A&B Healthcare Week in Review, January 23, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On January 20, 2015, the Government Accountability Office (GAO) issued a notice soliciting letters of nomination for appointments to the Medicare Payment Advisory Commission (MedPAC), to be effective May 1, 2015. MedPAC is an independent congressional agency established by the Balanced Budget Act of 1997 (P.L. 105-33) to advise the U.S. Congress on issues affecting the Medicare program. In addition to advising the Congress on payments to private health plans participating in Medicare and providers in Medicare's traditional fee-for-service program, MedPAC is also tasked with analyzing access to care, quality of care, and other issues affecting Medicare. Letters of nomination and resumes should be submitted by March 13, 2015 to ensure adequate opportunity for review and consideration of nominees prior to the appointment of new members. More information may be found here. 
• On January 23, 2015, the Defense Department published a proposed rule entitled “TRICARE; Reimbursement of Long Term Care Hospitals”. This proposed rule requests public comment on proposed implementation for Long Term Care Hospitals (LTCHs) the statutory provision at title 10, United States Code (U.S.C.), section 1079(j)(2) that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule sets forth the proposed regulation modifications necessary to implement a TRICARE reimbursement methodology similar to that applicable to Medicare beneficiaries for inpatient services provided by LTCHs. The rule was filed at the Public Inspection Desk on January 23rd and is scheduled to be published in the Federal Register on January 26, 2015; public comments are due within 60 days. 
• On January 23, 2015, the Food and Drug Administration (FDA) released a notice entitled “Guidance for Industry on Post-marketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application”. This notice solicits comments on the FDA guidance for industry on ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.’’ This guidance document provides recommendations on post-marketing serious adverse event reporting for nonprescription (over-the-counter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Comments are due March 24, 2015. 
• On January 22, 2015, the Department of Health and Human Services (HHS) released its “Annual Update of the HHS Poverty Guidelines”. This notice provides an update of the HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index. The guidelines in this 2015 notice reflect the 1.6 percent price increase between calendar years 2013 and 2014. After this inflation adjustment, the guidelines are rounded and adjusted to standardize the differences between family sizes. These guidelines will be effective immediately, beginning January 22, 2015, unless an office administering a program using the guidelines specifies a different effective date for that particular program. 
• On January 20, 2015, the Centers for Medicare and Medicaid Services (CMS) announced its decision to approve the Accreditation Commission for Health Care, Inc., (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. An HHA that participates in Medicaid must also meet the Medicare conditions for participation (CoPs) as required under 42 CFR 488.6(b). This final notice is effective February 24, 2015 through February 24, 2021.More information may be found here. 
• On January 20, 2015, FDA announced the availability of draft guidance entitled ‘‘General Wellness: Policy for Low Risk Devices.’’ FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). FDA invites comments on the draft guidance by April 20, 2015. More information may be found here. 
• On January 20, 2015, FDA announced the availability of draft guidance entitled ‘‘Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.’’ This draft document provides proposed guidance to industry and FDA staff about the regulation of accessories in medical devices. The guidance explains what FDA considers to be an ‘‘accessory,’’ outlines how the risk-based framework for the classification of devices applies to accessories, and describes the use of the de novo classification process for the classification of new types of accessories. FDA invites comments on the draft guidance by April 20, 2015. More information may be found here. 
• On January 20, 2015, FDA announced the availability of draft guidance entitled “Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes”. FDA has received reports of blood and stool traveling through colonoscope irrigation channels and into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place. This draft guidance document, when finalized, will highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. FDA invites comments on the draft guidance by April 20, 2015. More information may be found here. 
• On January 21, 2015, the Agency for Healthcare Research and Quality (AHRQ) released a notice of request for public comments entitled “Notice of Proposed Changes for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician & Group Survey”. AHRQ seeks comments on proposed changes to the CAHPS Clinician & Group (CG–CAHPS) Survey, including the Patient-Centered Medical Home (PCMH) Item Set. The CG–CAHPS survey is a product of the CAHPS program, which is funded and administered by AHRQ. AHRQ works closely with a consortium of public and private research organizations to develop and maintain surveys and tools to advance patient-centered care. AHRQ proposes these revisions in order to enhance the survey usability and functionality. AHRQ will implement these changes and release a new version of the CG–CAHPS Survey, Version 3.0. in 2015. Comments are due February 20, 2015. 
• On January 21, 2015, the AHRQ announced that the agency is seeking scientific information submissions to inform its review of Imaging for Pretreatment Staging of Small Cell Lung Cancer, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ requests comments by February 20, 2015. 
• On January 21, 2015, FDA released a notice entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products”. This notice solicits comments on the information collection provisions of FDA’s requirements on content and format of labeling for human prescription drug and biological products. Comments are due March 23, 2015. 
• On January 22, 2015, the Veterans Health Administration (VHA) announced that an information collection activity entitled “Medical Foster Homes Record Keeping Requirements” had been submitted to OMB for review and comment. As proposed, § 17.74(q) contains a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501–3521). Paragraph (q) of § 17.74 requires medical foster homes to comply with the recordkeeping requirements of 38 CFR 17.63(i) regarding facility records, and must document all inspection, testing, drills and maintenance activities required by this section. Such documentation must be maintained for 3 years or for the period specified by the applicable standards, whichever is longer. Documentation of emergency egress and relocation drills must include the date, time of day, length of time to evacuate the home, the name of each medical foster home caregiver who participated, the name of each resident, whether the resident participated, and whether the resident required assistance. Comments are due February 23, 2015. 
• On January 22, 2015, CMS announced that the following information collection activities had been submitted for OMB review: 1) Prior Authorization Form for Beneficiaries Enrolled in Hospice; and 2) Annual Eligibility Redetermination, Product Discontinuation and Renewal Notices. Comments are due February 23, 2015. More information may be found here. 
• On January 22, 2015, CMS announced an opportunity for the public to comment on a proposed information collection entitled “Verification of Clinic Data—Rural Health Clinic Form and Supporting Regulations”. The form is utilized as an application to be completed by suppliers of Rural Health Clinic (RHC) services requesting participation in the Medicare program. This form initiates the process of obtaining a decision as to whether the conditions for certification are met as a supplier of RHC services. It also promotes data reduction or introduction to and retrieval from the Automated Survey Process Environment (ASPEN) and related survey and certification databases by the CMS Regional Offices. Comments are due March 24, 2015. 
• On January 23, 2015, FDA announced that the Agency is requesting nominations for members to serve on the Science Board to the Food and Drug Administration, Office of the Commissioner, Office of the Chief Scientist. Nominations received on or before March 24, 2015 will be given first consideration for membership on the Science Board to the Food and Drug Administration. Nominations received after March 24, 2015 will be considered for nomination to the committee as later vacancies occur. More information may be found here.

