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26 posts from March 2012

March 30, 2012

HHS Regulatory Priorities for 2012

Priority 2

The Department of Health and Human Services (HHS) recently released a report of its Regulatory Priorities for FY 2012.    

HHS operates more than 300 programs covering a wide spectrum of activities, manages almost a quarter of all Federal outlays, and administers more grant dollars than all other Federal agencies combined.  The Department’s major program responsibilities include: 

  • Medicare and Medicaid;
  • Control and prevention of communicable and chronic disease;
  • Support for public health preparedness and emergency response;
  • Biomedical research;
  • Substance abuse and mental health treatment and prevention;
  • Assuring safe and effective drugs, devices, and other medical products;
  • Protecting the food supply;
  • Assistance to low-income families;
  • The Head Start program; and
  • Improving access to health care services to the uninsured, isolated, or medically vulnerable. 

HHS is also the principal agency charged with implementing one of the President’s signature achievements—transformative health care reform through the Affordable Care Act of 2010. 

To implement this vast program portfolio, HHS develops an active regulatory agenda each year, driven largely by statutory mandates and interactions with stakeholders. The President also called upon Federal agencies to reform the regulatory process in his January 18, 2011, Executive Order 13563 “Improving Regulation and Regulatory Review.”  A key directive in that Executive order was to require agencies to conduct an inventory of existing regulations to determine whether such regulations should be modified, streamlined, expanded, or repealed to make an agency's regulatory scheme more effective or less burdensome in achieving its programmatic objectives. 

With these regulatory drivers in mind, HHS Secretary Kathleen Sebelius has worked with HHS agencies to craft a regulatory agenda that reflects her commitments to implementing meaningful health care reform, access to health care coverage, and high value health care services that are safe and effective for all Americans.  The agenda also reflects her other strategic initiatives, which include: 

  • Securing and maintaining health care coverage for all Americans;
  • Improving quality and patient safety;
  • More rapidly responding to adverse events;
  • Implementing a 21st century food safety system;
  • Helping Americans achieve and maintain healthy living habits;
  • Advancing scientific research; and
  • Streamlining regulations to reduce the regulatory burden on industry and States.   

Within the agenda, the Secretary has also been mindful of the need to reform the ongoing regulatory process through retrospective review of existing regulations, and this agenda reflects her commitment to that review by incorporating some of the most significant burden reduction reforms across all Federal agencies.  In fact, of the $10 billion in savings from retrospective regulatory review across all Federal agencies announced by the Administrator of the Office of Information and Regulatory Affairs, $5 billion was attributable to regulations contained within HHH’s current regulatory agenda.  Below is a brief overview of mainly the health related priorities. 

Making Health Insurance Coverage More Secure for Those Who Have Insurance and Extending Coverage to the Uninsured 

As a result of the Affordable Care Act, HHS is making affordable health care coverage more stable and secure through insurance market reforms designed to protect consumers against unreasonable insurance premium increases, provide them with more comprehensive and understandable information with which to make decisions, and enable eligible consumers to receive financial support for health insurance easily and seamlessly.  In 2014, all people who suffer from chronic conditions will no longer be excluded from insurance coverage or charged higher premiums because of a pre-existing condition or medical history. 

Already, insurers are prohibited from putting lifetime dollar limits and restrictive annual caps on what they will pay for health care services needed by the people they insure, ensuring that those people have access to medical care throughout their lives, especially when it is most needed.  HHS is working with States to help identify and put a stop to unreasonable health insurance premium rate increases and will require new health plans to implement a comprehensive appeals process for those beneficiaries who have been denied coverage or payment by the insurance plan.  

New health insurers will also be required to spend the majority of health insurance premiums on medical care and health care quality improvement, not on administration and overhead.  As well, the Affordable Care Act is providing reimbursement to employers that offer health benefits to early retirees, providing insurance coverage through the Pre-existing Condition Insurance Plan to people who would otherwise be locked out of the insurance market because of their pre-existing health conditions, and requiring plans that offer dependent coverage to make that coverage available to young adults up to age 26. 

