A&B Healthcare Week in Review

by Alston & Bird
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I. REGULATIONS, NOTICES, & GUIDANCE

  • On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children’s Health Insurance Program (CHIP), and Alternative Benefit Plans.” This final rule will address the application of certain requirements set forth in the Public Health Service Act (“PHS Act”), as amended by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, to coverage offered by Medicaid managed care organizations, Medicaid Alternative Benefit Plans, and CHIP. These regulations are effective on May 29, 2016. The final rule will require states to disclose reasons for any denial of reimbursement or payment for mental health and substance use services. According to CMS, the final rule is expected to benefit approximately 22.3 million Medicaid beneficiaries and 880,000 CHIP beneficiaries in 2016. The final rule was released in conjunction with this week’s National Rx Drug Abuse and Heroin Summit, and it is part of the Administration’s new efforts to combat the opioid abuse epidemic along with the Mental Health Parity and Addiction Equity Act of 2008.
  • On March 29, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a proposed rule entitled, “Medication Assisted Treatment for Opioid Use Disorders." The proposed rule aims to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200. The purpose of the proposed rule is to increase access to treatment for opioid use disorder while reducing the opportunity for diversion of the medication to unlawful use. Comments must be received by May 29, 2016.
  • On March 28, 2016, the White House Office of Management and Budget (OMB) received for review an Equal Employment Opportunity Commission (EEOC) final rule entitled, “Amendments to Regulations Under the Americans With Disabilities Act." This final rule would amend the regulations to implement the equal employment provisions of the Americans with Disabilities Act (ADA) to address the interaction between Title I of the ADA and financial inducements and penalties as part of wellness programs offered through health plans.
  • On March 26, 2016, the Office of Management and Budget (OMB) received for review a CMS proposed rule entitled, “Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (CMS-5517-P),” for review. This proposed rule would implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS and APMs. In additional to repealing the Medicare Sustainable Growth Rate (SGR) formula, MACRA authorizes a new MIPS, which consolidates the current programs of the Physician Quality Reporting System, the Value-Based Modifier, and the Electronic Health Records Incentive Program into a single performance-based payment adjustment program. Additionally, MACRA authorizes incentive payments to providers who participate in eligible APMs.
  • On March 28, 2016, CMS issued an information collection request (ICR) entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Emergency Clearance (CMS’ Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey).” The HIP 2.0 demonstration provides authority for the State to not offer non-emergency medical transportation (NEMT) for the new adult group during the first year of the demonstration (except for pregnant women and individuals determined to be medically frail). Comments are due by April 8, 2016.
  • On March 28, 2016, the Food and Drug Administration (FDA) issued a notice entitled, “Pediatric Studies of Lorazepam; Establishment of Public Docket.” FDA is establishing a public docket to make available to the public a report of the pediatric studies of Lorazepam that were conducted in accordance with the PHS Act and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs. Comments are due by April 28, 2016.
  • On March 28, 2016, Health Resources and Services Administration (HRSA) issued a denial of a petition for rulemaking entitled, "Petitions for Rulemaking; Denials: National Vaccine Injury Compensation Program.” On September 19, 2015, a private citizen submitted an email to the Department of Health and Human Services (HHS) and the Commission, requesting that food allergies be added to the Vaccine Injury Table. The email was considered to be a petition to the Secretary of HHS to propose regulations to amend the Table to add food allergies as an injury associated with vaccines on the Table. In support of the request that food allergies be added to the Table, the petitioner asserts that food proteins present in vaccines cause the development of food allergies. This notice provides reasons for not conducting rulemaking proceedings to add food allergies as an injury associated with vaccines to the Vaccine Injury Table.
  • On March 28, 2016, CMS issued a data table entitled, “Reconciliation of the Cost Sharing Reduction Component of Advance Payments Attestation Errors Code List for Benefit Years 2014 and 2015." More information on the detailed description of errors, including an explanation on how CMS will process errors, and a list of which errors will cause a submission to fail entirely, can be found here.
  • On March 25, 2016, CMS issued a notice entitled, “Medicare Internet Only Manual Publication 100-04 Chapter 26 - Completing and Processing Form CMS-1500 Data Set.” The summary of changes modify the current version of Pub. 100-04, Chapter 26 - Completing and Processing Form CMS-1500 Data Set, Section 10.6 – Carrier Instructions for Place of Service (POS) to modify existing information. Also, additional clarification of instruction has been added to Chapter 26.
