A&B Healthcare Week in Review, January 2, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On December 29, 2014, the Internal Revenue Service (IRS) released final regulations entitled “Additional Requirements for Charitable Hospitals; Community Health Needs Assessments for Charitable Hospitals; Requirement of a Section 4959 Excise Tax Return and Time for Filing the Return”. This document contains final regulations that provide guidance regarding the requirements for charitable hospital organizations added by the Patient Protection and Affordable Care Act of 2010 (ACA). The regulations will affect charitable hospital organizations. The collection of information is required for hospital organizations to receive the benefits of being described in section 501(c)(3) of the Internal Revenue Code (Code) and flows from section 501(r)(3), which requires a hospital organization to conduct a community health needs assessment (CHNA) and adopt an implementation strategy to meet the community health needs identified through the CHNA at least once every three years; section 501(r)(4), which requires a hospital organization to establish a written financial assistance policy (FAP) and a written policy related to care for emergency medical conditions; and section 501(r)(6), which requires a hospital organization to make reasonable efforts to determine whether an individual is eligible for assistance under a FAP before engaging in extraordinary collection actions. The expected record keepers are hospital organizations described in sections 501(c)(3) and 501(r)(2). The regulations are effective immediately. 
• On December 29, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a notice of intent to develop regulations entitled “Solicitation of New Safe Harbors and Special Fraud Alerts”. In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts. Comments are being accepted until March 2, 2015. 
• On December 24, 2014, the Centers for Medicare and Medicaid Services (CMS) requested public comments on an information collection entitled “Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP)”. CMS requires that Medicare Advantage organizations and Prescription Drug Plans complete the Bid Pricing Tool (BPT) as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to us for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan’s bid, enrollee premiums, and payment rates. CMS publishes beneficiary premium information using a variety of formats (www.medicare.gov, the Medicare & You handbook, Summary of Benefits marketing information) for the purpose of beneficiary education and enrollment. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments are due January 23, 2015. 
• On December 24, 2014, CMS requested public comments on an information collection activity entitled “CMS–1557 Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations.” The form is used to report surveyor findings during a CLIA survey. For each type of survey conducted (i.e., initial certification, recertification, validation, complaint, addition/deletion of specialty/subspecialty, transfusion fatality investigation, or revisit inspections) the Survey Report Form incorporates the requirements specified in the CLIA regulations. Comments are due February 23, 2015. 
• On December 29, 2014, HHS released a request for nominations entitled “Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections”. The Office for Human Research Protections (OHRP), a program office in the HHS Office of the Assistant Secretary for Health, is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, through the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill two positions on the Committee membership that will be vacated during the 2015 calendar year. Previous nominees may be considered for the upcoming vacancies. Nominations for membership on the Committee must be received no later than February 12, 2015. More information may be found here. 
• On December 30, 2014, CMS requested public comment on an information collection entitled “Fee-for-Service Recovery Audit Prepayment Review Demonstration and Prior Authorization Demonstration”. The notice solicits feedback on the information collection activities associated with CMS’ Recovery Audit Prepayment Review and Prior Authorization Demonstrations Comments are due January 29, 2015. 
• On December 30, 2014, CMS released a final notice entitled “Medicare Program; Evaluation Criteria and Standards for Beneficiary and Family Centered Care Quality Improvement Organization Contract”. This final notice announces the general criteria CMS will use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that entered into contracts with CMS under the 11th Statement of Work (SOW) in May 2014. The activities for the BFCC–QIO SOW began August 1, 2014. (This contract allows for a transition period from the incumbent QIOs to the successor QIOs.) In addition, this notice addresses the public comments received on the July 28, 2014 notice with comment period entitled, ‘‘Evaluation Criteria and Standards for Beneficiary and Family Centered Care Quality Improvement Organization Contracts.’’ This notice is effective August 1, 2014 to July 31, 2019. 
