New York City’s Attempt to Crackdown on Prescription Drug Abuse Through the Emergency Room

January 20, 2013 by Tara Adams Ragone · 1 Comment
Filed under: Prescription Drugs

On January 10, 2013, New York City Mayor Michael Bloomberg announced [1] that the City’s eleven public hospitals will comply with voluntary emergency room guidelines aimed at stemming the abuse of prescription opioid painkillers.

The New York City Emergency Department Discharge Opioid Prescribing Guidelines (“Guidelines”) highlight that the federal Emergency Medical Treatment and Active Labor Act (“EMTALA”) “does not require the use of opioid analgesics to treat pain.” Given their risks, “[o]pioid analgesics should not be considered as the primary approach to pain management in discharge planning for patients.”

According to the Guidelines, only when deemed professionally appropriate to prescribe these drugs, emergency department (“ED”) prescribers should prescribe no more than a short course of short-acting opioid analgesics, such as hydrocodone (e.g., Vicodin), immediate-release oxycodone (e.g., Percocet), and hydromorphone (e.g., Dilaudid), for acute pain. The Guidelines define “short course” as no more than three days’ worth of medication for most patients.

ED providers should altogether avoid prescribing long-acting or extended release opioid analgesics, like OxyContin, Methadone, and Duragesic patches, however, because they “are not indicated in the management of acute or intermittent pain.”

The Guidelines further recommend that EDs as a matter of policy refuse to replace prescriptions for opioid analgesics that are claimed to be lost, stolen, or destroyed. In rare instances, it may be reasonable to dispense a single dose of the medication from the ED, but only where the ED physician “confirmed the need directly with the patient’s physician.”

An article in the New York Times reports some critics’ concerns that the Guidelines will prevent doctors from providing care to poor and uninsured patients who may use EDs as their primary source of medical care. In addition, Dr. Alex Rosenau, president-elect of the American College of Emergency Physicians, is quoted as criticizing the Guidelines for preventing him from being a professional and using his judgment.

In fairness to the Bloomberg Administration, the Guidelines expressly note that they are not intended to apply to “patients in palliative care programs or with cancer pain.” They further recognize that they “do not replace clinical judgment in the appropriate care of patients nor are they intended to provide guidance on the management of patients while they are in the ED.”

This suggests doctors retain the ability to exercise their professional judgment to deviate from the Guidelines in appropriate cases. Indeed, Dr. Rosenau apparently does not speak for the New York State Chapter of the American College of Emergency Physicians, which endorses the Guidelines, according to Bloomberg’s press release.

But implicit in the Guidelines is the assumption that appropriate prescribers are available to provide palliative care or substance abuse treatment to patients with needs that demand more than the Guidelines permit.

The number of uninsured Americans remains significant, even with the Affordable Care Act’s reforms. Many individuals with health insurance, moreover, have difficulty finding specialists who participate in their plans or may have to wait weeks or months for an available appointment. How are ED prescribers supposed to know which patients will be able to secure a timely follow-up appointment and which ones require ED discretion?

Another potential concern with the Guidelines is how they may impact ED use by patients seeking opioid prescriptions.

It is possible that the Guidelines will drive up demand for painkillers from ED services at private emergency rooms in New York City and public or private emergency rooms in areas bordering New York City that are not bound by the Guidelines. As the New York Times article reports, although the City cannot impose the Guidelines on its 50 or so private hospitals, some already have agreed to adopt them, including NYU Langhone Medical Center and Maimonides Medical Center. If they don’t, it’s reasonable to predict demand for pain medications may spike at these facilities, which effect would not address the underlying problem but instead would just shift its locus.

ED use could even increase at hospitals electing to comply with the Guidelines. A patient who previously obtained a ten-day dosage of pain medication from a single ED visit, for example, might more than triple her ED use because now she may only obtain a three-day dosage in each visit. This risks exacerbating the ED high utilizer problem that so many current reforms aim to reduce.

There also seem to be holes in New York’s prescription monitoring program that limit its value as a tool to help ED physicians decide how to exercise their discretion.

For one, although the Guidelines recognize that prescribers can “access the New York State Controlled Substance Information (CSI) on Dispensed Prescriptions Program for information on patients’ controlled substance prescription history,” the Guidelines do not require ED prescribers to do so.

Even if ED physicians access the database, current law only requires pharmacists to update the registry every two weeks. While this may identify historical patterns of abuse, the reporting delay severely hampers the ability of physicians to timely identify concurrent or more recent doctor shopping.

Effective August 27, 2013, New York’s database arguably should become more valuable as a tool for identifying drug seeking behavior. Pursuant to Public Health Law Section 3343-a, prescribers in New York will have to check the database before prescribing controlled substances, and pharmacists will have to update the database in real time.

But importantly, subparagraph (2)(a)(v) of this law exempts ED prescribers from the requirement to check the database prior to prescribing controlled substances as long as the prescription does not exceed a five day supply, which the Guidelines generally prohibit. New York’s registry also will not contain information about prescribing in other states, such as bordering New Jersey and Connecticut.

