services covered by federal healthcare programs (42 USC § 1320a-7a). There are several potentially relevant CMP exceptions, most of which focus on whether the screening is tied to the provision of other services payable by federal healthcare programs. In Advisory Opinion 09-11, the OIG approved a hospital’s free blood pressure screening program where (1) the free screening was not conditioned on the use of any other goods or services from the hospital; (2) the patient receiving the screening was not directed to any particular provider; (3) the hospital did not offer the patient any special discounts on follow-up services; and (4) if the screening was abnormal, the patient as advised to see their own health care professional. Under these circumstances, the OIG concluded that the test was not improperly tied to the provision of other services by the hospital.

For more information, see the OIG’s Special Advisory Bulletin: Offering Gifts and Other Inducements to Beneficiaries (August 2002), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf.

For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

HIPAA Omnibus Rule: Checklist for Compliance

March 1, 2013/in HIPAA

by Kim Stanger, Holland & Hart LLP

The new HIPAA omnibus rule modifies the privacy and security rules for covered entities (including health care providers and health plans), and their business associates. Although the new rules are effective March 26, 2013, covered entities and business associates generally have until September 23, 2013 to comply.¹ Before then, covered entities and business associates need to do the following:

Business Associates: Implement HIPAA Policies, Procedures and Safeguards. The HIPAA privacy and security rules now apply directly to business associates of covered entities.² “Business associates” are those outside entities that create, receive, maintain or transmit protected health information in the course of performing functions on behalf of a covered entity, including contractors, consultants, data storage companies, health information organizations, and subcontractors of business associates.³ Business associates must now implement many of the same policies, procedures and safeguards that have been required of covered entities for years, including the following:
1. Security Rule. Business associates will need to conduct and document a risk assessment of their information technology systems and implement the specific administrative, technical and physical safeguards specified in the Security Rule.⁴ The Office of Civil Rights’ website contains helpful guidance for Security Rule compliance: http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityruleguidance.html.
2. Privacy Rule. Most of the privacy rule provisions do not apply directly to business associates, but because business associates cannot use or disclose protected health information in a manner contrary to the limits placed on covered entities,⁵ business associates will need to implement many of the same policies and safeguards that the Privacy Rule mandates for covered entities, including rules governing uses and disclosure of protected health information and patient rights concerning their information.⁶ Those are typically outlined in the business associate’s agreement with the covered entity. Since business associates are now directly liable for HIPAA violations, they should ensure they understand and train their employees concerning HIPAA Privacy and Security Rule requirements.
3. Breach Notification. If a business associate becomes aware of a breach of unsecured health information, they must notify the covered entity and assist the covered entity in responding to the breach.⁷
Identify New Business Associates and Execute Agreements. Covered entities are required to have business associate agreements with their business associates before allowing them to use or disclose protected health information. The omnibus rule expanded the definition of “business associates” to include entities that provide data transmission services and require routine access to information such as health information organizations.⁸ Covered entities should identify any such business associates and execute appropriate agreements with them. Business associates must execute appropriate business associate agreements with their own subcontractors if the subcontractor creates, receives, maintains or transmits protected health information for the business associate.⁹
Review and, If Necessary, Amend Business Associate Agreements. Covered entities and business associates must ensure that their existing and future agreements contain the elements required by 45 CFR § 164.314(a) and .504(e). In addition to previous requirements, the agreement must require the business associate to:
1. Comply with the security rule.
2. Execute business associate agreements with their subcontractors.
3. To the extent the business associate carries out on obligation of a covered entity, comply with any HIPAA rule applicable to such obligation.
4. Report breaches of unsecured protected health information to the covered entity.
The OCR has published updated sample business associate language at http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html. The omnibus rule confirms that covered entities are liable for the misconduct of business associates if the business associate is acting as the agent of the covered entity.¹⁰ To minimize their exposure, covered entities and business associates should ensure their agreements confirm that their business associates and subcontractors are acting as independent contractors and not as the agents of the covered entity or business associate, and that the agreements do not give the covered entity too much control over day-to-day operations of the business associate.¹¹ Covered entities may also want to include indemnification or similar clauses to protect themselves. Covered entities have up to September 22, 2014 to modify business associate agreements if (1) the agreement they had in place on January 25, 2013, complied with the HIPAA rules as of that date, and (2) the agreement does not expire or renew (other than through evergreen clauses) prior to September 22, 2014.¹²