In addition, the Centers for Medicare & Medicaid Services (CMS) will finalize three rules that will expand access to health insurance and provide consumers with better options and information about insurance: 

-       CMS will issue standards for the establishment of the Affordable Insurance Exchanges (Exchanges) to provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality.  These Exchanges will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. 

-       Another rule helps to make coverage more secure by offsetting market uncertainty and risk selection to maintain the viability of Exchanges.  Under risk adjustment, HHS, in consultation with the States, will establish criteria and methods to be used by States in determining the actuarial risk of plans within a State to minimize the negative effects of adverse selection.  Under reinsurance, all health insurance issuers, and third-party administrators on behalf of self-insured group health plans, will contribute to a nonprofit reinsurance entity to support reinsurance payments to individual market issuers that cover high risk individuals. 

-       To extend health insurance to greater numbers of low-income people, Medicaid eligibility in 2014 will expand to cover adults under the age of 65 earning up to 133 percent of the Federal poverty level, and those who earn above that level may be eligible for tax credits through the Exchanges to help pay their premiums.  New, simplified procedures for determining Medicaid, CHIP, and tax credit eligibility will be forthcoming in 2012.  CMS will simplify eligibility rules to make it easier for eligible individuals and families to obtain premium tax credits and Medicaid coverage, including ensuring that Medicaid uses the same eligibility standards as other insurance affordability programs available through the Exchange, as directed by law.  The rule further outlines how Medicaid and CHIP will coordinate closely with the Exchange, including sharing data to ensure that individuals are determined eligible for the appropriate insurance affordability program regardless of where an applicant submits the application. 

Improving Health Care Quality and Patient Safety 

Across America and for all Americans, HHS is working to improve patient outcomes, ensure patient safety, promote efficiency and accountability, encourage shared responsibility, and reduce health care costs.  Through improved administrative processes, reforms, innovations, and additional information to support consumer decision making, HHS is supporting high-value, safe, and effective care across health care settings and in the community. 

In 2011, the Department published a key regulation to advance this priority—the final rule for Accountable Care Organizations (ACOs).  This rule establishes a system of shared savings for qualified organizations that deliver primary care services to a given patient population.  The objective is to promote accountability and shared responsibility for the delivery of care, especially to those with co-morbidities of chronic health problems in order to prevent unnecessary and costly in-patient hospital care, reduce health care acquired conditions, and improve the quality of life for those individuals.  

This rule serves as a companion to additional demonstration programs designed to explore alternative services delivery and payment systems that are being sponsored by the new Center for Medicare and Medicaid Innovation.  Several more key regulations are on the agenda to move forward in meeting these quality and patient safety goals:

-       CMS is implementing value-based purchasing programs throughout its payment structure in order to reward hospitals and other health care providers for delivering high-quality care, rather than just a high volume of services.  The payment rules scheduled for publication this year will reflect a mix of standards, processes, outcomes, and patient experience of care measures, including measures of care transition and changes in patient functional status. 

-       The Department continues to encourage health care providers to become meaningful users of health information technology (IT) by accelerating health IT adoption and promoting electronic health records to help improve the quality of health care, reduce costs, and ultimately, improve health outcomes.  Electronic health records and health information exchange can help clinicians provide higher quality and safer care for their patients.  By adopting electronic health records in a meaningful way, clinicians will know more about their patients to better coordinate and improve the quality of patient care, and they can make better decisions about treatments and conditions.

 Improving Response to Adverse Events 

In a related activity, the FDA will be proposing a new rule to establish a unique identification system for medical devices in order to track a device from pre-market application through distribution and use.  This system will allow FDA and other public health entities to track individual devices so that when an adverse event occurs, epidemiologists can quickly track down and identify other users of the device to provide guidance and recommendations on what steps to take to prevent additional adverse actions.   

