Posted on August 31, 2011 by Debra A. McCurdy

HHS Issues Final Financial Conflict-of-Interest Rules for Researchers

On August 25, 2011, HHS published a final rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. The final rule revises 1995 standards on this subject in order to “update enhance the objectivity and integrity of the research process” and provide “a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest.“ Among other thing, the rule revises: the definition of significant financial interest (SFI); modifies the extent of investigator disclosure (including lowering the monetary threshold at which SFI requires disclosure, generally from $10,000 to $5,000, and requiring investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities); changes the information reported to the PHS awarding component and made accessible to the public; and updates investigator training requirements. An institution applying for or receiving PHS funding covered by the rule must be in full compliance with the regulatory requirements no later than August 24, 2012; and immediately upon making its Institutional Financial Conflict of Interest policy publicly accessible, as described in the rule.  Additional information about the rule is available at the National Institutes of Health website.

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Posted on May 31, 2011 by Debra A. McCurdy

FDA Publishes Draft Guidance on Financial Disclosures by Clinical Investigators

FDA has released for public comment a draft guidance document entitled “Financial Disclosures by Clinical Investigators.”   The guidance, which will supersede March 2001 guidance on this issue, seeks to respond to a January 2009 HHS Office of the Inspector General (OIG) report that concluded that clinical investigators may not be disclosing all financial interests (). It also addresses questions FDA has received from industry and the public. The draft guidance describes: (1) the sponsor’s responsibility to collect the financial disclosure information prior to an investigator participating in a study and ensure that all required forms and attachments are submitted in marketing applications; (2) what is meant by ‘‘due diligence’’ in obtaining financial disclosures from investigators; and (3) how FDA will review financial disclosure information. The guidance also solicits comment on the circumstances under which FDA should consider public release of financial disclosure information related to an approved marketing application. FDA is accepting comments on the draft guidance until July 25, 2011.

 

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Posted on January 13, 2011 by Debra A. McCurdy

OIG Reports on Institutional Conflicts of Interest at NIH Grantees

The OIG has issued a report entitled "Institutional Conflicts of Interest at NIH Grantees." While noting that some National Institutes of Health (NIH) grantee institutions have voluntarily adopted institutional conflicts of interest policies, the OIG recommends that NIH promulgate rules to mandate that grantee institutions to identify, report, and address institutional financial conflicts in a consistent and uniform manner. Although the NIH is currently reviewing public comments on a proposed rule pertaining to researchers' conflicts, the OIG notes that that the proposal would not address institutional conflicts. 

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Posted on May 27, 2010 by Debra A. McCurdy

HHS Proposes Regulations on Financial Conflicts of Interest in Research

On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests. HHS is proposing these changes in light of the increasingly complex interactions among the government, research institutions, and private sector entities involved with biomedical and behavioral research. HHS will accept comments on the proposed rule until July 20, 2010.

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Posted on March 15, 2010 by Debra A. McCurdy

Unimplemented OIG Recommendations

On March 11, 2010, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its “2010 Compendium of Unimplemented Office of Inspector General Recommendations,” which outlines previous OIG recommendations designed to achieve savings and increase the effectiveness of HHS programs. The OIG highlights priority recommendations in a number of areas, including (among others): hospital bad debt payments; processing of remedies associated with noncompliant nursing homes; hospice claims for nursing facility beneficiaries; medical equipment supplier compliance with Medicare enrollment standards; Medicare payments for oxygen and inhalation drugs; Medicare payments to Medicare Advantage (MA) organizations; Medicare Part D drug plan payments and program integrity safeguards; Medicaid prescription drug reimbursement and rebate calculations; and oversight of clinical investigator and NIH grantee conflicts of interest. 

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Posted on February 11, 2010 by Debra A. McCurdy

CMS Manual Transmittal on Authorized Compendia for Off-Label Uses of Cancer Drugs

On January 30, CMS issued a Medicare Benefit Policy Manual transmittal entitled "Revision of Definition of Compendia as Authoritative Source for Use in the Determination of a Medically-Accepted Indication of Drugs/Biologicals Used Off-label in Anti-Cancer Chemotherapeutic Regimens." The transmittal makes changes to conform to the MIPPA compendia requirement that provides that effective January 1, 2010, no compendia may be included on the list of authorized compendia unless it has a publicly-transparent process for evaluating therapies and for identifying potential conflicts of interests.

