Today’s Top Story
OIG issues policy reminder regarding information blocking and anti-kickback statute.
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a policy reminder regarding information blocking and the federal anti-kickback statute. The anti-kickback statute prohibits individuals and entities from offering, paying, soliciting, or receiving remuneration to induce or reward referrals of business reimbursable under any federal healthcare program. A limited “safe harbor” exists through which providers may donate information technology or software to potential referral sources. However, the safe harbor condition requires that “[t]he donor (or any person on the donor’s behalf) does not take any action to limit or restrict the use, compatibility, or interoperability of the items or services with other electronic prescribing or electronic health records systems.” An article in Modern Healthcare notes that some observers have suggested that the OIG alert hints at a growing concern about the issue. Read more…(registration may be required)
Read the OIG statement (PDF)…
Other News
CMS announces proposed final rules for EHRs.
The U.S. Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) have released final rules regarding electronic health records (EHRs). The final rule for 2015 Edition Health IT Certification Criteria focuses on increasing interoperability and improving transparency and competition in health information technology, while the final rule with comment period for Stage 3 of the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Programs is designed to help move the healthcare industry away from paper-based record systems. CMS at the same time released a rule that finalizes modifications to Stages 1 and 2. However, HealthLeaders Media reports that more than 100 members of Congress and various healthcare stakeholders, including the AAOS, have requested Stage 3 rules be postponed, noting that many healthcare providers have yet to successfully achieve Stage 2 requirements. CMS has announced a 60-day public comment period to gather additional feedback about the EHR incentive programs. Read more…
Read the statement from HHS…
The American Association of Orthopaedic Surgeons (AAOS) has released a statement regarding the EHR rules. “We are disappointed that CMS did not listen to stakeholders and members of Congress who urged them to delay rulemaking for Stage 3 so that it would better align with the MIPS program and allow adequate time to prepare,” states Thomas C. Barber, MD, chair of the AAOS Council on Advocacy. “We certainly appreciate the recognition of concerns and added flexibility in the program, but rather than push forward with the next stage of meaningful use, CMS should first focus their attention on ensuring that providers can easily and efficiently share health information to support care delivery and new models of care. We will continue to advocate for meaningful use requirements that better align with upcoming programs, increase specialty specific quality measures, encourage interoperability, and expand hardship exemptions.” Read more…
Senate proposal would expand Open Payments database to include additional healthcare providers.
ProPublica reports on a bipartisan bill under consideration in the U.S. Senate that would require pharmaceutical and medical device manufacturers to publicly disclose payments to healthcare providers not currently covered under the Physician Payment Sunshine Act. The legislation is designed to expand the Open Payments system, which requires companies to report such payments to physicians, dentists, chiropractors, optometrists, and podiatrists. If enacted, the bill would take effect in 2017, and expand disclosure requirements to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. Read more…
Read a summary of the bill (when available)…
Study: Anti-osteoporotic therapy may help reduce risk of subsequent fracture after fragility fracture.
Data from a study published in the Oct. 7 issue of The Journal of Bone & Joint Surgery suggest that treatment with anti-osteoporotic therapy after a fragility fracture may reduce risk of subsequent fracture. The authors reviewed data on 31,069 patients aged 50 years or older who had sustained a fragility fracture (defined as any fracture of the wrist, proximal part of the humerus, hip, or vertebra) and who had 3 years of continuous follow-up. Overall, 10.6 percent of patients were treated with anti-osteoporotic therapy following the index fracture. Compared with the no-treatment cohort, the therapy cohort was older and had a greater proportion of female patients. At 3-year follow-up, the authors found that subsequent fracture rates were 7.5 percent in the therapy group and 9.7 percent in the no-treatment group. After adjustment for age and sex, they found that the anti-osteoporotic therapy group experienced a reduction in risk of 50 percent after an index wrist fracture, 52 percent after an index proximal humeral fracture, 34 percent after an index hip fracture, 43 percent after an index vertebral fracture, and 40 percent after all fractures combined. Read more…
Read the abstract…
Study: Use of decision instruments may reduce need for CT among patient with blunt trauma.