  • On March 25, 2016, CMS issued a notice entitled, “Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2016.” This notice lists the changes that will be included in the July 2016 quarterly release of the edit module for clinical diagnostic laboratory services. NCDs for clinical diagnostic laboratory services were developed by the laboratory negotiated rulemaking committee, and the final rule was published on November 23, 2001.
  • On March 29, 2016, Agency for Healthcare Research and Quality (AHRQ) issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey of Hospital Quality Leaders.” The proposed AHRQ study would attempt to: (1) characterize the role of Hospital Consumer Assessment of Healthcare Providers and System (HCAHPS) survey in hospitals’ efforts to improve patient experiences; (2) identify the types of quality improvement activities that hospitals implement to improve their HCAHPS scores; (3) describe hospitals’ perspectives on HCAHPS; and (4) determine the types of information collected by hospitals beyond those required for the Hospital Value-Based Purchasing (VBP) Program. Comments are due by May 29, 2016.
  • On March 29, 2016, AHRQ issued a notice of request for nominations for public members entitled, “Requests for Nominations: National Advisory Council for Healthcare Research and Quality." The Council is to advise the Secretary of HHS and the Director of AHRQ on matters related to activities of the Agency to carry out its mission. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within HHS and with other partners to make sure that the evidence is understood and used. The terms of seven current members will expire in November 2016. To fill these positions, AHRQ are seeking individuals who are distinguished in: (1) the conduct of research, demonstration projects, and evaluations with respect to health care; (2) the fields of health care quality research or health care improvement; (3) the practice of medicine; (4) other health professions; (5)representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) the representation of the interests of patients and consumers of healthcare. Nominations are due by May 29, 2016.
  • On March 28, 2016, OMB received for review an EEOC final rule entitled, “Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 2008.” This final rule would amend the regulations of the Genetic Information Nondiscrimination Act of 2008 to address inducements to employees' spouses or other family members who respond to questions about their current or past medical conditions on health risk assessments (HRA). The final rule will also correct a typographical error in the rule's discussion of wellness programs and add references to the Affordable Care Act (ACA), where appropriate.
  • On March 30, 2016, SAMHSA issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Project: Substance Abuse Prevention and Treatment Block Grant Synar Report Format.” Section 1926 of the PHS Act stipulates that funding Substance Abuse Prevention and Treatment Block Grant (SABG) agreements for alcohol and drug abuse programs for fiscal year 1994 and subsequent fiscal years require states to have in effect a law providing that it is unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18. For this ICR, SAMHSA's Center for Substance Abuse Prevention requests OMB approval of revisions to the current report format associated with Section 1926. Comments are due April 30, 2016.
  • On March 30, 2016, the Centers for Disease Control and Prevention (CDC) issued ICRs on the following topics: (1) Colorectal Cancer Control Program Monitoring Activities; and (2) Practice Patterns Related to Opioid Use During Pregnancy and Lactation. Public comments for the Colorectal Cancer Control Program monitoring ICR are due April 30th, while public comments on the opioid use during pregnancy ICR are due May 30th.
  • On March 31, 2016, the Department of Education, Department of Homeland Security, Department of Agriculture, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Labor, Department of Veterans Affairs, and HHS issued a final rule entitled, “Fundamental Principles and Policymaking Criteria for Partnerships with Faith-Based and Other Neighborhood Organizations.” This final rule amends regulations to implement Executive Order 13279, as amended by Executive Order 13559. Executive Order 13279 established fundamental principles to guide the policies of Federal agencies regarding the participation of faith-based and other community organizations in programs that the Federal agencies administer. Executive Order 13559 amended Executive Order 13279 to clarify those principles and add certain protections for beneficiaries of Federal social service programs. Comments are due by May 1, 2016
  • On March 31, 2016, CMS issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Outcome and Assessment Information Set (OASIS) OASIS-C2/ICD-10; Grandfathering Provisions of the Medicare DMEPOS Competitive Bidding Program; Medicare Enrollment Application; Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment.” CMS request comments on any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments are due by May 1, 2016.
