Life Science Compliance Update

June 06, 2016

Presidential Advisory Council on Combating Antibiotic Resistant Bacteria Asks for Input

The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria ("Advisory Council") has issued a Request for Information, seeking responses from industry stakeholders and the general public on five questions related to efforts and strategies to combat antibiotic-resistance.

The Advisory Council provides advice, information, and recommendations to the Secretary of the U.S. Department of Health and Human Services regarding programs and policies that are intended to support the implementation of the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria.

The Advisory Council recently published their first report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, at their second public meeting March 30-31, 2016. The purpose of this RFI is to gain additional information from the public on the subject matter in several areas that are addressed in the Action Plan. The responses that are gathered from the RFI will be reviewed by the Advisory Council and will be taken under advisement as the Advisory Council continues their work.

The five questions the Advisory Council would like to start reviewing in more detail are as follows:

  1. Describe how organizations are influencing curricula regarding primary prevention (antibiotic stewardship, infection prevention, and control). Please include information about certification examinations, requirements, and continuing education, if relevant.
  2. Describe how healthcare organizations can best: (a) educate and provide feedback to providers in clinics/facilities about infectious diseases diagnostic testing, optimal antibiotic prescribing, and infection prevention; where relevant, please include information about what incentives and disincentives these organizations have in place with the goal of improving antibiotic prescribing (e.g., using clinical decision support) and prevent spread of resistant infections; and, (b) encourage and/or incentivize providers to report antibiotic use and resistance data for all patient populations.
  3. Please provide examples of successful behavior change models that can be applied to preventive strategies, such as infection control and antibiotic stewardship.
  4. Please provide information on the best ways to collect data on antibiotic use [and resistance] in animal agriculture through public-private collaborations. Your response can include information on the types of data to be collected, including the method of collection, and the metrics for reporting the data. If helpful, please cite sample models as examples to depict your answer.
  5. Please provide information on the different resources that exist to promote the understanding of how antibiotics are being used in humans and animals in different parts of the world. Your response can include information on the types of support to connect with such resources, as appropriate (examples include public-private partnerships, strategic resourcing, or other means).

The RFI is expected to be published in the Federal Register on May 23, 2016, and responses to the questions must be received by 11:59 p.m. thirty days thereafter, putting the deadline on June 22, 2016. The questions are available for answering through an online form here. Alternatively, individuals who wish to send their response via email can do so by emailing, indicating the question number(s) for which they are responding.

The next public meeting of the Advisory Council will be June 21-22, 2016, and will focus on incentives for the development of vaccines, diagnostics, and therapeutics, in addition to the environment and anti-biotic resistance.

March 16, 2016

Office of the National Coordinator for Health Information Technology Proposes Rule on Information Blocking

The United States Department of Health and Human Services released a proposed rule last week that would permit the Office of the National Coordinator for Health Information Technology (ONC) to review certified health IT products for information blocking, in addition to potential risks to patient safety and public health. The proposed rule also gives ONC increased power to regulate authorized certification-testing bodies.


The ONC Health IT Certification Program was established as a Temporary Certification Program in June 2010, and was later transitioned into a Permanent Certification Program in January 2011. In September 2012, certification criteria were established to provide a clear implementation direction to ONC-Authorized Certification Bodies for certifying Health IT Modules.

In October 2015, HHS published a final rule that identified how health IT certification can support the establishment of an interoperable nationwide health information infrastructure through the certification and use of adopted new and updated vocabulary and content standards for structured recording and exchange of health information. This final rule also included provisions to increase the transparency of information related to health IT certified under the program.

The impetus behind this proposed rule is that as certified capabilities interact with other capabilities in certified health IT and with other products, it is important to ensure that concerns within the scope of the Program can be appropriately addressed.

The Health Information Technology for Economic and Clinical Health (HITECH) Act amended the Public Health Service Act (PHSA) in an attempt to improve the quality, safety, and efficiency of health care through the promotion of health IT and electronic health information exchange. The HITECH Act also required the National Coordinator for Health Information Technology perform specific statutory duties, including keeping or recognizing a program for the voluntary certification of health information technology.

This proposed rule proposes to expand the ONC's role in the Program to encompass the ability to directly review health IT certified under the Program and address non-conformities found in certified Health IT, as well as propose processes for ONC to timely and directly address testing issues. According to the drafters of the Rule, increased transparency and publication of identifiable surveillance results would support further accountability of health IT developers to their customers and users of certified health IT.

The Proposed Rule

The proposed rule asks to expand the ONC's role to encompass the ability to directly review health IT certified under the Program, independently of reviews conducted by ONC-ACBs. These reviews would extend beyond the continued conformance of the certified health IT's capabilities with specific certification criteria, test procedures, and certification requirements and would also extend to the interaction of certified and uncertified capabilities within the certified health IT.

ONC would also have broad discretion to review certified health, though the drafters of the rule anticipate that such a review would be relatively infrequent and would focus on situations that pose a risk to public health or safety.

The proposed rule also gives authority to ONC to initiate a direct review whenever it becomes aware of information, whether from the general public, interested stakeholders, ONC'ACBs, or by any other means, that certified health IT may not conform to the requirements of its certification.

