Life Science Compliance Update

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27 posts from October 2011

October 31, 2011

Patient Groups Encourage Congress to Remove Burdensome FDA Rules

Patient Groups and Washington
Patient organizations are encouraging congress to drop burdensome conflict of interest quotas on FDA advisory panels which are causing severe shortages of qualified committee members. 

Earlier this month, a group of patient foundations expressed their “deep concerns” about the issue of “current conflicts of interest statutory provisions and their impact on the appointment of experts, particularly researchers and patients, as Special Government Employees (SGE’s) on Food and Drug Administration (FDA) Advisory Committees and as otherwise needed.” 

Specifically, a coalition of over 80 organizations sent a letter to Senators Tom Harkin (D-IA) and Michael Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP). 

Each of these “organizations promote efforts to bring better treatments and cures to those struggling with diseases” however, “many of these conditions have no adequate treatments and, therefore, it is imperative that we challenge hurdles that impede the quality and efficiency of the treatment development process.” 

The groups recognized the importance of having protections in place when persons are appointed to positions where their own financial interests might influence their service to the federal government.  Nevertheless, they maintained that, “the current conflicts of interest statutes that apply to FDA have resulted in a system that is out of balance to the point that conflict avoidance is the primary driver of who serves on Advisory Committees, regardless of the extent of the conflict, the uniqueness of their expertise, or the government’s need for their services.” 

The groups explained how FDA SGE’s are subject to an additional layer of statutory conflict of interest provisions beyond those that already govern SGE’s for all other departments and agencies in the executive branch.  Specifically, under current law, the FDA must analyze potential committee members pursuant to Section 712 of the Food, Drug, & Cosmetic Act (FDCA), in addition to the government-wide provisions found in the Federal Advisory Committee Act and the Ethics in Government Act of 1978. 

The letter asserted that, “This additional FDA-specific provision appears to drive the FDA to look only for individuals to serve as SGE’s who have virtually no financial ties to any issue that might be addressed by a given Advisory Committee.” 

“While that may sound wise at first glance, in fact those with expertise in a given area often have foreseeable and unavoidable ties to the community as a result of their expertise,” the groups asserted. “Yet, under the current structure, the FDA is not allowing those individuals to serve as SGE’s, despite the fact that by doing so the FDA is being deprived of expertise by those who are best qualified.” 

Two years ago, 218 positions of the 600-plus on FDA's 49 advisory committees had yet to be filled, in part because the FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view.  This kind of absence rate is extremely disturbing for patients who are waiting for new treatments and products to be approved. 

While supporters of the tightened rules said they were necessary to protect the public from bias and to remain objective, a study published over five years ago dispelled these concerns.  Specifically, a study published in 2006 in the Journal of the American Medical Association (JAMA) examined a total of 221 meetings held by 16 drug advisory committees.  Overall, the study reported that the meeting-level analysis did not show a statistically significant relationship between conflict rates (“index conflict,” “competitor conflict,” or “any conflict”) and voting patterns.  From these findings, the researchers concluded that excluding advisory committee members and voting consultants with “conflicts” would not have altered the overall vote outcome at any meeting studied.

In the past few weeks and months, we have seen a renewed focus on FDA’s conflict of interest rules, with FDA Commissioner Dr. Hamburg and Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), coming out publicly and announcing that the agency needs to address these provisions.  In fact, Woodcock acknowledged that, “the [conflict of interest] limits have slowed down the advisory committee process.” 

Moreover, several pieces of legislation in both the Senate and House were recently introduced, which would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government, under the Federal Advisory Committee Act.   

Consequently, these patient groups added their support “to eliminate the additional conflicts of interest restrictions that apply only to the FDA.”  Specifically, the groups maintained that, “the existing provisions in the Federal Advisory Committee Act and the Ethics in Government Act of 1978 are adequate to safeguard against conflicts of interest, while still allowing those with the necessary expertise and perspective to serve on these very important committees.” 

Moreover, the groups acknowledged that, “the specific standard for SGE’s found in 18 U.S.C. 208(b)(3) recognizes that potential SGE’s may have conflicts of interest, but allows for their service nevertheless when the need for their services outweighs the potential for a conflict of interest created the financial interest involved.” 