  • On March 31, 2016, FDA issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications.” This notice is requesting comments on the collection of information associated with the Clinical Laboratory Amendments of 1988 (CLIA) waiver applications. Comments are due by May 31, 2016.
  • On March 31, 2016, FDA issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Format and Content Requirements for Over-the-Counter Drug Product Labeling.” The notice requests comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Comments are due by May 31, 2016.
  • On March 31, 2016, FDA issued a notice entitled, “Charter Renewals: Arthritis Advisory Committee.” The notice announced a renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until April 5, 2018.
  • On March 31, 2016, HHS issued guidance entitled, “Guidance: Temporary Reassignment of State, Tribal, and Local Personnel during a Public Health Emergency." HHS announced the availability of final guidance on the temporary reassignment of personnel during a public health emergency. Section 201 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Law 113-5 amends section 319 of the PHS Act to provide the Secretary of the Department of Health and Human Services with discretion to authorize the temporary reassignment of state, tribal, and local personnel during the time period when she has declared a federal public health emergency upon request by a state or tribal organization.
  • On March 31, 2016, CMS issued a notice entitled, “Medicaid Drug Rebate Program Notice: Transition Period Prior to Enforcement of 5i AMP Provisions.” As described in the notice, CMS will begin enforcement of the provisions of the Covered Outpatient Drugs Final Rule specific to the calculation of AMP for “5i drugs” on July 1, 2016. The transition period is specific to the provisions which require the identification of 5i drugs consistent with 42 CFR 447.507 and the calculation of AMPs for 5i drugs consistent with 42 CFR 447.504.
  • On March 31, 2016, CMS issued a notice entitled, “Enforcement of the Partial Hospitalization Program (PHP) 20 Hours per Week Billing Requirement.” This notice is intended for Outpatient Prospective Payment System (OPPS) providers submitting Partial Hospitalization Program (PHP) claims to Medicare A/B Medicare Administrative Contractors (MACs) for Partial Hospitalization Program services to Medicare beneficiaries.
  • On March 31, 2016, CMS issued a letter to State Medicaid Directors entitled, “Claims Processing and Information Retrieval Systems-Enhanced Funding.” This letter provides guidance concerning the enhanced federal Medicaid match rate, and other federal match rates, for various activities related to Medicaid Information Technology (IT) in both Medicaid Management Information Systems (MMIS) and Medicaid Eligibility and Enrollment (E&E) Systems, including the use of Commercial Off-the-Shelf (COTS) software.
  • On April 1, 2016, AHRQ issued a notice entitled, “Requests for Nominations: U.S. Preventive Services Task Force.” This notice solicits nominations for new members of the U.S. Preventive Services Task Force (USPSTF). All nominations must be received by May 15, 2016.
  • On April 1, 2016, FDA issued a direct final rule entitled, “Notice: Administrative Actions for Noncompliance; Lesser Administrative Actions.” FDA is amending the regulation describing lesser administrative actions that may be imposed by an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. The Agency is clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected.
  • On April 1, 2016, FDA issued a proposed rule entitled, “Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications.” FDA is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). FDA also proposes other changes to make the TEA process more efficient. Comments are due by June 1, 2016.
  • On April 1, 2016, FDA issued guidance entitled, “Emergency Use Authorization of Medical Products and Related Authorities.” The purpose of this draft guidance is to explain FDA's current thinking about policies on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by 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 are due by June 1, 2016.
  • On April 1, 2016, FDA issued guidance entitled, “Labeling for Biosimilar Products.” This draft guidance is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar products licensed under the PHS Act. Comments are due by June 1, 2016.
  • On April 1, 2016, HHS issued a notice entitled, “Requests for Nominations: Chronic Fatigue Syndrome Advisory Committee.” HHS is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Nominations must be received by April 21, 2016.
  • On April 1, 2016, National Institutes of Health (NIH) issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Women's Health Initiative.” Under this ICR, NIH is proposing to extend the Women’s Health Initiative (WHI), which comprises a group of research studies that will address critical issues about the most common causes of frailty, disability, and death among post-menopausal women aged 50 to 79 years. 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways 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.
  • On March 31, 2016, OMB received for review a CMS proposed rule entitled, “FY 2017 Hospice Rate Update.” This annual proposed rule would update the hospice payment rates and the wage index for the fiscal year 2017.