Event Notices 

• March 24, 2015: The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will convene a meeting on March 24th to discuss selected molecular pathology tests for the estimation of prognosis in common cancers (such as, adenocarcinoma of the colon and rectum, breast cancer—invasive duct and lobular cancers, non-small cell lung cancers). The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. The meeting is open to the public. It will take place at the main CMS auditorium in Baltimore, Maryland, and will be broadcast live via webinar. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On January 22nd, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Examining Job-Based Health Insurance and Defining Full-Time Work”. Witnesses for the hearing included Dr. Betsy Webb , Superintendent, Bangor School Department, Bangor, ME; Mr. Andrew F. Puzder , Chief Executive Officer, CKE Restaurants, Carpinteria, CA; Dr. Doug Holtz-Eakin , President, American Action Forum; and Mr. Joe Fugere , Founder, Tutta Bella Pizzeria. Of relevance, on January 8, 2015, the House of Representatives passed the Save American Workers Act of 2015 (H.R. 30). H.R. 30 would change how penalties are imposed under the Affordable Care Act (ACA) on employers that do not offer insurance (or offer insurance that does not meet certain criteria) and that have at least one full-time employee receiving a subsidy through a Health Insurance Exchange. The legislation would raise the threshold that defines full-time employment from 30 hours per week under current law to 40 hours per week, and it would apply that higher threshold in two ways in the calculation of penalties. More information on the hearing may be found here. 
• On January 22, 2016, Senator Elizabeth Warren (D-MA) announced at a conference in Washington, DC that she plans to introduce legislation next week—the Medical Innovation Act—that will increase funding for the National Institutes of Health (NIH) using revenues generated from “…blockbuster drug companies whenever they break the law and enter into major settlement agreements with the government”. In her remarks, Warren said, “In addition to selling life-changing cures, some of these [drug] companies are increasingly making money by skirting the law. They’ve been caught defrauding Medicare and Medicaid, withholding critical safety information about their drugs, marketing their drugs for uses that aren’t approved, and giving doctors kickbacks for writing prescriptions for their drugs.”

