CMS Declares War on
Prescription Drug Abuse in Medicare, Focus on Opioid, Acetaminophen
Begins with validation and analysis of Part D claims
data it receives from Part D sponsors
Jan. 9, 2014 – Prescription drug abuse, even in the
Medicare Part D drug program, is a nationwide epidemic, according to the
Centers for Medicare and Medicaid Services, which has committed to take
the problem seriously and begin actions to protect Medicare
beneficiaries and the Medicare Trust fund. Targets include Part D
enrollees who use opioid or acetaminophen, to see if they have
overutilization issues, and physicians who may over-prescribe.
CMS will focus its fraud and abuse strategy on the
validation and analysis of Part D claims data it receives from Part D
sponsors. It is referred to as Prescription Drug Even or PDE data.
“We are leveraging CMS’ access to all PDE data and
using it to guide our anti-fraud efforts and share the results of our
analysis with Part D plan sponsors, law enforcement agencies and
pharmacy and physician licensing boards, as appropriate, so this
information can assist our joint efforts to combat fraud and abuse,”
says a CMS news release.
“A centerpiece of this strategy that focuses on
protecting beneficiaries is the identification of Part D enrollees who
have potential opioid or acetaminophen overutilization issues that
indicate the need to implement appropriate controls on these drugs for
the identified beneficiaries.
“In addition, data analysis is employed to identify
prescribers and pharmacies that may warrant further action to curb
fraudulent or abusive activities. With the proposed rule issued January
6, 2014, CMS seeks to provide the agency with new tools to employ when
problematic prescribers and pharmacies are identified.”
The key provisions released by CMS with the
proposed rule, as well as ongoing CMS actions include the following.
Fraud and Abuse Provisions
in the CY 2015 Policy & Technical Changes to the Medicare Advantage and
Prescription Drug Program Proposed Rule
Require that Prescribers
of Part D Drugs Enroll in Medicare: Section 6405 of the
Affordable Care Act requires that physicians and non-physician
practitioners who order durable medical equipment, prosthetics,
orthotics and supplies (DMEPOS) or certify home health care must be
enrolled in Medicare.
The statute also permits the Secretary to extend
these Medicare enrollment requirements to physicians and non-physician
practitioners who order or certify all other categories of items or
services in Medicare, including covered Part D drugs. CMS is proposing
to require that physicians and non-physician practitioners who write
prescriptions for covered Part D drugs must be enrolled in Medicare for
their prescriptions to be covered under Part D.
Impact of Proposal: Requiring prescribers to enroll in
Medicare would help CMS ensure that Part D drugs are only prescribed by
Drug abuse is a serious public health problem that affects
almost every community and family in some way. Each year drug
abuse causes millions of serious illnesses or injuries among
Americans. Abused drugs include:
Drug abuse also
plays a role in many major social problems, such as drugged
driving, violence, stress, and child abuse. Drug abuse can lead
to homelessness, crime, and missed work or problems with keeping
a job. It harms
unborn babies and destroys families. There are different
types of treatment for drug abuse. But the best is to prevent
drug abuse in the first place.
Permit Revocation of
Medicare Enrollment for Abusive Prescribing Practices and Patterns:
CMS is proposing to add authority to revoke a physician’s or eligible
professional’s Medicare enrollment if:
CMS determines that
he or she has a pattern or practice of prescribing Part D drugs that
is abusive and represents a threat to the health and safety of
Medicare beneficiaries or otherwise fails to meet Medicare
His or her Drug
Enforcement Administration (DEA) Certificate of Registration is
suspended or revoked; or
licensing or administrative body for any state in which a physician
or eligible professional practices has suspended or revoked the
physician or eligible professional’s ability to prescribe drugs.
Impact of Proposal: Providing CMS the authority to revoke
such prescribers’ Medicare enrollment and would help protect
beneficiaries and the Medicare Trust Fund from fraud, waste and abuse.
Provide Direct Access to
Part D Sponsors’ Downstream Entities: The proposed
provision would provide CMS, its antifraud contractors, and other
oversight agencies the ability to request and collect information
directly from pharmacy benefit managers, pharmacies and other entities
that contract or subcontract with Part D Sponsors to administer the
Medicare prescription drug benefit.
Impact of Proposal: The provision would streamline CMS’ and
its anti-fraud contractors’ investigative processes. Currently, it can
take a long time for CMS’ contractors who are often assisting law
enforcement to obtain important documents like invoices and
prescriptions directly from pharmacies, because they must work through
the Part D plan sponsor to obtain this information. This proposal is
designed to provide more timely access to records, including for
investigations of Part D fraud and abuse, and responds to
recommendations from the Department of Health and Human Services (HHS)
Office of Inspector General.