This “standard is clear, reasonable, and balanced and appropriately recognizes that some potential SGE’s may come to the FDA with ties to the community that may pose some conflict of interest, but that the primary issue must be the government’s need for their services.” 

Ultimately, the groups recognized that, “The main goal of these committees, after all, is to help the FDA to make the best decisions possible” and “FDA can only do that if it has the best, most well-informed researchers, clinicians, and patients advising it.”

As more patient groups, legislators, and healthcare stakeholders begin to press FDA and Congress to change the current conflict rules at FDA, it is becoming more likely that the currently proposed legislation noted above will be included in the PDUFA V negotiations, especially given FDA’s recent proposals to increase and enhance innovation.

ACCME October News: Reminding Providers to Enter 2011 Activity Data

CME Conference 9
In this month’s Accreditation Council for Continuing Medical Education (ACCME) newsletter, the ACCME reminded providers of several new projects, upcoming programs, and reporting requirements.

ACCME Reminds Providers to Enter 2011 Activity Data in PARS

ACCME encouraged accredited providers to start entering 2011 activity data into the Program and Activity Reporting System (PARS) in anticipation of the year-end reporting deadline.  Providers can enter basic information about an activity before it has taken place and complete the entry after the activity.  To meet the year-end reporting deadline, providers must complete entering data for your 2011 activities and complete your 2011 program summary by March 30, 2012. (These instructions apply only to ACCME-accredited-providers, not to providers accredited by a state medical society.)

ACCME noted that it has made improvements to support provider data entry, based on provider feedback, updated the FAQs on the PARS Help Page, and produced PARS Release Notes to assist providers.

Coming Soon: ACCME's New Web Site

The ACCME is in the process of redesigning its Web site to offer a more user-friendly resource with improved navigation, organization, content, and design. The site restructuring incorporates feedback ACCME received from users of the Web site and is part of their ongoing efforts to improve services for accredited providers, Recognized Accreditors, and other stakeholders.  ACCME plans to launch the new site in the coming months.

Revised Materials for the Joint Accreditation Process

The ACCME, the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) released revised materials regarding the joint accreditation process. Launched in 2009, the ACCME, ACPE, and ANCC joint accreditation initiative seeks to reward organizations for offering team-focused continuing education that improves patient care.

The revised materials incorporate feedback received from providers and other stakeholders during the first two years of the joint accreditation process. Among the updates, the eligibility requirements have been expanded to accommodate state-accredited providers. Organizations that are already accredited in good standing by one of the three national accrediting bodies (ACCME, ACPE, or ANCC) and one state accrediting body (an ACCME Recognized Accreditor or an ANCC Accredited Approver) and that meet the other requirements are now eligible to seek joint accreditation. Previously, providers had to be accredited in good standing by two of the three national accrediting bodies in order to be eligible.

For more information, visit our Document and Forms Library and scroll down to the section Materials for ACCME/ACPE/ANCC Joint Accreditation.  To date, five continuing education providers have received joint accreditation. For more, see this news release.

Save the Date: 2012 CME as a Bridge to Quality Accreditation Workshops

The ACCME's 2012 CME as a Bridge to Quality Accreditation Workshops are scheduled for April 18-20 and August 15-17 in Chicago. ACCME will hold "Self-Study for Accreditation" sessions in conjunction with each workshop. They will invite providers whose next accreditation decisions are scheduled for July 2013, November 2013, and March 2014. Early next year, ACCME will send more information to providers in those decision cohorts.

The Accreditation Workshops offer participants the opportunity to work closely with ACCME staff, national CME leaders, and colleagues to learn practical strategies for complying with accreditation requirements and positioning CME as a Bridge to Quality within their organizations.  More workshop information is available here. Registration for the April workshop will open later this fall.

Recognized Accreditors: Registration Now Open for the ACCME State/Territory Medical Society Conference

Registration is now open for the ACCME State/Territory Medical Society Conference: A Conference of Leaders, scheduled for December 6-7, 2011, at the Intercontinental Chicago. Designed for Recognized Accreditors (state/territory medical societies approved by the ACCME as accreditors of local CME providers) and accreditation volunteers, this conference offers the opportunity for participants and the ACCME staff to engage in strategic discussions about the CME system’s national priorities.

