Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
September 16, 2014

September 15, 2014

Spreading the Fruits of Federal Medical Research

Federal spending on medical research produces results and the National Institutes of Health periodically seeks to license patents on new discoveries and novel medical research techniques. Today, NIH issued a notice of an exclusive license on cancer targeting compounds and a separate request seeking to license a variety of techniques for HIV research and x-ray imaging, plus a new surgical tool for eye surgery.

Many developing technologies and techniques stem from research funding at NIH or through federal grants. Disseminating the fruits of federally funded research is governed by a law enacted in 1980, which allows for licensing of federal patents to industry. The law (view Congressional Research Service description) gives the title to inventions made with government support to small business, universities or other non-profit organizations and is credited with forging a vibrant biotechnology industry. Federal researchers retain the right to use the new innovations and the licensees are responsible for the often-arduous process of perfecting and developing the new technology.

Earlier this year, (@CQHealthTweet) HealthBeat’s Kerry Young’s monitored the various licensing missives from NIH and reported on the licensing of a technique that uses a rabies virus to develop a vaccine against the Ebola virus.



Corn Industry Leader Gets Candid on High Fructose Corn Syrup

One of the frequently cited causes of rising levels of obesity is the widespread use of high fructose corn syrup (HFCS) as an ingredient in many soft drinks. The direct connection between corn syrup and obesity has long been questioned by the corn industry but in an interview last week, the outgoing chief of the National Corn Growers Association, Rick Tolman, acknowledged that HFCS is probably a contributing factor although not the only cause. CQ Roll Call’s Philip Brasher reported on Tolman’s comments on HFCS:

There certainly is an obesity issue in America and in the world, there’s no question about that. Is HFCS a contributor – absolutely. Is it more of a contributor than sugar or anything else? Personally, I don’t believe so and I think most of the science shows that.



Auditor Finds a Sixteen-Year Delay in Rural Clinic Rules

Major congressional health care legislation is often chock-full of various requirements for reports and program changes. Federal agencies are often hard pressed not only to keep track of congressional mandates but also to take timely action on them. Sometimes, federal agencies never get around to implementing new regulations based upon the congressional instructions.

The Department of Health and Human Services Inspector General last week reviewed  inaction by the Centers for Medicare and Medicaid Services (CMS) on changes mandated by Congress in 1996 that changed the terms of a certification requirement for rural health clinics. The health clinics, located in areas where there is a shortage of health care providers, receive enhanced Medicare and Medicaid payments. Congress rolled-back the previously unlimited certification of providers and called for the termination of providers that no longer are located in rural areas. The HHS auditor found several hundred clinics that do not meet the rural location requirement. However, the Medicare management agency, which has twice issued proposed rules on the matter, has yet to issue final regulations on rural clinic location requirements.




September 12, 2014

House Panel Discusses Genetic Research and Prospects for Personalized Medicine

Sept. 10 House Energy and Commerce Hearing

Amid congressional wrangling this week over spending bills and pre-election posturing, a bipartisan group of House Energy and Commerce Committee lawmakers were busy examining options for improving the process for developing and regulating new medical technologies and treatments. The committee on Tuesday hosted a roundtable discussion (view video) with HHS Secretary Sylvia Burwell, top agency chiefs and leaders from several medical research organizations.

National Institutes of Health Director Francis Collins reminded lawmakers that the U.S. took the lead in mapping the human genome, which has led to new technologies. However, China now provides largest current investment in genomics research. Separately, Food and Drug Administration Commissioner Margaret Hamburg and researchers on the panel stressed the need for regulatory improvements to foster the development of personalized medicine, which uses genetic analysis to tailor medical treatments specifically to an individual patient.

By Paul Jenks Posted at 3:46 p.m.
Genomics, Research

Senators Press for a Vote on Sunscreen Ingredient Measure

Overhauling the cumbersome Food and Drug Administration process for approving new sunscreen ingredients is high on the agenda of the bipartisan Senate duo of Democrat Jack Reed of Rhode Island and Republican Johnny Isakson of Georgia. In July, the House passed legislation that seeks to streamline the FDA sunscreen ingredient approval process and Reed and Isakson are urging action on the Senate counterpart measure. Lawmakers claim that slow FDA approval process is holding back the introduction of ingredients that have been approved in Europe.

The Senate version of the sunscreen bill is slated for committee consideration next week. CQ’s Melanie Zanona reported on a rally event on Thursday urging final action on either the House or Senate bills prior to the next recess break before the November elections.



By Paul Jenks Posted at 2:08 p.m.

Will Recent Data Breaches Scare Consumers Away from

This summer a test server behind the website was infiltrated by an alien computer code, or malware. The Department of Health and Human Services notified Congress last week on the security breach and said the infected server did not contain personal information. However, the event, combined with other recent consumer site data breaches, call into question how consumers will react to the site when the new open enrollment period begins on Nov. 15.  A House committee next week plans to quiz administration officials over the recent security breach and the exchange website security concerns.