Update Privacy Policies. Covered entities should update their privacy policies to comply with the new omnibus rules, including the following as applicable to the covered entity:
1. Deceased Persons. Covered entities may now disclose protected health information to family members or others who were involved in the decedent’s health care or payment for their care prior to the decedent’s death so long as the disclosure is relevant to the person’s involvement and is not inconsistent with the decedent’s prior expressed wishes.¹³
2. Patient Access to Electronic Information. If a patient requests an electronic copy of their information, covered entities must generally produce it in the form requested if readily producible.¹⁴ If the patient directs the covered entity in writing to transmit a copy of the electronic information to another person, the covered entity must generally comply.¹⁵
3. Response to Request for Access. Covered entities must generally respond to a patient’s request to access their information within 30 days; the omnibus rule eliminated the provision that gave covered entities extra time to respond if records were maintained offsite.¹⁶
4. Limits on Disclosures to Insurers. Covered entities cannot disclose information about a patient’s care to an insurer if (1) the insurer seeks the information for treatment or payment purposes; (2) the patient or someone on the patient’s behalf paid for the care to which the information pertains; and (3) the patient requests that the information be withheld from the insurer.¹⁷ Good luck implementing this requirement. Developing a workable solution may take some advance preparation. Fortunately, the limit only applies if a patient requests nondisclosure; most patients will not request this restriction unless asked, so covered entities should not raise the issue with the patient. If a patient does request nondisclosure, covered entities should require that such requests be directed to a central person who can coordinate the efforts among billing, medical records, IT, and other relevant departments to ensure the protected data is sequestered.
5. School Immunizations. Covered entities may now disclose information about immunizations to a school if (1) state law requires such information for school enrollment; and (2) the patient or their personal representative consents to the disclosure. The consent may be oral.¹⁸
6. Sale of Information. Covered entities must obtain written authorization to sell a patient’s information, and the authorization must disclose that the sale will result in remuneration to the covered entity.¹⁹
7. Marketing. Covered entities must obtain written authorization to use the patient’s information for marketing purposes, including most non-face-to-face communications for treatment purposes if the covered entity receives financial remuneration to make the communication.²⁰ If remuneration is involved, the marketing authorization must disclose that fact.
8. Fundraising. The new rule allows covered entities to disclose more information to institutionally related foundations to assist with fundraising, but fundraising communications must explain how the recipient may opt out of receiving such communications and the opt out method cannot be burdensome.²¹
9. Research. If the covered entity engages in research, it should review new standards applicable to research as described in 45 CFR § 164.508(b).
Update Breach Notification Policies. The omnibus rule modified the standard for reporting breaches of unsecured health information. Under the new standard, the unauthorized acquisition, access use or disclosure of protected health information in violation of the Privacy Rule is presumed to be a reportable breach unless (1) the covered entity or business associate demonstrates there is a low probability that the information has been compromised based on a risk assessment of certain factors, or (2) the breach fits within certain exceptions.²² Covered entities must ensure that their policies incorporate and that they apply this new, arguably lower standard. For more information about the breach notification standard, see my recent Healthcare Update at http://www.hollandhart.com/pubs/uniEntity.aspx?xpST=PubDetail&pub=2094. Given the lower standard, covered entities and business associates may want to consider encrypting records to the extent possible to avoid reportable breaches.
Modify Notice of Privacy Practices. Covered entities must update their notices of privacy practices to add the following:
1. A description of the types of information that require an authorization, i.e., psychotherapy notes, marketing, and sale of information.²³
2. A statement that other uses or disclosures not described in the notice will require an authorization.²⁴
3. A statement that the recipient of fundraising materials may opt out.²⁵
4. A description of the individual’s right to limit disclosures to insurers if the patient paid for the relevant care.²⁶
5. A statement that the covered entity must notify the patient of a breach of unsecured protected health information.²⁷
Train Employees. Covered entities and business associates must train their employees concerning the new rules.²⁸
Review HIPAA Compliance. Given the new, lower breach notification standard, covered entities will likely to be required to self-report more breaches. Those reports may result in more patient complaints and government investigations. Accordingly, it is a good time to review and, as necessary, improve your compliance with all the HIPAA rules, not just the new omnibus rules. Doing so may help you avoid reportable breaches and, if a breach occurs, sidestep HIPAA penalties, which can range from $100 to more than $50,000 per violation. Having the required policies and safeguards in place coupled with prompt action to correct any breach will likely establish an affirmative defense to any penalties. For suggested steps to avoid penalties, see my recent Healthcare Update at http://www.hollandhart.com/pubs/uniEntity.aspx?xpST=PubDetail&pub=1898.

