A&B Healthcare Week In Review, August 14, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On August 10, 2015, the Office of the National Coordinator for Health Information Technology (ONC) released a notice entitled “Health IT Policy Committee and Health IT Standards Committee; Call for Applications”. ONC is seeking applications to the Health Information Technology Policy Committee (HITPC) and the Health Information Technology Standards Committee (HITSC). The HITSC is charged to provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. Applications must be received by 12:00 p.m. on Friday, September 11, 2015.
• On August 7, 2015, the Centers for Medicare and Medicaid Services (CMS) Center for Consumer Information & Insurance Oversight (CIIO) released a notice entitled “Preliminary Risk Corridors Program Results”. According to the document, CMS has received timely submission of the risk corridors and Medical Loss Ratio (MLR) forms from virtually all QHP issuers, which were due July 31. This is the first year of data submissions for the temporary risk corridors program. CMS writes, “While conducting quality assurance of the risk corridors data, we have identified a significant number of discrepancies in the data, which makes it necessary to conduct additional data validation. This review includes, but is not limited to, comparing risk corridors submissions with other data available to CMS.” CMS had previously indicated its intention to publish preliminary estimates of program-wide payments and charges for the risk corridors program on August 14, 2015. In order to allow for full validation of these data discrepancies, however, CMS is postponing publication of the preliminary risk corridors program results at this time. CMS says that it will provide further information when the risk corridors data is accurate, complete, and validated.
• On August 11, 2015, the Departments of Health and Human Services (HHS), Treasury, and Labor (DOL) released a Frequently Asked Questions (FAQ) document (Part XXVIII, available here) about Affordable Care Act (ACA) implementation. This FAQ relates to transparency reporting rulemaking for non-qualified health plan (QHP) coverage.
• On August 11, 2015, CMS published the following transmittals:
  • New and Revised Place of Service Codes (POS) for Outpatient Hospital: This Change Request revises the description of Place of Service (POS) code 22 to On Campus-Outpatient Hospital, and creates a new POS code for Off Campus-Outpatient Hospital.
  • End Stage Renal Disease (ESRD) Home Dialysis Policy: In the CY 2015 Physician Fee Schedule (PFS) final rule (79 FR 67733) CMS finalized a change to home dialysis (less than a full month) to provide consistency with CMS’ policy for partial month scenarios pertaining to patients dialyzing in a dialysis center.
  • Reporting of Anti-Cancer and Anti-Emetic Drugs: This Change Request (CR) revises Medicare systems to allow oral anticancer and anti-emetic drugs to be reported on hospice claims, as intended by CR 8358.
• On August 12, 2015, CMS published a number of updates related to inpatient hospital reviews. Specifically, these updates pertain to changes in CMS’ education and enforcement strategies around the “Two Midnight” rule regarding when inpatient admissions are appropriate for payment under Medicare Part A. Of note, the update indicates that CMS will not approve Recovery Auditors to conduct patient status reviews for dates of admission of October 1, 2015 through December 31, 2015.
• On August 12, 2015, CMS announced an opportunity for the public to comment on a number of information collection requests. They are entitled: 1) Monthly File of Medicaid/Medicare Dual Eligible Enrollees; 2) Transparency in Coverage Reporting by Qualified Health Plan Issuers; and 3) Home Health Face-to-Face Encounter Clinical Templates. Comments are due October 13, 2015. More information may be found here.
• On August 12, 2015, CMS announced that an information collection activity had been submitted to the Office of Management and Budget (OMB) for review. It is entitled, “Skilled Nursing Facility and Skilled Nursing Facility Health Care Complex Cost Report Form”. Comments on this item are due September 11, 2015.
• On August 12, 2015, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled ‘‘Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.
• On August 12, 2015, FDA announced that it is s extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA’s negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. FDA is extending the closing date in the notice published June 3, 2015 (80 FR 31602). Submit notification of intent to participate by April 30, 2016. More information may be found here.
