I. REGULATIONS, NOTICES, & GUIDANCE
- On April 21, 2014, the Food and Drug Administration (FDA) solicited public comments on a study entitled “Risk and Benefit Perception Scale Development”. The study is designed to test different ways of measuring consumers' benefit and risk perceptions after exposure to direct-to-consumer (DTC) prescription drug advertising. FDA's Office of Prescription Drug Promotion has an active research program that investigates how DTC advertising influences consumer knowledge, perceptions, and behavior. Consequently, FDA needs a pool of reliable and valid measurement items for assessing consumers' drug risk and benefit perceptions—as well as other elements of prescription drug decision making—consistently across studies. The purpose of this project is to create that measurement pool, thus increasing the rigor and efficiency of FDA's research. Comments on the proposed study may be submitted through June 20, 2014.
- On April 25, 2014, FDA issued a proposed rule entitled “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products”. The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Option 1 of the proposed rule would extend the Agency's “tobacco product” authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of “tobacco product” in the FD&C Act. Products that meet the statutory definition of “tobacco products” can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco. Option 2 of the proposed rule would extend the Agency's “tobacco product” authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of “tobacco product” in the FD&C Act. FDA also is proposing to prohibit the sale of “covered tobacco products” to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements.
- On April 21, 2014, FDA announced that it is reopening the period for industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the pharmaceutical manufacturing industry and the pharmacy compounding industry on the Pharmacy Compounding Advisory Committee for the Center for Drug Evaluation and Research (CDER) to notify FDA of such interest. Interested industry organizations should send a letter stating the interest to FDA by May 5, 2014, for the vacancies announced in the Federal Register on January 13, 2014. More information may be found here.
- On April 22, 2014, the Agency for Healthcare Research and Quality (AHRQ) announced that it had submitted a proposed information collection project entitled “SelectMD 2.0 Clinician Choice Experiment” to the Office of Management and Budget (OMB) for review and approval. This study builds on previous research conducted as part of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) program to explore new ways of integrating patient comments with other performance metrics in web-based quality reports for consumers to support their choice of physicians. This follow-on study (referred to as SelectMD 2.0) will use an experimental design to test different methods of incorporating patient comments along with CAHPS survey results, the Healthcare Effectiveness Data and Information Set (HEDIS)-like measures of effective clinical treatments, and indicators of patient safety in web-based physician quality reports. The study will help AHRQ understand how people choose a doctor as their regular source of medical care and advice. Comments are due May 22, 2014.
- On April 22, 2014, the Health Resources and Services Administration (HRSA) announced that it had submitted an information collection request entitled “Children's Hospitals Graduate Medical Education Payment Program” to OMB for review and approval. The Children's Hospitals Graduate Medical Education (CHGME) Payment Program was enacted by Public Law 106-129 to provide federal support for graduate medical education (GME) to freestanding children's hospitals. On September 30, 2013, CMS published revised cost report forms on their Web site; specifically form CMS 2552-10, Worksheet E-4, requiring additional modifications of the data collection forms in the CHGME Payment Program application. The CHGME Payment Program application forms have been adjusted to accommodate the most recent CMS policy changes. These changes require OMB approval. Comments on the proposed changes are due May 22, 2014.
- On April 23, 2014, FDA announced the availability of a report entitled “Food and Drug Administration Transparency Initiative: Increasing Public Access to FDA's Compliance and Enforcement Data”. This report summarizes findings and recommendations from eight FDA working groups established to enhance the transparency and public accessibility of the Agency's compliance and enforcement data.
- On April 23, 2014, FDA announced the availability of draft guidance for industry entitled “Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval”. This draft guidance clarifies FDA's current policy on balancing premarket and post-market data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of post-market information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. The document may be accessed here.
- On April 23, 2014, FDA announced the availability of draft guidance for industry entitled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions.” This draft guidance outlines FDA's proposal for a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA). FDA believes that the Expedited Access PMA (EAP) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval. The document may be accessed here.
- On April 23, 2014, FDA announced the availability of draft guidance for industry entitled “Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.” The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations. The document may be accessed here.
- On April 23, 2014, AHRQ announced its intention to request that OMB approve a proposed information collection project entitled “Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP)”. This evaluation of HHS' Healthcare Associated Infections National Action Plan will assess the efficacy, efficiency and coordination of federal efforts to mitigate and prevent Healthcare Associated Infections (HAIs). Comments must be received by June 23, 2014.
- On April 24, 2014, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced that it was extending the comment period for a notice entitled “Respiratory Protective Devices Used in Healthcare”. The notice had been published originally in the Federal Register on March 14, 2014, and comments were due April 14, 2014. Comments are now due April 30, 2014.
- On April 25, 2014, the Centers for Medicare and Medicaid Services (CMS) issued its quarterly notice listing manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2014.
