OVERVIEW - CRITICAL NEWS
It is evident that
stricter enforcement of existing regulations is now being sought by regulators.
While financial penalties are generally the outcome some may result in more
serious sanctions or criminal penalties. The challenge to Health Care Providers
is seeking cost effective avenues while maintaining a high level of quality
health care. EMI provides practical and experienced guidance in the area of
strategic regulatory oversight to meet these challenges.
The health care industry
continues to be the subject of an unprecedented number of Criminal and civil
investigations by both federal and state government agencies; including the
Centers for Medicare & Medicaid Services (CMS), the HHS Office of the
Inspector General (OIG), the Department of Justice, individual U.S.
Attorney's offices, and the state Medicaid Fraud Control Units, all seeking to
enforce a myriad of federal and state anti-fraud laws. These entities
increasingly use extraordinary means to investigate and prosecute health care
providers. Their efforts are supported by vast resources, including those
allocated under the Health Insurance Portability and Accountability Act
(HIPAA). Finally, the number of "whistle blower" cases brought
against the industry continues to increase due in part to the significant
financial incentives for private individuals to bring information under the
federal statutes.
EMI utilizes a formidable group of associates to advise, audit, investigate and
conduct independent peer and coding reviews which provide assistance directly
to health care practitioners or through their legal representatives.
We assist clients on these anti-fraud efforts, including the installation of
compliance policies/programs, and support a successful defense against
government enforcement proceedings where the process is at an impasse.
PHARMACY BENEFIT
MANAGERS (PBMs)
Over the last few years
EMI has assisted pharmacy owners who are experiencing an increasing amount of
audits undertaken by the Pharmacy Benefit Managers (PBMs).
This is a cause for
concern and pharmacists should be aware that inventory purchase documentation
should be carefully kept and monitored periodically. It is often the case that
if some internal policies and procedures regarding these purchases were more
carefully monitored severe monetary penalties and possible removal from the PBM
panel could be avoided or mitigated.
EMI has assisted
pharmacies in the last two years throughout different phases of the PBM audit
process. In most cases we have achieved successful outcomes in either
preventative compliance consultation or as a tool in the litigation process.
OFFICE OF THE MEDICAID INSPECTOR GENERAL (OMIG)
The OMIG has issued repeated "alerts" regarding compliance with the
Deficit Reduction Act of 2005 (DRA).
A new NYCRR Part 521, entitled “Provider Compliance Programs,” was added to
Title 18 of the Codes, Rules and Regulations of the State of New York which
made Compliance Programs mandatory when health care providers receive $500
thousand or more in Medicaid payments during a single fiscal year.
Providers were required to create written policies and procedures and update
any employee handbook by January 1, 2007.
OMIG requires providers to certify to the OMIG that it has complied with the
employee education requirements (including adoption, publication and
dissemination of the written policies and any revised employee handbook, by
October 1, 2007, and each year thereafter by January 1st...)
The OMIG warned that it "will incorporate criteria to address these
mandates into its periodic audits and investigations".
OMIG plans to review the certifications of the health care entity, the written
policies and any employee handbook maintained by the health care entity, for
compliance. In addition The Centers for Medicare and Medicaid Services (CMS)
may, at its discretion, independently determine compliance with this regulation
and stated "Failure to timely submit the required certifications, or bring
the written policies and procedures and any employee handbook into compliance,
may be considered an unacceptable practice and subject the provider to
sanctions and/or penalties".
The requirement to have compliance programs in place will be considered a
condition for receiving Medicaid funds.
Effective compliance programs will enable practitioners and institutional
providers to identify Compliance issues prior to prohibitive government
intervention. They are an added cost to Providers but offer a comfort level to
the Government as well as the Provider. The implementation of Compliance
programs is mandated but incorporating an effective program is
the objective at EMI. We are mindful of budgetary constraints and have
been providing reasonably priced oversight guidance for more than a decade. We
provide assistance that tailors programs and incorporate existing resources to
deliver an effective compliance program.
We have worked successful outcomes with government and legal practices as part
of their Corporate Integrity Agreements and also independently with Health Care
Providers in oversight of their compliance programs and overall medical
practice.