Although not a substantive criticism of the Guidelines, it also is interesting to note the potential tension between this initiative and news that New York City’s public hospitals are negotiating to experiment with performance pay. As a recent article in Forbes chronicled, there is evidence that doctors overprescribe medications, including powerful narcotics, to help secure higher patient satisfaction scores and, in turn, greater compensation. If this performance plan goes through, it will be worth watching how ED doctors in New York City public hospitals balance the need to comply with the Guidelines with their desire to maximize their compensation.

Mayor Bloomberg rather cavalierly dismissed critics’ concerns about the Guidelines in his weekly radio show, reportedly responding, “[S]o you didn’t get enough painkillers and you did have to suffer a little bit. The other side of the coin is people are dying and there’s nothing perfect …. There’s nothing that you can possibly do where somebody isn’t going to suffer, and it’s always the same group [claiming], ‘Everybody is heartless.’ Come on, this is a very big problem.”

Certainly, prescription drug abuse is a very big problem. But that does not mean the Guidelines are the best we can do. We must continue to evaluate and revise our reform efforts.

Bloomberg’s announcement also touted the creation of NYC RxStat, which is a joint effort of the Mayor’s Task Force on Prescription Painkiller Abuse and the New York/New Jersey High Intensity Drug Trafficking Areas (HIDTA) Program to “leverage relevant public health and public safety data in support of monitoring and combating the problem of prescription painkiller abuse.”

Undoubtedly it is critical to bring together city, state, and federal agencies to address this cross-border problem by sharing data, assessing trends, and evaluating strategies to reduce prescription drug abuse. I hope part of its charge will be evaluating the Guidelines — and similar efforts in places like Seattle, Ohio, and Milwaukee — to address potential flaws and to make more effective use of prescription monitoring programs without denying appropriate care to patients in need.

[1] Although the Mayor’s press release states that the guidelines are included in the January 2013 Interim Report of the Mayor’s Task Force on Prescription Painkiller Abuse, this report references distinct, though related, evidence-based clinical guidelines for prescribing prescription painkillers that the New York City Department of Health and Mental Hygiene distributed to New York City providers in December 2011.

Tags: Emergency Department, Emergency Room, Health Care Reform, Health Law, Health Reform, New York, New York City Emergency Department Discharge Opioid Prescribing Guidelines, Prescription Drug Abuse, Prescription Drugs, Substance Abuse

Professional Licensing and Liability Round-Up

November 29, 2012 by Tara Adams Ragone · 1 Comment
Filed under: Health Law

Here are some highlights from recent headlines affecting licensing and liability of health care professionals:

Professional liability for failing to report child abuse in New Jersey: In L.A. v. Div. of Youth & Family Servcs., the Appellate Division of the Superior Court of New Jersey held that an emergency room physician must stand trial for medical malpractice because he failed to report to the State that a two year-old child brought to the ER had ingested cologne. The applicable standard of care is established by N.J.S.A. 9:6-8.10, which requires “[a]ny person having reasonable cause to believe that a child has been subjected to child abuse or acts of child abuse” to report this information to the Division of Child Protection and Permanency (previously DYFS). Although this statute does not expressly mention neglect, the court held that it “requires the reporting of injuries resulting from conduct that is reckless, or grossly or wantonly negligent, but not conduct that is merely negligent.” The court further held “that the triggering of the obligation to report, especially in the context of civil litigation involving professional malpractice, does not require the potential reporter to possess the quantum of proof necessary for an administrative or judicial finding of abuse or neglect. All that is required by N.J.S.A. 9:6-8.10 is ‘reasonable cause to believe.’” Because the paramount concern is the safety of children, “a physician has ‘reasonable cause to believe’ that there has been abuse if a ‘probable inference’ from the medical and factual information available to the physician is that the child’s condition is the result of child abuse, including ‘reckless’ or ‘wantonly negligent’ conduct or inaction by a parent of caregiver. The inference need not be the ‘most probable,’ but it must be more than speculation or suspicion.” The court found that it was a jury question whether the doctor here failed to satisfy this standard of care. Because there is a jury question as to the doctor’s liability, the court also reversed the dismissal of the plaintiff’s claim against the hospital based on the doctrine of respondeat superior. As Charles Toutant highlighted in a recent article in the New Jersey Law Journal, health care professionals need to pay attention to this case. The court reminded in a footnote that more than professional liability could be at issue because it is a disorderly persons offense under N.J.S.A. 9:6-8.14, 2C:43-8 to fail to make the required report.

