Posts tagged Stark I/II
Significant Health Law Developments
Jul 1st
During the last twelve months, we’ve seen significant developments in health law. At today’s opening session of the annual meeting of the American Health Lawyers Association, we took stock of many of these developments, which include the following:
Medicare Cuts Saga Continues to Unfold.
On June 30th, we witnessed the latest chapter in the Medicare cuts saga, as President Bush issued a 10-day stay of the impending 10% reimbursement cuts. This move temporarily forestalls the reimbursement cuts until Congress returns from its July 4th holiday with a 3-day window to reach a compromise. For more information on these cuts, please see my earlier blogs
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NPI “Simplifies” Claim Submission, Causing Widespread Confusion throughout the Provider Community.
After multiple delays, the NPI mandate finally took effect last month. Remarkably, the average Medicare claim rejection rate skyrocketed from approximately 5% to 25%, due to the NPI mandate. (I am proud to report that MTBC’s clients have not experienced any increase in rejection rates as a result of its comprehensive, proactive NPI plan.)
The Feds Get Serious about HIPAA.
Following a decade of virtually no criminal HIPAA prosecutions, during the past year, we’ve seen three felony prosecutions. In U.S. v. Jackson, a hospital employee was indicted for selling Farrah Fawcett’s PHI to a tabloid. The defendant-nurse in U.S. v. Smith, pled guilty to unlawfully disclosing a patient’s PHI to her husband for use in a litigation matter. Finally, in U.S. v. Howell, an employee was indicted under HIPAA for disclosing PHI to a third party as part of an identity theft scheme.
Physician Report Cards Get an “F.”
As we recently discussed, we’ve witnessed a great deal of controversy regarding certain payers’ physician “report cards.” In New York, Attorney General Andrew Cuomo threatened to sue certain payers, alleging that their physician “report cards” did not (as the payers argued) measure quality, but instead were rigged to give high marks to those physicians who saved the payers’ money. This controversy resulted in a transparent, multi-tiered rating system that places a greater emphasis on quality – not simply cost – and is serving as a template for other payers.
More on Fraud and Abuse.
As we discussed earlier this year, the OIG issued its Self-Disclosure Protocol (SDP), which is aimed at encouraging providers to voluntarily disclose billing fraud and abuse, by assuring disclosers that their voluntary confessions will be met with lessened penalties. Moreover, Stark II, Phase III, provided additional rules regarding physician recruitment, rental arrangements and joint ventures.
Disclaimer: The information contained within the MTBC® Learning Center is provided for general educational and informational purposes only and should not be construed as legal advice. The author of the Learning Center does not represent the Web site user or the individual submitting a particular question. Please seek the advice of legal counsel to address any specific questions you may have regarding your particular facts or circumstances
OIG Streamlines Provider Self-Disclosure Protocol
May 28th
In its recent Open Letter to Providers (“Letter”), the Department of Health and Human Services Office of the Inspector General (“OIG”) further refined and streamlined its Provider Self-Disclosure Protocol (“SDP”).
SDP Overview
OIG created SDP in 1998 to encourage providers to voluntarily disclose Medicare billing fraud and abuse. It provides such encouragement by creating a framework for reporting fraud and abuse, coupled with reduced penalties for reporting providers, i.e., typically resolving self-disclosures at a multiple of the amount of the benefit conferred, as opposed to a multiple of per-claim statutory amounts. OIG considers SDP a great success and credits it with returning more than $120 Million to the Medicare Trust Fund. SDP is not an appropriate vehicle for resolving routine billing mistakes or overpayments. These sorts of issues should be addressed to the appropriate Medicare contractor. However, SDP is appropriate for disclosing unlawful billing practices (e.g., Stark violations) that are so significant that the provider credibly risks exclusion from Medicare/Medicaid or monetary penalties under controlling law. Providers who voluntarily disclose billing practices through OIG’s SDP have the ability to avoid certain penalties so long as they fully disclose all details, provide appropriate reimbursement to the respective Federal program and cooperate with OIG in ensuring that any necessary remedial steps are taken to avoid future errors.
New Changes
A provider’s initial submission must contain the following:
- Complete description of the conduct being disclosed;
- Description of the provider’s internal investigation (or commitment as to when the same will be completed);
- An estimate of the damages to the respective Federal healthcare program, together with a description of how the amount was calculated (or commitment as to when the same will be provided); and
- Identification of the law(s) potentially violated by the conduct.
- In addition to these changes regarding initial submissions, OIG has modified its default position regarding the requirement of a Corporate Integrity Agreement (“CIA”) or Certification of Compliance Agreement (“CCA”) in the event of a disclosure. In the past, it was commonplace for OIG to require a CIA or CCA with providers who participated in SDP; however, OIG has now indicated that it will be predisposed not to require a CIA or CCA.
Finally, OIG indicates that it has streamlined its internal processes so as to expedite SDP resolution. Likewise, it has expressed its intention to require providers to reciprocate by responding in an expeditious manner.
Disclaimer: The information contained within the MTBC® Learning Center is provided for general educational and informational purposes only and should not be construed as legal advice. The author of the Learning Center does not represent the Web site user or the individual submitting a particular question. Please seek the advice of legal counsel to address any specific questions you may have regarding your particular facts or circumstances
Compliance Update – Providers and the Pharmaceutical Industry
Jul 26th
Regulators are increasingly focusing on the propriety of certain relationships and interactions between health care providers and the pharmaceutical industry. Since this issue is on the minds of many providers, I am including below an article I recently wrote for Florida Medical Business Journal, the region’s leading medical business publication.
