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Monday, June 15, 2015
Senators Seek to Address Concerns About Electronic Health Records
Senators Seek to Address Concerns About Electronic Health Records
By Melanie Zanona, CQ Roll Call
Concerns about a $30 billion federal program meant to encourage the adoption of electronic health records are likely to be addressed in a Senate medical innovation bill later this year, according to Health, Education, Labor and Pensions Chairman Lamar Alexander.
“This will be a central piece of our innovation project ... that’s why I’m spending so much time on it,” the Tennessee Republican told reporters after a Wednesday hearing. “The purpose of our innovation bill is to align federal polices so cures, treatments and devices can get through discovery to the medicine cabinet. This is just a part of it, but an important part.”
Alexander said his panel is on track to consider its version of legislation to speed medical cures after it finishes a planned reauthorization of higher education law in September. Parallel efforts in the House have been on a much quicker timeline, with the full chamber expected to consider its so-called 21st Century Cures bill (HR 6) as early as next week.
Lawmakers in both parties largely agree the government’s six-year-old Meaningful Use Program included in the 2009 stimulus package (PL 111-5) needs improvements. The effort was intended to incentivize doctors and hospitals to adopt electronic medical records, in the belief that they could facilitate information sharing and improve the quality of care.
But more than 250,000 physicians have struggled to meet the program’s second phase of requirements and have begun losing one percent of their Medicare payments as part of a penalty, according to the Centers for Medicare and Medicaid Services. The final rule for the next stage of the program is expected later this year.
“Physicians and doctors have said to me that they are literally terrified on the next implementation stage of electronic health records, because of its complexity and because of the fines that will be levied,” Alexander said at the hearing.
One witness suggested that Congress delay the third phase of the program until improvements are made. However, Christine Bechtel, advisor for the National Partnership for Women and Families and chairwoman of a Health IT Policy Committee Consumer Workgroup that advises the federal government, cautioned that could squelch a technical fix that would help us unlock data that is currently siloed. “I just want to recognize that wholesale delay of Meaningful Use stage three should be very thoughtfully considered in light of the things we would give up,” she said.
Alexander, however, said it “might be better to step back on some of the rules and take some advice on how to improve things.”
Five or Six Steps
Wednesday's hearing was part of efforts to identify “five or six” steps to improve electronic health records, according to Alexander. In addition to weekly meetings between staff and regular communication with the Health and Human Services Department, there will be at least two more hearings that will address the burdens facing physicians and the control that patients have over their own health information.
Potential solutions identified Wednesday include improving documentation requirements for doctors, refocusing and streamlining regulations, establishing unique identifiers for patients and supporting patient-centered care delivery.
“No place knows where my records are other than me. There is no system,” said Neal L. Patterson, co-founder and chief executive officer of Cerner Corp. “And everybody is very afraid and cautious of letting records out because of [Health Insurance Portability and Accountability Act federal privacy rules], which has very stringent penalties for sharing patient information.”
But one of the biggest challenges in improving electronic medical records is getting systems to talk to each other, an issue known as interoperability. Provisions meant to enhance communication between different systems were included in the House Cures bill and related language is likely to land in the Senate version as well.
Witnesses suggested implementing a public-private partnership on interoperability governance in order to provide “clear rules of the road," developing functional data standards, establishing transparency in the free flow of information and preventing deliberate information blocking by a company or provider.
“The goal should be to design and implement a secure health IT ecosystem that enables an easy exchange of health information in timely and cost-effective ways,” said Craig D. Richardville, senior vice president and chief information officer of Carolinas Healthcare System.
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Weekend Shifts Broaden Perspective of CMS Top Doctor (A Pediatrician)
Weekend Shifts Broaden Perspective of CMS Top Doctor (A Pediatrician)
By Kerry Young, CQ Roll Call
Hospitals may be saving as much as $459 million a year partly because a doctor on a weekend shift once too often witnessed a nutritionist having to dictate orders to a busy resident instead of ordering them directly. In his weekday job as a top Centers for Medicare and Medicaid Services official, Patrick Conway was well positioned to change the federal rule that blocked hospitals’ nutrition experts from entering the information on their own.