- May 7, 2014: The National Institute on Drug Abuse (NIDA) will host a meeting to enable public discussion on the Institute's proposal to reorganize its extramural program in establishment of a Division of Extramural Research. The proposal seeks to clearly delineate functions and streamline the services provided within the Office of the Director, as well as capitalize on emerging scientific opportunities, while reducing barriers to scientific and interdisciplinary collaboration. The meeting will take place at the Neuroscience Center in Rockville Maryland. More information may be found here.
- May 15-16, 2014: The Agency for Healthcare Research and Quality (AHRQ) announced that the Agency would hold a Special Emphasis Panel (SEP) meeting on “Patient-Centered Outcomes Research (PCOR) for Deliberative Approaches: Patient and Consumer Input for Implementing Evidence-Based Health Care (R21)”. The SEP meeting will commence in open session for thirty minutes, from 8:00 AM to 8:30 AM, before closing to the public for the duration of the meeting.
- May 19-20, 2014: FDA announced a public meeting to obtain stakeholder input on the design and conduct of the postmarketing requirements (PMRs) for the class-wide extended-release/long-acting (ER/LA) opioid analgesic drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA is seeking input on these issues from stakeholders, including patients, academia, researchers, State and other Federal regulators, health care organizations, health care providers, the pharmaceutical industry, and others from the general public. The meeting will be held from 8:00 AM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. Individuals who wish to present at the meeting must register by May 9, 2014. More information may be found here.
- September 24-25, 2014: FDA announced a public workshop entitled “Next-Generation Sequencing (NGS) Technology, Data Format Standardization and Promotion of Interoperability Protocols.” The goal of this public workshop is to facilitate establishing protocols for ensuring the safety and quality of next-generation sequencing (NGS)-related information without sacrificing scientific merit or interfering with innovative processes. The purpose of the workshop is to engage NGS stakeholders in a forum to discuss the current use of the technology and the development of data standards of NGS-related information. The public workshop will be held on September 24 and 25, 2014, from 8:30 AM to 4:30 PM at the National Institutes of Health Campus in Bethesda, Maryland.
II. LEGISLATION & COMMITTEE ACTION
- The Senate was adjourned for recess this week and will reconvene for regular legislative business on Monday April 28, 2014.
- Responding to today’s FDA proposed rule regarding regulation of tobacco products, Senators Dick Durbin (D-IL), John Rockefeller (D-WV), Richard Blumenthal (D-CT), Edward Markey (D-MA), Sherrod Brown (D-OH), Jack Reed (D-RI), and U.S. Representative Frank Pallone, Jr. (D-NJ) expressed disappointment that the Agency’s proposal does not go far enough to address marketing practices employed by the electronic cigarette industry. The proposal follows a report on these practices issued last week by a bicameral group of eleven Democratic lawmakers entitled “Gateway to Addiction? A Survey of Popular Electronic Cigarette Manufacturers and Targeted Marketing to Youth”. The Congressmen issued a statement Thursday on the proposed rule: “Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction. Prohibiting sales of these products to minors is a positive step, but it isn’t enough. As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction.”
House of Representatives
- The House was adjourned for recess this week and will reconvene for regular legislative business on Monday April 28, 2014.
III. REPORTS, STUDIES, & ANALYSES
- On April 21, 2014, the Government Accountability Office (GAO) issued a report entitled “Department of Health and Human Services: Solicitations of Support for Enroll America”. GAO’s review of written responses and documentation from the Department of Health and Human Services (HHS) found that, since enactment of the Affordable Care Act (ACA), the former Secretary of HHS Kathleen Sebelius contacted the Chief Executive Officers of five organizations to solicit support for one outside entity, Enroll America, involved in activities related to the ACA. Specifically, the Secretary requested financial support for Enroll America from the Robert Wood Johnson Foundation (RWJF) and H&R Block; and nonfinancial support, such as technical assistance, from Ascension Health, Johnson & Johnson, and Kaiser (which consists of the Kaiser Foundation Health Plans and Kaiser Foundation Hospitals). GAO’s review of the documentation also found that the Secretary received oral guidance from HHS’s Office of General Counsel in early February 2013 and written guidance on soliciting support for outside entities later in the month, after the contact with RWJF but prior to the four remaining contacts. Among other things, this guidance stated that HHS officials may encourage members of the public to support certain organizations assisting Americans to enroll in coverage under the ACA, pursuant to authority provided under sections 1703 and 1704 of the Public Health Service Act.
- A study published in the Journal of the American Medical Association (JAMA) this week on outpatient care patterns and organizational accountability in Medicare finds that of Medicare beneficiaries assigned to an Accountable Care Organization (ACO) in 2010 or 2011, only 66% were assigned to the same ACO in both years. In addition, the authors report that 66.7% of office visits with specialists were provided outside of a beneficiary’s assigned ACO. The authors note that these care patterns suggest distinct challenges in achieving organizational accountability in Medicare, and continued monitoring of these patterns may be important to determine the regulatory need for enhancing ACOs’ incentives and their ability to improve care efficiency.