The theme for this year’s conference is “Collaborating to Advance CME: Building Value, Enhancing Our Efforts.”  The conference will focus on how CME providers can support Maintenance of Certification®, Maintenance of Licensure, and health care quality improvement initiatives. Participants will identify best practices for improving accreditation programs and promoting the professional development of staff, volunteers, and intrastate providers.

The December conference will build upon discussions held at the 2011 ACCME regional forums, which brought together Recognized Accreditor staff and volunteers from 24 states to discuss the national CME environment and best practices in accreditation.  For more information and to register, click here.

ACCME Invited to US-India Higher Education Summit, CDC Editorial Summit

The ACCME was invited to participate in the first US-India Higher Education Summit, held in Washington, DC, in October. Hosted by the US and Indian governments, the summit brought together international leaders in government, business, and academia to discuss their strategic vision for building collaboration between the US and India in the area of higher education. Murray Kopelow, MD, ACCME Chief Executive, offered his perspective about how continuing professional education can contribute to this initiative. For more information, see the summit agenda and the US-India Joint Statement on Higher Education Cooperation.

The ACCME was invited to participate in the Centers for Disease Control (CDC) and Prevention Editorial Summit: Advancing Public Health Globally, held in September in Atlanta. The goal of the summit was to establish a sustainable, collaborative forum to facilitate the dissemination of scientific information to health care practitioners, policymakers, and the public. Dr. Kopelow discussed how CME can support the translation of new science into physician practice and improved patient care. He is also participating in ongoing efforts to further the forum’s goals.

ACCME Presents at National Medical Association Meeting

Kate Regnier, MA, MBA, ACCME Deputy Chief Executive and COO, gave a presentation at the National Medical Association (NMA) 2011 Fall Orientation Workshop, held in September in Washington, DC. The workshop provided an orientation for the NMA’s physician program committee chairs and their staff, who are responsible for developing CME activities. Ms. Regnier described how accredited CME supports health care quality improvement and safety efforts and aligns with the American Board of Medical Specialties Maintenance of Certification® (MOC) and the Federation of State Medical Boards Maintenance of Licensure (MOL) initiatives. She gave an overview of the Accreditation Criteria and the Standards for Commercial Support, provided a simple construct for approaching the Accreditation Criteria, and described examples of compliance with the criteria for achieving Accreditation with Commendation. NMA is an ACCME-accredited provider.

ACCME Participates in State Medical Society Conferences

Throughout the year, the ACCME provides ongoing support for the intrastate accreditation system, including participation in state medical society conferences and professional development trainings for intrastate providers, CME staff, and volunteers. In October, Sandra B. Norris, MBA, 2011 Vice-Chair, ACCME Board of Directors; and Marcia K. Martin, Manager, Provider Education and Outreach, ACCME, gave presentations at the Washington State Medical Association Provider Conference. Ms. Norris gave an overview of emerging changes in the health care system, leadership opportunities for CME, and the scope of the ACCME accreditation system. Ms. Martin discussed how to simplify approaches to CME, involve physicians in driving change, and identify local opportunities for positioning CME as a valued partner in public health initiatives.

So far this year, the ACCME also has participated in or is planning to participate in conferences and trainings held by various at least 20 other State medical associations.

ACCME Supports International CPD Initiatives

Over the years, the ACCME has participated in continuing medical education/continuing professional development initiatives with a wide range of countries as part of its commitment to support collaboration in the global CME community. In September, two delegations of medical professionals from China visited the ACCME as part of their study tours to learn about the US health care and CME systems. This fall, the ACCME participated in a meeting of the European Accreditation Council for Continuing Medical Education (EACCME) held in Athens, the 3rd National CPD Accreditation Conference held in Ottawa, and a meeting of the College of Physicians and Surgeons of Ontario held in Toronto.


ACCME welcomed John Sweeney, ACCME's new Manager, Data and Information Systems. Mr. Sweeney is managing the ACCME’s public Web site and the Program and Activity Reporting System (PARS), as well as contributing to the ACCME's technology strategic plan.

