Posts Tagged ‘Senator Mike Enzi’

Senate Passes Bill to Fund the FDA

Wednesday, June 6th, 2012

In a rare show of bipartisanship, the Senate voted 96 – 1 to fund the Food and Drug Administration (FDA), a regulatory powerhouse with far-reaching influence over the foods Americans eat and the medicines they take.  The bill’s goal is to speed approval of new drugs and devices and ensure food safety.  It reauthorizes fees from companies like Johnson & Johnson, Medtronic, Inc. and Roche Holding AG that facilitate FDA evaluation of new medical products prior to approval.

These user fees could provide approximately 50 percent of the FDA’s proposed $4.5 billion budget for 2013.  The FDA regulates products that make up nearly 25 percent of the American economy.  Similar legislation has passed a House committee with support from both sides of the aisle and may move to the full House for a vote quickly.  Senate leaders sped the bill through the chamber, emphasizing its importance in protecting consumer safety and promoting innovation in medicine.

“This bill is a shining example of what we can achieve when we all work together,” said Senator Tom Harkin (D-IA), who chairs the Senate committee that oversees the FDA.  Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the American market but must be renewed every five years.  The current version will expire in September.  Additionally, for the first time the FDA will also collect fees from makers of generic drugs and of copycat versions of complex biotech drugs, known as biosimilars.  “We’ve worked on this bill for 18 months,” Harkin said as he and ranking member Mike Enzi (R-WY) refereed the mostly cordial debate.  The two led opposition to all of the amendments that came up for a vote, and all were defeated.

Senator John McCain (R-AZ) proposed an amendment that would let Americans import drugs from approved Canadian pharmacies.  “In a normal world, this would require a voice vote,” McCain said.  “But what we’re about to see is the incredible influence of special interests here, particularly (the Pharmaceutical Manufacturers Association).”  Senator Robert Menendez (D-NJ) argued that it’s not about the special interests.  “It’s about the health and security of the American people, which is why time after time the Senate has rejected it,” Menendez said.

Senator Bernie Sanders (I-VT), who cast the sole “no” vote, got a vote on his amendment to take away exclusive marketing rights from drug makers if a company is found to be at fault for fraud involving a particular drug. The measure failed overwhelmingly, 9-88.  “Almost every drug company in this country is perpetrating fraud,” Sanders said.  “They’re ripping off Medicare; they’re ripping off Medicaid; and they’re ripping off the American consumer.”

The bill’s speedy passage surprised onlookers accustomed to the usual congressional gridlock.  “I haven’t seen anything move this fast in a long time,” said Lisa Swirsky, a senior policy analyst at Consumers Union.  “Congress is actually working.  It’s kind of like you learned about it in high school.”  Nevertheless, consumer advocates have mixed feelings about the Senate bill that now goes to the House.  “If you look back at what we saw in the House in December, you know this could have been a lot worse,” Swirsky said. She noted that she was “deeply disappointed” that some provisions consumer groups were pursuing to toughen FDA’s review of medical devices did not make it into the bill.  “I would say it’s bittersweet but mostly bitter.”

For more than seven decades, the FDA has primarily inspected U.S. factories.  In recent years, pharmaceutical companies have moved their operations overseas to take advantage of cheaper labor and materials.  Between 2001 and 2008 the number of American drugs made overseas doubled, according FDA figures.  Today approximately 80 percent of the ingredients used in U.S. medicines are made in other countries.

The Senate bill will end a requirement that the FDA inspect all American factories every two years, and give the agency increased discretion to focus on foreign facilities.  At present, the FDA inspects the typical foreign manufacturing facility once every nine years.  Under the bill,  FDA inspectors will target the most problematic manufacturing sites, no matter where they are located.  “This puts domestic and international facilities on an even playing field for the first time,” said Allen Coukell of the Pew Charitable Trusts, which has advocated for increased drug safety.  “It says to FDA, ‘you should inspect the highest risk facilities first, no matter where they are in the world.’”