• On August 12, 2015, the Office of Inspector General (OIG) released the following:
  • Advisory Opinion 15-12 Regarding a home health provider's policy to offer free introductory visits to patients who have chosen it as their home health provider
  • Advisory Opinion 15-11 Regarding a program to provide a drug for free for a limited time to patients who experience a delay in the insurance approval process
  • (A-01-14-00001): Entitled, “Connecticut Claimed Unallowable Medicaid Payments for Targeted Case Management Services Provided to Individuals With Chronic Mental Illness”
• On August 13, 2015, CCIIO released a notice entitled “Draft Fiscal Year 2016 ICD-10 Crosswalk for HHS-HCC Risk Adjustment Model”. The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10- CM) has been developed as a replacement for ICD-9-CM and is scheduled to be implemented in the United States beginning on October 1, 2015, in the last quarter of the 2015 benefit year of HHS-operated risk adjustment. All data reporting for the HHS-operated risk adjustment program must include ICD-10-CM codes for claims with dates of service on or after October 1, 2015. In an effort to prepare issuers for this implementation, CCIIO has prepared this document to describe the agency’s approach to mapping ICD-10 codes in the HHS-operated risk adjustment model. Additionally, CCIIO is providing a draft crosswalk mapping of the ICD-10 diagnosis codes to HHS-operated risk adjustment hierarchical condition categories (HCCs) for stakeholder feedback. The ICD-10 crosswalk is posted on the CCIIO webpage under the section labeled “Premium Stabilization Programs,” under “Regulations & Guidance” in Excel format for review here.
• On August 14, 2015, FDA announced the availability of a guidance entitled ‘‘Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,’’ which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA’s intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.
• On August 14, 2015, FDA announced the availability of the draft guidance entitled ‘‘Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.’’ This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time. Comments should be submitted by November 12, 2015.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate is out of session during the August recess. Both chambers of Congress are expected to resume regular legislative business on September 8th. The Senate calendar may be found here.

House of Representatives

• The House is out of session during the August recess. Both chambers of Congress are expected to resume regular legislative business on September 8th. The House calendar may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On August 10, 2015, the U.S. Government Accountability Office (GAO) released a report entitled “Medicaid: Additional Reporting May Help CMS Oversee Prescription-Drug Fraud Controls”. GAO found indicators of potential prescription-medication fraud and abuse among thousands of Medicaid beneficiaries and hundreds of prescribers during fiscal year 2011—the most-recent year for which reliable data were available in four selected states: Arizona, Florida, Michigan, and New Jersey. As required by federal law, the Medicaid Drug Utilization Review program is a two-phase review process states use to promote safety while also monitoring prescription-drug activity for fraud. Federal law requires each state to report on the operation of its review program, a key monitoring tool that CMS uses to oversee the review process in states, but GAO identified additional actions that could improve oversight. Specifically, GAO identified two potential controls that are not included in CMS's current reporting requirements:
  • Lock-in programs for non-controlled substances. GAO found that expanding lock-in programs that currently focus on controlled substances to restrict abusers of non-controlled substances, such as the human immunodeficiency virus medications Atripla and Truvada, to a single prescriber or pharmacy may help address potential fraud and abuse.
  • Prohibition of automatic refills. Pharmacies permitting automatic refills automatically refill prescriptions for certain medications without any customer action. Concerns with pharmacy automatic refill include the potential for stockpiling, continued fill of discontinued medications, and increased cost and waste of prescription medications. Two states GAO reviewed—Florida and Arizona—have prohibited the practice.
• According to a Gallup poll published Monday, the uninsured rate continues to drop in most states, with Arkansas and Kentucky seeing the sharpest reductions in their uninsured rates since the health law to effect at the beginning of 2014. Oregon, Rhode Island and Washington join them as states that have at least a 10-percentage-point reduction in uninsured rates. Seven of the 10 states with the greatest reductions in uninsured rates have expanded Medicaid and established a state-based marketplace exchange or state-federal partnership, while two have implemented one or the other. Collectively, the uninsured rate in states that have chosen to expand Medicaid and set up their own state exchanges or partnerships in the health insurance marketplace has declined significantly more since 2013 than the rate in states that did not take these steps. The uninsured rate declined 7.1 points in the 22 states that implemented both of these measures by Dec. 31, 2014, compared with a 5.3-point drop across the 28 states that had implemented only one or neither of these actions.
• An analysis of federal data on employment and the U.S. labor force by the Robert Wood Johnson Foundation finds that the ACA had virtually no adverse effect on labor force participation; employment; the probability of part-time work; and hours worked per week by nonelderly adults, despite pre-ACA predictions to the contrary. The report finds that while part-time employment has increased slightly, the increase is small enough that there is no overall change in labor supply; and that Medicaid expansion had virtually no effect on the labor market. The authors find that there is nothing particularly unusual about labor market outcomes in 2014 that would suggest the ACA has had much effect on employment, if any at all. And since they were able to find small changes, it is unlikely that the large labor market effects predicted prior to the ACA could come to fruition in the coming years.