For Your Reference

"Climate Change: It's Not about the Weather—Continuing Medical Education and Maintenance of Certification and Licensure," published by the Permanente Journal in the Summer 2011 issue, describes how the Accreditation Criteria support emerging continuous professional development systems such as Maintenance of Certification and Maintenance of Licensure. The article was co-authored by Carol Havens, MD, Director of Clinical Education, The Permanente Medical Group; and Jeffrey Mallin, MD, former Director of Medical Education, Kaiser Permanente Downey Medical Center. Dr. Havens serves on the ACCME Committee for Review and Recognition and previously served as a volunteer with the Institute for Medical Quality/California Medical Association (IMQ/CMA), an ACCME Recognized Accreditor; Dr. Mallin is a member of the ACCME Accreditation Review Committee and currently serves with IMQ/CMA.

October 28, 2011

HHS OIG Releases Work Plan for FY 2012

Work Plans
In 2009, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) created the Health Care Fraud Prevention and Enforcement Action Team, otherwise known as HEAT, which includes the Medicare Strike Force--an organization that most notably this year took down those responsible for $295 million worth of fraud in one fell swoop.

In fiscal year 2010, the Office of Inspector General (OIG) investigations led to $3.8 billion in court-ordered or agreed on civil settlements and $1.1 billion in OIG audits, according to the report.

OIG identifies and prevents fraud, waste, and abuse in the 300 programs under Health & Human Services, including CMS, NIH, FDA, CDC, and the Administration for Children and Families. OIG receives thousands of complaints each year regarding potential fraud. It works with local and federal law enforcement, including the Federal Bureau of Investigation, the Internal Revenue Service, the United States Postal Inspection Service, and State Medicaid Fraud Control Unites, investigating individuals, facilities, and other entities that bill Medicare and/or Medicaid for services that are not provided or inappropriate, false or overestimated claims, as well as kickbacks and self-referrals.

OIG recently detailed next fiscal year's work plan (165 pages) for the Office of Audit Services, Office of Evaluation and Inspections, Office of Investigations, and Office of Counsel to the Inspector General, calling for continued attention to fighting healthcare fraud. 

Of importance to continuing medical education (CME) providers, OIG stated that it will examine the Food and Drug Administration's (FDA) Implementation of the Risk Evaluation and Mitigation Strategies (REMS) Program.  Specifically, OIG stated that it will “examine the extent to which FDA ensures drug manufacturer compliance with the requirements of the REMS program.  OIG will also review drug manufacturer assessments of the REMS program’s efficacy in minimizing risk to consumers.

OIG asserted that, “ensuring the effectiveness of REMS plans is an important component of drug safety oversight, which is one of the Top Management and Performance Challenges that OIG identified for HHS.”

OIG Work Plan FY 2012


The Work Plan is one of OIG’s three core publications. The Semiannual Report to Congress summarizes OIG’s most significant findings, recommendations, investigative outcomes, and outreach activities in 6-month increments. The annual Compendium of Unimplemented Recommendations (Compendium) describes open recommendations from prior periods that when implemented will save tax dollars and improve programs.


The OIG Work Plan outlines OIG’s current focus areas and states the primary objectives of each review.  Below is a more detailed description of the report.  Among the work plan changes for hospitals regarding Medicare Parts A and B are the following:

Review of inpatient and outpatient payment to acute-care hospitals: Using computer-matching and data-mining techniques, OIG will select hospitals for focused review of their claims and policies and procedures to see if they follow billing requirements.  Inspectors will interview those hospitals' leadership and compliance officers about their compliance programs. That information will be used for the goal of recovering overpayments.

Review of present-on-admission indicators submitted on Medicare claims: Inspectors will review claims submitted in October 2008 by hospitals across the country, distinguishing hospital-acquired conditions from patient conditions at admission time.

Acute-care hospital inpatient transfers to inpatient hospice care: Inspectors will look at Medicare claims for inpatient stays in which patients were transferred to hospice care facilities.