“These are all the steps American families already think we have in place to protect them,” said Senator Michael Bennet, (D-CO), one of the bill’s authors.  “I cannot tell you how many town halls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected.”

Senators Question CMS Rules for ACOs

Wednesday, August 24th, 2011

Some Senators want the rules for Accountable Care Organizations (ACOs) rewritten to increase their acceptance by providers. “An ACO model that can increase provider coordination and patient accountability would be a step in the right direction compared to today’s fragmented delivery system,” wrote the senators, led by Mike Enzi (R-WY) to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and Centers for Medicare and Medicaid Services (CMS) Administrator Dr. Donald Berwick. “However, it is increasingly clear that this proposed rule misses the target.”

According to the Senators, the ACO rules have misaligned incentives and accountability, as well as an unclear return on investment for physicians and other providers. The Senators highlighted healthcare providers who have raised concerns about the ACO rules, including the American Hospital Association, which released a study that estimated six to 14 times higher start-up costs for the new entities than estimated by CMS.

The AHA study determined that the costs of elements to successfully manage the care of a defined population is considerably higher – $11.6 to $26.1 million – than the $1.8 million estimated by CMS in its proposed rule for start-up and one year of operations. “CMS’ estimate falls short of the mark,” said Rich Umbdenstock, president and CEO of the AHA. “The shared savings rate with ACOs should be adjusted to reflect these costs in order to encourage and enable participation in this important program.” Specific areas of concern include network development and management , care coordination, quality improvement and utilization management ; clinical information systems; and data analytics.

In addition to Enzi, the letter was signed by Tom Coburn (R-OK); Jon Kyl R-AZ); Mike Crapo (R-ID); John Cornyn (R-TX); Pat Roberts (R-KS); and Richard Burr (R-NC).  According to Coburn, who is also a physician, “The letter I signed today echoes the reservations of health professionals who have expressed deep concerns about the well-intended, but ultimately unworkable, ACO regulations recently proposed by the administration. It is certainly my hope that the administration will not misread this letter as partisan, but will work to address the underlying problems of misaligned incentives and regulatory uncertainty that have elicited such concern by a range of health care institutions and providers. If the administration withdraws the regulation, they will find strong bipartisan support among Congress and stakeholders to craft a proposal that encourages broad participation in innovative models to achieve lower costs and better care.”

Berwick and CMS officials believe that organizations that participated in demonstration projects will back the rules because the results showed that Medicare saved more than $38 million in the years of the pilot program; the medical groups that participated got performance payments from the feds totaling more than $31 million. Among the participants are some of the nation’s most prestigious medical systems, including The Mayo Clinic, The Cleveland Clinic and the Geisinger Health System in western Pennsylvania.

Part of the problem, according to The Hill, is that budgetary concerns were the elephant in the room when the Obama administration wrote the proposed ACO rule. This resulted in regulations requiring stringent quality improvements that offered no upfront funding for hospitals to change their procedures. According to regulators, the proposed regulation is open for public comment and can be fine-tuned. CMS recently unveiled new tools to help hospitals start care coordination efforts, for example, by giving them the money they’re supposed to save Medicare through more efficient patient care.

According to the letter, “We have been struck by the increasingly diverse chorus of concerns many of our nation’s leading health care institutions have raised in recent days. The concerns…from some of our nation’s most knowledgeable and innovative health care providers are clear. Incentives and accountability are misaligned. Detailed requirements are complex and return on investment is uncertain.”

Although the Senators complimented the work put into the ACO rules draft, the letter said that feedback received from providers around the country brought the Senators to the conclusion that the proposed ACO regulation will not fulfill its purpose.

