Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
December 18, 2014

December 18, 2014

FDA Looks to Eliminate Some Drug Label Papers

Prescription drug packages include not only medicine but also an array of folded printed instructions and warning notices, all of which are tightly regulated by the Food and Drug Administration. However, the drug regulatory agency wants to eliminate some of the dense reading material. In a rule proposal set for publication on Thursday, the FDA proposes eliminating drug-labeling information provided for those who prescribe the drug, such as physicians and pharmacists. Printed label instructions designed for consumers are not the subject of the rule proposal.

The proposal is not primarily focused on reducing the volume of drug inserts but to make sure the drug prescriber has access to the most current information on the drug. A printed sheet of information is likely immediately out-of-date and health care professionals are urged to seek electronic files on prescribing information. The proposal suggests that the drug label should note directions on finding the electronic label information and acknowledges some disadvantages cited in a 2013 Government Accountability Office report on the use of electronic drug labels.

The FDA estimates drug industry savings of $52-164 million by eliminating the labels or inserts and added pharmacy costs of $47-89 million.


Senate Committee Offers to Help Fight Prescription Drug Abuse

A reported epidemic of abuse of prescription drugs, which is largely focused on the misuse of prescription painkillers, will continue to focus the attention of the Senate Health, Education, Labor and Pensions Committee next year. Concern about the issue is one topic that enjoys broad bipartisan support within the committee but the panel is short on new ideas for legislative action.

Instead, the bulk of the members of committee on Wednesday wrote to the Department of Health and Human Services, the American Medical Association and groups representing state and local health departments, encouraging continued efforts to stem prescription drug abuse and urged them to tell the committee of any necessary legislative requirements.


Lawmakers Issue Warnings on Lost Subsidies Ahead of Supreme Court Decision

A Supreme Court decision next year could severely complicate the ongoing implementation of Affordable Care Act. A court ruling in favor of a challenge (King v. Burwell) on the legality of insurance subsidies offered on exchanges operated by the federal government could halt subsidies on the federal exchanges and cause a cascade of problems. Current subsidies for 13 million people could be voided and premium prices would effectively skyrocket.

Congressional anxiety over the impact of a possible ruling against the subsidies prompted a group of Republican senators on Wednesday to write to the Treasury Department inquiring about plans for managing the impact of voided subsidies and consumer repayments. The group also inquired about the implications for IRS rules on insurance coverage mandate tax penalties, since the availability of subsidies also triggers insurance coverage tax penalties.

Meanwhile, Democrats on the House Energy and Commerce Committee this week assembled a district-by-district analysis of the impact of a decision striking down the federal exchange subsidies.

HealthBeat’s (@CQHealthTweet) John Reichard reported (subscription) last month that the collapse of federal subsidies for 37 states with federal exchanges would not impact the 13 states that currently operate their own exchanges and could entice more states to take over exchange operations. Also, congressional action in response to a possible court decision to halt subsidies could hinge on Democrats finding a way to keep subsidies flowing nationwide and Republican efforts to halt employer and individual insurance coverage mandates.



December 17, 2014

Report: Teenagers Shifting from Tobacco to E-Cigs and Marijuana Food

Teenagers are switching from tobacco cigarettes to e-cigarettes and marijuana food. A University of Michigan study released on Tuesday indicates that teenagers are quickly shifting to the new e-cigarettes. The Monitoring the Future survey found 17 percent of 12th graders reported using e-cigarettes in the past 30 days, compared to 14 percent who reported use of a tobacco cigarette.

The study found that between 4 percent and 7 percent of teenagers who have never smoked a tobacco cigarette have tried e-cigarettes. Critics say e-cigarettes could serve as a gateway for use of nicotine, an addictive drug and California Democratic Sen. Barbara Boxer cited the survey as reason to finalize rules on banning e-cigarette sales to minors.

Separately, the report cites 6 percent of 12 graders report daily use of marijuana. Iowa Republican Sen. Charles E. Grassley expressed concern about the survey’s revelation that 40 percent of 12th graders — in states with medical marijuana laws and reported using marijuana in the past year — consumed marijuana in food products and critiqued the impression that marijuana is not harmful.




