Understanding Stark/Anti-Kickback Compliant EHR Donation Arrangements

February 25, 2014 By

In 2006 and extended in December 2013, CMS issued Stark and Anti-Kickback exceptions/safe harbors permitting EHR technology donation arrangements between hospitals (and other organizations) and physician groups.  This exception permitted hospitals to aid physician groups, who may be referral sources, in acquiring and implementing EHR and other health information technology.  Originally, hospitals had a seven-year window in which to engage in these donation arrangements, though in December 2013 CMS extended the donation arrangements for an additional 7 years through December 31, 2021.

The arrangement may include the non-monetary donation of “items or services in the form of software or information technology and training services.”  Key components of the exception/safe harbor include:

  • The donation is provided from an entity to a physician.
    • Change in 2013 rules, this entity cannot be a lab.
  • The software is interoperable
    • Change in  2013 rules, software is deemed interoperable if it has been certified as “certified EHR technology” as that term is used by the ONC for the meaningful use/EHR Incentive Program.
  • Donor cannot restrict or limit the use or interoperability of the technology with other eRx or EHR systems.
    • Change in 2013 rules, CMS interprets this rule more broadly by providing a non-exclusive list of the types of technologies that are included in this restriction: “health information technology applications, products, or services.”
  • Physician must pay at least 15% of the costs for the technology (which amount cannot be financed by the hospital).
  • Neither the physician nor the physician’s practice makes the receipt of the technology a condition of doing business with the donor.
  • Neither eligibility of the physician nor the amount or nature of the donation is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties.
  • The donation is set forth in writing, signed by the parties, specifies the items to be provided, the donor’s costs and the physician’s contribution, and covers all EHR items and services to be provided by the donor.
  • The donor cannot have knowledge of or disregard the fact that the physician already possesses equivalent items or services.
  • The donor cannot restrict or limit the physician’s right to use the software for any patient.
  • The donation cannot include staffing of physician offices and cannot be used to primarily conduct personal business or business unrelated to the physician’s medical practice.
    • Note the donation may also include other “software and functionality directly related to the care and treatment of individual patients (for example, patient administration, scheduling functions, billing, clinical support software, etc.” (71 FR 45152).
  • The donation arrangement does not violate the Anti-Kickback statute.
  • The exception expires December 31, 2021.

Beyond crafting a donation arrangement that satisfies both the Stark law exception and Anti-Kickback safe harbor, hospitals and physicians should assess overall technology alignment strategies and the goals and framework for such donation arrangements.  Making sure that clear expectations are set in advance, including understanding implementation, roll out and support, data ownership and extraction, and utilizing the EHR technology for government incentive programs, such as meaningful use, are important topics that should be addressed by the arrangement.

For those interested in learning more about this topic and are currently attending HIMSS14, David Schoolcraft, attorney at Ogden Murphy Wallace, and Michelle Holmes, principal at ECG Management Consultants, are presenting on Wednesday at 10 AM on Using Stark/Anti-Kickback To Support Hospital/Physician IT Alignment Strategies.  For further information about designing a compliant arrangement please contact Elana Zana or Dave Schoolcraft.

 

Filed Under: Anti-Kickback/Stark, Compliance, EHR, Hospitals, OIG, Stark Tagged With: , ,

High Number of HIPAA Mobile Device Breaches – Time to Use Safe Harbor Encryption

February 24, 2014 By

Most breaches of electronic protected health information (ePHI) reported to the Department of Health and Human Services (HHS) have related to the theft or loss of unencrypted mobile devices. These breaches can lead to potentially hefty civil fines, costly settlements and negative publicity (e.g. Stanford and Idaho laptops or APDerm thumb drive). Given the increasing use of mobile devices and the significant costs of breach notification, healthcare organizations and their business associates would be wise to invest in encryption solutions that fall within the “safeharbor” for HIPAA breach notification.

