A&B Healthcare Week in Review, March 11, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks comments on testing six different alternative approaches for Part B drugs to improve outcomes and align incentives to improve quality of care and spend dollars wisely. The proposed model would test: (1) whether changing the add-on payment to 2.5 percent plus a flat fee payment of $16.80 per drug per day changes prescribing incentives and leads to improved quality and value; (2) decreasing or eliminating cost sharing to improve beneficiaries’ access and appropriate use of effective drug; (3) creating evidence-based clinical decision support tools as a resource for providers and suppliers focused on safe and appropriate use for selected drugs and indications; (4) varying the payment for a drug based on its clinical effectiveness for different indications; (5) testing the practice of setting a standard payment rate—a benchmark—for a group of therapeutically similar drug products; and (6) allowing CMS to enter into voluntary agreements with drug manufacturers to link patient outcomes with price adjustments. Public comments are due May 9, 2016.
• On March 4, 2016, CMS issued a change request entitled, “July Quarterly Update to 2016 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement.” This notification provides updates to the lists of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS). The implementation of these changes will occur on July 5, 2016.
• On March 4, 2016, CMS issued a change request entitled, “Fiscal Year 2017 and After Payments to Long Term Care Hospitals That Do Not Submit Required Quality Data - This CR Rescinds and Fully Replaces CR9105.” This Change Request revises Pub. 100-22, Medicare Quality Reporting Incentive Programs, Chapter 3, Section 60, to reflect changes to the payment reduction reconsideration process. It also includes general clarifications to the section. This change request will be implemented on April 1, 2016.
• On March 7, 2016, CMS issued a final rule correcting amendment entitled, “Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; Corrections.” This document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016.”
• On March 7, 2016, the Health Resources & Services Administration (HRSA) issued an information collection request (ICR) entitled, “Telehealth Resource Center (TRC) Performance Measurement Tool.” HRSA is seeking public comments to better understand how TRCs can improve technical assistance to health care organizations, health care networks, and health care providers in the implementation of cost-effective telehealth programs to serve rural and medically underserved areas and populations. Public comments are due April 7, 2016.
• On March 7, 2016, HRSA issued a notice entitled, “Low Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act.” HRSA is updating income levels used to identify a “low income family” for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act.
• On March 7, 2016, the Department of Health & Human Services (HHS) issued data tables entitled, “Issuers of Stand-alone Dental Plans: Intent to Offer in FFM States.” The tables list the number of issuers that intend to offer standalone dental plans (SADPs) in states that are expected to have a Federally-facilitated Marketplace (FFM), including State Partnership Marketplaces, based on the current Marketplace Blueprint Approvals. This information is current as of February 25, 2016.
• On March 8, 2016, the Food & Drug Administration (FDA) issued a notice entitled, “Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.” This notice solicits comments on consumer research and will examine how the size and presentation of superimposed text influences the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs. Public comments are due May 8, 2016.
• On March 8, 2016, FDA issued a guidance entitled, “Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products.” The guidance document provides establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A.