By Paul Jenks Posted at 8:43 a.m.
Drug Policy

December 16, 2014

Report Examines Options for Improving Hospital Emergency Rooms

Hospital emergency room conditions and operations can be the focal point of early indicators of many health care delivery issues. Emergency rooms provide a large portion of heath care to the country, particularly for uninsured and Medicaid patients. Busy emergency departments are also costly operations for hospitals, which are required by federal law to treat all patients regardless of the patient’s ability to pay.

The Congressional Research Service, in a report published this month, offers a primer for lawmakers on role of emergency rooms in the health care delivery system.  The report also examines other concerns, including emergency room crowding, frequent patient visits, and providing care for persons with behavioral health conditions. CRS suggests a range of options from changing emergency department accreditation requirements and enhancing Medicaid and Medicare reimbursement rates, plus a suggested change to the emergency care law and requiring specialized behavioral health facilities to accept the transfer of patients from overwhelmed emergency rooms.


By Paul Jenks Posted at 2 p.m.

Lost in Translation: From Medical Journals to News, Avoiding Bad Information

Medical journal articles are a primary source of information on new medical advances and studies but they are usually laden with very detailed caveats and scientific jargon. The process of disseminating the new information to the public takes a circuitous pathway from the journal to media reports. However, an online or newspaper news article about the research study may offer misinformation, which in turn affects the behavior of the public and even other scientists and doctors.  Over time, the cumulative effect of contradictory reports can confuse the public.

A study from the BMJ (formerly the British Medical Journal) examines the process on how health information included studies can be exaggerated in media reports. The report highlights the major role of the press release written to tout a new study to the media, which can also be the original source for erroneous information. The pressures of a fast-paced news cycle, combined university competition and self-promotion largely accounts for any exaggeration of health issues presented to the public.

Senate Clears Brain Injury and Breast Health Measures

The Senate has extended its 2014 term for a few more days while it wraps up several unfinished matters. On Monday, amid maneuvering over a confirmation vote approving the nomination of Vivek Murthy as Surgeon General, the Senate also approved several health measures. Senators quickly completed action on a bill seeking to extend a pilot program offering assistance to veterans with traumatic brain injuries (HR 4276) and a measure reauthorizing an education campaign and research on prevention of breast cancer in young women (HR 5185). The Murthy nomination was confirmed in a 51-43 vote.

However, Oklahoma Republican Sen. Tom Coburn is fighting against further action other remaining measures, including a bill (HR 5059) calling for a review and adjustment of veteran suicide prevention programs. Sen. Coburn objects to the cost of bill and suggests that the measure duplicates existing programs.

Roll Call’s Niels Lesniewski reports that Coburn, a physician who is retiring from the Senate at the end of the year, is fighting a lonely battle against the veterans’ bill, plus other measures on energy efficiency and an extension of a terrorism risk insurance program.

December 15, 2014

Economist Critiques the Daft World Health Organization

Congress this weekend passed an omnibus spending bill, which includes $5.4 billion in added funds to respond to the Ebola crisis in West Africa.  The funding flows to federal agencies managing the Ebola response effort. However, leadership on the global response to combat Ebola rests on the World Health Organization (WHO). The UN agency has faced criticism for allowing the outbreak to grow out of control. In a lead commentary this week, the Economist newspaper urges a reorganization of the WHO’s broad mission to fit limited and largely dismal resources. The magazine also comments on the WHO’s “daft organizational structure,” which mirrors other United Nations organizations.  The Economist notes:

 The WHO’s failure to lead the response to the Ebola crisis should be used as a spur to rethink what the WHO is for, and how it is financed and run. Instead of doing the job of governments, it should focus on the things they cannot manage alone, such as helping poor countries set up health systems, disseminating the best medical research and policies, and combating global epidemics. Politicians must be stopped from using regional offices as a parking-place for friends and relations of their allies. Dr Chan should be able to direct her own organisation: that means being able to hire and fire. And if the world wants an outfit capable of dealing with emergencies such as Ebola, it needs to pay for it. That means increasing dues—and not leaving it to scrabble for handouts.