Encryption and the “Safeharbor” for HIPAA Breach Notification

Under HHS guidance, ePHI is not considered “unsecured” if it is properly encrypted by “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key” and such confidential process or key that might enable decryption has not been breached.  To avoid a breach of the confidential process or key, these decryption tools should be stored on a device or at a location separate from the data they are used to encrypt or decrypt.  Encryption processes “consistent with” (for data at rest) or which “comply, as appropriate, with” (for data in motion) the National Institute for Standards and Technology (“NIST”) guidelines are judged to meet the law’s standard for encryption.  If ePHI is encrypted pursuant to this guidance, then no breach notification is required following an impermissible use or disclosure of the information—this is known as the HIPAA breach notification “safeharbor”. [78 FR 5664]

NIST Guidelines for Data at Rest

The NIST guidelines for data at rest do not provide specific requirements for encryption technology– instead, it describes common storage encryption technologies (full disk, volume, virtual, and file/folder encryption) and offers recommendations for implementing a storage encryption solution. A main takeaway from this guide is that “the appropriate encryption solution for a particular situation depends primarily upon the type of storage, the amount of information that needs to be protected, the environments where the storage will be located, and the threats that need to be mitigated.” Despite the lack of bright-line rules, the NIST guide does offer some key recommendations, such as:

  • When selecting a storage encryption technology, consider solutions that use existing system features (such as operating system features) and infrastructure.
  • Use centralized management for all deployments of storage encryption except for standalone deployments and very small-scale deployments.
  • Select appropriate user authenticators for storage encryption solutions.
  • Implement measures that support and complement storage encryption for end user devices.

Encryption Technology for Apple iOS Devices: A Case Study

The good news is that the technology is available to properly encrypt ePHI without being too burdensome.  For instance, Apple’s popular iPhones and iPads fortunately have their own built-in encryption technology.  Every iOS device has a “dedicated AES (Advanced Encryption Standard) 256 crypto engine built into the DMA (Direct Memory Access) path between the flash storage and main system memory, making file encryption highly efficient.”  Setting a passcode turns on Data Protection, and the passcode becomes a key to encrypting mail messages and attachments (or other apps), using 256-bit AES encryption. Notably, Apple’s encryption technology (CoreCrypto Module and CoreCrypto Kernel Module) has been FIPS (Federal Information Processing Standards) certified, a standard that the NIST guide references and approves.

Based on the NIST guidelines for data at rest, the following are some basic steps for implementing a storage encryption technology solution specifically with Apple iOS devices:

  • Ensure that users have up-to-date devices and operating systems (e.g. iPhone 4 or higher running iOS 4 or higher).
  • Work with an IT administrator or security expert to manage deployment of iPhones.
  • Select appropriate passcode requirements to meet your security needs, including timeout periods, passcode strength and how often the passcode must be changed. The effectiveness of data protection depends on a strong passcode, so it is important to require and enforce a passcode stronger than 4 digits when establishing passcode policies.
  • Store/transmit the minimum amount of ePHI necessary to effectuate communication.
  • Disable access to Notification Center and Alerts from locked screen to prevent display of potentially sensitive data.
  • Revise and document organizational policies as needed to incorporate appropriate usage of the storage encryption solution.
  • Make users aware of their responsibilities for storage encryption, such as physically protecting mobile devices and promptly reporting loss or theft of devices.

For additional guidance on mobile device security, the HHS Office of the National Coordinator for Health Information Technology (“ONC”) has also provided helpful tips in “How Can You Protect and Secure Health Information When Using a Mobile Device?”.

As healthcare becomes more mobile, covered entities, business associates, and health information technology vendors should become familiar with the “safeharbor” for HIPAA breach notification and the NIST guidelines for encryption of data at rest and in transit.  For more information about the HIPAA “safeharbor”, encryption standards, or HIPAA in general, please contact Jefferson Lin, Lee Kuo or David Schoolcraft.