Critical access hospitals: Inspectors will examine how many and what kind of patients critical access hospitals treat to determine the appropriateness of a CAH designation.

Hospital Reporting for Adverse Events.  OIG will review the type of information that hospitals’ internal incident-reporting systems capture about adverse events and determine the extent to which hospital systems captured adverse events and reported the information to external patient-safety oversight entities.

Reliability of Hospital-Reported Quality Measure Data.  OIG will review hospitals’ controls for ensuring the accuracy and validity of data related to quality of care that they submit to CMS for Medicare reimbursement.


Duplicate Graduate Medical Education Payments.  OIG will review provider data from CMS’s Intern and Resident Information System (IRIS) to determine whether duplicate or excessive graduate medical education (GME) payments have been claimed. OIG will also assess the effectiveness of IRIS in preventing providers from receiving payments for duplicate GME costs.


Nursing Home Compliance Plans (New).  OIG will review Medicare- and Medicaid-certified nursing homes’ implemention of compliance plans as part of their day-to-day operations and whether the plans contain elements identified in OIG’s compliance program guidance.  OIG will assess whether CMS has incorporated compliance requirements into Requirements of Participation and oversees provider implementation of plans. Section 6102 of the Affordable Care Act requires nursing homes to operate a compliance and ethics program, containing at least 8 components, to prevent and detect criminal, civil, and administrative violations and promote quality of care. The Affordable Care Act requires CMS to issue regulations by 2012 and SNFs to have plans that meet such requirements on or after 2013.


Safety and Quality of Post-Acute Care for Medicare Beneficiaries (New).  OIG will review the quality of care and safety of Medicare beneficiaries transferred from acute-care hospitals to postacute care. OIG will evaluate transfer process and identify rates of adverse events and preventable hospital readmissions from post-acute-care settings. OIG will focus on three postacute settings: SNFs, IRFs and long-term-care hospitals.


Hospitalizations and Rehospitalizations of Nursing Home Residents.  OIG will review the extent to which Medicare beneficiaries residing in nursing homes have been hospitalized and rehospitalized. OIG will also assess CMS’s oversight of nursing homes whose residents have high rates of hospitalization.


Hospice Marketing Practices and Financial Relationships with Nursing Facilities (New).  OIG will review hospices’ marketing materials and practices and their financial relationships with nursing facilities.  OIG will focus our review on hospices that have a high percentage of their beneficiaries in nursing facilities


Medicare Enrollment and Monitoring for Suppliers of Durable Medical Equipment,

Prosthetics, Orthotics, and Supplies.  OIG will review Medicare contractors’ processes for enrolling and monitoring suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). OIG will assess their use of enrollment-screening mechanisms and post-enrollment monitoring activities to identify applicants that pose fraud risks to Medicare and the extent to which applicants omitted ownership information on enrollment applications.


Questionable Billing for Medicare Diabetic Testing Supplies (New).  OIG will review Medicare claims for diabetic testing strips and lancets (diabetic testing supplies) to identify questionable billing. OIG will also identify characteristics that may be indicative of fraud, waste, and abuse.


Physician-Owned Distributors of Spinal Implants (New).  OIG will determine the extent to which physician-owned distributors (POD) provide spinal implants purchased by hospitals. OIG will also analyze Medicare claims data to determine whether PODs OIG identify in our review are associated with high use of spinal implants.


Physicians: Impact of Opting Out of Medicare (New).  OIG will review the extent to which physicians are opting out of Medicare and determine whether physicians who have opted out of Medicare are submitting claims to Medicare. OIG will also examine whether specific areas of the country have seen higher numbers of physicians opting out and its potential impact on beneficiaries.


Chiropractors: Part B Payments for Services (New).  OIG will review Medicare Part B payments for chiropractic services to determine whether such payments were in accordance with Medicare requirements.


Ambulatory Surgical Centers: Payment System.  OIG will review the appropriateness of Medicare’s methodology for setting ambulatory surgical center payment rates under the revised payment system.


Ambulatory Surgical Centers and Hospital Outpatient Departments: Safety and

Quality of Surgery and Procedures (New).  OIG will review the safety and quality of care for Medicare beneficiaries having surgeries and procedures in ambulatory surgical centers and Hospital Outpatient Departments (HOPD). OIG will assess care in preparation for and provided during surgeries and procedures in both settings. OIG will identify adverse events in both settings.