- On April 22, 2014, the National Center for Health Statistics (part of the Centers for Disease Control and Prevention) released a report entitled “Rural and Urban Hospitals' Role in Providing Inpatient Care, 2010”. Among the report’s key findings, authors note that the average number of diagnoses and average length of stay in hospitals in 2010 were comparable across urban and rural populations, but a far greater proportion (68%) of rural hospital inpatients had no procedures performed while in the hospital, compared with urban patients (38%). In addition, following their hospitalization, a higher percentage of rural inpatients (7%) than urban inpatients (3%) were transferred to other short-term hospitals, and a higher percentage of rural (14%) than urban (11%) inpatients were discharged to long-term care institutions.
- On April 23, 2014, AHRQ released a statistical brief entitled “Conditions With the Largest Number of Adult Hospital Readmissions by Payer, 2011”. The study used readmissions data from the Healthcare Cost and Utilization Project (HCUP) to present the conditions with the largest number of 30-day all-cause readmissions among U.S. hospitals in 2011 and their associated costs. The results show that of the 3.3 million readmissions across all payers in the study population, Medicare had the largest share of total readmissions (55.9%) and associated costs for readmissions (58.2%). Medicaid had the second largest share of total readmissions (20.6%) and represented a lower share of associated costs (18.4%). Private insurance had a much smaller share of total readmissions (18.6%) and the second highest associated costs (19.6%). Of the ten conditions with the most all-cause, 30 day readmissions for Medicare patients, the top three principal diagnoses were: 1) congestive heart failure; 2) septicemia; and 3) pneumonia.
- On April 25, 2014, the Office of Inspector General (OIG) published a report which finds that Medicare improperly paid Medicare Advantage (MA) Organizations $26.2 million for unlawfully present beneficiaries between 2010 and 2012. Specifically, CMS did not notify the MA organizations of the unlawful-presence information in its data systems. In the absence of such notification, MA organizations could not prevent unlawfully present beneficiaries from enrolling. For the same reason, MA organizations could not disenroll beneficiaries whose unlawful-presence status changed after they had enrolled. As such, OIG recommended that CMS implement policies and procedures, similar to those in effect in the fee-for-service (FFS) system, to notify MA organizations of unlawful-presence information and thereby prevent enrollment in MA organizations, disenroll beneficiaries already enrolled, and recoup any improper payments.
- A study published this week in the journal Health Affairs sought to ascertain the stability of nongroup insurance coverage during years 2008-2011, before ACA provisions went into effect. The authors found that only 42% of people with nongroup coverage at the outset of the study period retained coverage after 12 months, and 80% of people experiencing coverage changes acquired other insurance within a year, most commonly from an employer. In addition, data showed varied turnover across groups, with stable coverage more common for whites and self-employed people than for other groups. The results suggest that the nongroup market was characterized by frequent disruptions in coverage before the ACA and that the effects of the recent cancellations are not necessarily out of the norm.
IV. OTHER HEALTH POLICY NEWS
- Last week CMS announced for the first time that quality measures from inpatient psychiatric facilities will be publicly reported on Hospital Compare, a consumer-oriented website that provides information on the quality of care hospitals are providing to their patients. Beginning April 17, 2014, Hospital Compare began featuring data from 1,753 inpatient psychiatric facilities on patient care for the period of October 1, 2012 through March 31, 2013. Public reporting will allow consumers to directly compare facilities based on data collected for the following measures: 1) Hours of Physical Restraint Use; 2) Hours of Seclusion Use; 3) Post-Discharge Continuing Care Plan Created; and 4) Post-Discharge Continuing Care Plan Transmitted to Next Level of Care Provider Upon Discharge. In addition to the Inpatient Psychiatric Facility Quality Reporting Program, Hospital Compare also reports quality measure data from CMS’ Hospital Inpatient and Outpatient Quality Reporting Programs and Hospital Value-Based Purchasing Program. More information may be found here.
- This week an internal memo from CMS Administrator Marilyn Tavenner announced that Jonathan Blum, CMS Principal Deputy Administrator, would be stepping down next month to pursue “new opportunities”. Blum has served in the Administration since President Obama’s first term.
- On April 24, 2014, HHS issued a policy giving individuals in the ACA’s temporary high risk health insurance pool program—known as the Pre-Existing Condition Insurance Program, or PCIP—until June 30th to sign up for new coverage through the ACA Health Insurance Marketplaces. The program will terminate April 30, 2014, and coverage for this population will be effective back to May 1, 2014.
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.