A&B Healthcare Week in Review, May 8, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On May 6, 2015, the Food and Drug Administration (FDA) announced the availability of the draft guidance entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.’’ This draft guidance is being issued to explain the circumstances in which it may be appropriate to leverage existing clinical data to support pediatric device indications in premarket approval applications (PMAs) and humanitarian device exemptions (HDEs). The draft guidance also describes the approach that FDA would use to determine whether extrapolation is appropriate in medical devices, and the factors that would be considered within a statistical model for extrapolation. Extrapolation may be appropriate when the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients and the adult data are of high quality for borrowing. This draft guidance is not final nor is it in effect at this time. Comments should be submitted by August 4, 2015. More information may be found here.
• On May 6, 2015, FDA announced the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.’’ The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act to require that certain submissions under the FD&C Act and Public Health Service Act be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance outlines Electronic Common Technical Document (eCTD) specification requirements for submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs).
• On May 6, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.’’ This guidance provides recommendations for sponsors of investigational new drug applications (INDs), and applicants that submit new drug applications, abbreviated new drug applications (ANDAs), and supplements to these applications for immediate release (IR) solid oral dosage forms, and who wish to request a waiver of in vivo bioavailability (BA) and/or bioequivalence (BE) studies.
• On May 6, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Clozapine,’’ for the orally disintegrating tablets (ODTs). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for clozapine ODTs. Comments should be submitted by July 6, 2015. More information may be found here.
• The Health Resources and Services Administration (HRSA) announced this week that the agency is requesting nominations to fill at least 16 vacancies on the National Advisory Council on Nurse Education and Practice (NACNEP). The Agency must receive nominations on or before July 15, 2015. The NACNEP provides advice and recommendations to the Secretary of the Department of Health and Human Services (HHS) and Congress in preparation of general regulations and concerning policy matters arising in the administration of Title VIII, including the range of issues related to nurse workforce education and practice improvement. More information may be found here.
• On May 4, 2015, the Internal Revenue Service (IRS) released correcting amendments to final regulations (TD 9708) that were published in the Federal Register on December 31, 2014 (79 FR 78954). The final regulations provide guidance regarding the requirements for charitable hospital organizations added by the Patient Protection and Affordable Care Act of 2010 (ACA). The correction pertains to “Requirements of a Section 4959 Excise Tax Return and Time for Filing the Return”, and is effective May 4, 2015, applicable December 31, 2014.
• On May 7, 2015, FDA announced an opportunity for public comment on the proposed information collection request entitled “Medical Device Reporting [MDR]: Manufacturer, Importer, User Facility, and Distributor Reporting.” The Agency believes that the majority of manufacturers, user facilities, and importers have already established written procedures to document complaints and information to meet the MDR requirements as part of their internal quality control system. There are an estimated 30,000 medical device distributors. Although they do not submit MDR reports, they must maintain records of complaints under § 803.18(d). The Agency has estimated that on average 220 user facilities, importers, and manufacturers would annually be required to establish new procedures, or revise existing procedures, in order to comply with this provision. Comments are due July 6, 2015.
• On May 5, 2015, the Office of Management and Budget (OMB) received a final rule for review, entitled “Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-F)”, from the Centers for Medicare & Medicaid Services (CMS).
• On May 6, 2015, OMB received guidelines for review, entitled “340B Program Omnibus Guidelines”, from HRSA.
• FDA’s Center for Drug Evaluation and Research (CDER) released its “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015” this week.