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Posted on December 4, 2009 by Debra A. McCurdy

NIH Grantees' Financial Conflicts of Interest Policies

The OIG has issued a report entitled “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health.” The OIG identified a number of vulnerabilities in National Institutes of Health (NIH) grantee institutions' identification, management, and oversight of financial conflicts of interest. For example, 90% of grantee institutions rely solely on researchers' discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported. The OIG also found that nearly half of grantee institutions do not require researchers to disclose specific amounts of equity or compensation, and researcher-submitted financial interest information is not routinely verified. The OIG also found problems with documentation supporting grantee institutions’ oversight of financial conflicts of interest; failure of the majority of grantee institutions to have policies and procedures that address subgrantee compliance with financial conflicts of interest regulations; inconsistent reporting of conflicts; and the lack of a requirement that grantee institutions report to NIH any financial interests that they have with outside companies. According to the OIG, the most common type of financial conflict of interest among researchers is equity ownership in companies in which the financial interests could significantly affect the research. Other financial conflicts of interest among researchers involved inventing technology, consulting, or holding positions with outside companies. The OIG recommended a series of steps address such financial conflicts of interest, including strengthened grantee institution reporting and oversight requirements, the development of NIH guidance on methods to verify researchers' financial interests, and expanded NIH oversight and regulations addressing financial conflicts of interest.

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Posted on June 8, 2009 by Debra A. McCurdy

Compendia Conflicts of Interest

CMS has posted a white paper on "Potential Conflict of Interest in the Production of Drug Compendia" produced by the Duke Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). The report addresses, among other things: where in the compendia processes conflict of interest may arise; an "ethical framework" for evaluating potential conflicts; a review of the conflict of interest policies of the four compendia used in Medicare coverage determinations; and a discussion of the adequacy of current compendia approaches and ways to minimize conflicts of interest.

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Posted on May 8, 2009 by Debra A. McCurdy

Objectivity in Research PHS-Funded Research

On May 8, 2009, HHS published an advance notice of proposed rulemaking seeking comments on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which Public Health Service (PHS) funding is sought. Specifically, HHS is considering whether to revise current regulations to provide a more rigorous approach to investigator disclosure, management of conflicts, and federal oversight. The notice invites comments on a range of related issues, including: the scope of the regulation and disclosure of interests; the definition of a “significant financial interest”; identification and management of conflicts; how to assure institutional compliance; reporting on conflicts of interest; and standards regarding institutional conflict of interest. Comments will be accepted until July 7, 2009.

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Posted on May 7, 2009 by Debra A. McCurdy

IOM Report on Conflicts of Interest in Medicine

On April 28, 2009, the Institute of Medicine (IOM) issued a report endorsing new voluntary and regulatory measures to strengthen protections against financial conflicts of interest in medicine. The report addresses conflicts of interest in a number of settings, including biomedical research, clinical care, physician training, and continuing medical education. Among other things, the IOM recommends improving disclosure of financial ties between the medical community and the pharmaceutical, biotechnology, and medical device industry; limiting company payments and gifts; stemming industry influence in medical education and the development of practice guidelines; and adopting safeguards pertaining to consulting arrangements.  

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Posted on February 27, 2009 by Debra A. McCurdy

MedPAC Report to Congress -- Medicare Payment/Transparency Provisions

On February 27, 2009, MedPAC released its March 2009 Report to the Congress: Medicare Payment Policy. The report includes a series of recommendations for Medicare payments designed to assure beneficiaries’ access to care and preserve Medicare’s long-term sustainability, particularly through reductions in payment updates for 2010. The report also includes recommendations to increase transparency of physician financial relationships. A listing of key recommendations follows after the jump. 

Hospitals

  • The Congress should increase payment rates for the acute inpatient and outpatient prospective payment systems in 2010 by the projected rate of increase in the hospital market basket index, concurrent with implementation of a quality incentive payment program.
  • The Congress should reduce the indirect medical education adjustment (IME) in 2010 by 1 percentage point to 4.5 percent per 10 percent increment in the resident-to-bed ratio. The funds obtained by reducing the IME adjustment should be used to fund a quality incentive payment program.

Physicians and Ambulatory Surgical Centers

  • The Congress should update payments for physician services in 2010 by 1.1 percent.
  • The Congress should establish a budget-neutral payment adjustment for primary care services billed under the physician fee schedule and furnished by primary-care-focused practitioners. Primary-care-focused practitioners are those whose specialty designation is defined as primary care and/or those whose pattern of claims meets a minimum threshold of furnishing primary care services. The Secretary would use rulemaking to establish criteria for determining a primary-care-focused practitioner.
  • The Congress should direct the Secretary to increase the equipment use standard for expensive imaging machines from 25 to 45 hours per week. This change should redistribute RVUs from expensive imaging to other physician services.
  • The Congress should increase payments for ambulatory surgical centers (ASC) services in calendar year 2010 by 0.6 percent. In addition, the Congress should require ASCs to submit to the Secretary cost data and quality data that will allow for an effective evaluation of the adequacy of ASC payment rates.