CQ HealthBeat’s (@CQHealthTweet) John Reichard inquired on Thursday about any administration concerns about negative consumer reaction to the recent reports of security breaches. Former White House health reform adviser Chris Jennings commented:

I doubt the White House is losing too much sleep over this particular issue, though the commitment to privacy and security should be and I think is always there. Re-enrolling the current covered population and targeting the harder to reach folks are much higher on the list.




By Paul Jenks Posted at 10:33 a.m.

September 11, 2014

New Hampshire Vote Brings Back Health Law Memories of January 2010

The results of the New Hampshire Republican primary this week offers a reminder about how the 2010 health care overhaul became law. Republicans in the New Hampshire on Tuesday selected former Sen. Scott P. Brown to challenge incumbent Democratic Sen. Jeanne Shaheen.

In January 2010, Brown won a surprising victory in a special election in Massachusetts to fill the Senate seat vacated by the late Sen. Edward Kennedy. The election victory immediately stalled congressional action on the health care overhaul, which had just passed the Senate a few weeks earlier but was awaiting a vote in the House.  Any House changes to the bill would require further Senate action and Brown’s opposition to the health law assured that Republicans, who assumed an extra Senate vote, could halt action on a revised measure. Regular Senate bills require 60-votes to proceed toward a vote and due to Browns’ victory, Democrats no longer held a 60-votes in support of the health law. Eventually, Democratic leaders coalesced on a strategy utilizing a cumbersome procedural process used for budgetary matters – bypassing the 60-vote requirement – and the health care overhaul passed in March 2010.

The budgetary reconciliation procedures used to adjust federal spending programs, which was enlisted to pass the health law, could return as a factor in Senate deliberations next year if Republicans retain control of the House and garner a majority of seats in the Senate. Part of the equation for Republican Senate control rests on the results of the Senate race in New Hampshire.


FDA Looking Toward Regulating Lab-Based Tests

Genetic testing advances have gotten ahead of federal regulators. That was a message delivered to lawmakers this week in a hearing on personalized laboratory-developed genetic tests. The tests examine genes and DNA to see if they indicate the presence of, or risk for developing, particular diseases or disorders, which can be used to develop treatment plans. A Government Accountability Office report in 2010 critiqued the quality of direct-to-consumer genetic tests and medical groups question the reliability of the information.

The Food and Drug Administration, which is tasked with regulating diagnostic testing, has held off focusing on the tests but has informed Congress that it will soon issue draft guidance regarding the oversight of laboratory-developed tests. However, while the agency is inching toward broader regulation, the process may take years.

CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported on Wednesday on the varying testimony from cancer research groups who are urging stepped-up oversight of the tests and laboratory groups who question the authority and capability of the FDA to regulate testing. The FDA’s director of the Center for Devices and Radiological Health Jeffrey Shuren told the House panel that he will seek input on new regulations but noted, “whatever we come up with, we are not going to satisfy everyone.”



Worker Premiums Ease But Deductibles Soar

Employer sponsored health insurance premiums are rising but increases in employee deductibles are soaring. The annual survey report on employer health coverage issued this week by the Kaiser Family Foundation notes that premiums have increased only 3 percent in 2014 but employee deductibles have increased 47 percent since 2009. On average a covered employee must pay $1,217 this year before their health costs are covered.

CQ HealthBeat’s (@CQHealthTweet) John Reichard reported Wednesday that the impact of new benefit requirements of the 2010 health care overhaul law are only slowly being reflected in premiums as plans are gradually adapting the health law’s new coverage requirements. Additionally, higher deductible levels entice covered employees to pay attention to health care costs.

By Paul Jenks Posted at 10:20 a.m.

September 10, 2014

Mapping the Impact of NIH Funding

The largest discretionary spending component of the budget of the Department of Health and Human Services funds the National Institutes of Health, the primary federal medical research agency. The sprawling NIH campus in Bethesda, Md., belies the fact that 85 percent of the agency’s $31 billion annual budget goes to fund medical research off campus in all 50 states.

A medical research advocacy group, United for Medical Research, this week updated its state-by-state map of NIH research funding flowing to each state and supporting an estimated 400,000 jobs. California and Massachusetts lead in receipt of NIH research grants and the larger states dwarf the totals for Idaho, Wyoming and Alaska. NIH has established an award program that seeks to ship research dollars to 23 states with a poor track record of competing for NIH grant money. However, parsing out medical research outside of the NIH also amplifies the nationwide impact of any reductions in the NIH budget.





States Graded on Telemedicine; CMS is Cautious on the Concept

Proposals to stem the increase in the cost and improve the efficiency of the delivery of health care services usually include the promotion of telemedicine. A shortage of health care professionals in rural and under served urban areas also makes remote medical visits and services a logical option. The American Telemedicine Association this week released two reports on the state of implementing telemedicine programs in the 50 states. The report cites gaps in coverage and reimbursement policies and state physician practice standards and licensure rules.

