ACA: Helping or Hurting Solo Practice?

It won’t surprise many to learn that the age of the solo practitioner has, for the most part, come to an end. Over the past several years, small and solo practices have closed, been sold to hospitals, or merged with larger groups. The reasons are fairly obvious. Declining payments, rising malpractice costs, increasing regulatory burdens, costly new health information technology requirements, and crushing medical school debt have made it difficult for physicians to operate the small practices that once were commonplace around the country.

Now add the Affordable Care Act (ACA) to the mix. At a July 19 hearing of the House Small Business Subcommittee on Investigations, Oversight and Regulations, lawmakers questioned whether the health reform law would help or hurt physicians looking to keep their practices small and independent. The answers from the expert panel were mixed.

Gone are the days of Marcus Welby. Courtesy Wikimedia Commons/Public Domain License

The emergence of accountable care organizations (ACOs) will drive more hospitals to buy up small physician practices, Mark Smith, president of the physician recruiting firm Merritt Hawkins, predicted. The health reform law heavily promotes the formation of ACOs, which call for physicians and hospitals to work more closely and to share in bundled payments for episodes of care. Mr. Smith said small practices aren’t well-positioned to enter the ACO world if they aren’t integrated with a hospital because the ACO model calls on practices to assume financial risk.

But Joseph M. Yasso, Jr., DO, a family physician in Independence, Mo., who sold his practice to a hospital group 20 years ago, said the ACA’s promotion of patient-centered medical homes could be a lifeline for small practices. Physicians are adapting to the new environment by becoming medical homes and participating in government pilots where they can share in the savings they generate by providing more efficient care, he said.

One thing everyone on the panel did agree on was the need to fix the Sustainable Growth Rate (SGR) formula used in setting physician payments under Medicare. No surprises there either.

— Mary Ellen Schneider

Louisiana’s Medicaid Nightmare

Physicians in Louisiana may find themselves holding the short end of the stick very soon, as the state struggles to figure out how to make up a sudden $859 million shortfall in Medicaid funding.

And it comes at a time when the state’s Republican governor, Bobby Jindal, has said that he will not take any additional federal money to expand the Medicaid program in 2014, as offered under the Affordable Care Act. He also said he would not accept federal funds to set up health insurance exchanges under the law.

Bobby Jindal. Courtesy Wikimedia Commons/dsb nola/Creative Commons Attribution 2.0 Generic License

If any hospital or physician wanted to know what it would feel like to go without that federal money, they now have their chance. The $859 million hole is the result of a reduction in the federal matching rate that Congress approved as part of the transportation bill that was signed by President Obama on July 6.

The provision affects only Louisiana. After Hurricanes Katrina and Rita, the state received hundreds of millions in aid. But there was no adjustment at that time in the federal Medicaid matching rate. So Louisiana’s Medicaid program was the recipient of millions of dollars more than what it was due. (For more on this byzantine situation, see the New Orleans Times-Picayune’s story here.)

Congress fixed that error in the transportation and student loan bill by dropping the state’s current match rate. But Gov. Jindal, in creating and finalizing his fiscal 2013 budget, was, ironically, depending on that federal money.

On July 13, his administration announced cuts to make up the shortfall. The decrease in the federal matching rate meant that the state had to come up with $287 million in cuts on its own; the rest of the $859 million will come from reductions in pay from the federal government.

According to the state Dept. of Health and Human Services, $518 million will come out of the pockets of physicians and hospitals.  The state already had announced an across-the-board almost 4% cut in Medicaid provider rates for fiscal 2013.

Under the latest cuts, the Louisiana State University system is taking the biggest hit: $329 million, or a quarter of its budget, according to news reports. LSU is one of the biggest charity care providers in the state. Interestingly, DHHS commented in its press release that it “does not anticipate this reduction of [disproportionate share hospitals] and Medicaid payments to affect Medicaid recipients’ access to hospital care.”

Among the other programs absorbing blows: the Greater New Orleans Community Health Connection (GNOCHC), a pilot that expanded health coverage to uninsured adults in the wake of Hurricane Katrina. Another program that provided family planning services to low-income women will have its qualifying income limit reduced from 200% to 133% of the Federal Poverty Level.