Dialysis Services

  • The Congress should maintain current law and update the composite rate in calendar year 2010 by 1 percent.

Skilled Nursing Facility Services

  • The Congress should eliminate the update to payment rates for skilled nursing facility services for fiscal year 2010.
  • The Congress should require the Secretary to revise the skilled nursing facility (SNF) prospective payment system by: adding a separate nontherapy ancillary (NTA) component, replacing the therapy component with one that establishes payments based on predicted patient care needs, and adopting an outlier policy.
  • The Secretary should direct SNFs to report more accurate diagnostic and service-use information by requiring that: claims include detailed diagnosis information and dates of service, services furnished since admission to the SNF be recorded separately in the patient assessment, and SNFs report their nursing costs in the Medicare cost report.
  • The Congress should establish a quality incentive payment policy for SNFs in Medicare and to improve quality measurement for SNFs, the Secretary should: add the risk-adjusted rates of potentially avoidable rehospitalizations and community discharge to its publicly reported post-acute care quality measures; revise the pain, pressure ulcer, and delirium measures currently reported on CMS’s Nursing Home Compare website; and require SNFs to conduct patient assessments at admission and discharge.

Home Health Services

  • The Congress should eliminate the market basket increase for 2010 and advance the planned reductions for coding adjustments in 2011 to 2010, so that payments in 2010 are reduced by 5.5 percent from 2009 levels.
  • The Congress should direct the Secretary to re-base rates for home health care services in 2011 to reflect the average cost of providing care.
  • The Congress should direct the Secretary to assess payment measures that protect the quality of care and ensure incentives for the efficient delivery of home health care. The study should include alternative payment strategies such as blended payments and risk corridors and outcome-based quality incentives.

Inpatient Rehabilitation Facilities

  • The update to the payment rates for inpatient rehabilitation services should be eliminated for fiscal year 2010.

Long-Term Care Hospitals

  • The Secretary should update payment rates for long-term care hospitals for fiscal year 2010 by the projected rate of increase in the rehabilitation, psychiatric and long-term care hospital (RPL) market basket index less the Commission’s adjustment for productivity growth.

Recommendations on Medicare Advantage Payments

  • The Congress should: Eliminate the stabilization fund for regional PPOs. Remove the effect of payments for indirect medical education from the MA plan benchmarks. Set the benchmarks that CMS uses to evaluate MA plan bids at 100 percent of FFS costs. Pay-for-performance should apply in MA to reward plans that provide higher quality care. Clarify that regional plans should submit bids that are standardized for the region’s MA-eligible population.
  • The Secretary should calculate clinical measures for the FFS program that would permit CMS to compare the FFS program with MA plans.

Recommendations on Public Reporting of Physician Financial Relationships

  • The Congress should require all manufacturers and distributors of drugs, biologicals, medical devices, and medical supplies (and their subsidiaries) to report to the Secretary their financial relationships with: physicians, physician groups, and other prescribers; pharmacies and pharmacists; health plans, pharmacy benefit managers, and their employees; hospitals and medical schools; organizations that sponsor continuing medical education; patient organizations; and professional organizations.
  • The Congress should direct the Secretary to post the information submitted by manufacturers on a public website in a format that is searchable by: manufacturer; recipient’s name, location, and specialty (if applicable); type of payment; name of the related drug or device (if applicable); and year.
  • The Congress should require manufacturers and distributors of drugs to report to the Secretary the following information about drug samples: each recipient’s name and business address; the name, dosage, and number of units of each sample; and the date of distribution. The Secretary should make this information available through data use agreements.
  • The Congress should require all hospitals and other entities that bill Medicare for services to annually report the ownership share of each physician who directly or indirectly owns an interest in the entity (excluding publicly traded corporations). The Secretary should post this information on a searchable public website.
  • The Congress should require the Secretary to submit a report, based on the Disclosure of Financial Relationships Report, of the types and prevalence of financial arrangements between hospitals and physicians.

