A&B Healthcare Week in Review, December 16, 2016

I. Regulations, Notices, & Guidance

• On December 12, 2016, the Food and Drug Administration (FDA) issued a revised guidance entitled, Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. The guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to the FDA.
• On December 12, 2016, the Center for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period entitled, Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities--Third Party Payment. The interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such payments directly, through a parent organization, or through a third party. These requirements are intended to protect patient health and safety; improve patient disclosure and transparency; ensure that health insurance coverage decisions are not inappropriately influenced by the financial interests of dialysis facilities rather than the health and financial interests of patients; and protect patients from mid-year interruptions in coverage. The interim final rule with comment period is effective on January 13, 2017 and comments are due by January 11, 2017.
• On December 12, 2016, the Center for Disease Control and Prevention (CDC) issued a final rule entitled, World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements. The final rule addresses public comments received during the notice of proposed rulemaking published on August 17, 2016, as well as finalizing the three interim final rules promulgated since 2011. The rule is effective on January 17, 2017.
• On December 13, 2016, the Department of Health and Human Services (HHS) issued a notice entitled, Announcement of Requirements and Registration for Privacy Policy Snapshot Challenge. According to HHS, the Model Privacy Notice (MPN) is a voluntary, openly available resource designed to help health technology developers who collect digital health data clearly convey information about their privacy and security policies to their users. Similar to a nutrition facts label, the MPN provides a snapshot of a product’s existing privacy practices, encouraging transparency and helping consumers make informed choices when selecting products. The MPN does not mandate specific policies or substitute for more comprehensive or detailed privacy policies. The Privacy Policy Snapshot Challenge is a call for designers, developers, and health data privacy experts to create an online MPN generator. Submissions are due by April 10, 2017.
• On December 13, 2016, the Drug Enforcement Administration (DEA) issued a final rule entitled, Establishment of a New Drug Code for Marihuana Extract. The final rule creates a new Administration Controlled Substances Code Number for “Marihuana Extract.” According to the DEA, the code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions.
• On December 13, 2016, the FDA issued a final rule entitled, Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program. The final rule amends the FDA’s regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work the FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA). The rule is effective on January 13, 2017.
• On December 13, 2016, the FDA issued a notice entitled, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2017. The notice announces the fiscal year (FY) 2017 fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by FSMA. The fee is effective on January 13, 2017 and will remain in effect through September 30, 2017.
• On December 13, 2016, the FDA issued a guidance entitled, Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'). The guidance describes the Center for Devices and Radiological Health's (CDRH) policy for notifying the public about medical device "emerging signals." The guidance describes the factors CDRH intends to consider in deciding whether to notify the public about an emerging signal and the processes and timelines it intends to follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options. Comments may be submitted at any time.
• On December 13, 2016, the Department of Veterans Affairs (VA) issued a final rule with comment period entitled, Advanced Practice Registered Nurses. The final rule with comment period amends the VA’s medical regulations to permit full practice authority of three roles of the VA advanced practice registered nurses (APRN) when they are acting within the scope of their VA employment. Certified Registered Nurse Anesthetists (CRNA) will not be included in the VA’s full practice authority under this final rule, but comment is requested on whether there are access issues or other unconsidered circumstances that might warrant their inclusion in a future rulemaking. The final rule with comment period establishes the professional qualifications an individual must possess to be appointed as an APRN within the VA, establishes the criteria under which the VA may grant full practice authority to an APRN, and defines the scope of full practice authority for each of the three roles of an APRN. The final rule is effective on January 13, 2017. Comments on full practice authority for CRNA’s are due by January 13, 2017.