Improve Payment Accuracy:
The proposed regulation also would implement the Affordable Care Act
requirement that MA plans and Part D sponsors report and return
identified Medicare overpayments.
Impact of Proposal: The provision would codify and clarify
rules regarding when Part D and MA plan sponsors must report and return
Results of Ongoing CMS
Actions Against Part D Fraud and Abuse
Reduction in the number of
Medicare beneficiaries receiving coverage for prescription drugs that
threaten their health and safety. The Medicare Part D
Overutilization Monitoring System (OMS) was fully implemented on July
31, 2013, to help CMS ensure that sponsors have established reasonable
and appropriate drug utilization management programs to assist in
preventing overutilization of prescribed medications.
CMS provides quarterly reports to sponsors on
beneficiaries with potential opioid or acetaminophen overutilization
issues identified through analyses of PDE data and through beneficiaries
referred by the CMS Center for Program Integrity (CPI).
Sponsors are required to respond to CMS within 30
days on the status of the review for each beneficiary case. The
principle performance metric for OMS is the number and percentage of
acetaminophen and opioid overutilizers. An initial comparison with 2011
PDE data pre-dating the implementation of OMS shows there has already
been a substantial reduction in the number of acetaminophen and opioid
overutilizers in Medicare Part D.
OMS July 31 Report Summary
Compared to 2011 Analysis
PART D OMS SUMMARY
CY 2013 through June1
(1/1/2011 to 12/31/2011)
% of Part D Population
% of Product Utilizers
(1/1/2013 to 6/30/2013)
% of Part D Population
% of Product Utilizers
All Part D
with Potential APAP Issues
with Potential Opioid Issues
Beneficiaries with CPI Referrals2
1 The OMS July 2013 reports included
analysis of PDE data with dates of service from January 1, 2013 to June
30, 2013, and received by June 30, 2013. The CY 2011 analysis used PDE
with dates of service from January 1, 2011 to December 31, 2011, and
received by June 2, 2012.
2 Beneficiaries with CPI referrals were not subject to Part D oversight
until mid-2012. CPI referral cases may originate several years prior to
being sent to Part D for follow-up with plan sponsors.
Increased Law Enforcement
and other referrals resulting from proactive data analysis:
To date, for FY 2013, CMS has made 60 referrals to law enforcement based
on proactive analysis and initiated 182 proactive investigations that
are open and being developed for referral to law enforcement. The
provisions of the proposed rule would provide CMS the additional ability
to take administrative action when a pattern or practice of abusive
prescribing is identified through data analysis and confirmed through
Identifiers Used to Confirm Prescribing Authority:
Through rulemaking finalized in 2012, CMS required Part D sponsors to
submit Prescription Drug Events (PDEs—Part D claims data) with active
and valid individual prescriber National Provider Identifiers (NPIs)
beginning January 1, 2013. CMS began to apply edits to any PDE without
an active and valid individual NPI on May 6, 2013. Of the 2013 PDEs
submitted through the end of June, only about 0.02 percent
(approximately 148,000 of the 611.3 million PDEs) were rejected by CMS
either because the prescriber identifier reported was not an NPI or the
NPI submitted by the provider was inactive or invalid. CMS will continue
to monitor sponsor performance regarding the use of valid and active
CMS examined the taxonomy codes for 2013 PDEs,
which are self-reported by the providers to identify their specialty in
the National Plan and Provider Enumeration System (NPPES). Of the 2013
PDEs (submitted through July 1, 2013) with a valid NPI, only about 0.5
percent were for drugs prescribed by providers with a taxonomy code that
would be inappropriate for a prescriber (such as, adult companion).
Based on a review of the PDEs reporting these
apparently inappropriate taxonomy codes, CMS determined that about 10.6
percent were for controlled substances. We further determined that, for
all but 16.5 percent of these PDEs for controlled substances, the
prescriber in fact did have a valid DEA number. Thus, despite the
inappropriate taxonomy code, the vast majority of these prescribers were
found to be authorized to prescribe. CMS is conducting ongoing analysis
to identify other possible sources of these errors, such as incorrect
selection of an NPI when the prescriber has multiple identifiers.
Financial Relief for Volkswagen Diesel Owners
You may be eligible for money damages if you owned or leased one of these VW, Porsche or Audi vehicles.
In the major scandal of 2015, Volkswagen cheated you and the world. They rigged diesel emission controls so you, nor regulators, would know how much pollution their cars were adding to our environment.
They were caught and have reserved $7.3 billion to help "make it right" with victims.
If you owned or leased one of these vehicles, contact us now.
Janicek Law attorneys are actively pursuing these cases against VW. Do Not Wait...