Concussion Prevention: When Equal Treatment Might Not Make Good Policy

tara-ragoneI was stunned to learn recently that female lacrosse players, at least in my town in New Jersey, may not wear hard helmets even though male lacrosse players must wear them.  This struck me as ludicrous and unfair.   Both sports involve athletes running around with long sticks, hurling dense rubber balls at high speeds.  It seemed to me that balls and sticks can strike players in the head and players can collide in either sport.  How could we care more about preventing traumatic brain injury (TBI) in boys than in girls?  I was outraged.  But as it turned out, I also was a bit uninformed.  It is not as clear as I thought it would be that we should require girls to wear helmets.

A common objection is that female and male lacrosse are very different sports subject to different rules and requiring different skills.  Male lacrosse involves much more brute physical contact, whereas female lacrosse does not permit body checking and demands finesse.   As a female senior lacrosse player explains, because girls’ lacrosse sticks have shallower pockets, girls “’have to be more skilled with our cradling, . . . [so our] game is more graceful.’”  A male senior midfielder acknowledged that the girls’ “’stick skills are unbelievable’” and that “’the girls’ version is more pure.’”  Some believe there is less need for helmets in girls’ lacrosse because of these differences.  Moreover, there is concern that requiring girls to wear helmets will encourage girls to play more like boys, which would risk losing the valuable uniqueness of girls’ lacrosse.

As much as I want to honor female players’ pride in their skills and finesse, science should drive the policy decision whether to require girls to wear helmets.  Research by Nationwide Children’s Hospital in Columbus, Ohio reveals that girls’ lacrosse has the third-highest rate of concussion among female sports, after soccer and basketball, and “its in-game rate is only about 15 percent less than the rougher male version.”  But what do we know about whether helmets can reduce that risk?  Not enough. Read more

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Professor John Jacobi in The Record on how the lack of a state-run health insurance exchange under the health reform law is ‘a lost opportunity’ for New Jersey

jacobi_johnProfessor John Jacobi appeared in a feature Op-ed in The Record, describing the veto of New Jersey’s health insurance exchange bill as “a lost opportunity.” Professor Jacobi writes:

MANY STATES are gearing up their health insurance exchanges to accept new enrollees in October. Others, including New Jersey, have refused to do so, leaving the management of these important new institutions to the federal Department of Health and Human Services.

Although he announced in budget address last month that New Jersey would expand its Medicaid program, Governor Christie left unchanged his veto of the state’s exchange law. When he vetoed the Legislature’s bill that would have created a New Jersey exchange, Christie decided to leave the task to the federal government, citing the possible costs the state would incur running the exchange.

The governor was correct that there would have been costs, notwithstanding the offer of extensive federal funding. And the rejoinder of some opponents of the governor’s position — that the costs could be covered by assessments on insurers — is too easy an answer. Insurance assessments, after all, raise the cost of coverage for individuals and businesses.

But the burden of the assessments was worth the cost, and, as I describe below, the risk of pushing the task off to the federal government puts the most vulnerable of New Jersey’s residents at risk.

Read The Record’s featured Op-ed, “Health reform: a lost opportunity.

 

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New Medicaid Donut Hole: Update

July 12, 2012 by · Leave a Comment
Filed under: Medicaid, State Initiatives 

jacobi_john1I recently wrote about the plight of poor adults in states that reject “Medicaid 2.0″ — that is, the expansions of Medicaid contained in the ACA.  Just to recap, the Supreme Court upheld the constitutionality of the expansions, but held that Medicaid’s historical power to enforce state uniformity — sanctioning states up to and including the withdrawal of some or all of their federal funding — could not be used to require states to adopt the ACA expansions.  Thus, Medicaid was conceptually split between Medicaid 1.0 (existing Medicaid) and Medicaid 2.0 (ACA expansion Medicaid), and a state could not lose Medicaid 1.0 funding if it declined to participate in Medicaid 2.0 funding.   Several governors have expressed the intent to refuse to participate in Medicaid 2.0.

My previous post highlighted Kevin Outterson’s observation of an under-appreciated effect of a state’s refusal to participate in Medicaid 2.0.  Of course, people living below the poverty level who were ineligible for Medicaid 1.0 will be shut out of Medicaid in refusing states.  But they’re also ineligible for any subsidies to purchase coverage under the exchanges.  Why?  Because Congress assumed that states would participate in Medicaid 2.0, and didn’t provide seemingly redundant subsidies.  These poor residents of refusing states will fall into a Medicaid donut hole — ineligible for Medicaid, but shut out of exchange-based subsidies.