• On December 13, 2016, the VA issued a notice entitled, Reasonable Charges for Medical Care or Services; v3.21, 2017 Calendar Year Update and National Average Administrative Prescription Drug Charge Update. The notice updates the data for calculating the “Reasonable Charges” collected or recovered by the VA for medical care or services. The notice also updates the “National Average Administrative Prescription Costs” for purposes of calculating the VA’s charges for prescription drugs that were not administered during treatment, but provided or furnished by the VA to a veteran.
• On December 14, 2016, the Internal Revenue Service (IRS) issued final regulations entitled, Premium Tax Credit Regulation VI. The final regulations relate to the health insurance premium tax credit (premium tax credit). The final regulations affect individuals who enroll in qualified health plans through Health Insurance Exchanges (Exchanges, also called Marketplaces) and claim the premium tax credit, and Exchanges that make qualified health plans available to individuals and employers. The final regulations also affect individuals who are eligible for employer-sponsored health coverage.
• On December 14, 2016, HHS issued a final rule entitled, Compliance with Title X Requirements by Project Recipients in Selecting Subrecipients. The final rule amends HHS regulations that apply to Title X Project Grants for Family Planning Services. The final rule amends eligibility requirements to require that no recipient making subawards for the provision of services as part of its Title X project may prohibit an entity from participating for reasons other than its ability to provide Title X services.
• On December 14, 2016, the FDA issued a guidance entitled, Use of Electronic Informed Consent-Questions and Answers. The guidance is intended for institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research under HHS and/or FDA regulations. The guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. The guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. Comments may be submitted at any time.
• On December 15, 2016, the FDA issued a proposed rule entitled, List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act. The FDA is proposing a regulation to identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the FD&C Act, although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the FDA proposes to place six bulk drug substances on the list. The proposed rule also identifies four bulk drug substances that the FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking. Comments are due by March 16, 2017.
• On December 15, 2016, the FDA issued a guidance entitled, Gifts to FDA: Evaluation and Acceptance. The Secretary of HHS has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. The guidance provides the process and principles to be used in implementing this authority. Comments may be submitted at any time.
• On December 15, 2016, CMS issued a notice entitled, Medicare Program; Start-up Funding in Support of the Vermont All-Payer Accountable Care Organization (ACO) Model - Cooperative Agreement. The notice announces the issuance of the November 23, 2016 single-source cooperative agreement funding opportunity available solely to Vermont’s Agency of Human Services in order to provide care coordination and bolster collaboration for practices and community-based health care providers as part of the Vermont All-Payer Accountable Care Organization (ACO) Model.
• On December 16, 2016, the FDA issued a final rule entitled, Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. The FDA has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, the FDA is banning these devices.
• On December 16, 2016, the FDA issued a final rule with comment period entitled, Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease. The final rule with comment period amends the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the "low fat" definition and/or the minimum nutrient content requirement to be eligible to bear the claim. The FDA is taking this action in response to a petition submitted by the American Heart Association (the petitioner). The amendment expands the use of this health claim to certain fruits and vegetables that are currently ineligible for the health claim. Comments are due 75 days after date of publication in the Federal Register (expected to be March 6, 2017).
• On December 16, 2016, the FDA issued a final rule entitled, General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet. The FDA is issuing the final rule to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. The FDA is also establishing a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. In addition, the final rule continues to allow both devices to be exempt from premarket notification and use of the device in traditional health care settings and permits prescription use of pediatric medical cribs and bassinets outside of traditional health care settings.
• On December 16, 2016, CMS issued a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018; Amendments to Special Enrollment Periods and the Consumer Operated and Oriented Plan Program. The final rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health plans; consumer assistance tools; network adequacy; the Small Business Health Options Programs; stand-alone dental plans; fair health insurance premiums; guaranteed availability and guaranteed renewability; the medical loss ratio program; eligibility and enrollment; appeals; consumer operated and oriented plans; special enrollment periods; and other related topics. The final rule is effective on January 17, 2017.