The state is also tightening its review of eligibility for all Medicaid recipients.

After the cuts were announced, the Louisiana Hospital Association said in a statement that, the total elimination of DSH payments to rural hospitals “will be critical and will lead to reductions in services and possible hospital closures.” That in turn will leave ” gaps in healthcare delivery for patients in rural areas, as well as economic losses to those communities,” said LHA.

With hospitals across the state possibly delivering less care, it seems likely that physicians could expect to see more pressure on their practices.

—Alicia Ault

Summer Doldrums for the SGR

The question of what to do about Medicare’s Sustainable Growth Rate formula, which governs physician pay, likely got its final serious look on Capitol Hill on July 11–that is, before Congress heads out the door for a protracted summer recess and then gets caught up in the fall campaign season. And it wasn’t much of a look.

Sen. John Kyl takes notes as physicians talk about SGR. Alicia Ault/IMNG Medical Media

The Senate Finance Committee held its third and final “roundtable” discussion on the SGR, this time allowing physicians to weigh in.  Representatives from the American Medical Association, American Academy of Family Physicians, American College of Surgeons, American College of Cardiology, and American Society of Clinical Oncology politely answered questions from committee members who showed up. Most of the Democrats on the committee sat in,  at least for a portion of the almost two-hour meeting, while only two Republicans attended–John Kyl (Ariz.) and John Thune (S.D.), who came for only the last half hour.

The discussion meandered quite a bit and quite often, with physicians talking about the need for aligning incentives, creating medical homes, and rewarding quality. Dr. W. Douglas Weaver, a past president of the ACC and current Vice President and Systems Medical Director of Heart and Vascular Services, Henry Ford Health System in Detroit, said that the instability caused by the ever-fluctuating SGR situation was thwarting efforts to create new delivery systems.

But there was little concrete discussion of what to do to avert the 27% cut mandated by the SGR that will take effect January 1, 2013.

Senator Max Baucus (D-Mont.), who chairs the Finance Committee and led the

Sen. Max Baucus and Sen. Orrin Hatch listen to physicians. Alicia Ault/IMNG Medical Media

roundtable, at one point said that while he was hearing great ideas, he wanted to know what action could be taken quickly.  Senator Kyl also tried to steer the discussion back to the practical. He also reminded physicians that Congress is driven by 10-year budget-setting imperatives; thus, any suggestions for the SGR proposed for the short term must also work over the long haul, he said.

The elephant in the room: how to pay for an SGR fix or replacement, now clocking in at about $300 billion and rising. Physicians have steered clear of suggesting any financial solutions.

The committee broke with no promises. In an interview afterwards, Dr. Glen Stream, AAFP president, said that any SGR tinkering would likely be put off until at least after the November election. That puts the onus on a lame duck Congress.

Do you think they will make a short term fix or come up with some kind of permanent solution?

—Alicia Ault (@aliciaault on twitter)

“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

Annual Meeting Focuses on Echocardiography and Its Future

©Ekko/Wikimedia Commons

Multimodality imaging is among the highlights of this year’s American Society of Echocardiography meeting, which starts on June 30 at the National Harbor, Maryland.

The society is pushing forward the concept, looking at different diseases and integrating different kinds of imaging such as echo plus nuclear, Cardiac CT, or Cardiac MR, in order to get the best diagnoses, said Dr. Melissa Wood, co-director of Massachusetts General Hospital Heart Center Women’s Heart Health Program, Boston, and the chair of ASE Public Relations Committee.

“This isn’t just about echo, it’s also about all the other imaging techniques that are out there and how we can work together and deliver the highest quality of care,” said Dr. Wood in an interview. “It’s also about what’s superfluous, and what we don’t need to do.”

On the policy front, Accountable Care Organizations will be in the forefront during the meeting. Dr. Wood said that the speakers will address how “ACOs affect those of us who read echos and do them, and how they affect practices.”

Echocardiography will also leave this planet for a bit during a symposium. ASE president Dr. James Thomas has been in the past actively involved in doing research with the space station and helping pick the right echo machine to go up there, said Dr. Wood. “There’s substantial interest in microgravity and the heart, and how heart changes its function in space. It’s something that’s very unique, and there are lessons that can be learned from that, and that experience will be somehow useful in our clinical practices, whether it’s specific type of research techniques or specific types of information that are gained in that environment.”

