A&B Healthcare Week in Review, July 8, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model.” This major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that the payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes proposals related to the Medicare Shared Saving Program, and the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. In addition, this rule proposes to expand the Medicare Diabetes Prevention Program model. Public comments are due September 6, 2016.
• On July 6, 2016, CMS issued a proposed rule entitled, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Certain Off-Campus Outpatient Departments of a Provider; Hospital Value-Based Purchasing (VBP) Program.” According to CMS, this proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2017 to implement applicable statutory requirements and changes arising from the continuing experience with these systems. In this proposed rule, CMS describes the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this proposed rule, CMS is proposing to make changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. CMS is also proposing to remove the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, CMS is proposing to implement section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus outpatient departments of a provider. Public comments are due September 6, 2016.
• On July 6, 2016, the Internal Revenue Service (IRS) issued a notice of proposed rulemaking (NPRM) entitled, “Premium Tax Credit NPRM VI.” According to the IRS, this outlines proposed regulations relating to the health insurance premium tax credit (premium tax credit) and the individual shared responsibility provision. Public comments are due by September 6, 2016.
• On July 6, 2016, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, “Medication Assisted Treatment for Opioid Use Disorders.” This final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/naloxone (hereinafter referred to as buprenorphine) in the office-based setting. The Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by FDA and allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted.
• On July 6, 2016, SAMHSA issued a supplemental notice of proposed rulemaking (SNPRM) entitled, “Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements.” On March 30, 2016, the Department of Health and Human Services (HHS) published an NPRM to increase the highest patient limit for qualified physicians to treat opioid use. In this SNPRM, HHS seeks further comment on the same reporting requirements outlined in the NPRM. Public comments are due by August 8, 2016.
• On July 6, 2016, HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) issued a request for information (RFI) entitled, “Opioid Analgesic Prescriber Education and Training Opportunities to Prevent Opioid Overdose and Opioid Use Disorder.” According to ASPE, deaths related to opioid analgesic overdose have quadrupled since 1999, and this increase in deaths has been linked to parallel increases in opioid prescribing. As part of its comprehensive response to the opioid epidemic, HHS is actively working to stem overprescribing of opioids in a number of ways, including by providing clinicians with the tools and education they need to make informed prescribing decisions. In particular, HHS has developed a number of activities that support opioid analgesic prescriber education. This RFI seeks comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them. Public comments are due September 8, 2016.
• On July 1, 2016, CMS issued an informational bulletin entitled, “Addendum to 2016 Medicaid Managed Care Rate Development Guide.” Following publication of the Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Final Rule on May 6, 2016, CMS is releasing a revision to the 2016 Medicaid Managed Care Rate Development Guide outlined in this informational bulletin to detail the provisions of the final rule that take effect July 5, 2016. The revised 2016 Medicaid Managed Care Rate Development Guide is in effect as of publication of this bulletin.
• On July 1, 2016, the Center for Consumer Information & Insurance Oversight (CCIIO) issued a notice entitled, “Alternative Schedule for Payment of Charges for Reconciliation of the Cost-sharing Reduction Portion of Advance Payments for the 2014 and 2015 Benefit Years Issuer Agreement.” In the June 17, 2016, Alternative Schedule for Payment of Charges for Reconciliation of the Cost-sharing Reduction Portion of Advance Payments for the 2014 and 2015 Benefit Years FAQ, CMS stated that, for issuers who meet certain requirements, it would provide flexibility on the payment schedule for reconciliation of the cost-sharing reduction component of advance payments to assist issuers with cash flow constraints, to ensure they may continue to provide coverage to enrollees through the end of the benefit year. In order to enter into an installment payment schedule, the issuer must enter into this agreement no later than 11:59 p.m. ET on Tuesday, July 12, 2016.
