A&B Healthcare Week in Review, November 14, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On November 10, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled “Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee”. This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. Nominations must be submitted by December 8, 2014.
• On November 10, 2014, CMS issued a proposed decision memo regarding “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)”.CMS proposes that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low dose computed tomography (LDCT), once per year, as an additional preventive service benefit under the Medicare program, if certain criteria are met.
• On November 14, 2014, CMS released a notice announcing a 3-year Medicare Prior Authorization model for repetitive scheduled non-emergent ambulance transport in the states of New Jersey, Pennsylvania, and South Carolina where there have been high incidences of improper payments for these services. This model will begin on December 1, 2014 in South Carolina, New Jersey, and Pennsylvania. More information may be found here.
• On November 11, 2014, the Food and Drug Administration (FDA) released a notice entitled “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals”. This notice solicits comments on the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Comments are due January 9, 2015.
• On November 11, 2014, FDA released a notice entitled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads”. This notice solicits comments on a research project which will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads. Comments are due January 12, 2014.
• On November 11, 2014, FDA announced the availability of a guidance for industry entitled “Combined Functionality for Molecular Diagnostic Instruments”. This guidance document provides industry and Agency staff with FDA’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. Comments may be submitted at any time.
• On November 12, 2014, the Medicaid and CHIP Payment and Access Commission (MACPAC) issued a request for public comments regarding policies “that can help ensure a seamless system of coverage that provides affordable and adequate health care services for children”. In its June 2014 Report to Congress, MACPAC recommended that federal CHIP funding be extended for a transition period of two years, and that during this time, policymakers address issues around affordability and adequacy of children’s coverage. The June report also stressed that further extensions of CHIP funding should be considered if more time is needed to ensure that the necessary reforms are in place. “As we develop our analyses and future recommendations,” Commissioners write, “we would like to hear from you on the factors affecting how well exchange coverage meets children’s health and developmental needs, and any changes that should occur to ensure that such needs are met.” Responses are due December 19, 2014.
• Earlier this month HHS released a bulletin regarding Health Insurance Portability and Accountability Act (HIPAA) privacy rules in emergency situations. In light of the Ebola outbreak and other events, the HHS Office for Civil Rights (OCR), provided the bulletin to ensure that HIPAA covered entities and their business associates are aware of the ways in which patient information may be shared under the HIPAA Privacy Rule in an emergency situation, and to “serve as a reminder that the protections of the Privacy Rule are not set aside during an emergency”.
• On November 13, 2014, the Office of Personnel Management (OPM) proposed to amend the Federal Long Term Care Insurance Program (FLTCIP) regulation to expand eligibility to apply for coverage under the Program. Under the proposed regulation, the definition of ``qualified relative'' is expanded to cover all individuals who are domestic partners (both same-sex and opposite-sex) of Federal and U.S. Postal Service employees, annuitants, members of the uniformed services, and retired members of the uniformed services. In addition, the proposed regulation provides that adult children of domestic partners will be considered one of the types of individuals comprising the statutory term ``qualified relative'' who may apply for FLTCIP coverage. Comments are due January 12, 2015. More information may be found here.
• On November 14, 2014, FDA released a proposed information collection activity for public comment, entitled “Export of Food and Drug Administration Regulated Products: Export Certificates”. This notice solicits comments on information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended. Comments are due January 13, 2015.
• On November 14, 2014, FDA released a proposed information collection activity for public comment, entitled “Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements”. This notice solicits comments on research entitled, ‘‘Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer (DTC) Prescription Drug Advertisements.’’ This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research. Comments are due January 13, 2015.
• On November 14, 2014, CMS released its Quarterly Listing of Program Issuances—July Through September 2014. This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS Web site or the appropriate data registries that are used as agency resources.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• Following the November 4th midterm elections, both chambers returned from recess on Wednesday to commence the brief, final session of the 113th Congress.