• On March 8, 2016, the Indian Health Service (IHS) issued a notice entitled, “IHS Reimbursement Rates for Calendar Year 2016.” IHS has approved the rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2016 for Medicare and Medicaid beneficiaries, beneficiaries of other Federal programs, and for recoveries under the Federal Medical Care Recovery Act. The Medicare Part A inpatient rates are excluded from the table as they are paid based on the prospective payment system. Since the inpatient per diem rates do not include all physician services and practitioner services, additional payment will be available to the extent that those services are provided.
• On March 9, 2016, FDA issued a proposed rule entitled, “Orthopedic Devices; Classification of Posterior Cervical Screw Systems.” FDA is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. Public comments are due June 9, 2016.
• On March 9, 2016, FDA issued a guidance entitled, “Guidance for Industry and Staff on Dear Health Care Provider Letters -- Improving Communication of Important Safety Information.” This guidance solicits comments on the information collection associated with the guidance for industry and FDA staff entitled "Dear Health Care Provider Letters: Improving Communication of Important Safety Information." This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. Public comments are due May 9, 2016.
• On March 9, 2016, FDA issued a guidance entitled, “Guidance--Emergency Use Authorization of Medical Products.” The guidance describes the Agency’s general recommendations and procedures for issuance of emergency use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Pub. L. 108-276). The FD&C Act permits the Commissioner to authorize the use of unapproved medical products or unapproved uses of approved medical products during an emergency declared under section 564 of the FD&C Act. Public comments are due April 9, 2016.
• On March 9, 2016, FDA issued a notice entitled, “Investigational Device Exemptions Reports and Records.” FDA is seeking public comments to determine if wider distribution of the investigational device exemption (IDE) supplement is in the interest of the public health. Public comments are due April 9, 2016.
• On March 9, 2016, the National Institutes of Health (NIH) issued an information collect request entitled, “NEXT Generation Health Study.” NIH is seeking comments on the following points: (1) whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) the quality, utility, and clarity of the information to be collected; and (4) options to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Public comments are due May 9, 2016.
• On March 10, 2016, FDA published a notice entitled, “Center for Devices and Radiological Health: Experiential Learning Program.” In this notice, the FDA Center for Devices and Radiological Health (CDRH) announces the 2016 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP.
• On March 11, 2016, CMS published a number of information collection notices. The notices covered the following topics: (1) Comprehensive Outpatient Rehabilitation Facility (CORF) Eligibility and Survey Forms and Supporting Regulations; (2) Notice of Denial of Medical Coverage (or Payment); and (3) Home Health Change of Care Notice (HHCCN). On the same day, CMS released notices of proposed and revised information collections, which covered the following: (1) Notice of Denial of Medicare Prescription Drug Coverage; (2) Student Health Insurance Coverage; (3) Minimum Essential Coverage under the Affordable Care Act (ACA); and (4) Long Term Care Hospital (LCTH) Continuity Assessment Record and Evaluation (CARE) Data Set.
• On March 11, 2016, the Centers for Disease Control & Prevention (CDC) published an information collection notice on a proposed CDC survey study entitled, “Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Nursing Homes.” Public comments on the information collection burdens associated with this survey are due May 10, 2016.