• On July 5, 2016, the Office of Management and Budget (OMB) received a final rule for review entitled, “FY 2017 Hospice Rate Update.” According to OMB, this annual final rule updates the hospice payment rates and the wage index for fiscal year 2017.
• On July 6, 2016, CMS issued Frequently Asked Questions (FAQs) entitled, “Covered Outpatient Drug Final Rule with Comment.” The FAQs respond to questions raised by various stakeholders regarding the Covered Outpatient Drug Final Rule with Comment final rule that was published in the Federal Register on February 1, 2016 as well as the State Medicaid Director Letter that was issued on February 11, 2016. These answers are intended to provide guidance regarding the Social Security Act and Federal regulations, and CMS may issue additional FAQs in the future.
• On July 7, 2016, FDA issued a notice entitled, “Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability.” FDA is announcing the issuance of an EUA for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas.
• On July 7, 2016, FDA issued a draft guidance entitled, “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” For a drug product compounded by an outsourcing facility to qualify for the exemptions under 19 section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), it must not be “essentially a copy of one or more approved drug products,” and must meet the other conditions in section 503B. This guidance sets forth the FDA’s or policies concerning the essentially a copy provision of section 503B. Public comments are due by October 11, 2016.
• On July 7, 2016, FDA issued a draft guidance entitled, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product, among other conditions. This guidance sets forth the FDA’s policies regarding this provision of section 503A, including the terms commercially available, essentially a copy of a commercially available drug product, and regularly or in inordinate amounts. Public comments are due by October 11, 2016.
• On July 8, 2016, CMS issued a notice entitled, “Medicaid Drug Program - Monthly and Quarterly Drug Reporting Format.” Labelers transmit drug product and pricing data to CMS within 30 days after the end of each calendar month and quarter. CMS calculates the unit rebate amount (URA) and the unit rebate offset amount (UROA) for each new drug application (NDC) and distributes to all State Medicaid agencies. Public comments are due August 11, 2016.
• On July 8, 2016, FDA issued a notice entitled, “List of Information Collections Approved By OMB.” FDA is publishing a list of information collections that have been approved by OMB.
• On July 8, 2016, FDA issued a notice entitled, “Current Good Manufacturing Practice for Positron Emission Tomography Drugs.” Positron emission tomography is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product. FDA’s Current Good Manufacturing Practice (CGMP) regulations are intended to ensure that positron emission tomography (PET) drug products meet the requirements of the FD&C Act regarding safety, identity, strength, quality, and purity.
• On July 8, 2016, FDA issued a notice entitled, “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h.” Manufacturers of biological products must submit a license application for FDA review and approval before marketing a biological product in interstate commerce. Licenses may be issued only upon showing that the establishment and the products for which a license is desired meets standards prescribed in regulations designed to ensure the continued safety, purity, and potency of such products. Public comments are due by September 11, 2016.
• On July 8, 2016, FDA issued a notice entitled, “Updating Abbreviated New Drug Application Labeling after the Marketing Application for the Reference Listed Drug Has Been Withdraw.” This draft guidance describes a process for updating labeling for abbreviated new drug applications (ANDAs) in cases where FDA has withdrawn approval of the new drug application NDA for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness. The process described in this guidance is intended to complement existing Agency authorities and processes. Public comments are due by September 11, 2016.