 

Filed Under: Breach Notification, Compliance, Health Information Technology, HIPAA, HITECH Tagged With: , ,

HHS Issues HIPAA Guidance For Mental Health

February 21, 2014 By

HHS recently issued HIPAA guidance for mental health practitioners, in an effort to help providers wade through complicated decisions of when disclosures of patient information are permissible.  This guidance, set up in a FAQ format, is designed to incorporate common questions related to the intersection of mental health and privacy laws.  The guidance addresses when healthcare providers are permitted to:

  • Communicate with a patient’s family members, friends, or others involved in the patient’s care;
  • Communicate with family members when the patient is an adult;
  • Communicate with the parent of a patient who is a minor;
  • Consider the patient’s capacity to agree or object to the sharing of their information;
  • Involve a patient’s family members, friends, or others in dealing with patient failures to adhere to medication or other therapy;
  • Listen to family members about their loved ones receiving mental health treatment;
  • Communicate with family members, law enforcement, or others when the patient presents a serious and imminent threat of harm to self or others; and
  • Communicate to law enforcement about the release of a patient brought in for an emergency psychiatric hold.

The guidance also addresses FERPA (privacy laws in a school setting), Federal alcohol and drug abuse confidentiality (42 CFR Part 2 Programs) and the rights of parents to have access to a minor child’s information.    Though not addressed in the guidance, those mental health practitioners practicing in Washington State should also be aware of  the new statutes regulating mental health record disclosures which take effect on July 1, 2014.

For assistance in navigating these privacy rules please contact Elana Zana or Dave Schoolcraft.

Filed Under: Compliance, HIPAA, Mental Health, Washington Tagged With: , ,

DOH Issues New Hospital CN Rule & Transparency Requirements

January 6, 2014 By

Prior to the end of the year, and in compliance with Governor Inslee’s directive, the Washington Department of Health (DOH) issued new hospital Certificate of Need (CN) rules and transparency requirements for existing hospitals.

Effective January 23rd, hospitals wishing to affiliate with one another (or other types of corporate restructuring) will now have to undergo full CN review.  The new rules modify WAC 246-310-010 and adopt a broad definition of “sale, purchase, or lease” to include affiliations, corporate membership restructuring, “or any other transaction.”  DOH, in response to the over 1,000 public comments received on these new rules (including the transparency rules below) explained:

The purpose of this clarification is to focus on the outcome of these transactions to bring them within CoN review.  CoN evaluation includes review of the reduction or loss of services and the community’s access to alternatives if there is a reduction or loss.

In addition, DOH issued a modification to the hospital licensing requirements.  This modification now requires hospitals to submit to DOH and publish on their own websites (“readily accessible to the public”) the following policies related to access to care:  admission, nondiscrimination, end of life care, and reproductive health care.  Hospitals must comply with this requirement no later than March 24, 2014.  Hospitals that make changes to these policies must also notify DOH of those changes within thirty days.

Since the amendment to the hospital licensing rules require online access to hospitals’ nondiscrimination policies, now is an excellent time for hospitals to review nondiscrimination policies to be sure they are consistent with all applicable laws.  Hospitals are “places of accommodation” under local, state, and federal nondiscrimination laws, which vary by jurisdiction.  For example, federal law prohibits genetic discrimination, which is not covered by Washington state law; state law prohibits discrimination on the basis of marital status, sexual orientation, and gender expression or identity, which are not covered under federal law; and the City of Seattle prohibits discrimination on the basis of political ideology, which is not covered under state or federal law.  Hospital nondiscrimination policies should be tailored to cover all the jurisdictions in which you provide services.  For assistance with drafting a nondiscrimination policy please contact Karen Sutherland.

For more information about the access to care policies or certificate of need generally please contact Elana Zana.

