FDA withdraws original OxyContin; issues compounding pharmacies alerts
The U.S. Food and Drug Administration (FDA) has approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route. The FDA has also determined that the benefits of original OxyContin no longer outweigh its risks, has withdrawn it from sale, and will not accept or approve any abbreviated new drug applications (generics) that rely upon the original OxyContin.

The FDA also alerted members of the healthcare community that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients, and any on hand should be quarantined.

CMS, HHS propose extension of “safe harbor” provisions
The U.S. Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) Office of Inspector General have issued a pair of complementary proposed rules to extend waivers that relaxed federal Stark and anti-kickback laws to promote the use of electronic medical record (EMR) systems. The provisions had been set to expire on Dec. 31, 2013, and the proposed rules would extend them until Dec. 31, 2016. If adopted in their current form, the new rules would also drop an e-prescribing requirement in the original rules and amend language on what types of EMRs qualify for the waivers.

ICD-10 transition progress slow
According to the HHS advisory organization Workgroup for Electronic Data Interchange (WEDI), the healthcare industry is behind schedule in its implementation of the ICD-10 coding system, which goes into effect on Oct. 1, 2014. Results of a survey on ICD-10 readiness found that little progress had been made over the past year. WEDI notes that the industry is well behind suggested milestones and proposes that contributing factors include a delay in compliance dates, competing internal priorities, and other regulatory mandates.

Information presented at the annual meeting of the American College of Physicians indicates that nearly 65 percent of clinical documentation doesn’t contain enough information for coders to use for billing under ICD-10. The switch to ICD-10 will greatly increase the specificity of diagnostic codes, and most physicians don’t provide enough detail for office coders to translate their notes to ICD-10. In addition, many payers have announced that they will not reimburse for unspecified codes.

HHS updates Medicare self-disclosure protocol
HHS has issued an updated self-disclosure protocol that describes exactly what a physician, hospital, or supplier must report to the government to avoid prosecution and receive a break on potential penalties. The three types of fraud most commonly disclosed by hospitals are submission of false or inflated Medicare bills, employment of people whom the HHS Office of Inspector General has excluded from Medicare, and payments to physicians to induce referrals of patients for treatment. HHS can assess penalties of up to three times the loss amount as defined by the government, plus per-violation penalties. As an incentive for turning itself in, a business can limit potential punishments, potentially to only one-and-a-half times the loss amount.

Medicare performance measures and registry data
According to HealthLeaders Media, CMS is considering how outcomes data submitted to specialty society registries could be folded into Medicare performance measures that assess quality of care. Voluntary reporting registries, which include the American Joint Replacement Registry, amass and risk-adjust, sometimes audit, and usually report back results to participating providers so they can benchmark their own performance. CMS collected 108 responses to a “request for information” about such registries, and whether the agency should “qualify” them to satisfy federal requirements under the Physician Quality Reporting System or the Electronic Health Record (EHR) Incentive Program.

EHR incentive payment program audits
Modern Healthcare reports that CMS plans to audit about 5 percent of participants in the federally funded electronic health record (EHR) incentive payment program. In January, CMS added payment applicants to an audit target list that previously included only providers who had already received payment. One of the most common problem areas is noncompliance with the requirement for a data security risk assessment.

FTC and scope of practice issues
An article in American Medical News addresses efforts by the U.S. Federal Trade Commission (FTC) to influence state-level legislation regarding the clinical roles of non physicians. A spokesperson for the American Medical Association states that a letter submitted by the FTC to Connecticut lawmakers in favor of a proposal that would eliminate collaborative practice agreements between physicians and advanced-practice registered nurses is an example of a more aggressive approach being taken by the agency on scope-of-practice issues. Since 2011, the FTC has weighed in on proposed clinical practice changes in at least seven states.

THA, TKA to be added to readmission measures?
Under a proposed rule updating FY 2014 Medicare payment policies and rates for inpatient stays at general acute care and long-term care hospitals, patients admitted for elective total hip or total knee arthroplasty (THA/TKA) would be added to the conditions and procedures calculated for 30-day readmission penalties. The rule also lays out a framework for a new patient safety program to be launched in FY 2015, aimed at reducing the frequency of hospital-acquired conditions and proposes to clarify admission and medical review criteria for hospital inpatient services.

No IPAB next year
The Washington Post reports that the Independent Payment Advisory Board (IPAB), which is called for under PPACA, will not be triggered for at least one more year. IPAB is designed to take effect only when Medicare per-enrollee spending grows faster than the average of medical price growth and overall price growth under the Consumer Price Index. PPACA required Medicare’s chief actuary to determine whether spending growth had hit the trigger point by April 30, and the trigger was not reached.

Support growing for 5-year transition to SGR replacement
According to Modern Healthcare, support may be gathering in Congress for a 5-year transition to a new Medicare physician payment system that would replace the Sustainable Growth Rate (SGR) formula. The Republican chair of the House Ways and Means Health Subcommittee says that legislators are focused on finding ways to fund the $138 billion, 10-year estimated cost of repealing the SGR, and one Democratic representative says she is prepared to get started “right now” on a move to a new payment system.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)