HealthBeat’s Kerry Young reported in July that the key to an expansion of telemedicine lies with the adoption of the concept by the largest purchaser of health care services, the federal government. However, the Centers for Medicare and Medicaid Services is taking a cautious approach due to conflicting recent studies that offer mixed reviews on the effectiveness of telemedicine. For this year, CMS has widened the geographic limits that previously restricted remote treatment services and allows telemedicine services reimbursement for 1 million more people enrolled in Medicare.


Congress Offers Ebola Response Funding; Health Care Volunteers Are Needed in Africa

House appropriators on Tuesday evening unveiled details of a fiscal 2015 continuing resolution to fund the government into the new fiscal year. The measure stretches funding through Dec. 11 and provides an extra $88 million to fight the Ebola outbreak in West Africa. The added funding matches the administration’s request to support medical specialists on the ground in Africa and speed the development and manufacturing of Ebola drugs.

Congress’ role in addressing the threat of the Ebola virus focuses on providing funding for medical supplies and drug and vaccine research. However, halting the spread of the disease will hinge on finding enough health professionals willing to volunteer. HealthBeat’s (@CQHealthTweet) Rebecca Adams (@RebeccaAdamsDC) reported Tuesday on the profound challenge of enticing health professionals to volunteer to go to Africa to directly assist in efforts to combat the spread of the virus.

The World Health Organization estimates that 760 foreign volunteers will be needed at any one time over the next six months to monitor infected people, test lab samples, run logistical offices and disinfect thousands of corpses. The global WHO appeal so far has generated only a handful of responses and the agency estimates that as many as three health care workers are needed for each patient. The gruesome impact of the virus on the human body and the paucity of proven drugs and a viable vaccine hinders the task of recruiting volunteer health workers.


September 9, 2014

IG Blast Homeland Security’s Pandemic Preparedness Program

In 2006, Congress appropriated $47 million to the Department of Homeland Security (DHS) to prepare federal employees for a possible influenza pandemic. The objective of the program was to ensure that employees were protected from a pandemic and could continue DHS security operations.

On Monday, the DHS Inspector General reviewed spending on the program and determined that the program acquisition process was mishandled. CQ’s Jennifer Scholtes (@JAscholtes) reported that auditors critiqued the department for not adequately taking stock of the department’s needs or developing a clear plan for how much and what types of equipment and antiviral medication to buy. The agency accumulated 300,000 courses of antiviral medical countermeasures without examining the department’s actual needs. The department also purchased 350,000 coverall suits, and 16 million surgical masks. Additionally, of the 5,000 bottles of hand sanitizer purchased under the program, 84 percent of the bottles have expired expiration dates.

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Lawmakers Press for Action to Repeal Blood Donation Limits on Gay Men

A group of lawmakers who are growing impatient with how long the Obama administration is taking to decide whether to lift the ban on gay men donating blood sent a letter on Monday to Health and Human Services Secretary Sylvia Burwell asking her what the agency is doing about this. But unless HHS changes the timetable it described in 2011, when it first announced that it was rethinking the Food and Drug Administration’s current lifetime ban on men who have sex with men being allowed to donate blood, the agency is on track to make a decision on the policy in the first quarter of 2015.

The group, led by Wisconsin Democratic Sen. Tammy Baldwin, wrote to Burwell seeking an update on repealing the HHS policies limiting blood organ and tissue donations. The current FDA policy states: “Men who have had sex with other men, at any time since 1977 (the beginning of the AIDS epidemic in the United States) are currently deferred as blood donors. This is because MSM are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.” Baldwin notes that the policy is no longer scientifically justified with current blood screening technology.

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New Rules on Prescription Drug Disposal

The complexities of the prescription drug distribution system is illustrated today in final regulations from the Drug Enforcement Administration on the retrieval of remaining controlled prescriptions from medicine cabinets around the country. The remnant drugs left over from legitimate prescriptions poses an avenue for illicit redistribution or the possibility of overdoses. Congress mandated an improved drug disposal regulatory regime in legislation enacted 2010 and the DEA began the modification process in proposed rules published 2012.

Today’s 194 pages of regulations includes some streamlining of procedures and record keeping for drop-off points for unused controlled drugs at pharmacies, doctors offices, hospitals and other health care oriented locations, plus drug take-back events and mail-in programs. The rules also set a framework for a special type of reverse drug distributor who retrieves previous dispensed drugs. Of course, like the original distribution rules, the disposal rules include stringent record keeping and custodial requirements. The regulations do not apply to disposal of controlled substances from the stock rooms of hospitals and pharmacies, nor the retrieval illegal controlled substances not available through a prescription.

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By Paul Jenks Posted at 11:17 a.m.
Drug Policy

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