A&B Healthcare Week in Review, January 13, 2017

I. Regulations, Notices, & Guidance

• On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry. The draft guidance addresses questions about and clarifies the FDA's expectations for annual reporting to the FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA). Comments are due by March 13, 2017.
• On January 9, 2017, the FDA issued a guidance entitled, Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus. The guidance notifies blood establishments that the FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with the FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The guidance applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. Comments may be submitted at any time.
• On January 9, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies. The final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. According to CMS, the requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers. The final rule is effective on July 13, 2017.
• On January 10, 2017, the Department of Veterans Affairs (VA) issued a notice entitled, Notice of Availability of a Record of Decision (ROD) for the Reconfiguration of VA Black Hills Health Care System (BHHCS). The notice announces the availability of the record of decision (ROD) for the Reconfiguration of VA Black Hills Health Care System (BHHCS). The ROD states the decision to implement VA’s preferred alternative as described in the Final EIS. Environmental consequences of the action are discussed in the ROD, along with the required minimization and mitigation measures.
• On January 10, 2017, the FDA issued a final guidance entitled, Current Good Manufacturing Practice Requirements for Combination Products. The final guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which was published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios. Comments may be submitted at any time.
• On January 10, 2017, the FDA issued a draft guidance entitled, Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery. The draft guidance is intended to promote the safe use of nonprescription (also referred to as over-the-counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart. Comments are due by March 13, 2017.
• On January 10, 2017, the FDA issued a notice entitled, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; 4- Methylethcathinone and Nine Other Substances. The notice provides interested persons with the opportunity to submit written comments, and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. According to the FDA the comments received in response to this notice and/or public meeting will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2017. Comments are due by February 10, 2017.
• On January 11, 2017, CMS issued a proposed rule entitled, Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics. The proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and customfabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom-fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, this rule would remove the current exemption from accreditation and quality standards for certain practitioners and suppliers. Comments are due by March 13, 2017.
• On January 11, 2017, the Office of Inspector General (OIG) issued a final rule entitled, Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General’s Exclusion Authorities. The final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS). The final rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions.
• On January 11, 2017, the Government Accountability Office (GAO) issued a notice entitled, Request for Medicaid and CHIP Payment and Access Commission Nominations. The notice announces that the GAO is now accepting nominations to the Medicaid and CHIP Payment and Access Commission (MACPAC) that will be effective May 1, 2017. Letters of nomination and resumes should be submitted no later than February 24, 2017.
• On January 11, 2017, the FDA issued a final order entitled, Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens. The final order reclassifies antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
• On January 11, 2017, CMS issued a technical guidance entitled, Standards for Self-Insured Non-Federal Governmental Health Plans and Health Insurance Issuers Offering Group and Individual Health Coverage Using the HHS-Administered Federal External Review Process. The technical guidance replaces the technical guidance issued June 22, 20111 with standards adopted in the final regulation at 76 FR 37208 that further define requirements under Public Health Service Act (PHS Act) section 2719(b)(1). Since the June 22, 2011 technical guidance was issued, MAXIMUS (a Federal contractor) has started conducting the HHS-Administered Federal external review process, which previously was conducted by the Office of Personnel Management (OPM). This Technical Release outlines the requirements for group health plans and health insurance issuers that are subject to the HHS-Administered Federal external review process under section 2719(b)(2) of the PHS Act.
• On January 12, 2017, the FDA issued a draft guidance entitled, 180-Day Exclusivity: Questions and Answers. The draft guidance is intended to address questions that have been raised about the provisions of the FD&C Act that relate to generic drug exclusivity, which commonly is known as "180-day exclusivity" for generic drug products. As a general matter, the FDA has implemented these statutory provisions within the context of application-specific decisions. Some FDA decisions have been made publicly available (e.g., in FDA citizen petition responses and documents released in litigation). The FDA intends to update this guidance to include additional questions and answers as appropriate. Comments are due by March 14, 2017.
• On January 12, 2017, the FDA issued a guidance entitled, Emergency Use Authorization of Medical Products and Related Authorities. The purpose of the guidance is to explain the FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the FD&C Act as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats. Comments may be submitted at any time.
• On January 12, 2017, the FDA issued a guidance entitled, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions. The purpose of the guidance is to provide greater clarity for FDA staff and Investigational Device Exemptions (IDE) application sponsors and sponsor-investigators regarding the principal factors that the FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others. Comments may be submitted at any time.
• On January 12, 2017, the FDA issued a draft guidance entitled, How to Prepare a Pre-Request for Designation. The purpose of the draft guidance is to explain the Pre-Request for Designation (RFD) process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. Comments are due by March 14, 2017.
• On January 12, 2017, the FDA issued a revised draft guidance entitled, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application. The revised draft guidance describes the conditions under which the FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which the FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. The revised draft guidance replaces the draft guidance of the same title issued in February 2015. Comments are due by March 14, 2017.
• On January 12, 2017, the FDA issued a final guidance entitled, Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. The final guidance describes the conditions under which the FDA does not intend to take action for violations of certain provisions of the FD&C Ac, when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products. Comments may be submitted at any time.
• On January 12, 2017, the Centers for Disease Control and Prevention (CDC) issued a final rule entitled, Control of Communicable Diseases. The final rule amends the CDC’s regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. According to the CDC, these amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent 2 the importation and spread of communicable diseases affecting human health into the United States and interstate.
• On January 13, 2017, the FDA issued a revised draft guidance entitled, Control of Listeria monocytogenes in Ready-To-Eat Foods. According to the FDA, the revised draft guidance is intended for any person who is subject to the FDA’s regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufactures, processes, packs, or holds readyto-eat (RTE) foods. The revised draft guidance is intended to help such persons comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes. Comments are due by July 17, 2017.
• On January 13, 2017, the FDA issued a draft guidance entitled, Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. The purpose of the draft guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA submission. Comments are due by March 20, 2017.
• On January 13, 2017, CMS issued a final rule entitled, Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures. The final rule revises the procedures that HHS follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, the final rule revises procedures that CMS and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
• On January 13, 2017, HHS issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule updates and modernizes the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitates information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. According to HHS, these modifications also help clarify the regulations and reduce unnecessary burden.