House of Representatives

• Following the November 4th midterm elections, both chambers returned from recess on Wednesday to commence the brief, final session of the 113th Congress.
• On November 13, 2014, the House Veterans Affairs Committee convened a hearing on the implementation of the Veterans Access, Choice, and Accountability Act of 2014 (PL 113-146) signed into law on August 7, 2014. The witness for the hearing was The Honorable Sloan Gibson, VA Deputy Secretary; he was accompanied by James Tuchschmidt, M.D., M.M., Acting Principal Deputy Under Secretary for Health, and Gregory L. Giddens, Executive Director, Enterprise Program Management Office. More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On November 12, 2014, a study was published in the Journal of the American Medical Association (JAMA) entitled “Association Between the Medicare Hospice Benefit and Health Care Utilization and Costs for Patients With Poor-Prognosis Cancer”. More patients with cancer use hospice currently than ever before, but there are indications that care intensity outside of hospice is increasing, and length of hospice stay is decreasing. Uncertainties regarding how hospice affects health care utilization and costs have hampered efforts to promote it. To address this uncertainty, authors of the study sought to compare utilization and costs of health care for patients with poor-prognosis cancers enrolled in hospice versus similar patients without hospice care. In this sample of Medicare fee-for-service beneficiaries with poor-prognosis cancer, those receiving hospice care versus those not receiving hospice care (control), had significantly lower rates of hospitalization, intensive care unit admission, and invasive procedures at the end of life, along with significantly lower total costs during the last year of life.
• On November 10, 2014, the Government Accountability Office (GAO) released a report entitled “Payment Practices Vary across Public Programs and Private Insurers, and Medicare Part B Policy Should Be Clarified”. GAO was asked to examine public programs’ and private health insurers’ payment practices for compounded drugs. GAO found that for drugs dispensed in pharmacy settings, claims contain sufficient information for public programs and private insurers to identify compounded drugs and their ingredients. For drugs administered in outpatient physician office settings, claims lack information to identify compounded drugs because there are no specific billing codes for most of these drugs. Additionally, GAO reports that the CMS national payment policy for compounded drugs under Medicare Part B is unclear. The policy generally states that drugs must be FDA-approved to be paid for under Medicare; payment may be available for compounded drugs, but the policy does not stipulate whether payment is available for ingredients that are bulk drug substances, which are generally not FDA-approved. GAO recommends that CMS clarify its Medicare Part B payment policy to either allow or restrict payment for compounded drugs containing bulk drug substances and align payment practices with this policy. HHS disagreed with this recommendation, stating that the Part B payment policy does not depend on drug ingredients. GAO maintains that the policy needs clarification.
• On November 6, 2014, the Kaiser Family Foundation released the results of a literature review comparing healthcare access and quality across Medicare Advantage (MA) and the traditional Medicare program. This literature review synthesizes the findings of studies that focus specifically on Medicare and have been published between the year 2000 and early 2014. The results suggest that Medicare Advantage, on average, scores more highly than traditional Medicare on subsets of Medicare HEDIS indicators – primarily those pertaining to use of preventive care services. Medicare beneficiaries generally rated Medicare Advantage lower than traditional Medicare on questions about health care access and quality, especially if beneficiaries had a chronic illness or were sick; however, the difference in ratings between traditional Medicare and Medicare Advantage narrowed on some metrics by 2009 (e.g., overall care ratings). Regarding readmission rates, the evidence from these studies is inconclusive because findings differ across the studies and many studies lack adjustments for important potentially confounding factors.

IV. OTHER HEALTH POLICY NEWS

• On November 10, 2014, HHS released an issue brief discussing the population who may have Marketplace coverage following the 2015 open enrollment period (OEP). HHS used a so-called “bottom-up” approach to project 2015 enrollments, incorporating data from the Department’s experience during the first open enrollment period and recent population surveys of insurance coverage. The bottom-up approach yielded an estimated range of 9.0 to 9.9 million for effectuated Marketplace enrollment in 2015. These figures are significantly lower than those originally forecast by the Congressional Budget Office (CBO): in April, CBO projected that in 2015 a total of 13 million people would have insurance and pay their premiums through the Marketplace. The HHS brief acknowledges the discrepancy, suggesting a broader context in which to view Marketplace enrollment: “One important goal of the law is reducing the number of uninsured people, and the Marketplace is just one means to that end. In practice, reducing the uninsured will be achieved through a combination of Marketplace retention, new Marketplace enrollment, increases in Medicaid enrollment, and continued support for a robust system of employer-sponsored insurance.”
• On Sunday November 9, 2014, HHS announced that it is offered a “window shopping” tool to help consumers view their Exchange plan choices in advance of the 2015 open enrollment period, scheduled to begin November 15th and run through December 15th, with coverage effective January 1, 2015. “Consumers can prepare for open enrollment by visiting HealthCare.gov and using the window shopping feature to see what plans will be available in their area,” said Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner in a press release. “Using this tool, consumers can compare plans, covered benefits, and physician and hospital networks before the Marketplace annual open enrollment period starts on November 15.” The press release also notes that window shopping remains the “single most popular section on HealthCare.gov and regularly has three times the amount of traffic than any other page on the Marketplace website”. A separate HHS press release on the open enrollment period beginning tomorrow may be found here.
• On November 12, 2014, CMS announced that it awarded $3.9 million for outreach and enrollment efforts aimed at American Indian and Alaska Native children eligible for Medicaid and the Children’s Health Insurance Program (CHIP). The grant awards will fund activities to engage schools and tribal agencies in Medicaid and CHIP outreach and enrollment activities. CMS awarded grant funds to health programs operated by the Indian Health Services, tribes, tribal organizations and urban Indian organizations located in seven states: Alaska, Arizona, California, Mississippi, Montana, New Mexico and Oklahoma. Several grantees will receive funds to conduct activities focused on helping eligible teens enroll in coverage. Grantees will work to ensure that eligible children retain coverage for as long as they qualify and will help guide families through the application process for Medicaid and CHIP. More information may be found here.

This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.