POLICY BRIEFINGS


HELP Releases HIT Interoperability Draft Bill


The Senate Health, Education, Labor, and Pensions (HELP) Committee released a staff discussion draft of bipartisan legislation to improve health information technology (HIT). The draft is result of the work of the committee’s HIT working group convened in April 2015. The legislation focuses on decreasing unnecessary physician documentation; enabling patients to have easier access to their own health records; and making electronic health records (EHRs) more accessible to the entire health care team, such as nurses. The bill would allow non-physician members of health care teams document information in EHRs on behalf of physicians. It establishes an unbiased rating system for HIT to help providers choose products. It also gives the U.S. Department of Health and Humans Services (HHS) Office of the Inspector General (OIG) the authority to investigate and establish deterrents to information blocking practices. The draft would establish an initial set of common data elements, such as standard formatting for entering a patient’s date of birth. It also includes a measure to support the certification and development of patient-centered EHR technology so that patients can access their information through secure software. The Committee identifies stopping information blocking – or intentional interference with access to personal health information, ensuring the government’s certification of a records system means what it says it does, and improving standards as the most critical steps to developing systems that achieve interoperability. Comments are due on the draft legislation no later than January 29 to HealthIT@help.senate.gov. The bill will be considered during the Committee’s first Innovation markup on February 9. A summary of the draft is available HERE.


Shkreli Subpoenaed Over Drug Price Increases


The House Oversight Committee has issued a subpoena to Martin Shkreli, the ex-CEO of Turing Pharmaceuticals who became notorious last year by increasing the cost of Daraprim by 5,000 percent overnight. Committee Chairman Jason Chaffetz (R-Utah) wrote to Shkreli last week demanding financial information and profits from the sale of this drug. Shkreli’s lawyer has told Rep. Chaffetz that the former executive will plead the Fifth Amendment and remain silent if he is forced to appear before the committee. Other hearing witnesses include Howard Schiller, the interim CEO of Valeant Pharmaceuticals. Valeant has also been accused of price gouging. The Director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) will also testify, in addition to Mark Merritt, president of the Pharmaceutical Care Management Association.


Hold Placed on Califf’s FDA Nomination


Sen. Ed Markey (D-Mass.) has placed a hold on Robert Califf’s nomination to be Commissioner of the Food and Drug Administration (FDA) because of the agency’s policies for evaluating prescription opioids. Specifically, Sen. Markey is concerned about the FDA’s approval of OxyContin for pediatric use in 2015. Sen. Markey has requested that the FDA convene an advisory panel of outside experts when making approval decisions on opioid painkillers. He also wants the agency to weigh the risks of abuse and addiction before approving an opioid drug. The hold follows Sen. Lisa Murkowski’s (R-Alaska) announcement that she would block a floor vote on Dr. Califf’s nomination until she receives more information about the agency’s decision surrounding genetically engineered salmon. Presidential candidate Bernie Sanders (D-Vt.) has also threated to place a hold on the nomination because of the Dr. Califf’s previous relationships with the pharmaceutical industry.



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