 

 

Filed Under: Certificate of Need, Compliance, Hospitals, Washington Tagged With: , ,

OIG’s Report Highlights Enforcement Successes in 2014

December 30, 2013 By

The Office of Inspector General (OIG) recently published its Semiannual Report to the U.S. Congress. This Report summarizes the OIG’s enforcement activities from March, 2013 to September, 2013.

The Report highlights the OIG’s significant efforts in the enforcement of fraud and abuse laws.  For fiscal year (FY) 2013, the OIG is expecting total recoveries of $5.8 billion, consisting of nearly $850 million in audit receivables and about $5 billion in investigative receivables.

Additionally, for FY 2013, the OIG brought 960 criminal and 472 civil actions against individuals or entities that engaged in health-care-related offenses.   Compared with FY 2012, the number of criminal actions in FY 2013 rose by 182 cases, and the number of civil cases rose by 105 cases.

According to the OIG, these enforcement results are partially due to the successes of the Health Care Fraud Prevention and Action Team (HEAT).  HEAT is a partnership between Federal, State, and local law enforcement to identify fraudulent health care schemes.   The program combines sophisticated data analysis and investigative intelligence to move quickly against violators of fraud and abuse laws such as the False Claims Act.

There is no doubt that the OIG’s accomplishments in FY 2013 will motivate investigators to root out more health care fraud and overpayment schemes in FY 2014.  To avoid a costly investigation and potential prosecution, providers should take extra care that they are following Medicare and Medicaid laws and properly billing for services rendered to patients.

You can read the entire OIG Semiannual Report here.

For more information about health care fraud and abuse laws, please contact Casey Moriarty.

Filed Under: Compliance, Medicare, OIG

OIG Issues Unfavorable Advisory Opinion Related to Fee Arrangement

November 15, 2013 By

Earlier this week the OIG issued an unfavorable Advisory Opinion concerning the relationship between an Anesthesiology Group (defined as the “Requester” in the OIG opinion), a Psychiatry Group and a Hospital.  The Psychiatry Group performed electroconvulsive therapy (ECT) services at the Hospital, requiring related anesthesia services.  The Requester had an exclusive contract with the Hospital for the provision of anesthesia services.  The specific arrangements reviewed by the OIG dealt with the Hospital’s pressure on the Requester to carve out exceptions to its exclusive contract that would have the effect of allowing the Psychiatry Group to have access to a new anesthesia revenue stream.  Ultimately, the OIG determined that the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute.

The Proposed Arrangement stemmed from negotiations between the Hospital and the Anesthesiology Group, which had held an 18 year exclusive relationship with the Hospital until 2011.  In late 2010 the Psychiatry Group relocated its practice, which centers around ECT services, to the Hospital; a member of the Psychiatry Group included an anesthesiologist.  In 2011 negotiations with the Anesthesia Group, the Hospital modified the exclusive relationship to allow the Psychiatry Group’s anesthesiologist to perform ECT anesthesia services, and to request the Anesthesiology Group’s coverage while he was not available.  In 2012, the Psychiatry Group requested a provision allowing it to bring in a part time anesthesiologist if the Psychiatry Group and the Anesthesiology Group could not agree on terms for those additional services.  After the 2012 contract went into effect, the Psychiatry Group notified the Anesthesiology Group that it wanted to bring in the additional anesthesiologist and asked the Anesthesiology Group to enter into the Proposed Arrangement.

The Proposed Arrangement provided that the Anesthesiology Group would provide the ECT anesthesia coverage services that were needed and would reassign all billing rights to Psychiatry Group.  In exchange the Anesthesiology Group would receive a per diem rate which the Anesthesiology Group asserts was less than fair market value and below what it would receive if it billed directly for the anesthesia services.  The Psychiatry Group would retain the difference between the amount collected and the per diem rate.  The OIG unequivocally rejected this Proposed Arrangement, finding that the per diem payment made to the Anesthesiology Group did not fall under the personal services and management contract safe harbor of the anti-kickback statute because it was not set in advance nor consistent with fair market value.  Further, the OIG determined that the fee generated for the Psychiatry Group was a door to solicit compensation for its patient referrals for ECT services:

 “The Proposed Arrangement appears to be designed to permit the Psychiatry Group to do indirectly what it cannot do directly; that is, to receive compensation, in the form of a portion of Requestor’s anesthesia services revenues, in return for the Psychiatry Group’s referrals of ECT patients to Requestor for anesthesia services. The Additional Anesthesiologist Provision gave the Psychiatry Group the ability to solicit this remuneration for its ECT patient referrals by allowing the Psychiatry Group to contract with an anesthesiologist other than Requestor if Requestor and the Psychiatry Group were not successful in negotiating the terms of an agreement for Requestor to provide ECT anesthesia services. The Proposed Arrangement therefore presents the significant risk that the remuneration Requestor would provide to the Psychiatry Group—i.e., the opportunity to generate a fee equal to the difference between the amounts the Psychiatry Group would bill and collect for Requestor’s anesthesia services, and the per diem amounts the Psychiatry Group would pay to Requestor—would be in return for the Psychiatry Group’s anesthesia referrals to Requestor. We discern no safeguards in the Proposed Arrangement that would minimize this risk.”

What perhaps might be the most interesting part of the opinion, are the OIG’s comments in concluding the opinion. Although not asked to opine on the Hospital’s relationships with the Psychiatry Group and Requester, the OIG commented in a footnote about the potential improprieties of the Hospital’s relationship with those parties:

“Although we have not been asked to opine on, and express no opinion regarding, any aspect of Requestor’s relationship with the Hospital, including the 2012 Contract or the Additional Anesthesiologist Provision, we cannot exclude the possibility that: (i) the Hospital agreed to negotiate for the Additional Anesthesiologist Provision in exchange for, or to reward, the Psychiatry Group’s continued referral of patients to the Hospital for ECT procedures; (ii) the Hospital leveraged its control over its large base of anesthesia referrals to induce Requestor to agree to the Additional Anesthesiologist Provision; and (iii) Requestor agreed to the Additional Anesthesiologist Provision in exchange for access to the Hospital’s stream of anesthesia referrals.”

This OIG opinion highlights the OIG’s continued concern regarding arrangements that allow referring providers access to new revenue streams in a manner that may be connected to the providers referrals.  Parties desiring to enter into these types of arrangements should take care to include as many safeguards (using the OIG’s language) to ensure that the payments are not related to referrals.  In the absence of such safeguards, it is pretty clear that the OIG will not look favorably upon the arrangement.

For more information about this particular OIG Opinion or the anti-kickback statute in general please contact Elana Zana or Don Black.

 

Filed Under: Anti-Kickback/Stark, Compliance, OIG Tagged With:

Joint Commission Standards for Boarding and Leadership Collaboration with Behavioral Health Community

November 8, 2013 By

Effective January 1, 2014, hospitals, accredited by the Joint Commission, will be required to meet the elements of performance (EPs) related to boarding and leadership collaboration for behavioral health patients, as part of The Joint Commission’s revised standard for managing the flow of patients through the emergency department. Overcrowding and patient boarding in the emergency department has drawn considerable attention recently (see e.g., Seattle Times article on psychiatric boarding), and The Joint Commission recognizes that the problems with patient flow may have multiple factors and stem from other areas within and outside the hospital, not just the emergency department.

Under Leadership Standard LD.04.03.11 or the “Patient Flow” Standard, the following EPs will go into effect for hospitals starting next year:

  • EP 6. The hospital measures and sets goals for mitigating and managing the boarding of patients who come through the emergency department. Note: Boarding is the practice of holding patients in the emergency department or another temporary location after the decision to admit or transfer has been made. The hospital should set its goals with attention to patient acuity and best practice; it is recommended that boarding time frames not exceed 4 hours in the interest of patient safety and quality of care.
  • EP 9. When the hospital determines that it has a population at risk for boarding due to behavioral health emergencies, hospital leaders communicate with behavioral health care providers and/or authorities serving the community to foster coordination of care for this population.