• On December 30, 2014, CMS released a final notice entitled “Medicare Program; Evaluation Criteria and Standards for Quality Improvement Networks Quality Improvement Program Contracts; Base and Task Orders”. This final notice announces the general criteria CMS will use to evaluate the effectiveness and efficiency of Quality Innovation Network (QIN) Quality Improvement Organizations (QIOs) that entered into contracts with CMS under the 11th Statement of Work (SOW) in July 2014. (The activities for the QIN–QIO SOW began August 1, 2014). In addition, this notice addresses public comments on the August 11, 2014 notice with comment period entitled, ‘‘Evaluation Criteria and Standards for Quality Improvement Networks Quality Improvement Program Contracts [Base and Task Order(s)]’’. This notice is effective August 1, 2014 to July 31, 2019. 
• On December 30, 2014, the Department of Defense released a proposed rule entitled “TRICARE; Revision of Nonparticipating Providers Reimbursement Rate; Removal of Cost Share for Dental Sealants; TRICARE Dental Program”. The Department of Defense (DoD) proposes several amendments to the TRICARE Dental Program (TDP) regulation. Specifically, this proposed rule revises the benefit payment provision for nonparticipating providers to more closely mirror industry practices by requiring TDP nonparticipating providers to be reimbursed (minus the appropriate cost share) at the lesser of billed charges: or the network maximum allowable charge for similar services in that same locality (region) or state. This rule also updates the regulatory provisions regarding dental sealants to clearly categorize them as a preventive service and, consequently, eliminate the current 20 percent cost-share applicable to sealants to conform the language in the regulation to the statute. Comments are due March 2, 2015. 
• On December 30, 2014, the Food and Drug Administration (FDA) announced the availability of draft and revised draft guidances for industry entitled “Industry Describing Product-Specific Bioequivalence Recommendations”. These recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’, which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Comments are due March 2, 2015. More information may be found here. 
• On December 30, 2014, FDA announced that a proposed information collection entitled “Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program” had been submitted to the Office of Management and Budget (OMB) for review and clearance. Comments are due January 29, 2015. 
• On December 30, 2014, FDA released a notice entitled “Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices”. This notice solicits comments on reprocessed, single-use device labeling. Comments are due March 2, 2015. 
• On December 30, 2014, FDA announced that a proposed information collection entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring” had been submitted to OMB for review. Comments are due January 29, 2015. 
• On December 30, 2014, the Department of Veterans Affairs (VA) released a notice entitled “Reasonable Charges for Medical Care or Services; V3.16, 2015 Calendar Year Update and National Average Administrative Prescription Drug Charge Update”. This Department of Veterans Affairs (VA) notice updates the data for calculating the ‘‘Reasonable Charges’’ collected or recovered by VA for medical care or services. This notice also updates the ‘‘National Average Administrative Costs’’ for purposes of calculating VA’s charges for prescription drugs that were not administered during treatment but provided or furnished by VA to a veteran. 
• On December 31, 2014, the Department of Defense released a final rule entitled “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Retired Reserve”. TRICARE Retired Reserve (TRR) is a premium-based TRICARE health plan available for purchase worldwide by qualified members of the Retired Reserve and by qualified survivors of TRR members. This final rule responds to public comments received to an interim final rule that was published in the Federal Register on August 6, 2010 (75 FR 47452–47457). That rule established requirements and procedures to implement the TRR program in fulfillment of section 705 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA–10) (Pub. L. 111–84). This final rule also revises requirements and procedures as indicated. This rule is effective January 30, 2015. 
