In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry to the Agency. The rapid movement by the Agency in this space is being driven by a congressional mandate included in the Food and Drug Administration Safety and Innovation Act (FDASIA).
It is important to note that the shift to electronic submissions does not change the underlying requirements for when the various filings must be made or the content of those filings; it only affects the method of submission and the technical specifications for the e-filings.
This blog post outlines some of FDA’s recent actions to expand the requirements for electronic submissions. If you are a regulated entity that regularly submits adverse event reports, product applications, or promotional materials to FDA (and who doesn’t?), you should ensure that you are aware of the relevant compliance dates and that you are implementing appropriate internal systems to produce and submit electronic data to the Agency.
Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
The top health policy story continues to be the bi-partisan 21st Century Cures legislation, discussed in this post, by my colleague Carrie Roll. The full House Energy and Commerce Committee will begin consideration of the legislation this week, with markup to begin today. A key question that remains for lawmakers is how to pay for the legislation. Stakeholders have been aggressively pushing for additions to the bill since it was introduced, and negotiations reportedly continue over pay-fors.
Other miscellaneous health care legislation moves forward as the Senate Finance Committee closed a request last week for non-controversial health care bills for possible markup during the June work period.
Past Health Care Updates are available here.
On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation. The proposed legislation includes certain telehealth-related provisions that, among other things, request cooperation between state medical boards to coordinate practitioner licensing, and requires CMS and the Medicare Payment Advisory Commission to conduct various studies and reports on barriers to wider telemedicine use. Continue Reading
Earlier this week, ML Strategies (MLS) posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
In its most recent edition, MLS highlights the submission of 340B discount drug program guidance to the Office of Management and Budget for review. This guidance has been highly anticipated since a number of legal challenges in 2014 called into question the authority of the Health Resources and Services Administration to oversee certain aspects this program.
Among a number of other topics, MLS also discusses the HHS Office of the National Coordinator for Health Information Technology’s release of a revised version 2.0 of their Guide to Privacy and Security of Electronic Health Information, as well as CMS’s finding that the Pioneer ACO program saved $348 million over two years.
Past Health Care Updates are available here.
On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date, provisional supplies, and “other authorized prescribers” (a newly defined term). CMS initially proposed rules relating to these topics in January 2014 as discussed in our earlier post. After issuance of these rules, many parties voiced their concerns that the proposed requirements would result in many beneficiaries losing access or having delayed access to their Part D drugs. The changes that CMS announced on May 6, 2015 appear positioned to address these concerns.
Under the interim final rules, prescribers (which include physicians and eligible professionals) now have until January 1, 2016 to enroll in Medicare or file an opt-out affidavit. This is the second time that CMS has delayed the requirement; first from June 1, 2015 to December 1, 2015, and now to January 1, 2016. By allowing prescribers more time to enroll or out-opt, CMS believes that fewer beneficiaries will be faced with the prospect of submitting a prescription to a pharmacy written by a prescriber who failed to meet the initial or second deadline.
The other two significant announcements in the internal final rules, those relating to other authorized prescribers and provisional supplies and beneficiary notices, may have a more significant impact on beneficiary access than CMS’s decision to delay the enroll/opt-out effective date. Continue Reading
After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” It includes the questions that were omitted from the finalized Q&A document and also several new questions and answers. For example, two of the new questions address pediatric research requirements and how a sponsor should initiate discussion on pediatric study plans with FDA. Another question deals with a technical issue regarding what dosage form of a proposed biosimilar would be considered the “same” dosage form as the reference product; and another offers details regarding how a non-U.S.-licensed product may be imported and used in a clinical study by a potential biosimilar applicant.
FDA is seeking stakeholder input on the Agency’s proposed responses to the revised and new questions, and it requests that interested parties submit their comments no later than July 13 to ensure that they are considered by the Agency as it begins work to finalize the document. Notably, FDA has been criticized for the length of time it has taken to provide substantive guidance to potential sponsors of biosimilar applications, most recently in an open letter from a group of GOP Senators who called the FDA’s work so far to implement the BPCIA “opaque.” The Senate letter also requested specific detailed information from the Agency on numerous issues. We expect additional draft guidances on important biosimilar topics (such as the policy for nonproprietary naming) from FDA over the remaining months of 2015, and it will be interesting to see whether and how critics of the Agency’s BPCIA implementation efforts respond to any new actions taken by FDA.
Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act. In addition to accepting the so-called “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after July 1, covered pharmacies also must have systems in place to segregate and investigate suspect products.
The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information. This revamped version has been reorganized and rewritten to be more user-friendly for small organizations addressing federal privacy and security requirements for their practices. Though the Guide is targeted to small providers, providers of all sizes, and their business associates, will find it useful. Continue Reading
ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
This week’s update focuses on developments around the 21st Century Cures Initiative and the expansion of the Pioneer ACO Program. The new draft legislation for the 21st Century Cures Initiative includes increased funding for the National Institutes of Health (NIH) and a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. The SOFTWARE Act would exempt health software products from FDA regulation except where FDA determines the product would pose a “significant risk to patient safety.” The draft legislation currently includes only placeholders on interoperability and telemedicine, key issues that lawmakers will need to work through. On the ACO front, The Pioneer ACO program is the first program to meet the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary’s approval for expansion. HHS Secretary Sylvia Burwell formalized the administration’s intention to expand the program.
Past Health Care Updates are available here.
The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers prescribed in 2013 under the Medicare Part D Prescription Drug Program. CMS’s press release touted the data as “part of the Obama Administration’s efforts to make our healthcare system more transparent, affordable, and accountable.” Following the Physician Payments Sunshine Act, which makes public the financial arrangements that pharmaceutical and medical device manufacturers have with physicians and teaching hospitals through the “Open Payments” program, and the release of 2012 physician Medicare Part B fee-for-service data, which my colleagues discussed in a previous post, the 2013 Part D data adds to the growing universe of publicly available information about the health care system. Continue Reading