Articles Posted in Compliance

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In the December 19, 2011 Federal Register, CMS published a Proposed Rule to implement the “Physician Payment Sunshine Act” portion of Patient Protection and Affordable Care Act (PPACA), or health care reform, which requires drug, medical device, biological and medical supply manufacturers to track and report payments made to physicians and teaching hospitals. The Proposed Rule clarifies several components of the Physician Payment Sunshine Act, including the following:

1. Applicable manufacturers must report the required information to CMS in an electronic format by March 31, 2013 and on the 90th day of each calendar year thereafter.

2. The Physician Payment Sunshine Act will apply to any manufacturer whose products are sold or distributed in the United States regardless of where they are manufactured.

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The Department of Health and Human Services (HHS) is required by the American Recovery and Reinvestment Act of 2009 to provide periodic audits to ensure covered entities are in compliance with the privacy and security rules of HIPAA. To satisfy the requirements under the Act, HHS’ Office for Civil Rights (OCR) initiated its pilot program to perform HIPAA audits of covered entities. OCR has awarded KPMG with the contract to conduct the audits. The audits under the pilot program are scheduled to begin this month and continue until the end of 2012. HHS believes that these audits “present a new opportunity to examine mechanisms for compliance, identify best practices and discover risks and vulnerabilities that may not have come to light through OCR’s ongoing complaint investigations and compliance reviews”

The first round of the pilot program will consist of 20 audits targeting covered entities of various sizes and specialties throughout the healthcare industry. The selected entities will be notified, in writing, by OCR that they have been selected for an audit. The written notification will explain the audit process and will also ask the entity to provide OCR with documentation of their privacy and security compliance efforts. The time allotted for the selected entities to satisfy the initial documentation request is 10 days. After OCR receives the requested documentation, entities will be notified that an onsite visit will be conducted. The onsite visit will likely take place between 30 and 90 days after the entity has been notified of the visit. Upon completion of the visit, the entity will be provided with a draft final report. Once received, the entity is given the opportunity to provide the auditor with written comments. After reviewing the entity’s comments, the auditor will submit a final audit report to OCR.

OCR plans to use the findings in the audit report to determine what types of technical assistance should be developed, and which types of corrective actions are most effective. By the end of 2012, OCR plans to conduct as many as 150 audits. The pilot program will be used by OCR to determine the most successful methods for conducting HIPAA audits in the future.

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HHS this week announced that it would again delay publishing rules implementing the Physician Payments Sunshine Act (“PPSA”), established in last year’s Patient Protection and Affordable Care Act (“PPACA” or “health reform”). PPSA requires drug and medical device manufacturers to publicly report gifts and payments made to physicians and teaching hospitals. While the law requires public disclosure on an annual basis, it does not limit financial relationships between drug and device manufacturers and physicians.

The penalties for non-compliance with this law are fines up to $10,000 per occurrence, not to exceed $150,000 per year, and for each knowing failure to report, the fines are increased to up to $100,000 per occurrence and $1 million aggregate per year.

Beginning January 1, 2012 all drug and device manufacturers must record all gifts and payments to physicians and teaching hospitals. Manufactures must report this information to HHS by March 31, 2013, for HHS publication beginning September 30, 2013.

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On October 20, 2011, the Centers for Medicare and Medicaid Services (CMS) released its final rule for Accountable Care Organizations (ACO) participation in the Medicare Shared Savings Program. With this rule, in response to concerns related to start up costs associated with ACOs, CMS has also announced the creation of its Advance Payment Model, which is scheduled to commence in 2012. The Advance Payment Model was created to assist participants in the Share Savings Program that may not have the necessary funds to become and ACO (e.g. physician-owned hospitals and rural providers). These participants would be advanced future payments, which would later be recouped from future shared savings. However, if the ACO fails to complete the full agreement period or earned shared savings then it will be required to return the advance payment. An ACO would receive future payments in three ways: (1) an upfront, fixed payment, (2) an upfront, variable payment, and (3) a variable monthly payment.

The Advance Payment Model may be available to two types of organizations participating in the Shared Savings Program: (1) ACOs that do not include any inpatient facilities AND have less than $50 million in total annual revenue; and (2) ACOs in which the only inpatient facilities are critical access hospitals and/or Medicare low-volume rural hospitals AND have less than $80 million in total annual revenue. ACOs that are co-owned by a health plan will not be eligible to participate. Participants of Pioneer ACOs will also be ineligible. CMS expects to select approximately 50 ACOs that meet the above eligibility requirements to receive funding.

The Advance Payment Model will only be available for ACOs beginning participation in the Medicare Shared Savings Program in either April 2012 or July 2012.

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On October 20, 2011, CMS released the much awaited final rule for implementation of the Medicare Shared Savings Program for providers and suppliers participating in Accountable Care Organizations (ACOs). The following are 20 notable aspects of the final rule:

•1. While the proposed rule would have required all ACOs to share risk of loss in the final year of the three year participation period, the final rule created an alternative for a “shared savings only” track (one-sided model) that will not require any sharing of losses. The final rule also retains the proposed two-sided model that will allow ACOs to share in an increased portion of savings, so long as the ACO also agrees to share in any losses to the program.

•2. The final rule will allow ACOs beginning in April 1, 2012 or July 1, 2012 to have a longer first performance year (21 months or 18 months respectively) and an option to receive an interim payment calculation following the first 12 months of participation. One-sided ACOs receiving an interim payment will be required to demonstrate a self-executing repayment mechanism similar to that which the two-sided ACOs must demonstrate.