• On December 31, 2014, the Department of Defense released a final rule entitled “TRICARE Program; Clarification of Benefit Coverage of Durable Equipment and Ordering or Prescribing Durable Equipment; Clarification of Benefit Coverage of Assistive Technology Devices Under the Extended Care Health Option Program”. This final rule modifies the TRICARE regulation to add a definition of assistive technology (AT) devices for purposes of benefit coverage under the TRICARE Extended Care Health Option (ECHO) Program and to amend the definitions of durable equipment (DE) and durable medical equipment (DME) to better conform the language in the regulation to the statute. The final rule amends the language that specifically limits ordering or prescribing of DME to only a physician under the Basic Program, as this amendment will allow certain other TRICARE authorized individual professional providers, acting within the scope of their licensure, to order or prescribe DME. This final rule also incorporates a policy clarification relating to luxury, deluxe, or immaterial features of equipment or devices. That is, TRICARE cannot reimburse for the luxury, deluxe, or immaterial features of equipment or devices, but can reimburse for the base or basic equipment or device that meet the beneficiary’s needs. Beneficiaries may choose to pay the provider for the luxury, deluxe, or immaterial features if they desire their equipment or device to have these ‘‘extra features.’’ This rule is effective January 30, 2015. 
• On December 31, 2014, the Department of Defense released a final rule entitled “TRICARE; Coverage of Care Related to Non-Covered Initial Surgery or Treatment”. This final rule revises the limitations on certain TRICARE basic program benefits. More specifically, it allows coverage for otherwise covered services and supplies required in the treatment of complications (unfortunate sequelae), as well as medically necessary and appropriate follow-on care, resulting from a non-covered incident of treatment provided pursuant to a properly granted Supplemental Health Care Program waiver. This final rule amends two provisions of the TRICARE regulations which limits coverage for the treatment of complications resulting from a non-covered incident of treatment, and which expressly excludes from coverage in the Basic Program services and supplies related to a non-covered condition or treatment. This final rule is effective January 30, 2015. 
• On December 31, 2014, FDA released a proposed rule entitled “Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products”. FDA is issuing this proposed rule to amend certain regulations regarding donor eligibiltiy, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is proposing this action in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos. Comments are due March 31, 2015. 
• On December 31, 2014, FDA announced the availability of a guidance for industry entitled ‘‘DSCSA Implementation: Product Tracing Requirements—Compliance Policy.’’ This guidance announces FDA’s intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to enforce these requirements against manufacturers, wholesale distributors, and re-packagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by the FD&C Act (product tracing information) for transaction of certain human, finished prescription drugs that are covered in the statute. The guidance is effective December 31, 2014.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION 

• On December 19, 2014, Senators Richard Blumenthal (D-CT), Sherrod Brown (D-OH) and Rand Paul (R-KY), along with seventeen members of the House of Representatives, issued a letter to CMS Administrator Marilyn Tavenner calling for increased consumer protections in Medicare Advantage (MA) plans. Specifically, the lawmakers urge Tavenner to strengthen the Special Enrollment Period (SEP) for subscribers whose providers have been dropped; redefine the “significant” provider changes that would make an enrollee eligible for a SEP; and apply network standards for other plans to MA plans, including applying annual review of Medicare-Medicaid Plans to all MA plans. “Over the last year, thousands of doctors and other providers have been removed without cause from MA plan networks, needlessly disrupting the care of seniors across the country,” the members wrote. “This blatant bait and switch should not be allowed. Therefore we urge you to require that MA plans to fix their provider networks in advance of the annual open enrollment period in you FY 2016 call letter. This will allow Medicare Advantage enrollees to select a plan with a provider network that meets their needs. It will also give MA enrollees security in knowing that their providers cannot be dropped from the network in between enrollment periods.” 
• Both the House and Senate are expected to reconvene for the start of the 114th Congress on Tuesday January 6, 2015. The House calendar may be found here; the Senate calendar may be found here.

III. REPORTS, STUDIES, & ANALYSES 

• On December 22, 2014, The Commonwealth Fund released an analysis of the ACA Marketplaces, which finds that, nationwide, premiums did not increase at all from 2014 to 2015, though there were substantial average premium increases in some states and declines in others. While average premiums nationwide did not change from 2014 to 2015, there were wide differences across states. There were double-digit increases in 10 states plus the District of Columbia (Alaska, the District of Columbia, Iowa, Louisiana, Minnesota, Nebraska, New Hampshire, North Carolina, Pennsylvania, South Carolina, and West Virginia). Average premiums declined in 14 states (Arizona, Colorado, Connecticut, Hawaii, Illinois, Maine, Michigan, Mississippi, New Mexico, Oklahoma, Oregon, South Dakota, Virginia, and Washington). The average premiums for the second lowest-cost silver plan—or benchmark plan for calculating the federal subsidy in a given state—were also unchanged. And the average deductible for a marketplace plan increased by just 1 percent year to year. 
