• On April 10, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Modifications to Meaningful Use in 2015 through 2017”. This proposed rule would change the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also would align the EHR reporting period in 2016 with the calendar year. In addition, this proposed rule would modify the patient action measures in the Stage 2 objectives related to patient engagement. Finally, it would streamline the program by removing reporting requirements on measures which have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs. A fact sheet about the proposed rule may be found here
  • On April 6, 2015, CMS released final updates to the Medicare Advantage (MA) and Medicare Part D programs through the 2016 Rate Announcement and Call Letter for MA Organizations and prescription drug plan sponsors. CMS had released the Advance Notice and Draft Call Letter on Friday, February 20, 2015, and accepted public comments through Friday, March 6. According to CMS, the expected change in revenue in the final Rate Announcement is 3.25, an increase over the 1.05% displayed in the Advance Notice and Draft Call Letter. The 2016 rate announcement reflects an underlying per capita growth of 1.9 percentage points of additional fee-for-service (FFS) spending for 2014 and 2015 and 0.6 percent for 2016, and 0.1 percent for the assumption that Congress will enact the pending legislation to permanently fix the Sustainable Growth Rate (SGR). A CMS fact sheet on the finalized policies may be found here
  • On April 6, 2015, CMS announced a proposed rule—the “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”—to align mental health and substance use disorder benefits for low-income Americans with benefits required of private health plans and insurance. The proposal applies certain provisions of the Mental Health Parity and Addiction Equity Act of 2008 to Medicaid and Children's Health Insurance Program (CHIP). The Act ensures that mental health and substance use disorder benefits are no more restrictive than medical and surgical services. The deadline to submit comments on the proposed rule is June 9, 2015. A press release on the proposed rule issued by CMS may be found here
  • On April 7, 2015, the Food and Drug Administration (FDA) announced the availability of guidance for industry entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions”. This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. There are different procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA review and action of such changes. In addition, this guidance provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. The definitions of REMS modifications and revisions apply to all types of REMS. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the guidance by June 8, 2015. 
  • On April 10, 2015, FDA released a guidance entitled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions”. This guidance outlines FDA’s 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 that are subject to premarket approval (PMA) applications or de novo classifications. FDA believes that the Expedited Access Pathway (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, consistent with the Agency’s mission to protect and promote public health. The document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework. The EAP program will become effective April 15, 2015. 
  • On April 10, 2015, FDA released a guidance entitled “Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval”. This guidance clarifies FDA’s current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket 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. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process.
  • On April 6, 2015, the Department of Health and Human Services (HHS) solicited written comments on the Human Papillomavirus Working Group’s Draft Report and Draft Recommendations for Improving Vaccination Rates in Adolescents for consideration by the National Vaccine Advisory Committee (NVAC). In February 2013, the NVAC created a working group to review the current state of HPV immunization, to understand the root cause(s) for the observed low vaccine uptake, both in initiation and in series completion, and to identify existing best practices to increase the use of the HPV vaccine in young adolescents. Through a series of teleconferences, electronic communications, and public discussions during the NVAC meetings, a working group identified a number of draft recommendations categorized into five priority areas of opportunity for improving vaccination coverage among adolescents. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. On behalf of NVAC, the National Vaccine Program Office (NVPO) is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public. Comments will be considered by the NVAC as it develops its final recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for discussion and adoption in NVAC meeting in June 2015. Comments should be submitted by May 6, 2015. 
  • On April 10, 2015, CMS released a proposed information collection request entitled “Medicare Prescription Drug Benefit Program” (CMS-10141). Part D plans and, to the extent applicable, MA organizations use this information to comply with the eligibility and associated Part D participating requirements. CMS use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and to ensure that correct information is disclosed to potential and current enrollees. Comments are due June 9, 2015. 
  • On April 10, 2015, CMS announced an opportunity for the public to comment on an information collection entitled “External Quality Review (EQR) of Medicaid Managed Care Organizations (MCOs) and Supporting Regulations”, which was submitted to the Office of Management and Budget (OMB) for review. State agencies must provide to the external quality review organization (EQRO) information obtained through methods consistent with the protocols specified by CMS. This information is used by the EQRO to determine the quality of care furnished by an MCO. Since the EQR results are made available to the general public, this allows Medicaid/CHIP enrollees and potential enrollees to make informed choices regarding the selection of their providers. It also allows advocacy organizations, researchers, and other interested parties access to information on the quality of care provided to Medicaid beneficiaries enrolled in Medicaid/CHIP MCOs. States use the information during their oversight of these organizations. Comments are due May 11, 2015. 
  • On April 8, 2015, OMB received a proposed rule for regulatory review entitled “340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations” (RIN 0906-AA89). 
  • On April 9, 2015, the CMS Office of the Actuary released a memo entitled “Estimated Financial Effects of the Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2)”. On March 26, 2015, the House passed the Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2). This bill includes a provision to replace the Sustainable Growth Rate (SGR) formula used by Medicare to pay physicians with new systems for establishing annual payment rate updates for physicians’ services. In addition, it would temporarily extend the Children’s Health Insurance Program (CHIP) and increase premiums for Part B and Part D of Medicare for beneficiaries with income above certain levels. H.R. 2 would also make numerous other changes to Medicare and Medicaid. This memorandum summarizes the Office of the Actuary’s estimates of the short-range and long-range financial effects of H.R.2, describes the bill’s major provisions, and discusses the implications and limitations of the estimates. From fiscal year 2015 through 2025, CMS estimates that H.R. 2 would increase combined Federal spending for Medicare, Medicaid, and the health insurance marketplace by $102.8 billion. The physician payment updates included in H.R.2 would eliminate the significant and immediate problems with the current SGR formula approach. Avoiding these implausible payment reductions (including the 21.2-percent decrease that was scheduled for April 1, 2015) results in a budget cost of $150.5 billion for fiscal years 2015 through 2025 compared to the current-law baseline. This cost is partially offset by other provisions in H.R. 2 that are estimated to have a net reduction in Federal expenditures of $47.7 billion. Accordingly, the net cost of the legislation, per the Office of the Actuary, is $102.8 billion.