 Advancing Scientific Research 

To effectively address the challenges HHS faces in crafting the best, evidence-based approaches to advance health services delivery, protect the public health, ensure essential human services, promote biomedical research, and ensure the availability of safe medical and food products, HHS must rely on research.  The lynchpin of this research is found in the ethical rules governing research on human subjects. 

In a major undertaking, HHS is in the process of reviewing and revising those ethical rules, commonly referred to as the Common Rule.  The Common Rule serves to guide researchers and investigators in the Department, but also throughout the Federal Government, in the conduct and protocols for doing research on human subjects.  The proposed revisions will be designed to better protect human subjects who are involved in research, while facilitating research and reducing burden, delay, and ambiguity for investigators. 

Streamlining Regulations to Reduce Regulatory Burdens 

Consistent with the President’s Executive Order 13563, HHS continues its commitment to reducing the regulatory burden on the health care industry through the use of modern technology.  As part of this effort, FDA will advance several rules designed to reduce the reporting and data submission requirements from manufacturers of drugs and medical devices. 

In one such rule, FDA will permit manufacturers, importers, and users of medical devices to submit reports of adverse events to the FDA electronically. This proposed change will not only reduce the paper reporting burden on industry, but also allow FDA to more quickly review safety reports and identify emerging public health issues.  

Under another proposed rule, FDA would revise existing regulations to allow clinical study data and bioequivalence data for new drug applications and biological license applications to be provided electronically.  Again, this rule will reduce the reporting burden on industry and also permit FDA to more readily process and review applications. 

CMS is also engaged in regulatory reduction and streamlining activities.  Of particular note are several rules on conditions of participation for hospitals and other providers.  The most comprehensive of these rules is the one reducing regulatory burdens on hospitals, which is expected to save as much as $940 million annually over the next 5 years.  This rule will implement changes to hospital conditions of participation to reflect substantial advances in health care delivery and patient safety knowledge and practices.

March 29, 2012

Study Dispels the Myth of Publication Bias in Industry Supported Rheumatoid Arthritis Research

A recent study published in the Journal of Arthritis & Rheumatism assessed the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). 

RA is a chronic systemic autoimmune disease that chiefly manifests as inflammatory destructive arthritis, and affects 0.5-1% of adults.  Drug therapy options for RA treatment have “remarkably improved over the past fifteen years.”  In particular, the discovery and availability of biologics as therapeutic agents for RA treatment was facilitated by the funding of clinical trials from pharmaceutical companies. 

The study found that the funding source of RCT’s was not associated with higher likelihood of positive outcomes favoring the sponsored experimental drug.  As a result, the authors concluded that “Industry funding was not associated with higher likelihood of positive outcomes of published drug therapy RCTs for RA, and reported better on some key RCT quality measures.


As the article explains, “a dramatic increase in pharmaceutical industry funding and support of biomedical research” over the past few decades,” has “led to strong concerns regarding inappropriate influence of industry funding on the biomedical research.  Some studies have shown that industry funded research is associated with an increased likelihood of pro-industry results and conclusions.

RCTs are considered the “gold standard” means to assess healthcare interventions.  They are designed to eliminate bias by randomly distributing known and unknown confounding factors.  RCTs need to be methodologically sound to eliminate sources of bias that may appear at various stages.

A previous study assessing secular changes in the methodological quality of published RCTs in rheumatology found no differences between industry and non-profit funded RCTs.  However, the authors acknowledged that there are no data on the influence of industry funding on outcome of RA drug therapy RCTs.   As a result, the objective of their study was to determine the association of industry funding with the characteristics, outcome and the reported methodological quality of drug therapy RCTs for RA.


Two reviewers independently assessed RCTs conducted in 2002-3 and 2006-7 for the funding source, characteristics, outcome (positive or not positive), and reporting of methodological measures whose inadequate performance may bias treatment effect assessment. 

103 eligible RCTs were identified with the following funding sources: 56.3% industry; 18.4% non-profit; 5.8% mixed; and 19.4% unspecified.  Outcome could be assessed for 86 (83.5%) of RCT’s.

