A&B Healthcare Week In Review, September 11, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• The Office of the Assistant Secretary for Health (OASH) has announced that it is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature. More information may be found here.
• On September 8, 2015, the Food and Drug Administration (FDA) announced that an information collection activity entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” had been submitted to the Office of Management and Budget (OMB) for review. The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study, and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs, describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor. Comments are due October 9, 2015.
• On September 8, 2015, FDA announced the availability of a revised draft guidance for industry and review staff entitled “Formal Dispute Resolution: Appeals Above the Division Level.” This guidance is intended to provide recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This draft guidance revises the draft guidance of the same name issued March 13, 2013. Comments should be submitted by December 8, 2015.
• On September 8, 2015, FDA announced the availability of a guidance for industry entitled “Nonclinical Evaluation of Endocrine-Related Drug Toxicity.” The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled “Endocrine Disruption Potential of Drugs: Nonclinical Evaluation” issued on September 20, 2013.
• On September 9, 2015, FDA announced the availability of a guidance entitled “Q3D Elemental Impurities.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance establishes permitted daily exposures for 24 elements in drug products based on evaluation of toxicity data. Permitted daily exposures are provided for each element by three routes of administration--oral, parenteral and inhalation. The guidance also provides for a risk-based approach to assessing the likelihood that elemental impurities with established permitted daily exposures will be present in a pharmaceutical product. The guidance is intended to provide a harmonized approach to control of elemental impurities in pharmaceutical products in order to avoid the uncertainty and duplication of work that results from different requirements in different ICH regions.
• On September 11, 2015, the FDA released a notice entitled “Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2016”. In this notice, FDA is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2016.
• On September 11, 2015, the Centers for Medicare & Medicaid Services (CMS) announced an opportunity for the public to comment on an information collection activity entitled “Medicare Enrollment Application - Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Suppliers”. The primary function of the CMS 855S Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) supplier enrollment application is to gather information from a supplier that tells CMS who it is, whether it meets certain qualifications to be a health care supplier, where it renders its services or supplies, the identity of the owners of the enrolling entity, and information necessary to establish correct claims payment. The goal of this revision of the CMS 855S is to simplify and clarify the current data collection and to remove obsolete and/or redundant questions.
• On September 11, 2015, CMS filed a Proposed Rule entitled “Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities; Reopening of Comment Period”. This document reopens the comment period for the July 16, 2015 proposed rule entitled “Reform of Requirements for Long-Term Care Facilities”. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days. The rule is expected to be published in the Federal Register on September 15th.
• On September 11, 2015, CMS announced an opportunity for the public to comment on an information collection activity entitled “Cost-Sharing Reduction Reconciliation”. Under established Department of Health and Human Services (HHS) regulations, qualified health plan (QHP) issuers will receive estimated advance payments of cost-sharing reductions throughout the year. Each issuer will then be subject to a reconciliation process at the end of the benefit year to ensure that HHS reimburses each issuer only for actual cost sharing. This revised collection eliminates some data elements and requires summary plan level reporting and reporting in the 2016 reconciliation cycle on the dollar amount of 2014 cost-sharing reductions used in calculations for medical loss ratio and risk corridors programs reporting. The rule is expected to be published in the Federal Register on September 14th; comments will be due 60 days thereafter.
• On September 8, 2015, the Centers for Disease Control and Prevention (CDC) submitted an information collection request to OMB entitled “Formative and Summative Evaluation of the National Diabetes Prevention Program”. The objective of this formative and summative evaluation of the National Diabetes Prevention Program (NDPP) is to collect additional information to identify program-level factors leading to successful implementation and best practices for achieving program sustainability and scalability at the community level. Comments are due within 30 days.