Event Notices

• December 20, 2016: CMS announced it would hold a special Open Door Forum on the Part D appeals process.
• January 9, 2017: HHS announced a meeting of the National Advisory Committee on Children and Disasters (NACCD) and the National Preparedness and Response Science Board (NPRSB). The meeting will be dedicated to the NACCD and NPRSB’s deliberation and vote on the NPRSB-NACCD Joint Youth Leadership Draft Report.
• April 6, 2017: The FDA announced a public meeting on Patient-Focused Drug Development for Sarcopenia. Those wishing to attend must register by March 27, 2017.

II. Congressional Legislation & Committee Action

U.S. Senate

• The Senate has adjourned until January 3, 2017.

House of Representatives

• The House has adjourned until January 3, 2017.

III. Reports, Studies, & Analyses  

• On December 13, 2016, the Office of Inspector General (OIG) released a report entitled, California Did Not Bill Manufacturers for Rebates for Physician-Administered Drugs Dispensed to Enrollees of Some Medicaid Managed-Care Organizations. The report found that from April 1 through December 31, 2010, the California Department of Health Care Services did not always comply with Federal Medicaid requirements for billing manufacturers for rebates for physician-administered drugs dispensed to enrollees of Medicaid managed-care organizations (MCOs). For the 20 MCOs the OIG reviewed, the California Department of Health Care Services billed for rebates for physician-administered drugs dispensed by 7 MCOs. However, the California Department of Health Care Services did not bill for rebates for physician-administered drugs dispensed by the remaining 13 MCOs.
• On December 13, 2016, the OIG released a report entitled, Audit of Medicaid Capitation Payments for Deceased Beneficiaries in Florida. The report found that Florida's Agency for Health Care Administration did not always stop making capitation payments after a beneficiary's death, despite its efforts to identify and recover any overpayments. Of the 124 capitation payments in the OIG’s random sample selected from payments to beneficiaries whose dates of death (DODs) preceded the payment date, Florida's Agency for Health Care Administration recovered 10 payments prior to the start of the audit and 1 was not recoverable. For the remaining 113 capitation payments, Florida's Agency for Health Care Administration made overpayments totaling $192,000 ($112,000 Federal share). During the course of the OIG’s audit, the Florida's Agency for Health Care Administration adjusted 34 of the 113 payments totaling $64,948. On the basis of the OIG’s sample results, the OIG estimated that Florida's Agency for Health Care Administration made overpayments to managed care organizations (MCOs) totaling $26.2 million ($15.4 million Federal share) during the OIG’s audit period. These overpayments amount to approximately 2 percent of the $1.3 billion that Florida's Agency for Health Care Administration paid to MCOs from July 1, 2009, through November 5, 2014, on behalf of deceased Medicaid beneficiaries. 
• On December 14, 2016, the OIG released a report entitled, Oregon State Medicaid Fraud Control Unit: 2016 Onsite Review. The report found that for fiscal years (FYs) 2013 through 2015, the Oregon Unit reported obtaining 92 criminal convictions, 34 civil judgments and settlements, and combined criminal and civil recoveries of nearly $33 million. The OIG found that the Oregon Unit was generally in compliance with applicable laws, regulations, and policy transmittals; however, the OIG identified three areas where the Unit should improve its adherence to performance standards and its compliance with applicable Federal requirements. Specifically, the Unit did not fully secure its case files, part of the Unit's memorandum of understanding with two of its State partners was inconsistent with the Federal regulation governing Medicaid payment suspensions, and the Unit did not report some convictions and adverse actions to Federal partners within the appropriate timeframes.
• On December 15, 2016, the Government Accountability Office (GAO) released a report entitled, Medicare: Initial Results of Revised Process to Screen Providers and Suppliers, and Need for Objectives and Performance Measures. The report found that the GAO’s analysis of CMS’s Medicare enrollment data found that CMS used its revised enrollment screening process to screen and revalidate over 2.4 million unique new applications and existing enrollment records. The GAO's analysis showed that the screening resulted in over 23,000 new applications being denied or rejected and over 703,000 existing enrollment records being deactivated or revoked. CMS estimates the revised process avoided $2.4 billion in Medicare payments to ineligible providers and suppliers from March 2011 to May 2015 and resulted in other benefits, such as more accurate provider and supplier enrollment data. In June 2015, the GAO reported some inaccuracies in the enrollment data after the revised process took effect, such as potentially ineligible practice location addresses, which CMS has taken action to address. 
• On December 15, 2016, the GAO released a report entitled, Newborn Screening Timeliness: Most States Had Not Met Screening Goals, but Some Are Developing Strategies to Address Barriers. The report found that most states that reported timeliness data had not screened newborns within recommended goals to detect conditions that may require treatment. HHS’s Advisory Committee on Heritable Disorders in Newborns and Children recommended time-frame goals in 2015 for newborn screening, such as reporting all results within 7 days of birth. Data provided by 38 states for 2012-2015 showed that states generally had not met the committee's suggested benchmark of meeting each time-frame goal for at least 95 percent of specimens, which the committee encouraged states to achieve by 2017. Missing data and variations in data collection limit a full understanding of timeliness trends, but HHS's Health Resources and Services Administration (HRSA) has supported activities to address these challenges. HRSA supports the Newborn Screening Technical assistance and Evaluation Program (NewSTEPs), which collects newborn screening data. NewSTEPs has been taking steps to improve data for future analysis, such as by clarifying data definitions and working with states to help ensure they use these definitions when submitting timeliness data.
• On December 15, 2016, the GAO released a report entitled, Patient Protection and Affordable Care Act: Results of Enrollment Testing for the 2016 Special Enrollment Period. The report found that the federal and selected state-based marketplaces approved health-insurance coverage and subsidies for 9 of 12 of the GAO's fictitious applications made during a 2016 Special Enrollment Period (SEP). The remaining 3 fictitious applicants were denied. The marketplaces instructed 6 of 12 applicants to provide supporting documentation, such as a copy of a recent marriage certificate, related to the SEP triggering event; the remaining 6 of 12 were not instructed to do so. For 5 applicants, the GAO provided no documents to support the SEP triggering event, but coverage was approved anyway. Officials from the marketplaces explained that they do not require applicants to submit documentation to support certain SEP triggering events. For other SEP triggering events, CMS officials explained that the standard operating procedure in the federal Marketplace is to enroll applicants first, and verify documentation to support the SEP triggering event after enrollment. The officials also noted that all applicants must attest to their eligibility for enrollment. 