In assessing the methodological quality of RCT’s, the authors looked at randomization; allocation concealment; blinding; participant flow description; and intention-to-treat analysis.  The authors also used an approach to assess publication bias. 


Industry funded RCT’s had a trend towards higher likelihood of non-publication and reported more frequent performance of double-blinding, adequate participant flow description, and performance of intention-to-treat analysis. However, non-profit studies were likely to last longer. Industry-funded RCTs had larger number of study subjects, and were more likely to be conducted in multiple centers and countries.  Non-profit funded RCT’s tended to evaluate established drugs and different strategies to use drugs for RA treatment, while industry-funded RCTs focused on assessment of efficacy and safety of newere therapeutic drugs.

These differences, the authors asserted, “clearly highlight the importance of both industry and non-profit sources for funding of RCT’s to generate efficacy and safety evidence for newer as well as established drugs and strategies for their use in clinical care. 

The authors acknowledged several advantages to industry funded RCT’s, such as the availability of greater financial resources allows performance of more expensive measures such as double-blinding and more vigorous tracking and follow-up of study subjects.  The higher quality of RCTs from industry also may be a product of rigorous requirements set by the Food and Drug Administration (FDA). 

There was some concern, however, that the study did not address whether trials asked questions that are relevant to doctors and patients.  In other words, the studies were only compared to an inactive placebo pill instead of currently used medications, and therefore, some argue that the study is not practical because it leaves doctors and patients unable to judge whether they would be better off by switching to the new drug.


Ultimately, the study concluded that industry funding of RCTs was not associated with a higher likelihood of positive outcomes favoring the RA experimental drug.  An association between industry funding and study outcome was not found when comparing RCTs with any industry funding with those that had no declared industry funding; or when comparing only RCTs that were exclusively industry funded with those exclusively non-profit source funded.   

Moreover, no association between funding source and the study outcome was found after adjustment for the type of study drug used, number of study center, study phase, number of study subject or journal IF.  Hence, among “published” RA drug therapy RCT’s, the authors found that relatively small differences exist in the study outcomes between those with industry and non-profit funding source.  

The lack of industry influence on positive outcomes coupled with the significantly better performance of certain methodological quality measures in industry funded RCTs should dispel the concerns of many about any alleged inappropriate influence of industry funded trials.  Studies like this should be replicated in other disease areas to further demonstrate and address concerns about the alleged bias industry funding creates.  

Of course the media had to include a critic who discarded the evidence David J. Rothman, who heads the Center for the Study of Society and Medicine at Columbia University in New York, called the findings “interesting” and told Reuters Health that, "It would be nice if industry studies were not biased as the literature suggests … [because] Nobody wants to demonize the industry."  

The more transparent research we have, the more we can address any concerns patients or physicians may have, so that industry can continue to fund these important breakthrough RCTs. 

March 28, 2012

HHS OIG: Pharmaceutical Compliance Roundtable 2012 Report

As we have covered numerous times over the past few years, pharmaceutical and medical device manufacturers have been increasingly prosecuted and fined for improper, illegal, and unethical behavior.  As a recent article from USA Today noted, “the nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade.” 

However, as the article noted, these companies “remain in business with the federal government because they are often the sole suppliers of critical products.”  In order to keep doing business with federal healthcare programs, companies have entered into Corporate Integrity Agreements (CIAs) with the Department of Health and Human Services (HHS) Office of the Inspector General (OIG).  

Consequently, HHS OIG recently released a report summarizing discussions from a Government-industry Pharmaceutical Compliance Roundtable the Office held on February 23, 2012. 

The Roundtable provided an opportunity for OIG to discuss with compliance professionals in the pharmaceutical industry their experiences under Corporate Integrity Agreements (CIAs) and with various types of compliance activities.  One goal of the Roundtable was to identify compliance measures that participants find effective and share these with others within and beyond the pharmaceutical industry. 