The Joint Commission notes that the four-hour time frame referenced in EP 6 serves as a guideline (not a requirement) to help the hospital set a reasonable goal for its institution. Also, the goal of EP 9 is to “facilitate the more efficient use of limited resources, and build leverage to implement more effective systems of care for individuals at risk of psychiatric emergencies.” Though the communication required in EP 9 will vary depending on the nature of the relationship, The Joint Commission advises that “such communication should occur at least annually and may range from conference calls and correspondence to meetings, education forums, and strategic working groups.”

EP 6 and EP 9 are in addition to the revised EPs that went into effect at the beginning of this year on January 1, 2013.  The other revisions address: the use of data and measures to identify, mitigate and manage issues affecting patient flow; the management of emergency department throughput as a system-wide issue; and the environment of care, staffing, assessment, reassessment and care for patients with behavioral health emergencies.

To help organizations implement these requirements, The Joint Commission released an “R3 Report on Patient Flow through the Emergency Department” that provides the requirement, rationale and references for the updated standards.  If you have questions about these accreditation standards, please contact Don Black or Jefferson Lin.

Filed Under: Compliance, Hospitals, Mental Health Tagged With: , ,

OIG Okays Provision of Free Services to Uninsured and Underinsured Patients

October 21, 2013 By

On October 15, 2013, the Office of Inspector General (OIG) released an Advisory Opinion concerning a community health services organization’s provision of free dental care to financially needy uninsured and underinsured patients that are not covered by Medicaid.

The organization was concerned that the free services violated two aspects of the Medicaid law: (1) the Social Security Act prohibits providers from billing Medicaid charges for items or services substantially in excess of the provider’s “usual charges,” and (2) the Anti-Kickback Statute prohibits providers from offering remuneration to Medicaid patients to induce them to receive services from the provider.

In the Advisory Opinion, the OIG stated that when a provider calculates its “usual charges,” it need not consider free or substantially reduced charges to uninsured or underinsured patients with financial need.  Therefore, the OIG would not seek to exclude a provider from the Medicaid program for providing discounts to financially needy uninsured and underinsured patients.

The OIG also stated that the organization’s provision of free services to financially needy uninsured or underinsured patients does not violate the Anti-Kickback Statute because the free services will not be provided to Medicaid patients.  The Anti-Kickback Statute would only be implicated if a provider used the free services as a means to induce Medicaid patients to order additional services that could be billed to the Medicaid program.

The bottom line is that providers may offer free services to uninsured or underinsured patients with financial hardship.  With that said, it is critical that providers have uniform eligibility criteria to determine whether such patients actually are financially needy.  In separate guidance released in 2004  the OIG outlined factors that providers should consider in determining financial need, including:

  • The local cost of living;
  • A patient’s income, assets, and expenses;
  • A patient’s family size; and
  • The scope and extent of a patient’s medical bills.

By applying these factors uniformly at all times, providers can ensure that their provision of free or discounted services meets OIG requirements.

If you would like more information please contact Casey Moriarty.

Filed Under: Anti-Kickback/Stark, Compliance, Medicaid, OIG Tagged With: , ,

Guidance on Refill Reminders and Enforcement Delay until Nov. 7th

September 22, 2013 By

The Office of Civil Rights recently released guidance related to the new HIPAA marketing requirements and refill reminders.  The guidance includes several FAQs and examples to help navigate the new HIPAA marketing/refill reminder rules.  In conjunction with the release of this guidance (and as a result of a lawsuit filed by Adheris, Inc.), HHS has decided to delay enforcement of the refill reminder requirements until November 7, 2013.  This enforcement delay is only with regard to the refill reminder rules and does not apply to the rest of the HIPAA requirements which will be enforced starting September 23, 2013.