“One of the things that triggered that is that I was watching for about the 100th time a dietitian tell the resident what to enter into the computer because only the resident, who is a physician, could enter diet orders,” said Conway, CMS’ chief medical officer, in a recent interview.
Conway, who also leads major quality-improvement and innovation initiatives within CMS, cited this as an example of how his decision to continue practicing medicine influences his work on health policy. A pediatrician, Conway said he works weekend shifts at Children's National Medical Center in Washington, D.C., about once every six weeks. That clearly takes some schedule juggling, as Conway also is the married father of three young children. But he said the weekend hospital shifts recharge him and he described the practice of medicine as “a calling.”
“It keeps me connected in a very important way,” Conway said. “It informs everything from payment policy to clinical standards.”
Nutritionists had pressed for several years for a change in hospital rules, which CMS has great sway over nationwide through the conditions that the agency sets for coverage and participation in its programs. With Conway’s help, the agency last year finalized a rule that makes it clear that dietitians can enter orders directly. The change could save as much as $291 million a year in labor-related costs, plus another $168 million from an expected reduction in the cases of inappropriate use of nutrition given by tube, CMS estimated in the final rule. The Academy of Nutrition and Dietetics, which represents about 75,000 registered dietitian nutritionists and other professionals in the field, greeted the new rule as a “major policy success.”
“You’re enabling people to practice to the top of their license,” Conway said of the change.
The weekend hospital shifts give Conway a first-hand look at the medical profession in the midst of what he described as “a long-term transformation.” CMS is a key driver of these changes, which include greater use of electronic health records and other steps that have caused grumbling among medical professionals. By continuing his own hospital work, Conway can relate more easily to colleagues facing pressures and inconvenience associated with these changes.
“I actually use the electronic health record in care delivery,” Conway said. “There’s a credibility factor. If you are still practicing, I think it helps you to communicate in a more credible way with physicians.”
Conway is also clearly comfortable on the wonkier side of medicine. After graduating from Baylor College of Medicine, he earned a graduate degree focused on health services research at the University of Pennsylvania. He’s listed along with CMS’ chief data officer Niall Brennan as one of the highlighted speakers for Health Datapalooza 2015, a major conference that starts May 31.
At CMS, Conway said he finds his days often filled with “a lot of meetings.” To try to improve efficiency within his parts of the agency, Conway is borrowing the “lean” method pioneered by automaker Toyota, with a focus on improving the effectiveness of processes and eliminating waste. For the clinical standards and quality unit that he oversees, this has dropped the contract modification time by 50 percent from 8 weeks to 4 weeks. In the Center for Medicare and Medicaid Innovation that Conway oversees at CMS, the time for providing technical assistance to participants in certain pilot programs fell by approximately 4.5 months, according to Conway.
The $10 billion innovation center was created by the 2010 health law (PL 111-148, PL 111-152), and Republicans have questioned its effectiveness. In his work, Conway seems to seek to stay out of the continuing conflicts about the law. He spends his time instead searching for better ways to deliver health care, said Mark McClellan, who led CMS during the Bush administration.
“He is really good about trying to reach out to a wide range of different perspectives, trying to do what's what right for patients and for the program and not focus on any partisan or political issues, but really try to make Medicare a stronger program for the future,” said McClellan, now a scholar at the Brookings Institution and a member of the board of directors of health giant Johnson & Johnson.
Monday, June 1, 2015
Antitrust Lawsuits Target Blue Cross and Blue Shield - Wall Street Journal
Antitrust Lawsuits Target Blue Cross and Blue Shield
Customers, health-care providers accuse insurance network of acting as a cartel
By
Anna Wilde Mathews : The Wall Street Journal
Updated May 27, 2015 5:06 p.m. ET
Blue Cross and Blue Shield health insurers cover about a third of Americans, through a national network that dates back decades. Now, antitrust lawsuits advancing in a federal court in Alabama allege that the 37 independently owned companies are functioning as an illegal cartel.