Secretary Sebelius, in a letter dated July 10, implicitly acknowledged this problem.  After reiterating previous offers to work with states flexibly in health reform matters, and expressing hope that states would take up the federal funds available for Medicaid expansion, she addressed a donut hole question: would poor residents in refusing states be subject to a triple whammy of (1) no access to Medicaid; (2) no access to subsidies for coverage through the exchanges; and (3) penalties for not having qualifying coverage?  Sebelius couldn’t offer much on the first two — refusing states won’t offer Medicaid coverage to many of their poor residents who would be eligible for Medicaid 2.0, and subsidies are simply not available (for reasons I explained in my previous post) for persons living below poverty.  But on the third, she promised that the very poor uninsured would at least escape sanction for noncompliance with the ACA’s individual responsibility provision: Sebelius assured the governors that she would use her authority to provide a “hardship exemption” from penalties for these uninsured folks where needed.   That may be snow in January for these disenfranchised folks, but those seem to be the tools left to Sebelius.

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Professor John Jacobi in New Jersey Spotlight on the impact thus far for the Affordable Care Act in New Jersey.

jacobi_johnProfessor John Jacobi appeared in a New Jersey Spotlight article which examined, rather comprehensively, the impact thus far for the Affordable Care Act in New Jersey. New Jersey Spotlight determined that

Healthcare in New Jersey is being profoundly altered by the 2010 Affordable Care Act, and no matter how the Supreme Court rules on its constitutionality, pilot programs to rein in spending and improve patient care will continue to roll.

New Jersey Spotlight details some rather impressive impact for the ACA in New Jersey thus far. It notes:

It will take several years for the ACA’s pilot programs to pay dividends, in the form of less inflation in healthcare costs and healthier people. But New Jersey has already reaped several benefits. The law has directed more than $700 million to New Jersey, according to an estimate by the Kaiser Family Foundation. That includes more than $100 million in prescription drug rebates, discounts for nearly 250,000 seniors on Medicare, and more than $300 million in grants to employers to help them pay for early retiree health benefits — a diverse list of about 90 public and private employers that includes the state of New Jersey, Princeton University, and Johnson & Johnson.

Extending Coverage

According to the federal Department of Health and Human Services, more than 68,000 young adults have health coverage today because the ACA requires insurance companies to keep dependents on their parent’s policies until age 26. More than 1.7 million New Jerseyans have benefitted from the ACA’s rule that private health providers can’t charge co-pays for certain preventive services, and nearly a million New Jersey Medicare members also are getting free preventive screenings.

Regarding ‘Coverage and Costs,’ the Spotlight notes:

Seton Hall Law School Professor John Jacobi said the ACA is more about getting people covered than trying to lower healthcare costs — with the exception of the ACO [Accountable Care Organizations], which “creates new incentives for healthcare providers to coordinate care, to care for people with multiple chronic illnesses at the right time and the right place with the right specialties, so there is a reduction in the duplication of services. It is a great step to take — to think about how we can actually save money.”

Read the full New Jersey Spotlight article, “The Affordable Care Act: Prescription for Change in NJ Healthcare

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Bill Requiring Licensure of One-Room Ambulatory Surgery Centers In New Jersey Dies in Gov. Christie’s Pocket

January 24, 2012 by · 1 Comment
Filed under: Health Reform, State Initiatives 

Photo by ArnoldReinhold

Governor Christie has pocket vetoed a bill that would have required one-room ambulatory surgery centers (ASCs) in New Jersey to be licensed by the State Department of Health and Senior Services (DHSS), as ASCs with more than one operating room already are.