House of Representatives 

• On January 21st and 22nd, the House Energy and Commerce Subcommittee on Health convened a two-day hearing entitled “A Permanent Solution to the SGR: The Time Is Now”. The purpose of the hearing was to discuss ways to advance a legislative solution to the flawed Medicare physician reimbursement formula known as the Sustainable Growth Rate (SGR). Witnesses for the first panel (on Wednesday) included Joseph I. Lieberman, former United States Senator; Alice Rivlin, Co-Chair, Delivery System Reform Initiative, Bipartisan Policy Center (BPC), and Director, Engelberg Center for Health Reform, the Brookings Institution; and Marilyn Moon, Institute Fellow at the American Institutes for Research. Thursday’s panelists included Richard Umbdenstock, President and Chief Executive Officer, American Hospital Association; Alan Speir, M.D. Medical Director of Cardiac Surgical Services for Inova Health System, Chair, Workforce on Health Policy, Reform, and Advocacy, The Society of Thoracic Surgeons; Eric Schneidewind, President-Elect, AARP; Geraldine O'Shea, D.O. First Vice President, AOA Board Of Trustees, Medical Director, Foothills Women's Medical Center in California; Barbara McAneny, M.D., Chair, AMA, Board of Trustees CEO, New Mexico Oncology Hematology Consultants, Ltd; and Ken P. Miller, PhD, R.N., Board President, American Association of Nurse Practitioners. More information on the hearings may be found here. 
• On January 22, 2014, the House passed the No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2015 (H.R.7) by a vote of 242 to 179. The measure would prohibit the use of federal funds for abortion except in cases of rape, incest, or life endangerment, and would exclude health plans that cover abortion services from the ACA definition of “qualified health plan” for the purposes of the premium assistance tax credit.

III. REPORTS, STUDIES, & ANALYSES 

• On January 21, 2015, the Blue Cross Blue Shield (BCBS) Association released a study entitled “A Study of Cost Variations for Knee and Hip Replacement Surgeries in the U.S.”. This report analyzed three years of independent BCBS companies’ claims data for typical knee and hip replacement surgeries to further assess cost variations across the U.S. According to the report findings, some hospitals across the U.S. charge tens of thousands of dollars more than others for the same medical procedures, even within the same metropolitan market. The report, which examines these procedures in 64 markets across the country, found that their cost can vary by as much as 313 percent, depending on where the surgeries are performed. 
• On January 23, 2014, CMS published findings from two large-scale tests of advanced primary care: the Comprehensive Primary Care (CPC) initiative and the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration. The CPC initiative is a multi-payer partnership between Medicare, Medicaid private health care payers, and primary care practices in four states (Arkansas, Colorado, New Jersey and Oregon) and three regions (New York’s Capital District and Hudson Valley, Ohio and Kentucky’s Cincinnati-Dayton region, and Oklahoma’s Greater Tulsa region). This initiative includes providing care management; improving health care access; tracking patient experience; coordinating care with hospitals and specialists; and using health information technology to support population health. Practices receive non-visit based care management fees from the participating payers, and the opportunity to share in savings. In its first year, the CPC decreased hospital admissions by 2% and emergency department visits by 3%, contributing to the reduction of expenditures nearly enough to offset care management fees paid by CMS. The MAPCP Demonstration is multi-payer initiative in which Medicare is participating with Medicaid and private health care payers in eight advanced primary care initiatives in Maine, Michigan, Minnesota, New York, North Carolina, Pennsylvania, Rhode Island, and Vermont. Unlike CPC, the states convene the participants and administer the initiatives rather than CMS. Under this demonstration, participating practices and other auxiliary supports (e.g., community health teams) receive monthly care management fees from the participating payers and additional support (e.g., data feedback, learning collaboratives, practice coaching). According to this week’s results, the MAPCP Demonstration generated an estimated $4.2 million in savings through the use of advanced primary care initiatives. 
• On January 23, 2015, the Centers for Disease Control and Prevention (CDC) released a report entitled “Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012”. CDC used Truven Health's MarketScan Commercial Claims and Encounters and Medicaid data from 2008–2012 to assess outpatient pharmacy prescription drug claims for opioid-containing medications among reproductive-aged women (15–44 years). There were approximately 4.4–6.6 million privately insured and 0.4–0.8 million Medicaid-enrolled reproductive-aged women in the study sample each year during 2008–2012. Of these, on average 27.7% of privately insured and 39.4% of Medicaid-enrolled women filled a prescription for an opioid from an outpatient pharmacy each year. In addition, CDC found an average of three opioids prescribed for every four privately insured women and nearly two opioid prescriptions for every one Medicaid-enrolled woman per year. “This is a significant public health concern,” CDC reports, “given evidence of adverse pregnancy outcomes with opioid exposure, the likelihood of exposures occurring among unrecognized or unintended pregnancies, and health care provider concerns about using other pain medications during early pregnancy.”