A federal judicial panel has consolidated the claims against the insurers into two lawsuits that represent plaintiffs from around the country. One is on behalf of health-care providers and the other is for individual and small-employer customers.
The antitrust suits allege that the insurers are conspiring to divvy up markets and avoid competing against one another, driving up customers’ prices and pushing down the amounts paid to doctors and other health-care providers.
The suits, which name all of the Blue Cross and Blue Shield companies as defendants as well as the Blue Cross Blue Shield Association, have already survived the insurers’ first major legal challenge.
U.S. District Judge R. David Proctor last year declined to dismiss them, saying that the plaintiffs “have alleged a viable market-allocation scheme,” which, if proven, could be an antitrust violation. Judge Proctor also said certain federal antitrust exemptions for the insurance business didn’t appear to apply to the behavior at issue in the lawsuits. The suits have moved into the discovery phase; the plaintiffs are seeking class-action status.
Antitrust experts who aren’t involved in the litigation say the suits pose a high-stakes test for the companies, which have long been at the heart of the American health system. “It is a very big deal,” said Tim Greaney, a professor at Saint Louis University School of Law. “The dollars involved are potentially huge.” He and others say the litigation will take years to resolve, unless a settlement is reached.
Both plaintiff groups have prominent attorneys. The legal team for the health-insurance customers includes David Boies, who represented federal antitrust regulators against Microsoft Corp. Whatley Kallas, a firm that has won high-profile settlements from insurers on behalf of physicians, is helping to lead the provider case.
The Blue Cross and Blue Shield companies trace their roots to the 1930s, when hospital and doctor groups started insurance plans to help people pay for medical care. Hospital plans used the Blue Cross name, and the physician plans were sold under the Blue Shield banner. Eventually, the names were trademarked.
Today, the Blue Cross Blue Shield Association licenses the brands to the insurers that use them. Companies typically hold exclusive rights to the Blue Cross and Blue Shield names within a certain territory.
Most of the 37 Blue Cross and Blue Shield companies are not-for-profit. Many do business in a single state. The biggest Blue Cross and Blue Shield company is publicly traded Anthem Inc., which operates the plans in 14 states. In a few places, Blue-branded plans compete directly against one another, as in California, where Anthem Blue Cross battles Blue Shield of California.
The Blue association says its licensing deals simply codify trademark rights that date back decades and “do not constitute an agreement to do anything unlawful.” Federal regulators have long known about the licenses and taken no antitrust action, the insurers said in a court brief. The association also says its arrangements ensure that its members focus on building the Blue brand, and increase competition by helping the Blue companies ally to go up against national insurers.
“This is a model that has withstood scrutiny over our entire history,” said Scott Nehs, general counsel of the Blue association. “There’s no smoky room involved, there’s no dividing up.” Also, he said, the insurers’ rates are closely watched by state regulators.
The plaintiffs, however, allege that the Blue association is controlled by its members, who use it to engage in “illegal market division.” The customer suit says the association also limits the amount of insurance business insurers can do under non-Blue brands. The suit also alleges that the Blue agreements result in “inflated premiums.”
“You have less competition in a market, so prices are higher,” said William Isaacson, an attorney with Boies, Schiller & Flexner LLP, which represents the customer plaintiffs. “That’s one of the basics of antitrust law.”
The suit filed by the health-care providers alleges that because of “decreased competition, health-care providers, including the plaintiffs, are paid much less than they would be” without the Blue association’s agreements. “The fact that someone’s been doing something a long time doesn’t make it right, and doesn’t make it legal,” said Joe Whatley, a lead attorney for the provider plaintiffs. Mr. Whatley declined to say whether there were settlement negotiations under way but said “we are always open” to talks.