More than One Room

Under current law (e.g., N.J.S.A. 26:2H-1 et seq.; N.J.A.C. 8:43A), ASCs with more than one operating room are subject to a variety of statutes and regulations, including that they must obtain a license that specifies the health care services they are authorized to perform (N.J.S.A. 26:2H-12(a)) and report certain information to DHSS on a quarterly basis (N.J.S.A. 26:25-5.1e).  ASCs providing surgical and related services must “obtain ambulatory care accreditation from an accredited body recognized by [CMS]” as a condition of licensure (N.J.S.A. 26:2H-12(h)).  They also must establish and maintain a uniform system of cost accounting, reports and audits; prepare and annually review a long range plan; and establish and maintain a centralized, coordinated system of discharge planning (N.J.S.A. 26:2H-12(a)).  The statute also assesses various fees, which it caps at $4,000 for applications for licensure or renewal and $2,000 for biennial inspections (N.J.S.A. 26:2H-12(b)).    Since 2004, licensed ASCs with gross receipts greater than $300,000 also must pay an annual assessment based on its gross receipts and the assessment, capped at $200,000 (N.J.S.A. 26:2H-18.57(b); N.J.A.C. 8:31A)), is deposited in the Health Care Subsidy Fund (N.J.S.A. 26:2H-18.58).

DHHS’s implementing regulations cover a broad array of topics, including the qualifications of  persons working at these facilities, housekeeping protocols, emergency equipment, disaster plans, physical plant requirements, and laundry policies and procedures (NJAC 8:43a-1 et seq.).   The regulations impose a biennial inspection fee (N.J.A.C. 8:43A-2.2(m), although DHSS’s web site says that it inspects licensed ASCs every three years.

One Room

room-of-ones-own1ASCs with only one operating room presently escape this licensure requirement (and its corresponding regulatory demands) because they are defined as physician’s surgical practices, which are excluded from the definition of surgical facilities that must be licensed.   (N.J.S.A. 26:2H-12(g)(5); N.J.A.C. 8:43A-1.3)  While surgical practices do not yet need to obtain a license,  they must register with DHSS, which registration, in turn, carries a variety of conditions.  For one, they must “obtain certification by the Centers for Medicare and Medicaid Services [(CMS)] as [] ambulatory surgery center provider[s] or obtain ambulatory care accreditation from an accrediting body recognized by [CMS]” – similar to larger ASCs.  They also must annually report to DHSS data regarding patients serviced by payment source and staffing levels.   The Commissioner of DHSS has the ability to revoke, suspend, or deny an application for a registration if the surgical practice is not in compliance.   The statute also prohibits ownership, management, or operation of a surgical practice “by any person convicted of a crime relating adversely to the person’s capability of owning, managing, or operating the practice.”  (N.J.S.A. 26:2H-12(j)) One-room ASCs also are regulated by the State Board of Medical Examiners as private physician practices.  The BME has enacted regulations establishing policies, procedures, staffing, and equipment requirements when practitioners perform surgery (other than minor surgery), special procedures, and anesthesia services in an office setting (N.J.A.C. 13:25-4A).  The BME has the authority to investigate and bring a licensing action against any physician who fails to comply with these regulations (N.J.S.A. 45:1-18, 45:1-21).  One-room ASCs serving Medicare or Medicaid patients also must satisfy federal standards and be certified by CMS.   If a one-room ASC is certified by CMS, DHSS conducts inspections on behalf of CMS every four years.  DHSS and the BME (N.J.S.A. 45:1-18(c)) also may conduct inspections to investigate complaints filed about a one-room ASC.  But there is no present state requirement that one-room ASCs be inspected by the BME or DHHS.

One Rooms Cited for ‘Immediate Jeopardy’

Photo by Justin_Levy via Flickr

A report issued by the New Jersey Health Care Quality Institute (NJHCQI) in April 2011 shined the spotlight on the lack of oversight of one-room ASCs.  NJHCQI reviewed reports of inspections in 2009 and 2010 of 91 ASCs in New Jersey that reportedly were funded by a one-time federal grant.  40 of the 91 inspected facilities were unlicensed one-room ASCs, 17 of which (43%) were cited for “immediate jeopardy,” which is “defined as noncompliance with established rules that has caused, or is likely to cause, serious injury, harm, impairment or death to a patient.”  (In comparison, 8 of the 51 licensed facilities (15%) that were inspected were found in “immediate jeopardy.”)   The cited violations included, among others, a variety of improper sterilization and infection control procedures; inadequate tracking of medications, including controlled substances and expired medications; improper anesthesia administration; and failing to have necessary emergency medications or an agreement to transfer patients requiring emergency care to a hospital.  The report concluded that, “[b]ased on this snapshot,  . . there is evidence that consumers may be at greater risk in unlicensed Surgical Practices than in licensed ASCs” (emphasis in original).  Thus, the NJHCQI urged the State to require regular inspections of one-room ASCs and warned patients, in the mean time, not to use these unlicensed facilities.