Event Notices

• July 26 &27, 2016, SAMHSA announced open and closed session meetings with the Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB).
• August 1, 2016, CDC announced a closed meeting with the Board of Scientific Counselors of the National Center for Injury Prevention and Control
• August 11, 2016, CDC announced a public advisory meeting with the State, Tribal, Local and Territorial (STLT) Subcommittee.
• August 22 &23, 2016, FDA announced a public workshop entitled, “Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities.” The purpose of the public workshop is to elaborate key aspects of the ICH Guideline Q3D: Guideline on Elemental Impurities in order facilitate a harmonized interpretation and implementation by industry and regulators.
• September 30, 2016, FDA in cosponsorship with the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) is announcing a public workshop entitled “Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.” The purpose of this workshop is to discuss the increasing prevalence of myopia, as well as suggested clinical trial design attributes for studies using contact lenses or other medical devices to control the progression of myopia.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

Conference Committee

• On July 6, 2016, the Senate and the House convened a conference committee meeting on S.524, the “Comprehensive Addiction and Recovery Act of 2016.” The legislation would authorize the Attorney General and Secretary of HHS to award grants to address the national epidemics of prescription opioid abuse and heroin use, and provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. A copy of the House and Senate conference draft bill may be found here.

House of Representatives

• On July 7, 2016, the House Appropriations on Subcommittee on Labor, HHS, Education, and Related Agencies convened a markup the FY2017 Labor, Health and Human Services, and Education Appropriations Bill.
• On July 7, 2016, the House Ways and Means Subcommittee on Oversight convened a hearing entitled, “Defying the Constitution: The Administration's Unlawful Funding of the Cost Sharing Reduction Program.” The witnesses included John Koskinen, Commissioner, Internal Revenue Service; Mary Wakefield, Acting Deputy Secretary, Department of Health and Human Services; Mark Mazur, Assistant Secretary for Tax Policy, Department of Treasury; and Michael Deich, Senior Advisor for Budget, Office of Management and Budget.
• On July 7, 2016, the House Energy and Commerce Subcommittee on Health convened a hearing entitled, “Examining the Advancing Care for Exceptional Kids Act.” The witnesses included Dr. Jay Berry MD, MPH, Assistant Professor of Pediatrics, Harvard Medical School; Ms. Maria Isabel Frangenberg, Project Coordinator, Family Voices; Dr. Steven Koop MD, Medical Director, Gillette Children’s Specialty Healthcare; Mr. Rick Merrill, President and Chief Executive Officer, Cook Children’s Health System; Mr. Matt Salo, Executive Director, National Association of Medicaid Directors; and Ms. Tish West, Parent of a Child with Medically Complex Conditions.
• On July 8, 2016, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled, “The ACA's Cost Sharing Reduction Program: Ramifications of the Administration's Decision on the Source of Funding for the CSR (Corporate Social Responsibility) Program.” The witnesses included Mr. Doug Badger, Senior Fellow, Galen Institute; Mr. Simon Lazarus, Senior Counsel, The Constitutional Accountability Center; Mr. Tom Miller, Resident Fellow, American Enterprise Institute; and Mr. Morton Rosenberg, Fellow, The Constitution Project.
• On July 7, 2016, House Energy and Commerce Committee and the House Ways and Means Committee released a joint report on the Obama administration’s decision-making processes on the source of funding for the cost sharing reduction (CSR) program.
• On July 5, 2016, the House passed H.R. 5210, the Patient Access to Durable Medical Equipment Act, under suspension. The legislation would postpone for three months a cut to Medicare reimbursement rates for DME that took effect July 1.
• On July 6, 2016, the House passed H.R. 2646, the Helping Families in Mental Health Crisis Act, by a 422-2 vote. The legislation would available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis.
• On July 6, 2016, the House passed H.R. 1270, the Restoring Access to Medication Act, by a 243-164 vote. The legislation would repeal provisions of the Internal Revenue Code, added by the Affordable Care Act (ACA), which limit payments for medications from health savings accounts, medical savings accounts, and health flexible spending arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs).

III. REPORTS, STUDIES, & ANALYSES

• On July 5, 2016, the Congressional Budget Office (CBO) released a cost estimate for H.R. 2646, Helping Families in Mental Health Crisis Act of 2015. CBO estimates that enacting H.R. 2646 would reduce net direct spending in the Medicaid program by $5 million over the 2017-2026 period. CBO also estimates that enacting the legislation would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
• On July 7, 2016, CBO released a cost estimate for the Conference Report for S. 524, the Comprehensive Addiction and Recovery Act of 2016, as posted on the website of the House Energy and Commerce Committee.
• On July 7, 2016, the Government Accountability Office (GAO) released a report entitled, “Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge.” GAO found that, as part of FDA's oversight of drug safety and quality, it generally issued an increasing number of warning letters to sterile injectable drug establishments during the time period GAO reviewed for noncompliance with manufacturing standards outlined in federal regulations. HHS reviewed a draft of this report and reiterated its commitment to addressing drug shortages.
• On July 7, 2016, CBO released a cost estimate for S. 1878, Advancing Hope Act of 2016. The CBO estimates that implementing S. 1878 would cost $12 million over the 2017-2021 period, assuming appropriation of the necessary amounts. CBO also estimates that enacting S. 1878 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.

IV. OTHER HEALTH POLICY NEWS

• On July 6, 2016, HHS Secretary Sylvia M. Burwell announced several new actions the Department is taking to combat the nation’s opioid epidemic. The actions include expanding access to buprenorphine, a proposal to eliminate any potential financial incentive for doctors to prescribe opioids based on patient experience survey questions, and a requirement for Indian Health Service prescribers and pharmacists to check state Prescription Drug Monitoring Program databases before prescribing or dispensing opioids for pain. In addition, the Department is launching more than a dozen new scientific studies on opioid misuse and pain treatment and soliciting feedback to improve and expand prescriber education and training programs.
• On July 1, 2016, Democrats issued their 2016 Democratic Party Platform Draft. Democrats will call for a public health insurance option in their national party platform as well as capping the amount individuals have to pay out-of-pocket every month on prescription drugs. “Americans should be able to access public coverage through Medicare or a public option… [Democrats] will also work to end surprise billing and other practices associated with out of control medical debt…and [Democrats] fight back against insurers trying to impose excessive premium increases,” according to the report.