Updates
- Summary of New E-Prescribing Rules
- New Regulations Outline Health Information Technology Exceptions
- Challenges Facing Physicians
- Fraud and Abuse Workshop
- Fraud and Abuse Resources
- Fraud and Abuse Links
Summary of New E-Prescribing Rules
On August 1, 2006, the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) issued final rules supporting physician efforts to electronically prescribe medication and electronically document and exchange patient information. Specifically, these rules create new exceptions and safe harbors under the federal physician self-referral and anti-kickback statutes allowing physicians and other providers to accept certain non-monetary compensation related to electronic prescribing and the creation and maintenance of electronic health records without fear of civil or criminal penalties.
Section 1877 of the Social Security Act, or the Stark Physician Self-Referral Law, prohibits physicians from referring Medicare patients for designated health services to hospitals or other entities in which the physician has a financial interest, unless an exception applies. In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), which amended the Social Security Act to include Medicare prescription drug benefits. Congress subsequently directed the HHS to establish standards allowing for the electronic prescription of medication in conjunction with the MMA. The MMA also directed the Secretary, in consultation with the Attorney General, to create an exception to the physician self-referral prohibition to permit certain entities to provide non-monetary assistance to physicians to encourage their use of electronic prescribing technology.
In response to this directive, the new CMS rule provides an exception to the physician self-referral law for donated electronic prescribing technology as well as electronic health records software or information technology and training services. The exceptions are contingent upon compliance with several enumerated criteria. For instance, physicians are allowed to receive donated electronic prescribing technology and training services only if they are necessary and used solely to receive and transmit electronic prescription information. Likewise, physicians may only receive donated electronic health records software, information technology, or training services that are necessary and used predominately to create, maintain, transmit, or receive electronic health records. The electronic prescribing technology exception applies only to items and services provided by a hospital to a physician who is a member of its medical staff; by a group practice to a physician who is a member of the group; or by a prescription drug plan sponsor or Medicare Advantage organization to a prescribing physician. The electronic health records exception applies more broadly to items and services provided to a physician by a hospital or other entity that furnishes designated health services.
Under the anti-kickback statute, it is illegal to knowingly offer, solicit, pay, or receive any compensation to induce or influence referrals to federal health care programs, including Medicare and Medicaid. However, twenty-one safe harbor provisions currently shield certain practices implicated by the anti-kickback statute from civil or criminal prosecution.
The new OIG rule now provides two additional safe harbors for certain arrangements related to electronic prescribing and electronic health records. These safe harbors closely mirror the exceptions outlined under the CMS rule. The first provision creates a safe harbor for the numerous health care entities that provide referring physicians and other health care providers with hardware, software, or other information technology, as well as necessary training services, used solely to communicate electronic prescription information. The second safe harbor provision protects certain arrangements that provide software or information technology and training services used primarily in the creation and transmission of electronic patient records. Like the new Stark II exceptions, each safe harbor has several conditions that must be met to qualify for protection from anti-kickback prosecution.
In announcing the new CMS and OIG rules, HHS Secretary Michael Leavitt noted that they will "help doctors provide higher quality patient care, improved efficiency, and with less hassle." Secretary Leavitt noted that encouraging physicians to electronically transmit prescriptions will enable patients to obtain medication at their choice of pharmacy or ancillary provider. Further, automating the prescription process will improve patient safety and convenience by enabling pharmacists to check for allergies and drug interactions, avoid any confusion caused by hard-to-read physician handwriting, and obtain drug plan information and medication history quickly and accurately.
The exchange of interoperable electronic health records offers many of the same benefits. According to Secretary Leavitt, as health care information becomes more portable, patients will be able to identify and change providers with greater ease and efficiency. Health care costs will also decrease as providers can avoid redundant medical tests as well as errors resulting from illegible charts. The transmission of electronic data also will improve the overall quality of patient care.