IV. Other Health Policy News

• On December 12, 2016, the Federal Trade Commission (FTC) issued a Commission policy statement entitled, Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs. The Statement describes the level of substantiation that the Commission expects for marketing claims for over-the-counter (OTC) homeopathic drugs. It also recognizes that marketing claims for OTC homeopathic products for an unsubstantiated indication might be made non-deceptive by the inclusion of additional explanatory information that effectively communicates to consumers that there is no scientific evidence that the product works and that the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
• On December 13, 2016, CMS released a fact sheet entitled, Pre-Enrollment Verification for Special Enrollment Periods. The fact sheet announces a pilot program starting in 2017 that will test the impact of pre-enrollment verification of special enrollment period eligibility through HealthCare.gov on compliance, enrollment, continuity of coverage, the risk pool, and other outcomes.
• On December 13, 2016, CMS issued a policy-based payments bulletin entitled, Temporary Manual Adjustment for Policy-Based Payments. The bulletin provides guidance on how CMS will assist issuers to ensure they have sufficient cash flow during the time lag involved with the transition to the 2017 coverage year as issuers collect premiums and report effectuations to CMS during the 2017 Open Enrollment.
• On December 13, 2016, CMS issued a fact sheet entitled, Promoting Transparency and Appropriate Coverage for Dialysis Patients. The fact sheet provides information on CMS’s interim final rule with comment period entitled, Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities--Third Party Payment.
• On December 14, 2016, CMS released a Biweekly Enrollment Snapshot for weeks 5 and 6 of Open Enrollment for the Health Insurance marketplace for 2017. According to CMS, as of December 10, over 4 million people had selected plans using HealthCare.gov since Open Enrollment began November 1, including over 1.1 million new consumers and 2.9 million renewing their coverage.
• On December 14, 2016, CMS released a fact sheet entitled, Long-Term Care Hospital (LTCH) Compare Website. The fact sheet contains information about the LTCH Compare website that was launched on December 14, 2016.
• On December 14, 2016, CMS released a fact sheet entitled, Inpatient Rehabilitation Facility (IRF) Compare Website. The fact sheet contains information about the IRF Compare website that was launched on December 14, 2016.
• On December 14, 2016, CMS issued an informational bulletin entitled, Indian Provisions in the Final Medicaid and Children’s Health Insurance Program Managed Care Regulations.  The informational bulletin summarizes the relevant Indian provisions of the final Medicaid and the Children’s Health Insurance Program (CHIP) managed care regulation into one document, clarifies current statute and regulation regarding mandatory enrollment of Indians into managed care, and provides sample language for an Indian Addendum that can be offered to managed care plans on a voluntary basis when executing network provider agreements with Indian health care providers (IHCPs).
• On December 15, 2016, CMS released a FAQ document entitled, FAQs concerning Medicaid Beneficiaries in Home and Community-Based Settings who Exhibit Unsafe Wandering or Exit-Seeking Behavior. The FAQs are in response to the regulation issued by CMS on January 16, 2014. The document begins with an articulation of how regulatory requirements can be met by settings providing home and community-based services (HCBS) to individuals with such behavior, and concludes with describing some options for HCBS stakeholder education and consideration.
• On December 15, 2016, CMS announced the Medicare-Medicaid Accountable Care Organization (ACO) Model. According to CMS, the new initiative is designed to improve the quality of care and lower costs for beneficiaries who are enrolled in both Medicare and Medicaid. The Medicare-Medicaid ACO Model builds on the current Medicare Shared Savings Program and advances efforts to partner with states in transforming the health care delivery system.
• On December 15, 2016, CMS issued a fact sheet entitled, Medicare-Medicaid Accountable Care Organization (ACO) Model. The fact sheet discussed the Medicare-Medicaid ACO Model.
• On December 15, 2016, CMS issued a fact sheet entitled, Comprehensive Primary Care Plus (CPC+) 2018 Payer and Practice Solicitation. The fact sheet provides information on the CPC+ Pay and Practice Solicitation.
• On December 15, 2016, CMS announced more new opportunities for clinicians to join Advanced Alternative Payment Models (APMs) to improve care and earn additional incentive payments under the Quality Payment Program. Beginning in January and February 2017, CMS will open applications for new rounds of two CMS Innovation Center models for the 2018 performance year – for new practices and payers in the CPC+ model and new participants in the Next Generation ACO model.
• On December 16, 2016, CMS issued a fact sheet entitled, Final HHS Notice of Benefit and Payment Parameters for 2018. The fact sheet summarizes key policies in the HHS Notice of Benefit and Payment Parameters for the 2018 final rule.
• On December 16, 2016, CMS released key dates for Calendar Year 2017 for QHP certification in the Federally-facilitated Marketplaces, rate review, risk adjustment and reinsurance.