Echocardiography is the second most commonly ordered test after EKG, according to Dr. Wood, and with the aging population, the use of the test is likely to increase.

“I see echo take off more because of this concern about heart failure being an epidemic. Echo as a way to diagnose heart failure before it becomes profound,” she said. And given the appropriate use criteria, “we’re tying to moderate the reasons echos are ordered, so they’ll continue to be fairly reimbursed by third parties and CMS (Centers for Medicare and Medicaid Services),” said Dr. Wood.

You can find the meeting’s program here. And be sure to check our coverage on ecardiologynews.com.

By Naseem S. Miller (@NaseemSMiller)

New Anti-Inflammatory Drugs Will End Anti-TNF Dominance

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

tumor necrosis factor (green, purple, black) and TNF receptors (blue)/courtesy Bassil Dahiyat; Science

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

—Mitchel Zoler (on Twitter “mitchelzoler)

PMA Process Taking Longer and Longer

In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan Inc. 

“A decade ago we used to see a PMA approval time of 9-12 months,” Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine 2012. “In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It’s something that we are anxiously watching. We don’t see any signs of that abating.” 

The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, “is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market.” 

— Doug Brunk (on Twitter@dougbrunk)

What Drives Change in Medicine?

During the last presentation on the last day of the Summit in Aesthetic Medicine 2012, Dr. R. Rox Anderson shared some of his observations on creating change in the world of medicine. As the person who conceived of or helped develop many of the non-invasive treatments now widely used to remove birthmarks; microvascular and pigmented lesions; tattoos; and hair, he should know a thing or two about that topic.

“It takes people with passion,” Dr. Anderson, professor of dermatology at Harvard Medical School, Boston, said of change-leaders in medicine. “We’re driven to help other people. That is my primary passion. I go to work every-day thinking, ‘Science for the people.’ It’s also important to get very specific about the problem. I’ve noticed that the ability to really define the problem and own it is often where some of the passion comes from. Working on something that someone else told you about often does not sustain the process that you have to go through to make substantial change.”

Dr. Rox Anderson

Medical change-leaders exhibit unbridled curiosity mixed with health skepticism. “It’s interesting how change can happen if you mix people who are very problem-oriented with people who are very technology-oriented,” said Dr. Anderson, who also directs the Wellman Center for Photomedicine. “I kind of walk around with two bags: One of them you might label ‘Problems I care about but don’t know how to solve,’ the other one ‘Stuff I know about technology-wise.’ The challenge is to connect the two. I don’t know how that happens, but when it happens right, you get change.”

Change-leaders tend to be resilient, he said, explaining that real change is usually either threatening or surprising. “There’s a phrase, ‘You can tell the pioneers by the arrows in their backs.’ People are very uncomfortable with change. You will find that if you’re trying to put something new out there, you may threaten someone’s paradigm.”

In the business of medicine, he continued, “the bottom line is helping others. In medicine, if the problem isn’t about helping people, it’s going to fail. If you’re not curious and skeptical about something important, you’ll be off on some tangent that won’t ultimately make a tangible change.”

Strong commitment to the problem you’re trying to solve is essential, he said. He likened the level of commitment to a marriage in which you “Write a grant and start making phone calls to your colleagues, get a collaborative group together and say, ‘We’re going to attack this problem.’ Then you and the problem have ‘children’ – 3 or 4 ideas [of how to] solve the problem. Some of them work, some of them don’t. It’s the ones that don’t work that teach you things. My definition for bad research is that you can predict the outcome.

— Doug Brunk

Can Cancer Trial Apps Boost Enrollment?

Participation in clinical trials — and cancer trials in particular — is agonizingly low. The National Cancer Institute has estimated that less than 5% of patients participate in cancer trials.  But that could possibly change with the growing availability of applications for smart phones and tablets that instantly link clinicians and patients with ongoing trials.

