OIG Narrows Self-Disclosure Protocol

The Department of Health and Human Services Office of Inspector General (OIG) narrowed its Self-Disclosure Protocol (SDP) for violations that give rise to civil monetary penalty liability under both the Anti-Kickback Statute and the Stark Law. OIG will no longer accept self-disclosures of a Stark Law violation alone, without a corresponding "colorable [A]nti-[K]ickback [S]tatute violation," according to the new Open Letter to Health Care Providers (Open Letter). The Open Letter also establishes a minimum settlement amount under the SDP of $50,000 for kickback-related submissions. The OIG stresses that the changes are being made to focus OIG resources "on kickbacks intended to induce or reward a physician's referrals," and that no inferences should be drawn regarding the government's approach to enforcement of the Stark Law. The full text of the Open Letter can be found here. More information regarding the SDP can be found here.

HHS Names the National Coordinator for Health Information

The Department of Health and Human Services (HHS) announced the selection of David Blumenthal, M.D., as the nominee for National Coordinator for Health Information Technology. As the National Coordinator, Dr. Blumenthal will spearhead the implementation of a nationwide health information technology infrastructure detailed in the American Recovery and Reinvestment Act of 2009.

Dr. Blumenthal is a physician and director of the Institute for Health Policy at The Massachusetts General Hospital/Partners HealthCare System in Boston, Massachusetts. He was also a professor of health care policy at Harvard Medical School. At Harvard, Dr. Blumenthal also served as director of the Harvard University Interfaculty Program for Health Systems Improvement. Before that, he was senior vice president at Boston's Brigham and Women's Hospital and served as executive director of the Center for Health Policy and Management and as a lecturer on Public Policy at the John F. Kennedy School of Government. The National Coordinator-designate previously worked on Capitol Hill for Sen. Edward Kennedy's Senate Subcommittee on Health and Scientific Research, and served as a senior health adviser to the Obama campaign. Dr. Blumenthal has considerable experience in health information technology and health care quality management. For more information, please click here.

CMS Explains Recent EMTALA Revisions

On March 6, the Centers for Medicare & Medicaid Services (CMS) summarized recent changes to the Emergency Medical Treatment and Labor Act (EMTALA) regulations in a letter to state officials. The changes were included in the 2009 Inpatient Prospective Payment System (IPPS) final rule.

The revisions cover on-call obligations, responsibilities for hospitals with specialized capabilities, and emergency waivers, and were effective on October 1, 2008.

On-Call Obligations

A new provision in the 2009 IPPS rule allows hospitals to share on-call responsibilities by participating in a formal community call plan (CCP). Participation in a CCP is entirely voluntary.

The new regulation requires that a formal CCP have:

  • "A clear delineation of on-call coverage responsibilities; that is, when each participating hospital is responsible for on-call coverage (for a specific time period, or for a specific service, or both);
  • A description of the specific geographic area to which the plan applies;
  • A signature by an appropriate representative of each hospital in the plan;
  • Assurances that any local and regional EMS system protocol formally includes information on community on-call arrangements;
  • A statement specifying that even if an individual arrives at a hospital that is not designated as the on-call hospital, that hospital still has an obligation under 42 C.F.R. § 489.24 to provide a medical screening exam and stabilizing treatment within its capability, and that hospitals participating in the community call plan must abide by the regulations under Section 489.24 governing appropriate transfers; and
  • An annual assessment of the community call plan by the participating hospitals."

The regulation does not relieve any participating hospital of its EMTALA obligations to anyone who comes to the hospital’s emergency department when that hospital is not on-call for a specific specialty service.

Hospitals with Specialized Capabilities

The 2009 IPPS rule clarified that an admitting hospital will have satisfied its EMTALA obligation for an individual once the individual is admitted in good faith, even if the individual remains unstabilized. Thereafter, a hospital with specialized capabilities does not have an EMTALA obligation to accept a transfer of that individual. However, this rule does not apply to an individual who is protected under EMTALA and placed in observation status rather than admitted as an inpatient. This individual will be considered an outpatient.

The full memorandum can be found here.

HHS Seeking Ideas on New Technology

The Department of Health and Human Services (HHS) has issued a Request for Information (RFI) to solicit ideas and information on how to encourage development and use of new medical technologies. Comments must be submitted by 5 p.m. (Eastern time) on April 16, 2009, and may be submitted electronically.

The agency is asking for comments on a number of issues, including:

  • Are there specific CMS coverage or payment policies that should be considered to help ensure timely, affordable access to effective new technologies for beneficiaries?
  • Are there specific refinements within CMS's control, or that would require rulemaking to the criteria or methods used to determine eligibility for Medicare inpatient add-on payments, outpatient new medical technology, Ambulatory Payment Classification payments or pass- through payments that may be modified to potentially improve access to new medical technologies and provide greater value for the program and its beneficiaries?
  • Is there research on medical technology, tools or funding that is not currently being conducted that could be conducted and/or funded by the Agency for Healthcare Research and Quality?
  • What role should HHS play in making information regarding the cost and quality of new medical technologies available and encourage its use by health care providers and patients to make informed health care decisions?
  • To what extent should HHS participate in and fund comparative effectiveness research? What should HHS’s role be and how should the results be used?
  • How can federal medical technology research funds be better coordinated with state and private sector research to maximize value to society?
  • How do the terms and conditions of National Institutes of Health research awards affect the development of innovation, and what specific changes would encourage innovation?
  • How can the Food and Drug Administration’s practices and procedures be enhanced to further encourage innovation while ensuring safety and effectiveness?

The RFI is the result of a series of conferences HHS hosted around the country in the latter half of 2008 to discuss how various agencies facilitate the development of innovative medical technologies. For more information, please click here and here.

CMS Issues Guidance for Medicare Advantage and Prescription Drug Plans

In its annual Call Letter issued to organizations that intend to offer Medicare Advantage and Prescription Drug Plans, CMS announced steps it is taking to give beneficiaries more information when they make choices regarding the Prescription Drug Plans.

Among other things, Prescription Drug Plan sponsors will be required to outline utilization management criteria on their websites, list specific details about quantity limits and step therapy requirements, and provide comprehensive information about other types of utilization management tools such as prior authorization. Prescription Drug Plan sponsors will also be required to provide additional, easy-to-understand information about coverage in the gap on the Medicare Prescription Drug Plan Finder website. This information will include how the plan will cover brand and generic drugs in the gap.

Organizations can generally use the information contained in the Call Letter to help prepare bids that must be submitted by June 1, 2009. The annual enrollment period for beneficiaries begins Nov. 15, 2009. More than 10 million beneficiaries are enrolled in Medicare Advantage Plans and more than 17 million are enrolled in Part D Prescription Drug Plans.

Source: Health Law Regulatory Update