Event Notices

• November 4, 2015: The FDA has announced a public workshop entitled “Osteoporosis Drug Development”. The purpose of this workshop is to seek input from experts on scientific issues important to clinical development of drugs and therapeutic biologics intended to treat osteoporosis. During the workshop, attendees will discuss potential surrogate endpoints and the endpoints’ ability to predict clinical benefit. The workshop will be held on November 4, 2015, from 8 a.m. to 5 p.m. Registration to attend the workshop must be received by October 21, 2015. Submit electronic or written comments by October 7, 2015.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On September 10, 2015, Senator Bernie Sanders (I-VT) and Representative Elijah Cummings (D-MD) introduced legislation entitled the “Prescription Drug Affordability Act of 2015”. According to a press release on the bill from Sanders’ office, the bill, “…authorizes the Secretary of Health and Human Services to negotiate drug prices with pharmaceutical companies to bring down costs for Medicare drug benefits. The bill also includes tougher penalties for drug companies that commit fraud and bans the practice of brand name drugmakers paying competitors to keep lower-priced generic substitutes off the market. The bill also lowers barriers to the importation of lower-cost drugs from Canada.”
• On September 9, 2015, Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) reintroduced the “Preserve Access to Affordable Generics Act”, which would, among other things, prohibit the practice of brand name drug manufacturers using “pay for delay” agreements. “Pay-for-delay pharmaceutical deals force consumers to pay higher prices by keeping affordable alternatives to brand-name drugs off the market,” said Klobuchar in a press release. “Our legislation will help ensure people have access to the medications they need at a price they can afford by putting an end to these harmful agreements once and for all.”

House of Representatives

• On September 9, 2015, the U.S. District Court for the District of Columbia issued an opinion in the matter of United States House of Representatives v. Burwell. The Court held that the House of Representatives has standing to sue the Administration on one set of claims (non-appropriation claims), but not the other. According to the opinion: “The only issue before the Court is whether the House can sue the Secretaries; the merits of this lawsuit await another day…If its non-appropriation claims have merit, which the Secretaries deny, the House has been injured in a concrete and particular way that is traceable to the Secretaries and remediable in court. The Court concludes that the House has standing to pursue those constitutional claims. In contrast, the House’s claims that Secretary Lew improperly amended the Affordable Care Act concern only the implementation of a statute, not adherence to any specific constitutional requirement. The House does not have standing to pursue those claims. The Secretaries’ motion to dismiss will be denied as to the former and granted as to the latter.”
• On September 10, 2015, the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law convened a hearing entitled "The State of Competition in the Health Care Marketplace: The Patient Protection and Affordable Care Act's Impact on Competition." Witnesses for the hearing included Thomas L. Greaney, professor of law, St. Louis University School of Law; Richard J. Pollack, executive vice president, advocacy and public policy, American Hospital Association; Barbara L. McAneny, member, Board of Trustees, American Medical Association; Dan Durham, executive vice president, strategic initiatives, American Health Insurance Plans; and Scott Gottlieb, resident fellow, American Enterprise Institute. During the hearing Subcommittee Chairman Tom Marino (R-PA) said that the hearing marks the first in a series to examine the state of competition in the health care marketplace. The hearings will focus on impact the Affordable Care Act (ACA) has had on competition within each of three health care sectors – hospital, physician, and insurance. More information on the hearing may be found here.