Another perspective is offered by Robert Tennant, a managing associate with Health Directions, who says that “I’d like to offer another point of view. Certainly, for most healthcare organizations, transitioning to an ACO will create short-term expense and disruption. At Health Directions, we are finding that healthcare organizations are not dismissing ACOs outright, but they are first asking: What do we stand to gain? In some cases the answer may be either not clear or not favorable. Regardless, there is a potential upside if the focus remains on increasing quality and efficiency of care delivery. As we weigh the future of ACOs, let’s not throw the baby out with the bathwater. The point of discussion needs to shift from whether or not to become a formally organized ACO down the road toward a more focused evaluation of which ACO-type elements are worth adopting now. A commitment to achieving meaningful use with an electronic health record (EHR) is a step in that direction, as is participating in a quality-driven pay for performance program. Both have short-term, well-defined financial rewards attached to them and both will likely increase quality of care. The key is for healthcare organizations to remain focused on the underlying thought behind ACOs — improving care and reducing costs. And that really is worth getting excited about.”

Senate Republicans Refusing to Confirm Dr. Donald Berwick

Monday, March 14th, 2011

Senate Republicans are trying to block the nomination of Harvard-educated pediatrician Dr. Donald Berwick to serve a full term as the administrator of the Centers for Medicare and Medicaid Services.  Led by Senators Orrin Hatch (R-UT), the ranking member of the Senate Finance Committee, and Mike Enzi (R-WY), the ranking member of the Senate Health, Education, Labor and Pensions Committee, the senators contend that President Barack Obama’s recess appointment last year was completed before a hearing was held.  The senators contend that this hindered the 111th Congress’ ability to fully consider Berwick’s nomination.

“This abrupt and unilateral action meant that no senator — Democrat or Republican — was given the opportunity to ask Dr. Berwick a single question before he was placed in charge of an agency with a budget larger than the Department of Defense; which controls four percent of our nation’s gross domestic product; and, most importantly, directly impacts more than 100 million American lives every single day,” according to the Senators’ letter.  The senators say that Berwick’s “past record of controversial statements, and general lack of experience managing an organization as large as complex as CMS should disqualify him” from the post.  “Once you have withdrawn his nomination, we are confident we can all work together to find a nominee for administrator we can support and confirm after appropriate hearings are held,” the letter stated.

Even some Congressional Democrats are urging the Obama administration to find another Medicare chief after concluding that the Senate is unlikely to confirm Dr. Berwick. The most-favored nominee is Dr. Berwick’s principal deputy, Marilyn B. Tavenner, a nurse and former Virginia secretary of health and human resources who has extensive management experience and would likely be confirmed.  President Obama bypassed Congress and named Dr. Berwick to his post while the Senate was in recess last summer.  The current appointment allows him to serve to the end of 2011.

Despite the vocal opposition to Dr. Berwick, President Obama is refusing to withdraw his nomination. “The president nominated Don Berwick because he’s far and away the best person for the job, and he’s already doing stellar work at CMS: saving taxpayer dollars by cracking down on fraud, and implementing delivery system reforms that will save billions in excess costs and save millions of lives,” White House spokesman Reid Cherlin said.  Unfortunately for the president, even some Senate Democrats believe that Berwick cannot be confirmed.  Senate Finance Committee Chairman Max Baucus (D-MT) has said that he would not commit to a confirmation hearing, and other Democrats have acknowledged that the nomination is in trouble.  “I think it would be very tough in this environment.  If we can get some bipartisan products moving forward, then the answer is yes. If you can’t get some bipartisan products moving forward, it’s going to be difficult,” said Senator Ben Cardin, (D-MD).

The Medicare administrator’s job involved significant responsibilities under the healthcare law, such as establishing new insurance markets, expanding Medicaid, and overhauling the way Medicare pays providers to reward quality instead of volume. Republicans need 41 votes to block Berwick’s confirmation in the full Senate; their letter indicates they have more than enough.  The loss of Berwick, a respected medical innovator and patient advocate, would be a blow to the administration as it moves ahead in its implementation of the healthcare reform law.

Five Republican senators did not sign Hatch’s letter.  They are Scott Brown (R-MA), Susan Collins (R-ME),  Olympia Snowe (R-ME), Lisa Murkowski (R-AK), and Rob Portman (R-OH).