IV. OTHER HEALTH POLICY NEWS 

• On January 22, 2015, CMS announced that the agency has added star ratings to the Dialysis Facility Compare (DFC) website. The DFC rating gives a one to five-star rating based on information about the quality of care and services that a dialysis facility provides. Currently, nine DFC quality measures are being used collectively to comprise the DFC star ratings. In the future, CMS will add more measures. “Star ratings are simple to understand and are an excellent resource for patients, their families, and caregivers to use when talking to doctors about health care choices,” said CMS Administrator Marilyn Tavenner. “CMS has taken another step in its continuous commitment to improve quality measures and transparency.” In related news, CMS announced that it plans to add the Standardized Readmission Ratio (SRR) for dialysis facilities to the publicly reported quality outcome measures available on the Compare website. SRR is a measure of care coordination. SRR is not included in DFC’s star rating at this time. 
• On Tuesday January 20, 2014, the Supreme Court heard oral arguments in a case (Armstrong v. Exceptional Child Center, Inc.) which considers whether or not physicians and hospitals can sue states if they feel their Medicaid reimbursement rates are too low. In 2011, a service provider for Medicaid beneficiaries with developmental disabilities sued Idaho officials when the state failed to increase Medicaid payments past 2006 rates, despite studies showing that the cost of providing care had risen. When a lower court ordered that payments to these providers increase because the rates were stagnant “for purely budgetary reasons”, Idaho appealed. Twenty-seven states, the National Governors Association, and the Obama Administration are supporting Idaho’s appeal. 
• The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a series of meetings in Washington, DC on January 22nd and 23rd to discuss Medicaid and CHIP policy issues. The agenda included sessions on: Affordability of Exchange Coverage for Children Now Covered by CHIP; Network Adequacy and the Future of CHIP; Medicaid’s Role in Behavioral Health; The Effect of Medicaid Coverage of Medicare Cost Sharing on Access to Care; An Update on the Medicaid Primary Care Payment Increase; and Policy Issues and Preliminary Options for the Future of CHIP. More information on the meeting, including presentations and transcripts as they become available, may be found here. 
• During President Obama’s State of the Union Address on Tuesday, the President outlined a newly announced “Precision Medicine Initiative” that will “…help deliver the right treatment to the right patient at the right time”. A briefing posted on the White House website explained: “The President is calling for a major increase in R&D investments, including precision medicine, combatting antibiotic resistance, and the President’s signature BRAIN Initiative. Recent advances in genomics and digital data have produced powerful new discoveries about health and disease that have made it possible to design highly effective, targeted treatments for cancer and other diseases. The President’s proposal will engage patients and healthcare providers in delivering this new era of medicine. To help address the global threat of infectious disease created by rampant spread of antibiotic-resistant bacteria, the President also proposes to nearly double the Federal investment in antibiotic discovery. The President’s proposal also continues to invest in Alzheimer’s research and the multi-agency BRAIN Initiative.” 
• On January 21, 2015, HHS released its latest enrollment snapshot for qualified health plans (QHPs) selected in the 2015 Open Enrollment Period on Federally-Facilitated Exchanges (FFEs) between November 15, 2014 and January 16, 2015. According to the figures, more than 7.1 million consumers selected a plan or were automatically re-enrolled in coverage during this period. “With just four weeks before the February 15 deadline and the end of Open Enrollment, more than 7.1 million consumers are counting on the Marketplace for affordable health coverage,” HHS Secretary Sylvia Burwell said. “Last week, just before the deadline for February 1 coverage, approximately 400,000 people across the country selected a plan that worked for their family.”