While positive highlights of CIAs were discussed at the Roundtable, government investigators say their hands are tied with the tools they have.  They can exclude Pfizer and other pharmaceutical companies from providing medications to Medicaid and Medicare beneficiaries as punishment for bad behavior, but that would leave beneficiaries without drugs patented through a particular company.  Alternatively, OIG can fine the companies and force them to enter CIAs. 

However, OIG is “seeing some of the big companies a second and third time,” said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services.  “The corporate integrity agreement is not sufficient to deter further misconduct.”  In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said. 

To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said OIG, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement.  That could begin with cases being investigated now, he said. 

Sen. Chuck Grassley, R-Iowa, introduced a bipartisan bill that would make it easier for the government to find a middle ground, saying the law now forces “the inspector general to use all-or-nothing, mandatory exclusion penalties against corporations that have committed fraud.”  The bill would allow the exclusion of individuals from working with the government even after they've left the company where the fraud occurred. 

At least 12 pharmaceutical and medical device companies are lobbying specifically against a House bill, HR 675, that complements Grassley's.  The industry's trade group, the Pharmaceutical Research and Manufacturers of America, says excluding an individual should occur only when there is "significant wrongdoing" that the individual knew about and did nothing to stop, said Matthew Bennett, the group's senior vice president. 


Forty-two compliance officers and other compliance professionals from 23 pharmaceutical manufacturers currently under CIAs attended the day-long event.  The Roundtable consisted of large and small group sessions.  During the small group sessions, industry representatives engaged in dialogue with more than 15 representatives from the Office of Counsel to the Inspector General, including several CIA monitors for the companies in attendance.  

The Roundtable began with a large group session during which Inspector General Daniel Levinson and Chief Counsel Lewis Morris delivered introductory remarks.  The large group then divided into smaller breakout sessions.  During the day, all attendees discussed each of these five topics:

(1) Challenges in Implementing CIAs;

(2) Compliance Program Structure and Oversight;

(3) Risk Assessment and Monitoring Activities;

(4) Policies, Procedures, and Training Activities; and

(5) Compliance Post-CIA. 

Topic 1: Challenges in Implementing CIAs


Participants discussed issues related to challenges in implementing CIA requirements. The primary issues were:

(1) the definition of “Relevant Covered Person,”

(2) the deadlines for the initial implementation of CIA requirements,

(3) training requirements,

(4) the health care provider (HCP) notice letter,

(5) payment-posting requirements, and

(6) working with Independent Review Organizations (IROs). Participants described their experiences in implementing the CIAs and recommended changes to CIAs. 

Definition of “Relevant Covered Persons”:  CIAs require that companies provide specified written policies and procedures and training to individuals who meet the CIA definition of “Relevant Covered Persons.”  Participants reported that their companies interpret the definition broadly and that this creates challenges in correctly identifying all Relevant Covered Persons. 

Deadline for initial implementation of CIA requirements: CIAs typically require companies to develop and implement codes of conduct, policies and procedures, and training within specific timeframes following the effective date of the CIAs.  Participants expressed concern that the timeframes are too short to allow for effective development of company-specific policies, procedures, and training materials.  Participants reported that as a result, their companies may use “generic” policies, procedures, and training materials to meet the CIA deadlines for initial implementation.  Participants recommended that to allow for development of more meaningful and effective policies, procedures, and training, CIA deadlines be extended.

Training requirements: CIAs require companies to certify that they have trained all Relevant Covered Persons.  Participants reported that these requirements cause companies to develop and implement computer-based training modules for which completion is easier to track. While participants believe that small group training (such as that provided during in-person sales meetings) is more effective than computer-based training, attendance at such training may be difficult (and labor-intensive) to track. 

Participants offered several suggestions to improve training. These included:

(1) permitting companies to develop more flexible training plans (especially after the initial reporting period of the CIA) that would be approved by the CIA monitor annually;

(2) permitting general training requirements to be satisfied through competency testing (in such cases, employees who pass a compliance test would be exempted from additional training requirements for the year); and

(3) revising CIA requirements to allow companies to satisfy CIA obligations with training tailored to identified risk areas. 