• An article released in the journal Health Affairs on December 19th finds no evidence that employer-sponsored health insurance has declined as a result of the ACA. This article takes advantage of timely data from the Health Reform Monitoring Survey for June 2013 through September 2014 to examine, from the perspective of workers, early changes in offer, take-up, and coverage rates for employer-sponsored insurance under the ACA. Authors found no evidence that any of these rates have declined under the ACA. They have, in fact, remained constant: around 82 percent, 86 percent, and 71 percent, respectively, for all workers and around 63 percent, 71 percent, and 45 percent, respectively, for low-income workers. 
• An article in the December 25th issue of the New England Journal of Medicine (NEJM) considers the future of the ACA in the context of a Republican-controlled Congress, as well as the implications of the Supreme Court decision (King v Burwell) regarding the availability of premium tax credits in states with FFMs. (Justices will hear the case beginning March 4, 2015). In the “Perspective”, author Jonathan Oberlander, PhD, suggests that Congressional Republicans will pursue a nuanced approach to altering the health law rather than full repeal, specifically targeting the individual mandate, the medical device tax, or the Independent Payment Advisory Board (IPAB). Regarding the King case, Oberlander suggests that a ruling in favor of the plaintiffs could “…produce enormous pressures on affected states and Congress to adopt measures to stave off those outcomes. Yet the ACA's shaky political foundations would complicate policymakers' responses, and Obamacare's opponents would be emboldened to resist any fixes.” 
• A study published in the Journal of the American Medical Association (JAMA) this week examines whether an enhanced medical home providing comprehensive care prevents serious illness and reduces costs among children with chronic illness. The randomized trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) at the University of Texas, Houston showed that comprehensive care reduced the number and rate of children with a serious illness (10 per 100 child-years versus 22 treated with usual care); while also decreasing the total hospital and clinic costs. However, the authors suggest that these findings from a single site of selected patients with a limited number of clinicians require study in larger, broader populations before conclusions about generalizability to other settings can be reached.

IV. OTHER HEALTH POLICY NEWS 

• On December 30, 2014, HHS released a monthly issue brief with ACA Health Insurance Marketplace enrollment figures for the period November 15th (when Open Enrollment commenced) through December 15th. The report includes data through December 15 for the 37 states using the HealthCare.gov platform, and through December 13 for 12 states and the District of Columbia that are using their own Marketplace platforms. Data for California are through December 14. About 87 percent of people who selected health insurance plans through HealthCare.gov for coverage beginning Jan. 1, 2015 were determined eligible for financial assistance to lower their monthly premiums, compared to 80 percent of enrollees who selected plans over a similar period last year. In addition, more than 4 million people in both the state and federal Marketplaces signed up for the first time or reenrolled in coverage for 2015 during the first month of open enrollment. “We’re pleased that nationwide, millions of people signed up for Marketplace coverage starting January 1. The vast majority were able to lower their costs even further by getting tax credits, making a difference in the bottom lines of so many families,” HHS Secretary Sylvia M. Burwell said. “Interest in the Marketplace has been strong during the first month of open enrollment. We still have a ways to go and a lot of work to do before February 15, but this is an encouraging start.” An HHS press release highlighting findings may be found here.
• On December 30, 2014, CMS announced that the agency has awarded the Region 5 Medicare Recovery Audit contract to Connolly, LLC, to assist CMS with its “mission through the identification and correction of improper payments for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), and home health/hospice (HH/H) claims”. The Recovery Auditor will review all applicable claims types through the appropriate review methods and work with CMS and the DME and HH/H Medicare Audit Contractors (MACs) to adjust claims to recoup overpayments and pay underpayments.