• This week the Centers for Disease Control and Prevention (CDC) published a research brief entitled “Health Insurance Coverage: Early Release of Estimates from the National Health Interview Survey, January–March 2015”. This report from CDC’s National Center for Health Statistics (NCHS) presents selected estimates of health insurance coverage for the civilian noninstitutionalized U.S. population based on data from the January–March 2015 National Health Interview Survey (NHIS), along with comparable estimates from the 2010– 2014 NHIS. Estimates for 2015 are based on data for 26,121 persons. CDC reports that the number of uninsured persons continued to decline from 2013; in the first 3 months of 2015, 29 million persons of all ages (9.2%) were uninsured at the time of interview, 7 million fewer persons than in 2014. Among adults aged 18–64, the percentage uninsured decreased from 16.3% in 2014 to 13.0% in the first 3 months of 2015. There was a corresponding increase in private coverage, from 67.3% to 70.4%.
• On August 11, 2015, the Urban Institute published a report entitled “After King v. Burwell: Next Steps for the Affordable Care Act”. With the Supreme Court deciding the King v. Burwell case in favor of the government, premium tax credits and cost-sharing subsidies for the purchase of private health insurance policies remain available to residents in all states, including those with federally facilitated health insurance marketplaces (FFMs). This paper discusses several outstanding problems related to implementation of the health law, and proposes potential solutions. Issues discussed in the paper include:
  • A continued lack of affordability for some leads to high financial burdens and limits enrollment and reductions in the number of uninsured people;
  • The employer-based insurance “family glitch” prevents some families from getting affordable coverage;
  • Twenty-one states that have not expanded Medicaid eligibility; and
  • Underfunding of administrative functions.
• On August 13, 2015, CMS released the 2015 Special Enrollment Report for the period between February 23rd and June 30th. This “snapshot” provides information about consumers who selected a plan between February 23 and June 30, 2015 through the HealthCare.gov platform, which includes 37 states with Federally Facilitated Marketplaces, State Partnership Marketplaces, and supported State-Based Marketplaces, as part of a Special Enrollment Period (SEP). According to the report, nearly 950,000 new consumers selected a plan through the HealthCare.gov platform using a SEP between February 23 and June 30, 2015.

IV. OTHER HEALTH POLICY NEWS

• On August 10, 2015, consulting firm Booz Allen Hamilton announced that it was awarded a $202 million contract to be the CMS Marketplace System Integrator (MSI). The MSI contract was awarded for $202 million, and is composed of a base plus 4 option years, with the potential for support to continue through July 2020. The MSI program covers system integration, release management, and environment management activities, as well as facilitating communication and participating in the change control process for Marketplace environments. ”We are pleased to serve as a strategic partner through this engagement with CMS to further the centers’ mission to provide affordable healthcare to American citizens,” said Executive Vice President Kristine Martin Anderson, who leads the company’s civil health business. “In the role as systems integrator, Booz Allen will work closely with a broad set of stakeholders across CMS, other Federal Agencies, State entities, and Issuers to coordinate the implementation of the Federally-facilitated Marketplaces (FFM) so that American citizens will continue to receive high-quality, affordable health insurance through the Marketplace.” UnitedHealth Group subsidiary Quality Software Services Inc., which was put in charge of fixing the problem-plagued federal website in 2013, will remain for a three-month transition period from August to October, the agency said.
• On August 11, 2015, HHS announced $169 million in ACA funding to 266 new health center sites in 46 states, D.C., and Puerto Rico. These new health center sites are projected to increase access to health care services for over 1.2 million patients. These awards build on the $101 million awarded to 164 new health center sites in May 2015. “Across the country, health centers have provided a source of high-quality primary care for people in rural and urban communities for 50 years,” said Acting Deputy Secretary Mary Wakefield. “These Affordable Care Act funds build on the strong legacy of the health center program and provide even more individuals and families with access to the care they need the most.” A list of award winners may be found here; the Presidential proclamation may be found here.
• On August 13, 2015, CMS announced that additional providers have joined the Bundled Payments for Care Improvement (BPCI) Initiative. Specifically, CMS announced that that over 2,100 acute care hospitals, skilled nursing facilities, physician group practices, long-term care hospitals, inpatient rehabilitation facilities, and home health agencies transitioned from a preparatory period to a risk-bearing implementation period in which they assumed financial risk for episodes of care. The participants include 360 organizations that have entered into agreements with CMS to participate in the BPCI and an additional 1,755 providers who have partnered with those organizations. More information may be found here.