Notice to health care providers: Some CIAs require companies to send to HCPs a letter briefly describing the terms of the settlement between the Government and the company and the alleged misconduct at issue.  Some participants reported that sending this letter is expensive and that it is not an effective vehicle to promote awareness of compliance issues among HCPs.  Some participants recommended that OIG permit more flexibility in how the content of the letter is delivered. Suggested alternatives were:

(1) hand delivery of the letter by sales representatives;

(2) posting the pertinent information on a company Web site; or

(3) sending the letter by less expensive means (e.g., by regular mail or email) than required by the CIA. 

Payment-posting requirements:  Certain CIAs require companies to track and post on company Web sites information about payments made by the companies to HCPs.  Participants expressed concern about the differences between, and possible inconsistencies in, the CIA requirements and those in the ACA—the Sunshine Act. Some participants requested that OIG permit companies to satisfy CIA requirements by certifying that they complied with the ACA provisions.  Others requested that OIG suspend or alter the transparency requirements in CIAs after the ACA transparency regulations are finalized. 

Topic 2: Compliance Program Structure and Oversight 

These sessions focused on two main topics:

(1) boards of directors’ oversight of, and participation in, compliance-related activities;

(2) integration of compliance activities into business functions beyond the compliance department.  Participants uniformly agreed that it is critical for boards of directors to be involved in compliance oversight and that the integration of compliance efforts into business activities materially enhances compliance effectiveness.  

Board resolutions and certifications: Some CIAs require that board members annually pass and sign a resolution confirming, if they can, that the company has implemented an effective compliance program.  Participants reported that these requirements lead board members to better understand compliance issues and ask more questions about compliance (and their own potential liability). 

Some participants opined that the CIAs did not adequately account for differences in the organizational and oversight structures of companies.  These differences may arise, in part, because of the national or international nature of the company (including whether there are national and/or international boards) and whether the company is publicly traded or privately held.  Participants recommended that OIG take into account these differences and consider: (1) more flexible approaches to board training requirements and (2) flexibility in IRO and compliance expert review requirements. 

Examples of compliance/business integration:  

(1) appointing deputy compliance officers within individual business units;

(2) requiring business unit managers to incorporate compliance considerations in business decisionmaking;

(3) increasing individual accountability by requiring compliance-related certifications from senior management in key business units;

(4) imbedding compliance representatives (sometimes called liaisons, ambassadors, or champions) in individual business units;

(5) including compliance-related requirements as an element in performance plans of all employees;

(6) staffing compliance committees with individuals from varied business units and disciplines; and

(7) fostering lines of communication between headquarters compliance staff and business unit personnel, including through monitoring of field activities by headquarters staff. 

Topic 3: Risk Identification and Monitoring Activities  

These sessions focused on risk-assessment processes and methods by which companies conduct internal monitoring.  Many CIAs require companies to monitor specified types of activities during each year of the CIA (through internal programs and/or IROs).  Participants commented on various types of monitoring activities and recommended that CIAs allow for increased flexibility for required monitoring activities. 

Participants reported that compliance training for management and field representatives is essential to an effective risk-identification program because it enables individuals “in the business” to better identify compliance risks and take appropriate mitigation steps. In addition, participants reported that if compliance personnel have "a seat at the table" when sales and marketing activities are planned or discussed, they can help ensure that risks are preemptively identified and addressed.

Many CIAs require companies to annually monitor a specified set of activities.  Required monitoring activities include reviews of: (1) sales representative call notes; (2) the activities of the medical information department (including responses to inquiries about off-label uses of drugs); and/or (3) speaker program activities.  Several CIAs also require that compliance personnel "ride along" with field representatives on sales calls to HCPs. 