Pursuant to HIPAA, a covered entity or business associate must receive a patient’s written authorization before using or disclosing PHI to make a marketing communication to him/her – unless another exception otherwise applies.  The new HIPAA marketing definition includes a generally common sense definition of marketing, with certain limited exceptions.  The new marketing rule creates an explicit exception “to provide refill reminders or otherwise communicate about a drug or biologic that is currently being prescribed for the individual, only if any financial remuneration received by the covered entity in exchange for making the communication is reasonably related to the covered entity’s cost for making the communication.”  The focus of the guidance is on two key phrases within the definition:  (1) whether the drug is  “currently being prescribed” and (2) whether there is financial remuneration and if so if it is “reasonably related to the covered entity’s cost of making the communication”.

The guidance identifies the following as satisfying the first requirement that the drug is currently being prescribed:

WITHIN EXCEPTION

• Refill reminders.

• Communications about generic equivalents of a drug being prescribed.

• Communications about a recently lapsed prescription (one that has lapsed within the last 90 calendar days).

• Adherence communications encouraging individuals to take prescribed medicines as directed.

• Where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system.

NOT WITHIN EXCEPTION

• Communications about specific new formulations of a currently prescribed medicine.

• Communications about specific adjunctive drugs related to the currently prescribed medicine.

• Communications encouraging an individual to switch from a prescribed medicine to an alternative medicine.

With regard to the second prong, whether there is financial remuneration and if so whether it is related to the cost of making the communication, HHS provides the following information:

WITHIN EXCEPTION

• Communication does not involve remuneration.

• Communication involves only non-financial or in-kind remuneration, such as supplies, computers, or other materials.

• Communication involves only payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication, such as payment from a health plan.

• Remuneration involves payments to the covered entity by a pharmaceutical manufacturer or other third party whose product is being described that cover the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials, and supplies, as well as capital and overhead costs.

• Remuneration involves payments to a business associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications, up to the fair market value of the business associate’s services.  The payments may be made by a third party whose product is being described directly to the business associate or through the covered entity to the business associate.

NOT WITHIN EXCEPTION

• Communication involves financial remuneration other than as described above.

The guidance then provides a series of examples and FAQs that are quite helpful in explaining what is and what is not permissible under the refill reminder exception to the marketing rule.  Though refill reminders are permitted, a covered entity should be careful to ensure that it is following the exception requirements or it should request patient authorization for such communications.  For more information about HIPAA and the marketing rule specifically please contact Elana Zana.

 

Filed Under: Compliance, HIPAA, HITECH Tagged With: ,

OIG Approves Venture Spawned by CMS Hospital Readmission Penalties

August 20, 2013 By

In a recent Advisory Opinion, the OIG approved a business venture intended to reduce preventable hospital readmissions by providing post-discharge services to patients.  The venture would sell a package of services to hospitals intended to better coordinate post-discharge care and to help patients adhere to their post-discharge plans of care.  The focus would initially be on those conditions CMS has identified as potentially triggering readmission payment penalties.

Hospitals would be charged a flat annual “set-up” fee and an additional “per patient” fee. Patients would have to elect to receive the services.  Under the service, the patient would have access to assistance 24 hours a day, seven days a week, either through a Patient Liaison or through a nurse hotline.

The OIG found a low risk of fraud or abuse under the anti-kickback law because, among other things, the program could potentially save federal money by decreasing excessive hospital readmissions.  The proposed program also was unlikely to interfere with clinical decision making since its purpose was to ensure such decision making was implemented for the benefit of the patient.

The OIG also found a low risk of any Civil Monetary Penalty violation.  The proposed program appeared to be intended to assist patients in the post-discharge period without influencing or limiting a patient’s choice of providers or suppliers.  If you have questions regarding this opinion please contact Greg Montgomery.

Filed Under: Anti-Kickback/Stark, Compliance, OIG
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