Sleep Disorder Clinics: Medicare Payments for Sleep Testing.  OIG will review the appropriateness of Medicare payments for sleep test procedures provided at sleep disorder clinics and determine whether they were in accordance with Medicare requirements.


Sleep Testing: Appropriateness of Medicare Payments for Polysomnography.  OIG will review the appropriateness of Medicare payments for sleep studies. OIG will also examine the factors contributing to the rise in Medicare payments for sleep studies and assess provider compliance with Federal program requirements.


Payments for Off-Label Anticancer Pharmaceuticals and Biologicals.  OIG will review Medicare payments for drugs and biologicals used on an off-label basis (prescribed for a condition that is not listed on the product’s label) in anticancer chemotherapeutic regimens to determine whether patients with particular indications were prescribed anticancer drugs approved by FDA for such indications before resorting to anticancer drugs not approved for those indications.  If so, OIG will determine whether there were improvements in the patients’ medical conditions before the use of off-label drugs.  If the beneficiaries’ medical conditions improved before the use of off-label drugs, OIG will determine how much Medicare could have saved had the previously administered anticancer drugs continued to be used.


Physician-Administered Drugs and Biologicals (New).  OIG will compare Medicare and Medicaid payments for commonly used physician-administered drugs and biologicals to determine whether changes in the reimbursement methodologies for the Part B drug program would result in significant savings.


Off-Label and Off-Compendia Use of Medications in Government Prescription Drug Programs (New).  OIG will review the extent of off-label and off-compendia use of Medicare- and Medicaid-funded prescription drugs, and the extent to which specified compendia provide support for coverage. OIG will also determine CMS oversight mechanisms related to off-label use of drugs.


Medicare Outpatient Payments for Drugs (New).  OIG will review Medicare outpatient payments to providers for certain drugs and the administration of those drugs (e.g., chemotherapy) to determine whether Medicare overpaid providers because of incorrect coding or overbilling of units.


Increase in Prices for Part D Brand Name Drugs (New).  OIG will review annual changes in prices for brand-name prescription drugs used by Medicare Part D beneficiaries and determine whether Part D prices (including rebates) are rising faster than inflation. OIG will also determine how price increases for brand-name drugs affect Medicare Part D payment amounts.


Characteristics Associated With Part D Billing in 2009.  OIG will review Part D drugs billed in 2009 to identify characteristics of associated pharmacies, prescribers, and beneficiaries. OIG will also identify the pharmacies, prescribers, and beneficiaries associated with atypically high billing and determine what, if any, characteristics they have in common.


Part D Payments for Drugs Dispensed at Retail Pharmacies With Discount Generic Programs (New).  OIG will determine whether Part D claims were paid at the discounted prices available at certain retail pharmacies, and whether the Plan Finder Website is accurately reporting these prices to beneficiaries.


Questionable Part D Billing for HIV Drugs (New).  OIG will identify questionable billing for human immunodeficiency virus (HIV) drugs under Medicare Part D. OIG will determine the extent to which Part D paid for HIV drugs for beneficiaries who did not appear to have the appropriate medical indications. OIG will also identify pharmacies and prescribers associated with a high number of beneficiaries with questionable characteristics.


Part D Pharmaceutical Manufacturer Rebates.  OIG will review contracted pharmaceutical manufacturer rebates collected by Part D sponsors and pharmacy benefit managers (PBM). OIG will identify the rebate amounts negotiated between the sponsors/PBMs and pharmaceutical manufacturers, compare them with the actual rebates paid, and analyze any discrepancies.


Safety and Effectiveness of Part D Drugs.  OIG will review whether the drugs used in the Part D program were previously found to be safe and effective by FDA and whether Part D beneficiaries were dispensed only drugs that FDA had deemed safe and effective.


