Medical News, August 2014
Authored by Christopher J. Shaughnessy
The Centers for Medicare & Medicaid Services ("CMS") has issued final regulations which require doctors prescribing drugs for Part D patients to enroll in Medicare and establishes authority for CMS to revoke a doctor's Medicare eligibility for abusive prescribing practices, among other provisions.
According to CMS, in a release dated May 19, the regulations are part of the ongoing effort to curb fraud and abuse and to improve benefits and the quality of care for seniors and people with disabilities enrolled in these programs.
The changes follow on the heels of last year's release of the Prescriber Checkup database. In 2013, ProPublica, an independent nonprofit that produces investigative journalism, released a series of stories about Medicare's failure to oversee its own drug program, Part D, effectively. Using data obtained under the Freedom of Information Act, ProPublica created a massive database of Part D records collected from 2007-2010. The searchable database consisted of physicians' identities and prescription patterns, prescription trends by state, top-prescribed drugs, and other Medicare Part D figures. Before ProPublica first obtained the data in 2012, Medicare had not released prescribing information with provider identities.
The historic data dump made headlines, much like CMS's release in April of this year that detailed the same kind of information about the Medicare Part B fee-for-service program. After ProPublica mined the data several disconcerting statistics surfaced, including one that showed about 70 providers each churned out more than 50,000 prescriptions and refills, averaging at least 137 a day, in 2010.
One of the problems with ProPublica's data, as they acknowledged, is that some prescriptions may have been attributed to a doctor, although another prescriber actually wrote the prescription. For example, Indiana physician Daniel J. Hurley led the country with more than 160,000 prescriptions under Part D in 2010, but subsequently explained that nursing home pharmacies had credited him with prescriptions by other health professionals in his practice. These are the same kind of provider concerns that followed the more recent Part B database release.
After the ProPublica information became public, the popular consensus was that Medicare Part D was overrun with rampant fraud, with doctors prescribing inappropriate or risky medications and Medicare wasting billions of dollars on needlessly expensive drugs. In the past, Medicare publicly stated it had no authority to discipline Medicare Part D doctors or providers even if troubling prescriber behavior was found. The new regulations greatly change that stance.
Now, physicians and eligible professionals who prescribe covered Part D drugs must be enrolled in Medicare or have a valid record of opting out of Medicare in order for prescriptions to be covered under Part D. CMS now has the authority to revoke a physician or eligible professional's enrollment in the program if it so determines that he or she "has a pattern or practice of prescribing that is abusive, represents a threat to the health and safety of Medicare beneficiaries, or otherwise fails to meet Medicare requirements." Further, CMS may now revoke Medicare enrollment upon the suspension or revocation of a DEA registration or suspension or revocation of prescribing privileges from a state licensing board.
The changes provide CMS with a great amount of prosecutorial discretion, as "abusive" prescribing, without further definition, appears to be open to interpretation. Particularly alarming is the fact that CMS can revoke enrollment following a suspension from the DEA or state licensing board, even though a suspension is often lifted after a provider complies with stipulated requirements. An "excluded provider" title from Medicare is a death knell in the industry and is not on par with a temporary suspension. Entities who hire excluded providers may become an excluded provider themselves, virtually guaranteeing that someone with this title becomes unhireable. It is extremely important that providers take the necessary steps now to enroll in Medicare or formally opt out in order to continue prescribing. The deadline is June 1, 2015.
CMS projects it will save an estimated $1.615 billion over the next ten years thanks to the changes. In addition to its new disciplining power, CMS will also broaden the release of privacy-protected Part D data and expand on prevention and health improvement initiatives.
Christopher J. Shaughnessy is a member at McBrayer Law. Mr. Shaughnessy concentrates his practice area in health care law and is located in the firm's Lexington office. He can be reached at firstname.lastname@example.org or at (859) 231-8780, ext. 1251.
This article is intended as a summary of state law enforcement activities and does not constitute legal advice.