According to a study published online in the journal PLOS Medicine, use of a decision instrument (DI) for trauma evaluation may reduce a need for computed tomography (CT) scans of the chest for certain blunt trauma patients. The research team conducted a prospective, observational study of 11,477 patients older than 14 years who presented at one of eight Level 1 trauma centers in the United States. The derived Chest CT-All DI consisted of: abnormal chest radiograph, rapid deceleration mechanism, distracting injury, chest wall tenderness, sternal tenderness, thoracic spine tenderness, and scapular tenderness. The Chest CT-Major DI contained the same criteria without the rapid deceleration mechanism. In a validation phase of 5,475 patients, the Chest CT-All DI had a sensitivity of 99.2 percent, specificity of 20.8 percent, and negative predictive value (NPV) of 99.8 percent for major injury, and a sensitivity of 95.4 percent, specificity of 25.5 percent, and NPV of 93.9 percent for either major or minor injury. The Chest CT-Major DI had a sensitivity of 99.2 percent, specificity of 31.7 percent, and NPV of 99.9 percent for major injury and a sensitivity of 90.7 percent, specificity of 37.9 percent, and NPV of 91.8 percent for either major or minor injury. Read more…
Read the complete study…
FDA decision on oxycodone for pediatric patients stirs controversy.
An article in The New York Times looks at the recent move by the U.S. Food and Drug Administration (FDA) to approve oxycodone for use in certain pediatric patients. Under new labeling, the drug should be used only for children 11 years or older who are in severe pain and who have already been on an opioid for at least 5 days. Critics of the move argue that the FDA decision may lead to increased prescribing of oxycodone among younger patients, and note that the approval was made without input from an advisory panel. Supporters respond that the move will offer providers more information on appropriate prescribing of the drug, which has already been used off-label for pediatric patients experiencing extreme pain from cancer and spinal fusion surgery. Read more…
Read the FDA approval letter (PDF)…
Guidelines network issues list of principles for managing COIs in development of CPGs.
The Guidelines International Network—an association of organizations and individuals involved in the systematic development and application of clinical practice guidelines—has issued a series of principles for disclosing interests and managing conflicts of interest (COI) during the development of clinical practice guidelines (CPGs). The nine principles address financial, intellectual, and personal conflicts of interest, and include:
- Guideline developers should make all possible efforts to not include members with direct financial or relevant indirect COIs.
- The definition of COI should apply to all stakeholders, and be determined before a panel is constituted.
- A guideline development group should disclose interests publicly.
- Chairs of guideline development groups should have no direct financial or relevant indirect COIs, and if a COI is unavoidable, a co-chair with no COIs should be appointed to lead the guidelines panel.
- No member of the guideline development group deciding about the direction or strength of a recommendation should have a direct financial COI.
The complete principles are available in the Oct. 6 issue of the journal Annals of Internal Medicine. Read more…
Read the complete principles…
AAOS releases information statement on use of opioids.
AAOS has released an information statement on opioid use, misuse, and abuse in orthopaedic practice. The statement notes that more than 50 million people in the United States are estimated to have been prescribed an opioid during 2011—a nearly 100 percent increase in narcotic pain medication prescriptions since 2008. “Orthopaedic surgeons and their team members can more effectively depersonalize discussions about opioids by using standardized opioid protocols in all settings (inpatient, outpatient, office) to control opioid use,” the statement reads. “Orthopaedic practices should establish protocols/policies to better control and limit opioid prescription dosages as well as appropriate/inappropriate opioid uses for acute musculoskeletal injuries, postsurgical pain, and chronic pain.” The statement outlines a series of protocols and policies, including but not limited to:
- Each practice should set ranges for acceptable amounts and durations of opioids for various musculoskeletal conditions treated.
- A prescription should only include the amount of pain medication that is expected to be used/appropriate, based on the protocol established.
- Patients at risk for greater opioid use should be identified.
- Surgeons should script and practice empathetic and effective communication strategies, appropriate for all levels of health literacy.