Sponsors’ Internal Controls for Fraud, Waste, and Abuse.  OIG will review the reliability of Medicare Part D sponsors’ internal controls to guard against fraud, waste, and abuse. Federal law requires Part D sponsors to have such programs. (Social Security Act, § 1864D-4(c).) Federal regulations require sponsors to have in place compliance plans that include comprehensive methods to detect, correct, and prevent fraud, waste, and abuse.


Sponsors’ Pharmacy and Therapeutics Committees: Potential Conflicts of Interest.  OIG will review Part D Pharmacy and Therapeutics committees’ disclosed potential conflicts of interest and describe the nature of such conflicts. Sponsors using formularies must have Pharmacy and Therapeutics committees that select the drugs on sponsors’ formularies and determine cost sharing, prior authorization, quantity limits, generic substitution, and other issues affecting drug access. (42 CFR § 423.120(b)(1).) Each committee must have at least one physician and one pharmacist who are free of conflicts of interest.


Payments for Health-Care-Acquired Conditions (New).  OIG will determine whether selected State agencies made Medicaid payments for health-care acquired conditions and provider-preventable conditions and quantify the amount of Medicaid payments for such conditions.


Review of Entities That Do Not Enter Into Corporate Integrity Agreements (New).

OIG will review entities, including providers and/or suppliers that settled fraud cases with the Government but declined to enter into CIAs with OIG.  OIG reviews may be similar to or more extensive than those that would be performed by Independent Review Organizations under CIAs to assess the entity’s compliance with Federal health care program standards.


Early Implementation of Patient Safety Organizations (New).  OIG will review the policies and activities of Patient Safety Organizations (PSO) to determine the extent of participation among hospitals, their practices in receiving and analyzing adverse event

reports, and the extent to which they provide information to providers and the Network of Patient Safety Databases maintained by AHRQ. OIG will evaluate PSOs’ efforts to identify and resolve patient safety problems in hospitals and identify any barriers to the full and effective implementation of the PSO program.


Prevention and Public Health Fund Recipient Capability Audits (New).  OIG will perform limited-scope reviews to determine whether CDC’s grantees have the capability to manage and account for Federal funds, including Patient Protection and Affordable Care Act of 2010 funds, in accordance with Federal regulations. OIG will also determine whether Prevention and Public Health Fund grantees are able to fulfill program requirements.


Grantees’ Use of Funds From the Prevention and Public Health Fund (New).  OIG will determine whether CDC grantees’ use of funds from the Prevention and Public Health Fund were properly used for the purposes outlined in Federal laws and directives.


FDA’s Oversight of Investigational New Drug Applications.  OIG will review FDA’s process for evaluating investigational new drug (IND) applications. OIG will assess FDA’s timeliness and identify challenges in the IND review process.


FDA’s Policies and Procedures for Resolving Scientific Disputes.  OIG will describe the extent and nature of formal internal scientific disputes that occured during the approval of medical devices at the FDA Center for Devices and Radiological Health’s (CDRH). OIG will assess the extent to which regulations, policies, and procedures were followed during the dispute resolution process. OIG will also assess CDRH's implementation of its new policies and procedures for addressing scientific disputes.

510(k) Process for Device Approval.  OIG will review documentation of devices that FDA cleared using the Premarket Notification process, known as the 510(k) process, and describe characteristics of the cleared devices.


FDA Oversight of Claims Made on Dietary Supplement Labels (New).  OIG will review a sample of dietary supplements to determine the extent to which their labeling complies with FDA regulations regarding structure function claims.  OIG will also determine the extent to which manufacturers of supplements are listed in FDA’s Food Facility Registry as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). OIG will review the accuracy of the information in the FDA’s registry of manufacturers of supplements and determine how FDA monitors and responds to claims that do not comply with the regulations.


Informed Consent and Privacy Protection Procedures for NIH Grantees Conducting Genetic Research (New).  OIG will determine the extent to which NIH grantees conducting genetic research comply with regulations and guidance on informed consent procedures. OIG will also assess the informed consent and privacy protection procedures used by these grantees and determine the extent to which they ensure that human subjects’ private information stored in biobanks is protected in future research.


Inappropriate Salary Draws From Multiple Universities (New).  OIG will determine whether faculty members working on NIH grants were inappropriately drawing salaries from multiple universities.


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