The plaintiffs have “some surprisingly strong claims,” said Mark Hall, a professor at Wake Forest University School of Law. “It’s sort of antitrust law 101 that direct competitors can’t agree to divvy up their territory.”
Still, said Scott E. Harrington, a professor at the University of Pennsylvania’s Wharton School, “it’s going to be hard to show those entities are making the large margins implied by” the allegations. The Blue Cross and Blue Shield plans don’t always have big profits, he said.
Glenn Melnick, a professor at the University of Southern California, said the two sets of plaintiffs in the case had diverging interests, because higher payments to health-care providers would likely push up premiums for insurance customers. “They appear to be arguing conflicting outcomes,” he said.
The Blue plans often have significant market share. According to an analysis by the Kaiser Family Foundation, Blue Cross and Blue Shield companies were the biggest players in the vast majority of states’ small-business and individual insurance markets in 2013, the most recent data available. In some states, their share was a commanding one. Blue Cross and Blue Shield of Alabama held 91% of the individual business and 97% of the small-group market in its state.
A spokeswoman for Blue Cross and Blue Shield of Alabama referred questions to the association, which said that the insurer competes with 10 other companies selling commercial health insurance, and that a federal survey showed Alabama has the lowest average family premiums in the U.S. and among the lowest employer premiums.
Ultimately, the antitrust cases may hinge on tensions between the laws governing trademark rights and the antitrust statutes, antitrust experts said. A restaurant operator, for example, can legally license its brand to franchisees, granting each a certain territory. The question is whether the Blue setup is more like a franchising arrangement or if it involves unacceptable agreements between potential rivals, said Barak D. Richman, a professor at Duke University School of Law.
“You’ll be looking for cartel-like behavior or the protection of intellectual property,” he said. “That will probably be the most significant evidentiary test.”
Medicaid Officials Release Long-Awaited Managed Care Rule
Medicaid Officials Release Long-Awaited Managed Care Rule
By Rebecca Adams, CQ Roll Call
Medicaid plans would have to spend a minimal amount of their revenues on medical costs rather than administrative expenses, under a long-awaited proposal that federal Medicaid officials released Tuesday.
The proposed rule would streamline regulations that were last updated in 2003. Since then, managed care plans have become grown to cover a rising portion of the Medicaid population, including an increasing number of people with long-term service needs or disabilities.
“A lot has changed in terms of best practices and the delivery of important health services in the managed care field over the last decade,” said Centers for Medicare and Medicaid Services Acting Administrator Andy Slavitt. “This proposal will better align regulations and best practices to other health insurance programs, including the private market and Medicare Advantage plans.”
The rule will require plans to spend at least 85 percent of their revenues on medical costs for beneficiaries rather than administrative costs, similar to requirements for private plans in the Medicare Advantage program. The Medicaid program currently does not have such a requirement, known as a “medical loss ratio.”
The rule also addressed the availability of information to the public. The proposed rule said that states should send consumers information on their right to disenroll from a plan, the basic features of managed care, the service area of each managed care plan, covered benefits, provider directory information, cost sharing requirements of patients, care coordination services available, and measurements of the quality of each managed care plan. CMS officials proposed that a new ratings system of managed care plans be created.
The Government Accountability Office also has found CMS’ oversight of the rates that Medicaid managed care organizations set to be inconsistent, so the regulators are trying to make sure that the rates are sufficient to cover beneficiaries’ care but not too high.
The existing rules for actuarial soundness require that plans’ rates are certified by a qualified actuary. The proposed revisions to the rules for setting payment rates for Medicaid managed care plans would spell out the type of data to be used and the level of documentation that would be required so that CMS officials can more effectively review and approve rates.
The proposal went to the Office of Management and Budget for review on March 19 and was cleared for publication on May 21.
The public has until July 27 to comment on the rule.
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