Event Notices

• July 16, 2015: CMS has announced a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2016. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The public meeting is scheduled for Thursday, July 16, 2015 from 9:00 a.m. to 3:00 p.m. ET. All presenters for the public meeting must register and submit their presentations electronically to Glenn McGuirk at Glenn.McGuirk@cms.hhs.gov by July 2, 2015. More information may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Tuesday May 5th, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients”. Witnesses for the hearing included Francis Collins, MD, PhD , Director, National Institutes of Health (NIH); Karen DeSalvo, MD, MPH, MSc , National Coordinator for Health Information Technology (ONC); and Jeff Shuren, MD, JD , Director, Center for Devices and Radiological Health, Food and Drug Administration (FDA). More information on the hearing may be found here.
• On May 7th, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies convened a hearing on rural health and telemedicine. The witness for Panel I of the hearing was Mr. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare Centers for Medicare and Medicaid Services; Mr. Tom Morris, Associate Administrator, Federal Office of Rural Health Policy, Health Resources and Services Administration. Witnesses scheduled for Panel II of the hearing included Mr. Tim Wolters ,Director of Reimbursement, Citizens Memorial Hospital; Dr. Kristi Henderson, Chief Telehealth & Innovation Officer, University of Mississippi Medical Center; Ms. Julie Petersen, Chief Executive Officer, PMH Medical Center; and Mr. Allen Van Driel, Chief Executive Officer, Smith County Memorial Hospital. More information on the hearing may be found here.

House of Representatives

• The House of Representatives was in recess this week; the chamber will return to regular legislative business on May 12th. The House calendar for 2015 may be accessed here.

III. REPORTS, STUDIES, & ANALYSES

• The May issue of Health Affairs includes an article entitled “Hospital Closures Had No Measurable Impact On Local Hospitalization Rates Or Mortality Rates, 2003–11”. Study authors identified 195 hospital closures in the United States between 2003 and 2011, and found no significant difference between the change in annual mortality rates for patients living in hospital service areas (HSAs) that experienced one or more closures and the change in rates in matched HSAs without a closure (5.5 percent to 5.2 percent versus 5.4 percent to 5.4 percent, respectively). Nor was there a significant difference in the change in all-cause mortality rates following hospitalization (9.1 percent to 8.2 percent in HSAs with a closure versus 9.0 percent to 8.4 percent in those without a closure). HSAs with a closure had a drop in readmission rates compared to controls (19.4 percent to 18.2 percent versus 18.8 percent to 18.3 percent). Overall, the authors found no evidence that hospital closures were associated with worse outcomes for patients living in those communities. “These findings may offer reassurance to policy makers and clinical leaders concerned about the potential acceleration of hospital closures as a result of health care reform,” the study suggests.
• A study published in the Journal of the American Medical Association (JAMA) examined outcomes following initiation of buprenorphine in the emergency department in a randomized clinical trial involving 329 opioid-dependent patients. Among opioid-dependent patients, the study found, emergency department (ED)-initiated buprenorphine treatment vs. brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. The authors write that, “…research is needed to improve the efficacy of using a brief intervention for drug use disorders, particularly promoting short-term treatment engagement…Expanded use of ED-initiated buprenorphine with community follow-up should help increase access to treatment options for this chronic and relapsing medical condition that has substantial morbidity and mortality and that affects health care use and costs.”
• On May 6, 2015, the Kaiser Family Foundation released a report entitled “Medicaid at 50”. The report trace’s Medicaid’s evolution, discussing major legislative changes and other inflection points in the program’s history. The report concludes by looking forward to consider main issues that will concern the Medicaid program in the decades ahead, and to assess how Medicaid is poised to meet future needs.
• This week the Catalyst for Payment Reform released the results of an independent review of Medicare payment entitled the “CPR Scorecard on Medicare Payment Reform”. The results show that 42% of the money Medicare spent in fee-for-service in 2013 was tied to programs designed to get better health care outcomes or make providers more efficient. Fifty-eight percent of Medicare payments in traditional fee-for-service did not include such incentives. These dollars were paid to providers for the amount of services they perform regardless of quality or outcome. CPR’s study did not examine the approach taken by Medicare Advantage (MA) plans.
• On May 5, 2015, the Office of Inspector General (OIG) released a report entitled “Incorrect Place-of-Service Claims Resulted in Potential Medicare Overpayments Costing Millions”. OIG determined that Medicare contractors potentially overpaid physicians approximately $33.4 million for incorrectly coded services provided from January 2010 through September 2012. Physicians performed these services in facility locations, but physicians incorrectly coded the services as performed in non-facility locations. OIG attributed the overpayments to internal control weaknesses at the physician billing level and to insufficient post-payment reviews at the Medicare contractor level to identify potential place-of-service billing errors. OIG recommend that CMS direct its Medicare contractors to (1) initiate, in accordance with CMS policies, the immediate recovery of $7.3 million in potential overpayments from physicians who incorrectly coded physician services performed in ambulatory surgical centers; (2) monitor the recoveries from the 87 physicians who expressed their intent to refund approximately $7.1 million in potential overpayments for incorrectly coded physician services performed in hospital outpatient locations; (3) recover, in accordance with CMS policies, the additional $19 million in potential overpayments related to the services that may have been performed in hospital outpatient locations that we identified through our computer match; (4) continue to educate physicians and billing personnel on the importance of internal controls to ensure the correct place-of-service coding for physician services; and (5) expand and strengthen efforts to perform coordinated data matches of non-facility-coded physician services and facility claims to identify physician services that are at a high risk for place-of-service miscoding and recover overpayments. In written comments on the draft report, CMS concurred with the recommendations and described corrective actions it has taken.