The rule also proposes to require ONC-ACBs to make identifiable surveillance results publicly available on their websites on a quarterly basis. The rule drafters believe that by publishing "positive" surveillance results, as well as "negative" ones, will provide a more complete context of surveillance.

Analysis and Conclusion

According to Sherilyn Pruitt, director of ONC's Office of Programs and Engagement, "our goal is to work with developers. Our goal is not to get to decertification." Ms. Pruitt expects the office to work with noncompliant vendors to develop action plans to fix their products and practices.

The proposed rule follows announcements by dozens of health IT vendors, major health systems, and other industry organizations, that they will provide wider consumer access to health data, avoid information blocking, and adopt federally recognized interoperability standards. In announcing the interoperability pledge, HHS Secretary Sylvia Mathews Burwell stated, "we must demand interoperability. We have to work together to unblock data."

The proposed rule also comes after the Precision Medicine Initiative Summit at the White House, where data liquidity was in focus. According to national health IT coordinator Dr. Karen DeSalvo, "the president of the United States has a keen interest in seeing that data moves. We would like to see change [to interoperability] as rapidly as possible, but as safely and securely as possible."

Comments will be accepted on the proposed rule through May 2, 2016, and can be submitted via the Federal eRulemaking Portal or the mail.

February 22, 2016

White House Budget includes Prescription Drug Cost Provisions and Publish NPI Numbers on Open Payments

Recently, the White House released its 2017 Budget through the Office of Management and Budget (OMB). In the Budget, the Administration lays out some of its concerns about our current healthcare system, including drug costs as they relate to Medicare, Medicaid, and transparency.

Addressing the High Cost of Drugs

The cost of drugs continues to take center stage, with constant Congressional hearings and Congressional inquiries and probes. The saga now moves to the Executive Branch of the government, with this budget including a package of proposals that focus on Medicare, Medicaid, and drug price transparency.

Improving Quality and Lowering Drug Costs for the Medicare Program

The White House Budget includes proposals that are expected to lower drug costs, while at the same time increasing transparency and evidence development in the Medicare Part D program.

One such proposal is to increase data collection to demonstrate the effectiveness of medications in the Part D program in the Medicare population, and to inform real world clinical treatment. Additionally, the Budget allows the Secretary of Health and Human Services to continue to have the authority to negotiate drug prices for both biologics and more expensive drugs in Medicare Part D. The Budget also includes a new proposal to incentivize Part D plan sponsors to "better manage care provided to beneficiaries with high prescription drug costs."

The Budget also proposes to accelerate discounts for brand name drugs for senior citizens who fall into Medicare's coverage gap by increasing manufacturer rebates from 50% to 75% in 2028 and to require drug manufacturers to provide rebates that are generally consistent with Medicaid rebate levels for drugs provided to low-income Part D beneficiaries.

OMB estimates that making these changes will save $140 billion over the course of ten years.

Lowering Medicaid Drug Costs for States and the Federal Government

The Budget also includes several policies to lower drug costs for Medicaid, including providing the States with a new, voluntary tool to help negotiate lower drug prices through the creation of a Federal-State Medicaid negotiating pool for high cost drugs.

The Budget also proposes that work be done to continue supporting and building on previously-proposed reforms to the Medicaid drug rebate program, including reforms that enhance manufacturer compliance with rebate requirements, and improve patient access to certain medications.

The Budget also works to improve and correct the Affordable Care Act (ACA) Medicaid rebate formula for new drug formulations, such as by exempting abuse deterrent formulations.

These proposals are estimated to save the Federal Government $11.4 billion over the course of ten years.

Increasing Transparency of Prescription Drug Pricing and Ensuring Access to Generic Medications

The Budget gives the Secretary of Health and Human Services more latitude and responsibility by giving her the authority to require drug manufacturers to publicly disclose certain information, like their R&D costs, discounts, and other data as determined through regulation.

The Budget also includes three reforms that were previously proposed to increase access to generic drugs and biologics by preventing companies from entering into anti-competitive deals that are intended to block consumer access to safe and effective generics. One reform does this by offering brand biologic manufacturers seven years of exclusivity (instead of the twelve offered under current law), and by prohibiting additional periods of exclusivity for brand biologics who made minor changes in product formulations.

It is estimated that these proposals would save the Federal Government $21 billion over 10 years.

Other Transparency Proposals

Tucked away in the body of the text is a proposal to Allow CMS to publish the National Provider Identifier (NPI) of covered recipients on the Open Payments website to make it easier for data users to connect Open Payments records with covered recipient information.

Other Healthcare Related Topics Covered in the Budget

The Budget was not only about the cost of drugs, bust also covered topics such as: improving access to primary care providers (include

s expanding the National Health Service Corps clinicians and encourages provider participation in Medicaid); strengthening HIV and Hepatitis C services (through continued implementation of the National HIV/AIDS Strategy); expanding access to mental health care (including $500 million in new funding over two years to help engage individuals with serious mental illness in care and to expand the behavioral health system workforce); and combating prescription drug abuse and heroin use (through community-based efforts to prevent drug use, improve opioid prescribing practices, and increase access to opioid use disorder treatment services).


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