Congress Quietly Clears Steroid and Doping Agency Bills

Two measures addressing the control of the use of anabolic steroids used by athletes quietly cleared Congress late last week. Senators Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., gained Senate action on a bill (HR 4771) that seeks to add 25 known designer steroids to the Drug Enforcement Administration’s list of controlled substances and allows the DEA to list any new steroids in the future.

Separately, the House on Friday — in a pro-forma session — completed action on a separate bill (S 2338) renewing funding authorization for the U.S. Anti-Doping Agency (USADA). The independent agency was established by the U.S. Olympic Committee to monitor doping in U.S. Olympic sports. The renewal bill broadens the definition of performance-enhancing drugs monitored by agency. The Olympics provides large portion of funding for the USADA and the measure allows for $91 million in possible federal appropriations over the next 5 years.

By Paul Jenks Posted at 11:06 a.m.

Senate Prepares to Approve Surgeon General Nomination; Groups Offer Medicare Suggestions

Week Ahead

The Senate, after passing the fiscal 2015 omnibus funding bill on Saturday, does not want to leave too quickly. A few items remain on the agenda over the next two days. Today, senators will vote to confirm the nomination of Vivek Murthy as Surgeon General. The position advises the Department of Health and Human Services on public health matters and manages the Commissioned Corps of the Public Health Service. Early procedural maneuvering towards a vote on the nomination, which is contested by many Republicans, was enabled by weekend deliberations on the omnibus spending bill.

Separately, this week the Medicare Payment Advisory Commission, which is charged with advising Congress on payments to Medicare providers, holds a two-day public meeting on Thursday and Friday. Also, on Tuesday the bipartisan duo of former senators Bob Kerrey and Jack Danforth will release an update to a hallmark 1994 effort to devise a overhaul of federal entitlement spending. The two senators led one of several efforts to overhaul funding for Social Security and Medicare but – like other efforts – failed to garner a consensus agreement. Next year, with Republicans in control of both congressional budget panels, suggestions on changing Medicare funding will lurk on the agenda for possible addition to annual congressional budget proposals.




December 12, 2014

Congress Keeps Tabs on “Three-person Embryos”

A fertility technique that can produce “three-person embryos” to prevent women from passing on rare genetic diseases has drawn the attention of  lawmakers who set the budgets for federal agencies including the Food and Drug Administration.

At issue is mitochondrial manipulation, in which genetic material from one woman can be moved into the egg of another. This technique has been developed to help women who otherwise would risk passing on rare mitochondrial diseases to their children, but there’s some thought that it also may aid older women seeking to become mothers.

Full story

Health Care Agency Funding Bill Races Toward Finish Line

Week in Review

The Senate today is the last stop before final passage of an omnibus year-end spending bill. The House on Thursday — in contentious voting — approved the package, along with a stopgap spending resolution keeping federal agencies open over the next few days as senators deliberate on the larger spending bill.

The measure has been in negotiations for several weeks, but added spending is limited due to previously established budgetary caps, which left lawmakers little room to add money for discretionary health programs. Overall, funding for the agencies within the Department of Health and Human Services remain largely at last year’s levels or receive modest increases. However, separate mandatory spending for the Medicare and Medicaid programs jumps by more than $60 billion compared to 2014 levels, spurred by a huge increase in Medicaid funding to the states due to the Affordable Care Act.

Additional funding to respond to the Ebola crisis, particularly focused on assistance to West African countries and FDA and NIH drug and vaccine development, reduced any wiggle room for new spending. The original $6.2 billion White House Ebola response request was reduced in the spending package to $5.4 billion and is spread out between HHS agencies, the State Department and the Defense Department. Also, Republicans claimed no new health care overhaul law funding but omitted any major health law program cuts, except for a continued hold on money for a dormant health law provider payment advisory board. Separately, the measure continued a long-standing federal abortion ban and calls for administration action to clarify health plan abortion coverage requirements.