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Today, the Centers for Medicare and Medicaid Services (CMS) released its final rule for Medicare’s Accountable Care Organizations (ACO). The program is designed to encourage health care providers to coordinate care in order to achieve cost-savings and improve the quality of care for Medicare patients. Due to substantial criticism from the health care industry, CMS made a number of significant modifications to the proposed rules that were released in March. According to CMS, these modifications include:

  • Greater flexibility in eligibility to participate in the Shared Savings Program
  • Multiple start dates in 2012
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On October 3, 2011, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion regarding a proposed arrangement under which physicians would invest in a company that would provide pathology laboratory management services to a third party.

Under the proposed arrangement, a physician who owns and manages a limited liability company (“Requestor”) would enter into a management contract with a pathology laboratory (“Path Lab”), whereby the Requestor would provide the Path Lab with various clinical laboratory services for a fixed number of hours each year. The Requestor would also provide utilities, furniture, fixture, the exclusive use of laboratory space and equipment, and marketing and billing services. In return, the Path Lab would pay a usage fee to the Requestor that would be calculated based on a percentage of the lab’s income which would be fixed in advanced for a 12-month term.

The Requestor’s owner/manager would offer an opportunity for physicians to invest in the Requestor. The new physician investors are anticipated to have little or no background experience in the clinical laboratory services field. According to the Requestor, the value of the investment interest that would be held by physician investors in a position to generate business for the Requestor through referral of laboratory specimens to the Path Lab would exceed 40 percent. Additionally, the Requestor anticipates that the business generated through referrals by physician investors would equate to substantially more than 40 percent of the Requestor’s gross revenue related to the furnishing of health care items and services. Finally, the Requestor has certified that each of the physician investors would have the option of referring specimens to the Path Lab but referrals are not implicitly or explicitly a condition of the arrangement.

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In its role of overseeing the Medicare and Medicaid Programs, the Senate Finance Committee released a staff report alleging that the four largest publicly traded home health agencies were providing medically unnecessary care by encouraging therapists to meet the 10 visit threshold in order to receive a  “bonus” payment  under the PPS system.  The report was based on an investigation initiated by Committee Chairman Max Baucus and Senior Member Chuck Grassley.  The Senators instigated the investigation based upon a Wall Street Journal analysis.

Among other findings, the report alleges that an analysis of therapy billings from these home health agencies show a pattern of concentrated billings at or just above the 10 visit threshold.  The report further alleges that the companies encouraged billing of medically unnecessary services to reach this threshold.

Home Health Agencies should be aware that Medicare contractors will likely be closely scrutinizing PT visit frequency and patterns.  Also, providers are likely to see changes in the payment system as a result of this report.

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On August 29, 2011, the U.S Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion regarding a health system’s proposal to enter into arrangements to provide neuro emergency clinical protocols and immediate consultations with stroke neurologists via telemedicine technology to certain community hospitals.

The Requestor is an operating division of a not-for-profit corporation with a mission of increasing access to quality neuroscience care by providing access to the nationally ranked neuroscience care available through its flagship program. Under the proposed arrangement, Requestor would provide the following services to community hospitals in its service area free of charge: (1) neuro emergency telemedicine technology, (2) neuro emergency clinical consultations, (3) acceptance of neuro emergency transfers, and (4) neuro emergency clinical protocols, training and medical education. The Requestor would enter into a written agreement with the participating community hospitals, which would establish all of the services that each party would provide under the agreement. In recognition of Requestor’s investment of time and capital in the proposed arrangement, the participating hospital would be required to agree not to participate in any other neuro emergency telemedicine service without prior approval of Requestor for the length of the agreement (anticipated at 2 years). The exclusivity requirement would not (1) restrict a participating hospital’s emergency or attending physician from consulting with any stroke specialist of his or her choice, (2) require either party or its physicians to refer patients to the other party, or (3) restrict the freedom of a patient or physician to request a transfer to a stroke center other than Requestor’s.

Due to the agreement creating the potential for Requestor and the participating hospital to refer federal healthcare business to one another, OIG acknowledged that the proposed arrangement could possibly implicate the Anti-Kickback Statute. However, OIG concluded that it would not subject Requestor to administrative sanctions under the Anti-Kickback Statute for the following reasons:

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On September 13, 2011, the Office of Inspector General (OIG) responded to a letter from the Senate Finance Committee which addressed its concerns about the recent increase of physician-owned distributorships (PODs) and the potential adverse effects that these entities could have on the Medicare program and its beneficiaries.  The Committee asked the OIG to assess the adequacy of the adequacy of the guidance that the OIG has issued in regards to the legality of PODs under the Federal Anti-Kickback Statute and whether further guidance or action is required to address the growing trend of these entities.

OIG will be initiating a review of PODs that will seek to determine the extent to which PODs provide spinal implants purchased by hospitals. This study will be nationally representative of hospitals that bill Medicare for these services, and OIG will review information from hospitals to determine the prevalence of PODs, what services PODs offer to hospitals, and whether PODs save hospitals money when acquiring spinal implants. In addition, OIG will look at Medicare claims data to analyze whether the identified PODs are linked with a high use of spinal implants. OIG will use the information from this study to determine whether or not to issue further guidance relating to PODs.

Current guidance from OIG establishes that the opportunity for the referring physician to earn a profit may be deemed illegal under the Federal Anti-Kickback Statute. However, OIG makes clear in the letter to the Committee that the Anti-Kickback Statute is an intent-based statute and different POD models raise different levels of legal concern. Therefore, OIG emphasizes the view that several of the legal questions raised by the Committee depend on the specific facts of the case (e.g. the terms under which a physician-owner may invest in the entity and the return on the physician’s investment).

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