What Could have Been

S.2780 looked to close the regulatory gap between one-room and larger ASCs – for the most part.  The version that passed New Jersey’s Assembly and Senate on January 9, 2012 would have amended N.J.S.A. 26:2H-12 to require ASCs with one operating room to be licensed by DHSS within one year of enactment as an “ambulatory care facility licensed to provide surgical and related services.”  This licensure requirement would have replaced the current registration requirements.  DHHS, then, would have had to inspect one room ASCs, just as it inspects larger ASCs.

But S.2780 also included provisions that treated one-room ASCs differently than larger ASCs.  All one-room ASCs would have been exempt from paying the ambulatory care facility assessment required by N.J.S.A. 26:2H-18.57.  Those that are certified by CMS (whether in operation on the day of enactment or not) or accredited by the American Association for Accreditation of Ambulatory Surgery Facilities or other CMS-recognized accrediting body (and in operation on the day of enactment) would not have had to meet the physical plant and structural requirements detailed in N.J.A.C. 8:43A-19.1 et seq.  The rest of the one-room ASCs that fail these exemptions would still have been able to seek a waiver (N.J.A.C. 8:43A-2.9) of the physical plant and structural requirements, which the Commissioner could have granted if it would not have “endanger[ed] the life, safety, or health of patients of the public.”  These concessions seemed to respond to reported warnings from some one-room ASC owners that “a new fee and a potential requirement to remodel their offices might drive [them] out of business.”  The bill also would not have subjected one-room ASCs to the current restrictions on DHSS’s ability to issue new licenses to ASCs with more than one operating room (N.J.S.A. 26:2H-12(i)).

Jeffrey Shanton, chair of Advocacy & Legislative Affairs Committee for the New Jersey Association of Ambulatory Surgery Centers, is quoted as describing S2780 as “one of the most important pieces of legislation concerning the ASC industry in New Jersey in years.”  Reportedly, the New Jersey Hospital Association and the Medical Society of New Jersey joined NJAASC in supporting its passage (in addition to consumer groups, like NJHCQI).

But now, S.2780 is dead.  Governor Christie did not veto it – directly.  Instead, by not taking action on this bill, which was passed on the last day of the legislative session, he has killed it via a “pocket veto.”

Going Forward

high-contrast-media-skip-forwardsvgLegislators can’t override a pocket veto, but they may re-introduce the bill and try again.  If they do, it seems eminently reasonable to require inspections of one-room ASCs, whether by DHHS or BME, as long as there is adequate funding and staffing to complete these inspections without draining resources from other critical public health programs.    It would be critical to ensure that the $2,000 inspection fee is sufficient to cover DHSS’s costs and that the Department would not be prohibited from hiring necessary staff to fulfill this legislative requirement.

The Legislature also should be sure public safety requires the one-size fits all regulation model that this bill proposed.  If the costs of complying are too high, small offices may not seek licensure as an ASC and cease performing procedures that patients may have appreciated.  Perhaps that’s an acceptable outcome, but the Legislature should study the public safety benefits against the potential costs on physicians and patient access to services.  The standard of care and quality should not vary in different settings, but perhaps there is a way for the level of formality and overhead to be in proportion to the size of the facility without compromising public safety.

It also is notable that S.2780 did nothing to resolve the existing tangle of issues caused when in-network providers refer their patients to out-of-network ambulatory surgery centers that then charge an out-of-network facility fee.    (Senator Vitale’s earlier amendment to S.2780 conditioning waiver of the ambulatory care facility assessment on the one-room ASCs’ agreement “not to charge patients or third party payors a facility fee, room charge, or other similar fee or charge” did not survive legislative negotiations.)  S.2780 also would have amended N.J.S.A. 45:9-22.5 to extend the exception to the Codey Act’s self-referral prohibitions for larger ASCs to one-room ASCs.  As Kate Greenwood has discussed, there are reasons to question the wisdom of this exception (much less to extend it).

While legislators tackle these issues, one-room ASCs still do not have to be licensed in New Jersey.  But the State may investigate complaints, so be sure to speak up, if you have concerns.  There are links here to check if a facility is licensed, get copies of inspection reports, file a complaint, and search for information about providers.

Photo (Pocket) by ArnoldRheinhold
Photo (Jeopardy!) by Justin_Levy via Flickr
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