Event Notices

• March 21-23, 2016, the Department of Veteran’s Affairs (VA) will convene a meeting entitled, “VA Commission on Care.” The purpose of the Commission is to examine the access of veterans to health care from the Department of Veterans Affairs and strategically examine how best to organize the Veterans Health Administration, locate health care resources, and deliver health care to veterans during the next 20 years.
• March 31, 2016, CMS will hold a public conference to discuss potential improvements to the HHS Risk Adjustment methodology for the 2018 benefit year and beyond.
• April 8, 2016, the CDC will hold a teleconference entitled, “State, Tribal, Local and Territorial Subcommittee.” The STLT Subcommittee members will discuss progress on implementation of ACD-adopted recommendations related to the health departments of the future, additional developments that may expand these recommendations, and how CDC can best support STLT health departments.
• April 11, 2016, NIH National Cancer Institute will hold a public meeting entitled, “Advocacy Community Engagement in Future National Cancer Research Initiatives.”
• April 25-27, 2016, FDA, in co-sponsorship with the Drug Information Association (DIA), is announcing a public conference entitled “Tenth Annual DIA/Food and Drug Administration Statistics Forum--2016.” This public conference is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop and review new drugs and biologics. A primary focus for this public conference will be to establish an ongoing dialogue between industry and regulatory Agencies--emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials and measuring the progress being made in designing and implementing innovative solutions.
• May 2, 2016, FDA is announcing a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices.
• May 20, 2016, FDA will hold a public hearing entitled, “Generic Drug User Fee: Regulatory Science Initiatives.” The hearing will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On March 9, 2016, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a full committee markup entitled, “Pending Legislation/King Nominations.” At the markup, the following bills were favorably reported out of the HELP Committee: S.1878, the "Advancing Hope Act of 2015"; S.1077, the "Advancing Breakthrough Medical Devices for Patients Act of 2015"; S.1101, the "Medical Electronic Data Technology Enhancement for Consumers Health Act"; S.2055, the "Medical Countermeasures Innovation Act of 2015"; S.1767, the "Combination Products Innovation Act of 2015"; S.1597, the "Patient Focused Impact Assessment Act of 2015"; and S.2512, the “Adding Zika Virus to the FDA Priority Review Voucher Program Act”.
• On March 9, 2016, the Senate Appropriations Subcommittee on Interior, Environment and Related Agencies held a hearing entitled, “Indian Health Service Budget.” The witnesses included Mary Smith, Principal Deputy Director, Indian Health Services; Elizabeth Fowler, Deputy Director for Management Operations, Indian Health Services; and Gary Hartz, Director of the Office of Environmental Health and Engineering, Indian Health Services.
• On March 10, 2016, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, “Affordable Care Act CO-OP Program.” Witnesses for this hearing included: Andy Slavitt, Acting Administrator, CMS; Kevin Counihan, Marketplace Chief Executive Officer and Deputy Administrator, CMS; and Scott Harrington, Chair of the Health Care Management Department at the Wharton School, University of Pennsylvania.
• On March 8, 2016, the Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released draft legislation of the Mental Health Reform Act of 2016. In a related press release, Chairman Alexander said that, “this bill will help address this crisis by ensuring our federal programs and policies incorporate proven, scientific approaches to improve care for patients. States like Tennessee and local governments are on the forefront in treating mental illness and substance abuse, and this legislation will support their efforts so people can get the help they need.”
• On March 9, 2016, Senate Majority Leader Mitch McConnell (R-KY) was joined by ten other Senate Republicans insending a letter to Acting CMS Administrator Andy Slavitt regarding concerns with the proposed policy changes in the 2017 Advance Notice that would reduce payments under the Medicare Advantage Program. “Recognizing the serious threat these proposals pose to the health coverage of Medicare Advantage enrollees, we strongly recommend that you carefully consider the impact of these changes on Medicare beneficiaries and, instead, adopt policies to strengthen Medicare Advantage,” the letter stated.

House of Representatives

1. The House has adjourned and will reconvene on Monday, March 14, 2016.
2. On March 8, 2016, House Energy & Commerce Committee Chairman Fred Upton (R-MI); Rep. Tim Murphy (R-PA),Chairman, Subcommittee on Oversight and Investigations; and Rep. Joe Pitts (R-PA), Chairman, Subcommittee on Health, sent a letter to America’s Health Insurance Plans (AHIP) regarding 2015 CMS Reinsurance Program payments. The letter stated that the Committee is seeking information from AHIP on the reinsurance payments made to insurers by CMS.

III. REPORTS, STUDIES, & ANALYSES

• On March 7, 2016, Government Accountability Office (GAO) released a report entitled, “Provider Networks: Comparison of Child-Focused Network Adequacy Standards between CHIP and Private Health Plans.” GAO was asked to review the inclusion of pediatric providers, including children’s hospitals—where many children access pediatric specialists—in CHIP and QHP networks. Officials from most of the selected states told GAO that they rely primarily on complaints, network changes, and other concerns to prompt the frequency with which they monitor QHPs’ network adequacy.
• On March 8, 2016, the HHS Office of The Assistant Secretary for Planning and Evaluation (ASPE) released a report entitled, “Observations on Trends in Prescription Drug Spending.” The report stated that, “factors underlying the rise in prescription drug spending from 2010 to 2014 can be roughly allocated as follows: 10 percent of that rise was due to population growth; 30 percent to an increase in prescriptions per person; 30 percent to overall, economy-wide inflation; and 30 percent to either changes in the composition of drugs prescribed toward higher price products or price increases for drugs that together drove average price increases in excess of general inflation.”

IV. OTHER HEALTH POLICY NEWS

• On March 10, 2016, the New Hampshire House of Representatives voted, by a 216-145 margin, to pass legislation that would reauthorize the State’s expansion of Medicaid under the ACA for an additional two years, through 2018. The bill’s outlook in the State Senate is still to be determined.