Avoiding Dangerous Medicine
Developing an Office Policy Regarding Doctor-Pharmaceutical Industry Interactions
Florida Medical Business Journal
by Stephen Snyder
By now, most physicians have resigned themselves to the unfortunate reality that virtually every practice management decision has a legal dimension. This reality is particularly acute with regard to a physician’s relationship and interactions with pharmaceutical companies.
Pharmaceutical company-doctor interactions are indirectly and directly governed by various laws and advisory guidelines. This article focuses on restrictions imposed on a provider’s receipt of things of value from a pharmaceutical company and thus relies upon the federal Anti-Kickback Statute, which prevents a doctor from receiving anything of value in return for prescribing or dispensing a drug to a patient who is the recipient of any federally-financed program (e.g., Medicare, Medicaid, VA). Guidance documents from the Department of Health and Human Services Office of Inspector General (“OIG”) and the Pharmaceutical Research and Manufacturers of America also contain important, albeit not directly controlling, ground rules. Finally, the American Medical Association has developed rules regarding such relationships and interactions.
The typical patient-focused physician cannot possibly review all of these laws and advisory documents; much less the other regulations that may govern in certain scenarios. If he or she somehow manages to do so, he or she will still have to consider how these regulations should be applied to his or her unique situation. This reality is troubling since inappropriate interactions or relationships with pharmaceutical companies can result in civil and criminal penalties.
In view of this labyrinth of regulations and advice, every hospital and practice -especially medium to large practices – should consider developing a written policy regarding interactions with pharmaceutical companies. While the development of such a policy is not a legal requirement, an appropriate policy will ensure that every physician understands the expectations of the practice, act as protective legal hedge and simplify every physician’s daily decision making process.
As with every policy, the pharmaceutical company interaction policy should be as straightforward and non-technical as possible. Further, the policy should, at a minimum, address the following issues.
Commitment to Compliance
The policy should begin with a statement regarding the practice’s commitment to complying with all controlling laws and standards of professional ethics.
Nature of Interactions
The policy should state that the primary purpose of every interaction between a physician and a pharmaceutical representative should be the exchange of scientific and educational information, so as to maximize the wellbeing of patients.
Food and Beverage
Survey results published in the April 2007 issue of the New England Journal of Medicine demonstrate that 83% of its respondents received food or beverages from pharmaceutical representatives. Such meals are acceptable so long as they are “modest.” Generally speaking, the AMA indicates that “modest” means that the meal is of the type and value that the physician would purchase if he or she was picking up the tab.
Cash Payments
Your policy should indicate that cash payments are never acceptable. However, modest contributions to a charity on the doctor’s behalf may be acceptable; especially if the pharmaceutical company selects the charity.
Other Gifts
A doctor may accept non-cash gifts of nominal value (i.e., approximately $100). Your policy may permit a physician to accept certain gifts that somehow entail a benefit to the patients and these gifts may include textbooks, stethoscopes, pens, writing pads, handheld device or the like.
Conference or Continuing Education
Payments made to the sponsors of a legitimate professional conference or continuing education course in order to subsidize the events are acceptable. The sponsor may then reduce the attendance fees, on an equal basis, due to its receipt of the contribution. Payments made directly to attendees relative to registration, travel or lodging expenses are not permitted.
Speaking, Consulting and Clinical Fees
23% of the physician-respondents to the New England Journal of Medicine survey indicate they have received fees from pharmaceutical companies for consulting, speaking engagements or enrolling patients in clinical trials. If these fees are customary in their amount and nature and are paid for the legitimate purpose of compensating a physician for his actual work, these fees are acceptable. However, the policy should provide certain guidelines for determining whether a fee arrangement is appropriate (e.g., range of fees, requirement that actual work – not simply listening to a sales pitch – be undertaken and documented, etc.)
Drug Samples
Physicians, especially those in private practice, often receive drug samples from pharmaceutical representatives. The compliance policy may sanction this practice since it is typically aimed at benefiting a physician’s patients and is thus wholly appropriate. However, the policy should state that a physician’s use of free samples for himself/herself, family members or friends should be rare.
Quid pro Quo
A doctor may not accept any incentive for writing prescriptions. The compliance policy should reiterate the fact that any ’switching arrangements’ or payments offered to induce prescription writing or dispensing are unlawful.
HIPAA
Gone are the days when a physician could allow a pharmaceutical representative to see a patient’s file. The policy should provide that all disclosures must comply with HIPAA and a practice’s policies relating to same.
The rules governing a physician’s inĂeractions with pharmaceutical companies can be complex. Nevertheless, by devoting a minimal amount of time and effort to the creation of a policy, a hospital or practice can ensure that its physicians understand the proper rules of interaction and can protect itself from possible civil and criminal liability.
Disclaimer: The information contained within the MTBC® Learning Center is provided for general educational and informational purposes only and should not be construed as legal advice. The author of the Learning Center does not represent the Web site user or the individual submitting a particular question. Please seek the advice of legal counsel to address any specific questions you may have regarding your particular facts or circumstances