How Tightened Controls on Prescribing for Medicare Part D Patients May Affect Health Care Providers-Part 2

Friday, June 6, 2014
By Lance O. Leider, J.D., The Health Law Firm

Under a rule finalized by the Centers for Medicare and Medicaid Services (CMS) on May 19, 2014, doctors and other health care professionals will be required to enroll in the Medicare program, or have a valid opt-out affidavit on file, for prescriptions to be covered under Part D. The new requirement takes effect on June 1, 2015. To read more on the details of this rule and why CMS implemented it, click here for the first blog of this two-part series.

Through the rule, the federal government granted itself new authority to expel physicians from Medicare if they are found to prescribe drugs in an abusive manner or in violation of Medicare rules. In addition, the agency will be able to strip away a physician or health care provider's Medicare enrollment if his or her Drug Enforcement Administration (DEA) certification to handle controlled substances has been revoked, or if the state licensing board has stripped his or her authority to prescribe drugs.

CMS asserted that this authority would be utilized only in rare instances where abuses have been well documented.

Click here to read the 487-page final rule from CMS.

When CMS Can Deny a Medicare Enrollment Application or Revoke Medicare Enrollment.

In the rule, CMS states the agency views a DEA certificate or registration to prescribe controlled substances as similar to a state's requirement that a physician or eligible professional be licensed by the state to furnish health care services.

CMS will have the authority to deny a physician or health care provider's Medicare enrollment application if:

1.    His or her DEA certificate is currently suspended or revoked; or
2.    The applicable licensing or administrative body for any state in which the physician or health care provider's ability to prescribe drugs, has been suspended or revoked and such suspension or revocation is in effect on the date he or she submits his or her enrollment application to the Medicare contractor.

CMS will also have the authority to revoke a physician or eligible professional's Medicare enrollment if:

1.    His or her DEA certificate is suspended or revoked; or
2.    The applicable licensing or administrative body for any state in which the physician or eligible provider practices suspends or revokes his or her ability to prescribe drugs.

According to CMS, if a health care provider loses the ability to prescribe drugs, from either a suspended or revoked DEA certificate or by state action, that is seen as an indicator that the provider is abusing his or her prescribing privileges.

How CMS Will Determine Abusive Prescribing Patterns.

CMS will be responsible for determining if a physician or health care provider is exhibiting an abusive prescribing pattern. In determining what constitutes abuse and a threat to the safety of Medicare beneficiaries, CMS will consider several factors, including:

-    Whether there are diagnoses to support the indications for which the drugs were
-    Whether there are instances where the necessary evaluation of the patient for whom
the drug was prescribed could not have occurred (for example, the patient was              deceased or out of state at the time of the alleged office visit);
-    Whether the eligible professional has prescribed controlled substances in excessive  dosages that are linked to patient overdoses;
-    The number and type of disciplinary actions taken against the eligible professional by the licensing body or medical board for the state or states in which he or she                 practices, and the reason for the action;
-    Whether the eligible professional has any history of "final adverse actions;"
-    The number and type of malpractice suits that have been filed against the eligible professional related to prescribing that has resulted in a final judgment against the eligible professional or in which the eligible professional has paid a settlement to the plaintiff (to the extent this can be determined);
-    Whether any state Medicaid program or any other public or private health insurance program has restricted, suspended, revoked, or terminated the eligible professional's ability to prescribe medications, and the reason; and
-    Any other relevant information provided to CMS.

CMS states that honest physicians and eligible professionals who engage in reasonable prescribing activities will not be impacted by the new rule.

Revocation Will be Determined on a Case by Case Basis.

When determining whether or not a revocation is warranted, CMS will look into each circumstance individually. However, the organization is not required to do so. There may even be situations in which CMS decides that the DEA certificate revocation or suspension alone is sufficient justification to revoke Medicare enrollment.

Questions and Responses from CMS on Final Rule.

CMS received a number of comments related to the final rule. Here are a few of those comments and responses:

-    Question: Does CMS intend to revoke the billing privileges of an enrolled eligible professional whose DEA certificate is suspended or revoked at the time the final rule becomes effective?
-    Answer: CMS will have the authority to revoke the billing privileges of an enrolled physician or eligible professional whose DEA certificate is suspended or revoked at the time the final rule becomes effective.

-    Question: Does the final rule apply to non-controlled substances?
-    Answer: A DEA certificate is not required to dispense non-controlled substances. So if a health care provider's DEA certificate is suspended or revoked, he or she would still be able to prescribe non-controlled substances (although his or her billing privileges could still be revoked by CMS). If the state rescinds the health care provider's ability to prescribe any drugs, the individual would be prohibited from prescribing Medicare Part D controlled and non-controlled drugs.

-    Question: Would voluntarily surrendering a DEA certificate invoke the final rule?
-    Answer: The voluntary surrender of a DEA certificate would not constitute grounds for revocation under the new rule. The provision as written is limited to certificate revocations and suspensions. (Author's note: This will not likely apply to cases where the voluntary surrender is done in the face of disciplinary action as the DEA considers this a revocation.)

-    Question: Would a physician be able to re-enroll in Medicare after the suspension or revocation of the DEA certificate is lifted?
-    Answer: A physician would be able to submit an application for enrollment upon the expiration of his or her re-enrollment bar.

Contact Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program.

The attorneys of The Health Law Firm have experience in dealing with RAC audits, ZPIC audits CMS investigations, DOH investigations, DEA investigations, the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at


What do you think about CMS's new authority? Do you think this new rule will affect you or your practice? Please leave any thoughtful comments below.


Demko, Paul. "Docs Will Need to Enroll in Medicare if They Want to Prescribe Part D Drugs." Modern Healthcare. (May 19, 2014). From:

Ornstein, Charles. "Following Abuse, Medicare Tightens Reins on its Drug Program." National Public Radio. (May 20, 2014). From:

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area.  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

Tag Words: Medicare, Medicare fraud, Medicare abuse, Centers for Medicare and Medicaid Services, CMS, audits, CMS audits, doctors, pharmacies, prescribing practices, Medicare Part D, over prescribing, abusive prescribing, suspicious prescribing practices, DEA investigation, DOH investigations, RAC audit, ZPIC audit, administrative hearing, applying to Medicare, doctor’s license, suspended license, revoked license, prescribing painkillers, controlled substances, prescription drug abuse, enroll in Medicare, Medicare overpayments, defense attorney, defense lawyer, health law, health law firm, The Health Law Firm

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
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