The new rules are effective 60 days after publication in the Federal Register on August 8, 2006. The exceptions and safe harbor provisions will sunset on December 31, 2013. For more information, the OIG rule is available at www.oig.hhs.gov/authorities/docs/06/OIG%20E-Prescribing%20Final%20Rule%20080806.pdf. The CMC rule is available at www.cms.hhs.gov/PhysicianSelfReferral/Downloads/CMS-1303-F.pdf.
New Regulations Outline Health Information Technology Exceptions--Federal regulators released new guidelines last week to support physician adoption of electronic prescribing and electronic health records technology. The directives create new exceptions and safe harbors to two key federal fraud and abuse laws for arrangements involving the donation of certain electronic health information technology services. One of the regulations, from the Centers for Medicare and Medicaid Services, creates two new exceptions to the physician self-referral law, which generally prohibits a doctor from referring Medicare patients to entities with which the physician has a financial relationship. The other, from the Office of the Inspector General, establishes two new safe harbors under the federal anti-kickback statute.
Under the new rules, physicians may accept donated e-prescribing software and training as well as other health information technology from certain entities. The final rules include a significantly broader definition of donors and recipients than the proposed rule issued last October. Recipients of electronic prescribing technology will be required to pay 15 percent of the cost. While these new guidelines offer a great deal of opportunity for adoption of health information technology tools, the AMA strongly recommends that physicians secure legal counsel to review any proposed arrangements with technology donors. (Article written by AMA Federation News)
View www.hhs.gov/news/press/2006pres/20060801.html for more information about these regulations.
No one is immune from the challenges of complying with today's health care laws. As a practicing physician you are responsible for understanding a myriad of complex federal and state laws, including Medicare rules and the fraud and abuse laws.
Meanwhile, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) reinvigorated the Office of Inspector General’s (OIG) mission to reduce improper payments, established a national anti-fraud campaign under the joint direction of the Attorney General and the OIG, and expanded the scope of investigations and enforcement.
You face not only the real possibility that you may be audited by state and federal health care programs, but you are now under the scrutiny of private third party payers as well. The stakes are high - the potential consequences for violating the law are enormous - and having your own internal safeguards to prevent illegal activity is critical. As the government and private payers continue their stepped-up efforts to combat inappropriate payments and fraud and abuse, physicians must devote even more of their attention and resources to understanding the rules and preventing and detecting their own violations.
For questions about fraud and abuse, e-mail joy@theoma.org.
The OMA Fraud and Abuse Workgroup came together as a result of a resolution passed by OMA's House of Delegates in April, 1998. The resolution asked that OMA seek ways to protect its members from unreasonable allegations of criminal and civil wrongdoing in the submission of claims for medical services. One of the ways OMA met this challenge was by creating a cooperative relationship between parties in government and the private sector.
The workgroup meets on an annual basis and includes representatives from Centers for Medicaid and Medicare Services (CMS) Region X , Federal Bureau of Investigation (FBI), Office of the Inspector General (OIG), Department of Justice, Oregon Medical Professional Review Organization (OMPRO), Nordian Administrative Series (Oregon's Medicare Part B Carrier), the Oregon Association of Hospitals and Health Systems (OAHHS), the US Attorneys office, Office of Medical Assistance Programs (OMAP's) Auditing Department, Oregon State Bar Fraud and Abuse Section, and the Oregon Medical Group Management Association.
Fraud and Abuse Resources
Past workshops topics have included:
- Implementing a Physician Office Compliance Plan
- Auditing Your Way to Compliance-Chart Review
- Stark II- What Physicians Need to Know
- How to Avoid Fraud and Abuse in Medicare Billing
Centers for Medicaid and Medicare Services: www.cms.hhs.gov/FraudAbuseforProfs
HHS Office of Inspector General, which includes Medicare advisory opinions, the exclusion list and special fraud alerts: http://oig.hhs.gov/fraud.asp
Noridian Medicare www.noridianmedicare.com/provider/fraud/index.html