Event Notices

• March 9, 2017: The FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season.
• March 13, 2017: The FDA announced a public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products.
• March 17, 2017: The FDA announced a public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee. The committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products. Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products.
• February 3, 2017: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The theme of the February meeting will be clinical trials for Alzheimer’s disease and related dementias and recruitment challenges. Additional presentations in the afternoon will include updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council’s 2017 Recommendations, due in April 2017.
• February 14 – 15, 2017: The FDA announced a public hearing regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. The hearing will focus on partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk-based decision making; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation’s entire food safety system.

II. Congressional Legislation & Committee Action

U.S. Senate

• There were no healthcare related hearings this week.

House of Representatives

• There were no healthcare related hearings this week.

III. Reports, Studies, & Analyses 

• On January 9, 2017, the OIG released a report entitled, Colorado Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs. The report found that the Colorado Department of Health Care Policy and Financing (State agency) did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs. The State agency did not invoice manufacturers for rebates associated with $13 million ($6.5 million Federal share) in physician-administered drugs. Of this amount, $10.5 million ($5.2 million Federal share) was for single-source drugs, and $2.6 million ($1.3 million Federal share) was for top-20 multiple-source drugs. Because the State agency's internal controls did not always ensure that it invoiced manufacturers to secure rebates, the State agency improperly claimed Federal reimbursement for these single-source drugs and top-20 multiple-source drugs. Further, the State agency did not submit the utilization data necessary to secure rebates for all other physician-administered drugs. Although the State agency generally collected the drug utilization data necessary to invoice the manufacturers for rebates associated with these claims, providers submitted claims totaling $2.6 million ($1.3 million Federal share) that did not have National Drug Codes (NDCs). Furthermore, under the Medicaid drug rebate program, claims totaling $635,000 ($317,000 Federal share), which contained NDCs, could have been eligible for rebates.
• On January 9, 2017, the GAO released a report entitled, Public Health Emergencies: HHS Needs to Better Communicate Requirements and Revise Plans for Assessing Impact of Personnel Reassignment. The report found that the Office of the Assistant Secretary for Preparedness and Response (ASPR), within HHS, has primary federal responsibility for overseeing medical and public health preparedness and response and coordinating the reassignment of personnel in a public health emergency. ASPR has developed processes to review and approve states’ and tribes’ requests for personnel reassignment. Should ASPR receive a request for personnel reassignment, it would convene relevant officials from the HHS agencies and offices from which states were requesting reassignment, with the goal of the agencies and offices considering requests and ASPR communicating reassignment decisions within four days. However, ASPR’s efforts to communicate these processes to the HHS agencies and offices that administer programs eligible for personnel reassignment have been limited.
• On January 10, 2017, the GAO released a report entitled, Indian Health Service: Actions Needed to Improve Oversight of Quality of Care. The report found that the Indian Health Service’s (IHS) oversight of the quality of care provided in its federally operated facilities has been limited and inconsistent. According to the GAO, while some oversight functions are performed at the headquarters level, the agency has delegated primary responsibility for the oversight of care to nine area offices. Area officials stated that the oversight they provide has included, for example, holding periodic meetings with facility staff, reviewing available quality performance data and reviewing adverse events. However, GAO found that this oversight was limited and inconsistent across IHS facilities, due in part to a lack of agency-wide quality of care standards. Specifically, GAO found: (1) variation in the frequency of governing board meetings and the extent to which quality was a standing agenda item at these meetings; (2) limited and inconsistent reporting of quality data across IHS areas and facilities; and (3) inconsistent reporting of adverse events at federally operated facilities.
• On January 10, 2017, CMS issued a report entitled, Health Insurance Marketplaces 2017 Open Enrollment Period: January Enrollment Report. The report provides interim data on enrollment-related activity in the Marketplaces during the first part of the 2017 Open Enrollment Period (OEP) for all 50 states and the District of Columbia (covering the period from November 1, 2016 through December 24, 2016). The report indicates that, as of December 24, 2016, more than 11.5 million individuals are signed up for 2017 coverage through the Marketplaces, an increase of 286,000 people compared to the comparable period last year. The addendum to the report can be found here.
• On January 12, 2017, the OIG released a report entitled, Louisiana Did Not Always Comply With Federal and State Requirements for Claims Submitted for the Nonemergency Medical Transportation Program. The report found that during the period April 1, 2013, through March 31, 2014, the Louisiana Department of Health and Hospitals claimed Federal Medicaid reimbursement for some nonemergency medical transportation (NEMT) services claims submitted by transportation providers that did not comply with certain Federal and State requirements. Of the 120 NEMT claims in the OIG’s sample, the Louisiana Department of Health and Hospitals properly claimed Medicaid reimbursement for 83 claims. However, the remaining 37 claims contained services that did not comply with certain Federal and State regulations. Of the 37 claims, 14 contained more than 1 deficiency. The claims for unallowable services were made because the Louisiana Department of Health and Hospitals’ policies and procedures for overseeing the Medicaid program did not ensure that providers complied with Federal and State requirements for documenting and claiming NEMT services. On the basis of the OIG’s sample results, the OIG estimated that the Louisiana Department of Health and Hospitals claimed approximately $1.1 million in improper Federal Medicaid reimbursement.
• On January 12, 2017, the OIG released a report entitled, Delaware Did Not Bill Manufacturers for Some Rebates for Physician-Administered Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. For the period January 1 through December 31, 2013, the Delaware Department of Health and Social Services, Division of Medicaid and Medical Assistance did not fully comply with Federal Medicaid requirements for billing manufacturers for some rebates for physician-administered drugs dispensed to enrollees of managed-care organizations (MCOs). The Delaware Department of Health and Social Services, Division of Medicaid and Medical Assistance properly billed for most rebates for MCO drug utilization in the OIG’s judgmental sample. However, they did not have valid National Drug Codes (NDCs) for other drug utilization data submitted by MCOs for physician-administered drugs, and they did not bill manufacturers for rebates for these drugs. The OIG estimate that the Delaware Department of Health and Social Services, Division of Medicaid and Medical Assistance did not bill manufacturers for rebates totaling $230,000 ($127,000 Federal share). The OIG did not have enough information to determine an estimate for some of the utilization. The Delaware Department of Health and Social Services, Division of Medicaid and Medical Assistance did not bill manufacturers for rebates for this utilization because the MCOs submitted this utilization data to the State without valid NDC information. Although the State required MCOs to submit valid NDCs for all physician-administered drug utilization, the Delaware Department of Health and Social Services, Division of Medicaid and Medical Assistance did not ensure that MCOs submitted utilization with valid NDC information. Therefore, the State did not obtain rebates for this utilization.

