Compliance Commitment

While the recently passed health reform law — the Patient Protection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), known as PPACA — will make major changes to our nation's health care system, there are a series of significant and new provisions focused on preventing fraud, waste and abuse in the health care system.

There are over 32 sections in the new law relating to health care fraud and abuse and program integrity. There are also significant changes to existing criminal, civil and administrative anti-fraud statutes. The new provisions establish new expectations for regulatory compliance, disclosure and transparency, and are matched by enforcement provisions that may greatly increase potential legal exposure.

What this all means for the HME community is the need for an increased commitment to compliance. All providers should quickly familiarize themselves with the new requirements and stay close to Medicare as it issues implementation details.

Notably, on May 5, the Centers for Medicare and Medicaid Services issued an interim final rule — "Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements" (CMS-6010-IFC) — that addresses some of the issues in PPACA. The rule is effective July 6, and includes requirements related to PECOS enrollment and physician ordering of DME.

At press time, it was unclear if the CMS-established deadline of Jan. 3, 2011, for PECOS information on DME claims would be moved up to July 2010, based on a provision of PPACA. The law is unclear with respect to the effective dates of some of the fraud, waste and abuse provisions. While some provisions do specify their own effective date, others do not have one, and presumably are effective upon enactment of the law on March 23, 2010.

• Face-to-Face Exam for All DME
  This provision will require beneficiaries to have an in-person doctor's visit in order for a physician to prescribe any items of DME. This is modeled on the current face-to-face exam requirement for power mobility devices. The face-to face exam must be within six months of the physician order. (This also applies to home health agency services that a physician prescribes for beneficiaries.) The Health and Human Services Secretary will be able to apply this requirement to items paid for under state Medicaid programs as well, and the provision was effective upon enactment.

• Potential Revocation of Enrollment for Failure to Maintain or Provide Access to Medical Necessity Documentation
  This provision allows the HHS Secretary to revoke enrollment for a period of not more than one year for each act of a physician or supplier who fails to maintain or does not provide access to documentation relating to written orders of requests for payment for DME, certifications for home health services or referrals for other items or services specified by the Secretary. Providers should educate physicians about this provision, which was effective Jan. 1, 2010, to encourage them to provide the appropriate medical necessity documentation for all DME orders.

• Medicare-Enrolled Physician Requirement to Order DME and Home Health Services
  This provision, effective July 1, 2010, will require any physician who orders/prescribes DME or home health services that are billable to Medicare to be Medicare participating physicians. CMS detailed this requirement in its interim final rule, which was published in the May 5 Federal Register.

• Mandatory Corporate Compliance Plans
  The new health care law requires all DME suppliers (as well as all Medicare providers and suppliers) to establish corporate compliance programs as a condition for enrollment in the Medicare program. The law also mandates the states to require compliance programs of suppliers enrolled in Medicaid programs. There is no specific implementation timeline for the development or implementation of these compliance programs. Instead, Congress has left the establishment of core compliance program elements and implementation deadlines to the discretion of HHS.