Event Notices

  • May 9 & 10, 2016, HRSA announced a meeting with the Advisory Committee on Heritable Disorders in Newborns and Children. The meeting will be open to the public with attendance limited to space availability.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

  • The Senate has adjourned and will reconvene on Monday, April 4, 2016.

House of Representatives

  • The House has adjourned and will reconvene on Tuesday, April 12, 2016.
  • On March 30, 2016, Republican Energy & Commerce Committee leaders sent a letter to FDA Commissioner Dr. Robert Califf. In the letter to Commissioner Califf, the committee leaders write, “In late 2007 and the first months of 2008, dozens of patients throughout the United States experienced allergic-type reactions from heparin sold by Baxter International. Several patients died and numerous patients suffered severe allergic-type reactions. Baxter heparin was soon recalled and then came off the market. Scientific evidence obtained by FDA, other authorities, researchers, and industry showed that the reactions were linked to a contaminant, overly sulfated chondroitin sulfate, or OSCS, that was intentionally introduced in China during the crude heparin manufacturing process. The contaminant was man-made, not a natural impurity.” The leaders requested documents and answers to questions outlining those problems by April 12, 2016.
  • On March 29, 2016, the House Energy and Commerce Committee and the House Committee on Ways and Means issued subpoenas to HHS to obtain information regarding unlawful spending. The Committees said that HHS has failed to comply with the Committees’ continued request for information. “We’ve been trying to get answers since last June, but HHS simply will not cooperate. The administration funneled $1.3 billion last year into the Basic Health Program without a congressional appropriation - a clear violation of the law. Our good faith attempts to learn basic and targeted facts have been met with resistance every step of the way. The American public deserves answers now,” said Chairman Upton (R-MI) and Chairman Brady (R-TX).

III. REPORTS, STUDIES, & ANALYSES

IV. OTHER HEALTH POLICY NEWS

  • On March 31 & April 1, 2016, the Medicaid and CHIP Payment and Access Commission (MACPAC) convened its March meeting. MACPAC serves as an independent source of information on Medicaid and CHIP, publishing issue briefs and data reports throughout the year to support policy analysis and program accountability. MACPAC staffers presented on the following topics: Review of Draft Chapter for June Report: Medicaid Spending Trends; Review of Draft Chapters for June Report: Alternative Approaches to Federal Medicaid Financing, and Addressing Growth in Medicaid Spending: State Option; The Medicaid Institution for Mental Diseases (IMD) Exclusion; The Future of Children’s Coverage: Review and Discussion of Policy Options: Briefing on 1332 and 1115 Waivers: Reductions in Adult Eligibility Post-ACA; Panel on Long-Term Care (LTC); and Review of Draft Chapter for June Report: Long Term Services and Support (LTSS).
  • On March 31, 2016, CMS hosted a webinar on the Department of Health and Human Services (HHS)-Operated Risk Adjustment (RA) methodology. The purpose of this stakeholder meeting was to solicit feedback on the HHS-operated RA methodology and to discuss potential improvements to the HHS-operated RA methodology for the 2018 benefit year and beyond. CMS released the RA White Paper in advance of the webinar on March 24, 2016. The discussion paper provides a comprehensive summary of the HHS RA Methodology, including detailed explanations of the RA models and payment transfer formula. The paper also includes potential modification to the RA methodology for the 2018 benefit year and beyond. CMS is requesting comments on the proposals discussed in this paper through hhshccraops@cms.hhs.gov or REGTAP at https://www.REGTAP.info by April 22, 2016. Comments sent in direct response to the white paper will inform future rulemaking and continued evaluation of the methodology.
  • On March 30, 2016, CMS announced that Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs) can collaborate with health care providers and partners to compete for 28 Special Innovation Project (SIP) awards that fall within two topic categories totaling $8 million. Statements of Objectives will be released in early April to the QIO community. Information regarding award dates will be included in the Statement of Objectives. CMS encourages those in the larger healthcare community who are leading quality work in these areas, with interventions and proven results, to reach out and explore potential partnerships with QIN-QIOs.
  • On March 31, 2016, the Federal Trade Commission (FTC) filed a complaint in federal district court alleging that Endo Pharmaceuticals and others for illegally blocking lower-cost generic versions of the branded drugs Opana ER and Lidoderm. FTC said the companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to these lower-cost generic drugs. Settlements between drug firms that include ‘no-AG commitments’ harm consumers twice – first by delaying the entry of generic drugs and then by preventing additional generic competition in the market following generic entry,” said FTC Chairwoman Edith Ramirez. “This lawsuit reflects the FTC’s commitment to stopping pay-for-delay agreements that inflate the prices of prescription drugs and harm competition, regardless of the form they take.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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