IV. Other Health Policy News

• On January 9, 2017, HHS released FAQs About Affordable Care Act Implementation Part 36. The FAQs discuss coverage of preventive services under Section 2713 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act.
• On January 11, 2017, CMS issued a fact sheet entitled, Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics. The fact sheet provides and discusses key provisions of the proposed rule.
• On January 11, 2017, the House Energy and Commerce Committee unveiled a web portal entitled, Health Care Central. The portal is dedicated to providing a one stop shop for all things related to health care reform.
• On January 11, 2017, CMS released FAQs on Medicaid Family Planning Services and Supplies. These FAQs provide additional information and address questions raised from previous guidance regarding the delivery of family planning services and supplies to Medicaid beneficiaries.
• On January 12, 2017, CMS released FAQs about Affordable Care Act Implementation Part 37. The FAQs address questions related to the application of the Affordable Care Act market reforms to health reimbursement arrangements (HRAs) and employer payment plans (EPPs).
• On January 12, 2017, CMS released FAQs on the Health Services Initiative. The FAQs provide additional information and address questions raised regarding health services initiatives.
• On January 12, 2017, CMS announced the Pennsylvania Rural Health Model. According to CMS, the Model seeks to increase rural Pennsylvanians’ access to high-quality care and improve their health, while also reducing the growth of hospital expenditures across payers, including Medicare, and increasing the financial viability of the state’s rural hospitals to ensure continued access to care facilities. Pennsylvania, through its Department of Health, will be a key partner in jointly administering this model with CMS.
• On January 12, 2017, HHS released information that showed that more than 11.8 million Medicare beneficiaries have received discounts over $26.8 billion on prescription drugs – an average of $2,272 per beneficiary – since the enactment of the Affordable Care Act. In 2016 alone, over 4.9 million seniors and people with disabilities received discounts of over $5.6 billion, for an average of $1,149 per beneficiary. This is an increase in savings compared to the 2015 information released this time last year, when 5.2 million Medicare beneficiaries received discounts of $5.4 billion, for an average of $1,054 per beneficiary.