IV. OTHER HEALTH POLICY NEWS

• On May 4, 2015, HHS announced that the Pioneer Accountable Care Organization (ACO) Model had generated over $384 million in savings to Medicare over its first two years—an average of approximately $300 per beneficiary per year. According to an analysis by L&M Policy Research LLC, ten Pioneers had statistically significant savings in both performance years; ten had statistically significant savings in only one of two performance years; and twelve had no statistically distinguishable savings or losses. Overall spending performance was mainly accompanied by utilization reductions in acute inpatient settings. As a group, Pioneer ACO results showed lower-than-expected utilization in acute inpatient stays and physician services in the first and second performance years compared to local markets. The 10 Pioneers with savings in both performance years had particularly steep reductions in acute inpatient stays. Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys of aligned Pioneer beneficiaries found that Pioneer ACOs exhibited few changes in patient experience between the first and second performance year. In addition, the independent CMS Office of the Actuary certified that this model is the first to meet the criteria for expansion to a larger population of Medicare beneficiaries. “Both the Pioneer and MSSP ACOs have been shown to produce savings relative to fee-for-service Medicare,” the Office of the Actuary report concludes. “As a result, the additional ACOs that are expected to be gained by the expansion would generate further savings to the Medicare program. Since the cost impact of those ACOs switching from MSSP to Pioneer is expected to be minimal, we have concluded that the additional savings that would be achieved from increased ACO enrollment would lead to an overall reduction in Medicare costs for the expansion of the Pioneer ACO Model.”
• On May 6, 2015, the White House announced that Dr. Karen DeSalvo, National Coordinator for Health Information Technology, had been nominated for HHS Assistant Secretary for Health. Before joining HHS, DeSalvo served as Health Commissioner for the City of New Orleans, Louisiana, and also as Senior Health Policy Advisor for New Orleans Mayor Mitch Landrieu from 2011 to 2014.
• On May 5, 2015, the US Court of Appeals for the Federal Circuit in Washington granted Amgen’s request for an injunction blocking Novartis’s Zarxio (a biosimilar form of Amgen’s drug Neupogen, which prevents infections in cancer patients) from the U.S. market. Although a lower court rejected Amgen’s request for an injunction, the Court of Appeals ruled this week that the injunction could take effect while Amgen’s appeal is pending. Oral arguments in the case have been set for June 3rd.
• On May 4, 2015, the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved a three-year, $14 million clinical trial designed to determine the best dose of aspirin to use to prevent heart attacks and strokes in people with heart disease. The study, called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness), will compare the benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease. It is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. ADAPTABLE will be led by researchers at Duke and involve researchers, clinicians, and patients from six of PCORnet’s clinical data research networks (CDRNs), each made up of multiple large healthcare systems. More information may be found here.
• On May 5, 2015, 11 brand and generic drug manufacturers announced the formation of a “Biosimilars Forum”. According to the Forum’s website, the group represents “the first nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States.” A press release further indicates that the Biosimilars Forum will be submitting a public statement about “the need for appropriate coding for biosimilars” to the CMS Healthcare Common Procedure Coding System (HCPCS) Public Meeting on May 7, 2015.
• On May 5, 2015, HHS announced approximately $101 million in Affordable Care Act funding to 164 new health center sites in 33 states and two U.S. Territories for the delivery of comprehensive primary health care services. A press release may be found here; a list of award winners may be found here.