Congress this week completed action on a bill reauthorizing newborn screening programs (HR 1281), offering education, information tools and research on inheritable disorders in newborns and children. Also, the House passed bills updating veterans’ suicide prevention efforts (HR 5059) and renewing breast health education programs (HR 5185). The Senate could quickly complete action on the two measures today or this weekend prior to ending the term of the 113th Congress. The House has already retired for the year.

Planning on Reading the Spending Bill? Try the Explanatory Report First

The Senate today is racing toward completing votes on a spending bill package  that includes money for health care programs through the end of fiscal 2015.  The 1600+ page bill details spending levels for most federal agencies, except for temporary stopgap funding provided for the Department of Homeland Security. However, the main bill text itself offers very dense reading material. A separate accompanying explanatory statement on the bulk of the bill’s health care agencies provides useful background and commentary on many health care issues that have recently attracted lawmaker attention. At 110 pages, the document — complete with copy-editor notations — describes congressional views and suggestions for health programs and regulatory activities.

CQ HealthBeat’s (@CQHealthTweet) KerryYoung reported (subscription) on several elements included in the explanatory statement. The Centers for Disease Control and Prevention is ordered to direct funding for fighting prescription drug overdoses to states hit hardest by the drug abuse (see explanatory statement page 30). The report also urges the Centers for Medicare and Medicaid Services to reconsider a decision on Medicare coverage for a high-tech heart pump, with an eye toward expanding eligibility for the device (see bottom of page 75).

Items noted in the explanatory statement may not be included in the actual bill text. Often a provision is too contentious for the bill, but a compromise can land some commentary in the accompanying report. Such a compromise in this year’s bill led to explanatory instructions clarifying coverage requirements for health plans purchased through health insurance exchanges, with an eye toward a dispute over plan coverage of abortion services. The report instructs HHS to take heed of a recent federal audit of health plan abortion coverage and orders quick responses to complaints on violations of “conscience protection” provisions on abortion services coverage (view health plan transparency and provider complaint comments beginning on page 81).


Medicaid Doctors Set for a 42 Percent Payment Reduction

Congress is preparing to conclude the current term without action on extending relief from upcoming cuts in Medicare and Medicaid physician payments. There still is time for the next Congress to act on what is familiarly known on Capitol Hill as the “doc fix” before payments are reduced on April 1. However, a separate cut in Medicaid physician fees for primary care services is set to begin on January 1, 2015.

The Affordable Care Act included a temporary increase in federal Medicaid funding to increase payments to physicians to match Medicare payment levels. The temporary period expires at the end of the year. A report released on Wednesday by the Urban Institute estimates that the payment expiration will lead to a 42.8 percent reduction in fees for primary care services for eligible providers. However, the fee reduction varies because some states plan to continue higher physician payments by using separate state funds.




By Paul Jenks Posted at 9:31 a.m.

Is the Veterans’ Health Care System Cheaper than Private Care?

A Congressional Budget Office report released this week looks at the Veterans Health Administration (VHA) and examines the difficulties in comparing the cost effectiveness of federal and private health care. At first, the CBO assumed – based upon earlier studies – that VHA care costs less than equivalent care provided in the private sector. Now, the budget agency is no longer so sure.

Changes at the VHA, the complexities of cost comparisons and the paucity of new studies make a current comparison difficult. Meanwhile, the VHA is expanding the use of private health care services to compensate for highly publicized and very long treatment waiting times.

Factors favoring lower costs for veterans care include lower prices for pharmaceutical products and likely lower pay rates for doctors. Also, the private sector’s favoring of fee-for-service payments probably hikes the cost of private care. However, the report notes in conclusion: “even if VHA currently provided care at a lower cost than the private sector, expanding the VHA system might not be cheaper in the longer term than increasing the use of private-sector providers.”

And as my colleague Connor O’Brien wrote recently in CQ Weekly (subscription), some health care experts say it might be better to subsidize private heath care for veterans than to keep up the current government-run system.


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