• On September 9, 2015, the House Energy & Commerce Health Subcommittee convened a hearing entitled “Protecting Affordable Coverage for Employees”. The hearing considered H.R. 1624, the Protecting Affordable Coverage for Employees Act of 2015, which would amend the Public Health Service Act to redefine small employer as one with 50 or fewer employees and give States the option to expand the definition to include employers with up to 100 employees. Witnesses for the hearing included Monica Lindeen, Montana Commissioner of Securities and Insurance and State Auditor, President, National Association of Insurance Commissioners (NAIC); Kurt Giesa, FSA, MAAA, Partner, Oliver Wyman; and, Mike Kreidler, Washington State Insurance Commissioner. More information on the hearing may be found here.
• On Wednesday September 9th, the House Judiciary Committee convened a hearing entitled “Planned Parenthood Exposed: Examining the Horrific Abortion Practices at the Nation's Largest Abortion Provider." More information on the hearing may be found here.
• On September 11, 2015, the House Energy & Commerce Subcommittee on Health held a hearing entitled, “Strengthening Medicaid Program Integrity and Closing Loopholes.” At this hearing, the Health Subcommittee reviewed six bills that would make changes to Medicaid program requirements and standards. These were:
  • “Ensuring Terminated Providers are Removed from Medicaid and CHIP Act”—This legislation would: require that State Medicaid and CHIP programs report providers terminated for cause to the Centers for Medicare and Medicaid Services (CMS); require providers participating in Medicaid Managed Care plans or Children’s Health Insurance Program (CHIP) plans to be enrolled with the State; require CMS to include State reported provider terminations and Medicare provider terminations in its Termination Notification Database or equivalent system; and require States to pay back the Federal portion of Medicaid and CHIP payments made to providers for services performed more than two months after a provider’s termination is included in the CMS Termination Notification Database.
  • “Medicaid and CHIP Territory Fraud Prevention Act”—This bill would encourage U.S. territories to create Medicaid Fraud Control Units (MFCUs) by exempting Federal funding for the fraud control units from territories’ cap on Medicaid funding and by exempting territories from the statutory ceiling on quarterly Federal payments for the units.
  • “Electronic Visit Verification System Required for Personal Care Services Under Medicaid”—Revised from its original form as introduced as H.R. 2446, the bill would require that State Medicaid programs establish electronic visit verification (“EVV”) systems for personal care services provided to Medicaid beneficiaries in the home setting. States that failed to establish EVV systems would be assessed a penalty on their Federal Medical Assistance Percentages (FMAP) matching funding rates.
  • H.R. 1570, the “Medicaid and CHIP Territory Transparency and Information Act”—This legislation would require that CMS include on its website profiles of U.S. territories’ Medicaid programs, as well as information on their eligibility and enrollment levels and waivers
  • H.R. 2339, “To amend title XIX of the Social Security Act to clarify the treatment of lottery winnings and other lump sum income for purposes of income eligibility under the Medicaid program, and for other purposes”—This bill would allow State Medicaid programs, for purposes of determining Modified Adjusted Gross Income (“MAGI”) for Medicaid and CHIP eligibility, to consider monetary winnings from lotteries (and other lump sum payments) as if they were obtained over multiple months, even if obtained in a single month.
  • H.R. 1771, “To amend title XIX of the Social Security Act to count portions of income from annuities of a community spouse as income available to institutionalized spouses for purposes of eligibility for medical assistance, and for other purposes”—This legislation would require that half of the income generated from an annuity purchased by a community spouse within the 60-month Medicaid “look back period”— the period of time before applying for Medicaid in which an individual’s or couple’s assets are reviewed—be countable for purposes of determining the institutionalized spouse’s Medicaid eligibility for long term care (LTC) services.