Recommendations on Reforming the Hospice Benefit

  • The Congress should direct the Secretary to change the Medicare payment system for hospice to: have relatively higher payments per day at the beginning of the episode and relatively lower payments per day as the length of the episode increases; include a relatively higher payment for the costs associated with patient death at the end of the episode; and implement the payment system changes in 2013, with a brief transitional period. These payment system changes should be implemented in a budget neutral manner in the first year.
  • The Congress should direct the Secretary to: require that a hospice physician or advanced practice nurse visit the patient to determine continued eligibility prior to the 180th-day recertification and each subsequent recertification and attest that such visits took place, require that certifications and recertifications include a brief narrative describing the clinical basis for the patient’s prognosis, and require that all stays in excess of 180 days be medically reviewed for hospices for which stays exceeding 180 days make up 40 percent or more of their total cases.
  • The Secretary should direct the Office of Inspector General to investigate: the prevalence of financial relationships between hospices and long-term care facilities such as nursing facilities and assisted living facilities that may represent a conflict of interest and influence admissions to hospice, differences in patterns of nursing home referrals to hospice, the appropriateness of enrollment practices for hospices with unusual utilization patterns (e.g., high frequency of very long stays, very short stays, or enrollment of patients discharged from other hospices), and the appropriateness of hospice marketing materials and other admissions practices and potential correlations between length of stay and deficiencies in marketing or admissions practices.
  • The Secretary should collect additional data on hospice care and improve the quality of all data collected to facilitate the management of the hospice benefit. Additional data could be collected from claims as a condition of payment and from hospice cost reports.
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Posted on January 27, 2009 by Debra A. McCurdy

Clinical Investigator Financial Disclosure

The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests. The OIG found that only 1% of clinical investigators disclosed a financial interest, and the FDA cannot determine whether sponsors have submitted financial interest information for all clinical investigators. Further, FDA's oversight of such information is lacking, since: almost half of marketing applications were missing financial interest information; FDA reviewers did not document a review of financial interest information in almost one-third of marketing applications; and neither FDA nor sponsors took action to minimize potential bias in 22% of marketing applications with a disclosed financial interest. The OIG recommends that FDA ensure that sponsors submit complete financial information for all clinical investigators; use a review template and provide reviewer training; and require sponsors to submit financial information as part of the pretrial application process. While the FDA generally agreed with the recommendations, it did not agree to require sponsors to submit the financial information during the pretrial application process.

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Posted on October 16, 2008 by Debra A. McCurdy

GAO Report on FDA Advisory Committees

The Government Accountability Office (GAO) has issued a report examining the FDA’s advisory committee processes. Specifically, the GAO examined: (1) how FDA recruited individuals for membership and evaluated candidates for potential conflicts of interest, (2) barriers that were reported to recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, and the frequency with which members with conflict of interest determinations participated in meetings. 

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Posted on August 14, 2008 by Debra A. McCurdy

FDA Advisory Committee Guidance

On August 4, 2008, the Food and Drug Administration (FDA) released a series of final guidance documents designed strengthen its management of FDA advisory committees. Among other things, the new policies include stricter limits on financial conflicts of interest for committee members (including a $50,000 cap on the personal financial interest an advisor may have in all companies potentially affected by a meeting), revised voting procedures, strengthened processes for disclosing information regarding advisory committee members’ financial interest information; and procedures for developing and distributing briefing materials considered at advisory committee meetings. The FDA also released draft guidance regarding factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration.  Notices regarding the guidance documents also were published in the Federal Register.

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Posted on February 28, 2008 by Debra A. McCurdy

FDA Draft Guidance on Distributing Off-label Use Journal Articles

On February 20, the Food & Drug Administration (FDA) proposed guidelines for manufacturers of drugs and devices who would like to distribute scientific and medical articles that discuss off-label uses of approved products. The draft guidance is entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." The document proposes that distribution be limited to peer-reviewed scientific or medical articles that are published by an with an editorial board that has a policy of disclosure of conflicts of interest. The publication should not be written for, edited by, or funded by the manufacturer, and it cannot be false or misleading or pose a significant risk to public health. Letters to the editor, abstracts of a publication, reports of Phase 1 trials in healthy subjects, or reference publications that contain insufficient substantive discussion of the data would not be acceptable. The draft guidance also proposes guidelines on the manner in which companies should distribute scientific and medical information. For instance, a company should not abridge, highlight, or summarize the article. In addition, FDA would expect that the article be accompanied by numerous disclosures and addendums, including: the approved labeling of the drug or medical device; a comprehensive bibliography of related information; a disclosure about the unapproved use being discussed, a disclosure of the manufacturer's interest in the product, a disclosure of any financial interest held by the author, and, a representative publication of any articles that call into question the conclusions of the article being disseminated. The journal article should also be distributed separately from promotional materials. Comments on the guidance are due April 21, 2008. The draft guidance document is posted here; details regarding comment submission are available here. Reed Smith has prepared a bulletin analyzing the draft; the bulletin is available here. 

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