Flexibility in monitoring:  As a general comment, many participants requested that OIG permit greater flexibility under CIAs to monitor new or different activities in later years of a CIA.  Participants asserted that the monitoring obligations of CIAs can be focused on past conduct and that by the time a CIA is implemented, the company has likely identified new risk areas (e.g., as a result of risk-assessment or auditing practices) to which oversight resources would be better deployed.  Some participants also suggested that companies be relieved of certain obligations in the later years of the CIA if they are able to demonstrate compliance with CIA requirements and positive results through auditing and monitoring. 

Identity of monitors:  Participants requested that CIAs permit more extensive use of outside consultants or company employees from outside the compliance department in conducting auditing and monitoring activities. This would allow companies to deploy their limited compliance resources for collaborative and educational purposes. 

Speaker programs: CIAs require compliance or other personnel to attend speaker programs in order to conduct “live” monitoring of the programs.  Some participants recommended that the CIAs permit the monitoring of speaker programs or other events via teleconference or videoconference.  This would reduce costs associated with deploying headquarters-based compliance personnel to attend programs throughout the country. 

Ride-along activities:  Many participants reported that such ride-alongs do not generally lead to the identification of specific noncompliant conduct by sales representatives.  However, participants widely agreed that these activities are beneficial because they establish a line of communication between field and compliance personnel and enable the development of relationships between the two groups.


Topic 4: Policies, Procedures, and Training Activities  

Participants offered insights about the development and dissemination of policies and procedures and training activities at their companies. 

Development and revision of policies and procedures: Participants uniformly recommended that to generate the most effective policies and procedures, business unit personnel and other affected stakeholders participate in the development and revision process. 

Accessibility and format:  Participants agreed widely that policies must be accessible to employees and be provided in a useful format.  Participants also emphasized the need to make compliance information available in different formats and to permit questions to be asked through various mechanisms.  In addition to reporting a compliance department Intranet site and a hotline, some participants reported that their companies established electronic search capabilities that enable employees to search for particular topics within compliance-related documents. 

Training of contractors:  Participants reported that they spend a significant amount of time determining which contractors must receive training under the CIAs.  Participants suggested that OIG and/or companies under CIAs create baseline training for Relevant Covered Person contractors and permit the completion of the baseline training to satisfy CIA training requirements for all companies.  Another variation on the theme was a suggestion that CIAs permit contractors to use certificate-based training.


Topic 5:  Compliance Post C.I.A. 

In these sessions, participants were asked to identify which CIA-required compliance measures they would recommend their companies continue after the conclusion of the CIAs.  Participants were also asked to predict the biggest compliance risks likely to face their companies and the industry in the next 5 years.  Most participants expect that their companies will continue a number of compliance activities following the conclusion of the CIA. 

Certifications and board involvement: Participants expressed wide agreement that management certifications are valuable and would likely be continued.  Participants also predicted that boards would continue to be substantively involved in post-CIA compliance programs and that such involvement would be vital. 

Training and disclosure programs: Participants indicated that their companies would continue training efforts but would make the training more flexible and tailor it to their companies’ current risks and values.  Participants expect that post-CIA training will emphasize quality of training over the number of hours of training.  In addition, participants recommended that disclosure programs be continued because they permit employees to raise compliance issues and underscore that every employee has a role in ensuring compliance. 

Field monitoring: Participants expect their companies to continue to monitor field-based activities after their CIAs ended, including ride-alongs.  However, participants also suggested that the monitoring likely would become more flexible to focus on current risk areas (which change over time).  However, participants also expect their companies to conduct fewer such activities and use other means to monitor the field sales force. 

Changing regulatory and other requirements: Across the board, participants identified their biggest compliance challenge as staying abreast of changing requirements and regulatory complexities, especially in the area of transparency.  Many participants cited as an example the requirements relating to the ACA sunshine provisions and the analogous (but different) State reporting requirements.  Other participants identified compliance with expanding global requirements (including those in the area of transparency) as a challenge.  Finally, participants noted that their companies also face challenges associated with new Government requirements, including those relating to accountable care organizations. 

Social media and technology: Participants also identified growing future challenges associated with information about products found on the Internet, including on social media Web sites.  This would include information posted by manufacturers as well as other information found on the Internet.


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