Witnesses for the hearing included: John Hagg, Director of Medicaid Audits, Department of Health & Human Services-Office of the Inspector General (HHS-OIG); Nico Gomez, Chief Executive Officer, Oklahoma Health Care Authority; and Trish Riley, Executive Director, National Academy for State Health Policy, and Commissioner, Medicaid and CHIP Payment and Access Commission (MACPAC).

More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On Tuesday September 8, 2015, the American Medical Association (AMA) released two analyses of commercial health insurance markets. In a press release on the reports, AMA summarizes their findings as follows:
  • “On an individual basis, the Anthem-Cigna merger would enhance market power in 85 metropolitan areas within 13 states, including California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio and Virginia. The merger would also raise significant competitive concerns in additional markets. All told, the Anthem-Cigna merger would diminish competition in up to 111 metropolitan areas within all 14 states that Anthem currently operates: California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia and Wisconsin.
  • A closer look at the Aetna-Humana merger shows that it would enhance market power in 15 metropolitan areas within 7 states, including Florida, Georgia, Illinois, Kentucky, Ohio, Texas and Utah. The merger would also raise significant competitive concerns in additional markets. All told, the Aetna-Humana merger would diminish competition in up to 58 metropolitan areas within 14 states, including Arizona, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Mississippi, Ohio, Tennessee, Texas, Utah, Wisconsin and West Virginia.”
• A study published in Health Affairs on Tuesday used data on more than 1.5 million Medicaid enrollees to examine the impact of changes in prescription drug use on medical costs. For three distinct groups of enrollees, authors estimated the effects of aggregate prescription drug use—and, more specifically, the use of medications to treat eight chronic non-communicable diseases—on total nondrug, inpatient, outpatient, and other Medicaid spending. They found that a 1 percent increase in overall prescription drug use was associated with decreases in total nondrug Medicaid costs by 0.108 percent for blind or disabled adults, 0.167 percent for other adults, and 0.041 percent for children. Reductions in combined inpatient and outpatient spending from increased drug utilization in Medicaid were similar to an estimate for Medicare by the Congressional Budget Office. “Moving forward”, authors wrote, “policy makers evaluating proposed changes that alter medication use among the nearly seventy million Medicaid recipients should consider the net effects on program spending to ensure that scarce federal and state health care dollars are allocated efficiently.”
• On September 9, 2015, the Government Accountability Office (GAO) released a report entitled “Private Health Insurance: The Range of Premiums and Plan Availability for Individuals in 2014 and 2015”. As of 2014, key provisions of the Patient Protection and Affordable Care Act (PPACA) resulted in the establishment of health insurance exchanges in each state and changed how insurers determined health insurance premiums. Individual market consumers generally had access to more health plans in 2015 compared to 2014, and in both years the lowest-cost plans were available through exchanges in most of the 1,886 counties GAO analyzed in the 28 states for which it had sufficiently reliable data for plans offered either on or off an exchange. In addition, consumers in most of the counties analyzed had six or more plans to choose from in three of the four health plan metal tiers (bronze, silver, and gold) in both 2014 and 2015, and the percentage of counties with six or more plans in those metal tiers increased from 2014 to 2015. Consumers had fewer options regarding platinum plans, although the availability of platinum plans generally also increased from 2014 to 2015. The lowest-cost plan available in a county was available on an exchange in most counties. The range of premiums available to consumers in 2014 and 2015 varied among the states and counties GAO analyzed. An interactive graphic reporting by state and county the minimum, median, and maximum premium values for all individual market plans (either on or off the exchange) and for exchange-only plans, is available at http://www.gao.gov/products/GAO-15-687. It includes either data for both years, or partial data (e.g., data for one of the two years) for 49 states.

IV. OTHER HEALTH POLICY NEWS

• The Medicare Payment Advisory Commission (MedPAC) convened a series of Medicare payment policy discussions in Washington D.C. on September 10th and 11th for the first time since April. The full agenda, briefs, and presentations may be found here. Also of note, on Tuesday, MedPAC released its comment letter regarding the CMS proposed rule entitled “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016,” published in the Federal Register, vol. 80, no. 135.
• On September 8, 2015, CMS’ Office of Minority Health (CMS OMH), unveiled the first CMS plan to address health equity in Medicare. The CMS Equity Plan for Improving Quality in Medicare (CMS Equity Plan for Medicare) is an “action-oriented plan that focuses on six priority areas and aims to reduce health disparities in four years”, according to a CMS announcement. The Equity Plan focuses on Medicare populations that experience disproportionately high burdens of disease, lower quality of care, and barriers accessing care. These include racial and ethnic minorities, sexual and gender minorities, people with disabilities, and those living in rural areas.
• On September 8, 2015, CMS released the June 30, 2015 Effectuated Enrollment Snapshot, showing that as of that date, about 9.9 million consumers had effectuated Health Insurance Marketplace coverage – which means those individuals paid their premiums and had an active policy at the end of June. These numbers are consistent with HHS’s effectuated enrollment target of 9.1 million for the end of 2015. Of the approximately 9.9 million consumers nationwide with effectuated Marketplace enrollments at the end of June 2015, about 84 percent, or more than 8.3 million consumers, were receiving an advanced premium tax credit (APTC). The average APTC for those enrollees who qualified for the financial assistance was $270 per month.