Resources. To assist clients in complying with the new omnibus rule and HIPAA in general, I have prepared sample Privacy Rule policies, forms, and agreements. If you would like to obtain a set of the sample documents, please contact me at kcstanger@hollandhart.com.

¹45 CFR § 160.105
²Id. at § 164.104(b)
³Id. at § 164.103
⁴Id. at §§ 164.302 to .316
⁵Id. at § 164.502(a)(3)
⁶Id. at § 164.502 to .528
⁷Id. at § 164.410
⁸Id. at § 164.103
⁹Id. at § 164.314(a)(2) and .502(e)(1)
¹⁰Id. at § 164.402(c)
¹¹See 78 FR 5581
¹²45 CFR § 164.532(e)
¹³Id. at § 164.510(b)(5)
¹⁴Id. at § 164.524(c)(2)(ii)
¹⁵Id. at § 164.524(c)(3)(ii)
¹⁶Id. at § 164.524
¹⁷Id. at § 164.522(a)(1)(vi)
¹⁸Id. at § 164.512(b)(1)(vi)
¹⁹Id. at § 164.502(a)(5)(ii) and .508(a)(4)
²⁰Id. at § 164.501 and .508(c)
²¹Id. at § 164.514(f)
²²Id. at § 164.402
²³ Id. at § 164.520(b)(1)(ii)(E)
²⁴Id. at § 164.520(b)(1)(ii)(E)
²⁵Id. at § 164.520(b)(1)(iii)
²⁶Id. at § 164.520(b)(1)(iv)(A)
²⁷Id. at § 164.520(b)(1)(V)(A)
²⁸ Id. at § 164.530(b)

For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

HHS Issues New HIPAA Omnibus Rule

January 18, 2013/in HIPAA

by Kim Stanger, Holland & Hart LLP

HHS issued the new HIPAA omnibus rule yesterday. The new rule contains important changes for health care providers and their business associates. For example, the new rule:

Modifies the standard for reporting breaches to patients and HHS. HHS replaced the former “no harm, no foul” rule with a new standard: a breach is presumed unless the covered entity can demonstrate a low probability that the protected health information has not been compromised. This requires an assessment of specified factors and will likely increase the number of reportable breaches.
Confirms HIPAA requirements for business associates and their subcontractors. Business associates are subject to HIPAA penalties if they fail to comply. The definition of “business associates” was expanded to include entities that provide data transmission services for protected health information and require routine access to the information.
Confirms providers are liable for their business associate’s violations if the business associate is acting as the agent for the provider. The rule’s commentary contains a helpful analysis for determining whether an agency relationship exists.
Makes it easier for family members to obtain information about decedents. The rule also confirms that HIPAA does not apply to information 50 years after the decedent’s death.
Expands patients’ right to obtain electronic copies of their records.
Prohibits providers from disclosing information to health insurers if the patient pays for the treatment and requests that the information not be disclosed to insurers. Implementation will create significant practical problems for practitioners.
Prohibits the sale of protected health information unless certain conditions are satisfied.
Imposes additional requirements for the use of protected health information for marketing or fundraising. Among other things, an authorization is required to disclose information for treatment purposes if the provider is receiving remuneration for the disclosure.
Requires new provisions to be added to providers’ Notice of Privacy Practices, including a description of disclosures that require authorizations and notice of a patient’s right to receive notice of HIPAA breaches.

The new rules take effect March 23, 2013, but covered entities and business associates will have until September 23, 2013 to comply. Before then, providers will need to take certain actions to remain compliant, including:

Modify their Notice of Privacy Practices.
Update and/or execute new business associate contracts, including contracts for subcontractors and health information organizations. Existing compliant contracts do not need to be modified until September 2014.
Revise privacy, security and breach notification policies to incorporate the new requirements.
Modify authorizations and other forms as necessary to track the new rules.
Ensure their electronic medical records programs have the functionality to address the new regulatory requirements.
Take even greater care to protect patient information given the new standard for evaluating whether breaches are reportable.

Business associates will also need to implement HIPAA privacy and security policies and safeguards applicable to business associates. HHS estimates that complying with the new requirements will cost affected parties a total of $114 million to $225 million during the first year. The new rule can be accessed at: http://www.ofr.gov/OFRUpload/OFRData/2013-01073_PI.pdf. HHS’s press release can be accessed at www.hhs.gov/news/press/2013pres/01/20130117b.html.

For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

OIG Issues Revised Self-Disclosure Protocol

New OSHA Webpage for Health Care Clinicians

May our group offer free screenings?

HIPAA Omnibus Rule: Checklist for Compliance

HHS Issues New HIPAA Omnibus Rule

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