Screenshot of Lilly Oncology Clinical Trials Resource

Just as the American Society for Clinical Oncology was starting off its annual meeting, Eli Lilly announced that it was launching a clinical trials app.  According to Lilly, the free app is available for the Apple iPad and iPhone, the RIM BlackBerry, and the Google Android. Physicians — or patients — can use the app to search oncology trials that are enrolling new patients by disease state, molecule being studied, study phase, country, state, and keyword.

The Lilly app also links patients and clinicians to resources such as support groups, financial help, and nutritional counseling, for instance.  Because it was developed by a drug maker, it also prominently features a search tool for Lilly-sponsored trials. Other than that, it appears to be very comprehensive and easy to use.

Lilly is not the first manufacturer to venture into a trials app. Last June, GlaxoSmithKline, in partnership with MedTrust Online LLC, launched a similar app that lets users search for trials for all cancer types. Unlike the Lilly app, it does not try to push users towards GSK-sponsored trials. It, too, appears to be very comprehensive and easy to use.

Screenshot of MedTrust search

The National Cancer Institute also has a free app, but only lets patients search for trials at the National Institutes of Health campus in Bethesda, Md.  As I attempted to explore the app, however, it crashed multiple times. Not a good omen.

Similarly, the Seattle Cancer Care Alliance has created an app — but it is narrowly focused only on trials for  acute myeloid leukemia at its member facilities.

iHealthVentures LLC has created an app with the snappy name of “Clinical Research Trials” that allows users to search all of clinicaltrials.gov database. It costs $1.99.

As more Americans turn to smartphones and tablets to manage their lives and health, these trial apps could come in handy. And maybe even save or extend lives by getting people enrolled earlier in protocols that could help them.

Just an aside — OncologyPractice.com has a link to ongoing trials on its website here.  And it has just launched a free app that features the latest news and views in the field.

–Alicia Ault (@aliciaault on Twitter)

Seeking Primary Care Elsewhere

Patients who can’t get in to see their primary care physicians on a timely basis–or when it’s convenient for them–seem to be increasingly voting with their feet, seeking care at retail clinics or after-hours urgent care centers.  And that seems to be one factor that’s expected to drive down the cost of health care next year, says PriceWaterhouseCoopers.

Image Courtesy CVS Caremark

The accounting and consulting behemoth released its annual “Behind the Numbers” report on health cost trends. Health spending has been lower than expected for the last three years and will likely stay low, rising by about 7.5% in 2013, according to the report.

PwC found that one of the slowest areas of growth is physician spending. From 2007-2012, spending on physician services by private health plans grew only 5.4%–compared to 8% growth for inpatient care and 10% for outpatient hospital care.  They slowdown in doctor spending “is expected to continue in 2013 as consumers choose alternatives to the traditional doctor’s office visit,” said the report. Those alternatives include “lower-cost options such as workplace and retail health clinics, telemedicine, and mobile health tools,” which are viewed by employers and consumers “as cost effective and convenient.”

In 2010, about 17% of consumers said they had sought care at a retail clinic; by 2011, that had risen to 24%, according to a PwC survey conducted each year to help flesh out the medical spending picture.

It’s no secret that use of retail clinics and urgent care centers has skyrocketed. Last fall, the RAND Corp. reported that there was a ten-fold increase in use of those retail clinics between 2007 and 2009. Using data from a commercially-insured population of 13.3 million, RAND determined that 3.8 million made at least one clinic visit between 2007 and 2009. Monthly visits jumped from 0.6 per 1,000 in January 2007 to 6.5 per 1,000 in December 2009.

Interestingly, availability of primary care physicians did not seem to be a factor in determining use. Those who went to retail clinics tended to be in good health, between 18 and 44, and have a higher income.

In other words, those are paying customers who are choosing to spend their money elsewhere for their care. PriceWaterhouseCoopers advises physicians to make their pricing “defensible” to help stem the tide of patient outflow to these clinics.

One reason why consumers may be going to a lower-priced environment: because employers are increasingly asking workers to shoulder more of the costs of their care. And that is expected to continue.

“We’re seeing long-term trends that could keep cost increases in check,” said Michael Thompson, principal, human resource services at PwC in a press release.  “As employers shift expenses to their employees, for example, these workers are pursuing lower-cost alternatives. Even as the economy strengthens, changes in behavior by employers and consumers may help limit medical growth.”

—Alicia Ault