A supervising doctor in Vermont is not subject to professional discipline based solely on the unprofessional conduct of the physician assistant he supervised: The Vermont Supreme Court in In re Porter, 2012 Vt. 97, held that the state Board of Medical Practice may not find a doctor guilty of unprofessional conduct based only on the unprofessional acts of the physician assistant (PA) whom he supervised where the supervising physician met or exceeded all standards of care. The PA had admitted that his improper prescribing of opiates constituted professional negligence and unprofessional conduct. Under Vermont law, “[t]he supervising physician delegating activities to a physician assistant shall be legally liable for such activities of the physician assistant, and the physician assistant shall in this relationship be the physician’s agent” (emphasis added). 26 V.S.A. § 1739. The Court distinguished “between legal liability, typically at issue in a civil action or for a monetary penalty, and unprofessional conduct at issue in a professional licensing disciplinary proceeding.” Because the statute references only legal liability, the Court concluded that the statute “encompasses only the concept of civil liability, and does not render a supervising physician vicariously answerable or guilty for the unprofessional acts of his or her PA simply on the basis of their relationship.” That the statute made the PA the physician’s agent did not change the analysis because “agency theory applies in tort or contract cases, not professional responsibility actions.”

Bill to permit advanced practice nurses to prescribe medication without supervision in New Jersey: New Jersey Senator Joseph Vitale introduced S.2354 on November 21 to permit advanced practice nurses (APNs) with more than twenty-four months or 2,400 hours of licensed, active advanced practice experience to prescribe medication without a joint protocol with a physician; reportedly Assemblywoman Nancy Munoz will introduce an Assembly version on December 3. Under current New Jersey law, although APNs may practice independently of physicians, they are only permitted to write prescriptions pursuant to a joint protocol developed with a collaborating physician. See N.J. Stat. § 45:11-49(b)-(c); N.J.A.C. 13:35-6.6; N.J.A.C. 13:37-8.1. According to a recent Health Affairs Health Policy Brief, eighteen states and the District of Columbia permit nurse practitioners, which are a type of APN, to prescribe without a doctor’s involvement. A 2010 report from the Institute of Medicine urged more states to move in this direction. Although the language of S.2354 is not yet available on the Legislature’s web site, Andrew Kitchenman reports in NJ Spotlight that it would make it easier for APNs to open their own practices. A study published in the November/December 2012 Annals of Family Medicine predicts that the United States will require nearly 52,000 additional primary care physicians by 2025 while noting that the number of internal medicine residents choosing primary care is decreasing. Given the existing shortage of primary care providers throughout the country and in New Jersey, which is expected to intensify with Medicaid expansion and increased coverage under the Affordable Care Act, S.2354 could help relieve the primary care supply pressures in New Jersey. Although this bill circumvents the turf battles between the State Boards of Medical Examiners and Nursing, it is sure to meet substantial pressure from physician groups in the State. The Health Affairs Health Policy Brief provides helpful context for this important debate.

New York begins accepting applications for professional licenses from nonimmigrant aliens: Following the Second Circuit’s decision in Dandamudi v. Tisch, 686 F.3d 66 (Jul. 10, 2012), New York has begun accepting applications for thirteen professional licenses, including medical, podiatric, chiropractic, dental, pharmacy, and veterinary, from applicants who previously were categorically precluded from licensure because they are neither citizens nor legal permanent residents (LPRs). At issue in Dandamudi was New York’s requirement that pharmacists be citizens or legal permanent residents, which denied licensure to a “subclass of aliens known as nonimmigrants who are lawfully admitted to the United States pursuant to a policy granting those aliens the right to work in this country . . . .” Because the Circuit in Dandamudi found that these nonimmigrant aliens are a suspect class, “[a]ny discrimination by the state against this group is subject to strict scrutiny review.” The state had conceded that it lacked any compelling interest in treating this class differently, and thus the court found the New York law violated nonimmigrant aliens’ right to equal protection. Although limiting its ruling to equal protection grounds, the court also credited Supremacy Clause and preemption concerns with New York’s law because it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’ decision to admit these individuals to the country for the express purpose of working in these specialty professions. In reaching its decision, the Second Circuit expressly refused to follow decisions of the Fifth (see, e.g., Van Staden v. St. Martin, 664 F.3d 56 (5th Cir. 2011)) and Sixth (LULAC v. Bredesen, 500 F.3d 523 (6th Cir. 2007)) Circuits that required only rational basis review of statutes that treated nonimmigrant aliens differently than citizens or LPRs. Despite the circuit split created by Dandamudi, the United States Supreme Court on October 1, 2012 denied the petition for certiorari filed in Van Staden. Although the New York professions web site states that the time to seek a petition for certioriari in Dandamudi has not yet expired, a search of the Supreme Court’s online docket does not reveal that New York has filed a petition within 90 days of the decision or sought an extension of time in which to do so.

Tags: Advanced Practice Registered Nurses, APN, Health Law, Health Reform, Medical License, New Jersey, New York, Prescription Drugs, Proposed Legislation, Vermont

Recent Research Regarding Potential Best Practices for Prescription Drug Monitoring Programs

October 17, 2012 by Tara Adams Ragone · Leave a Comment
Filed under: Fraud & Abuse, New Jersey, Prescription Drugs

As this blog has chronicled (see here and here), New Jersey has begun implementing the 2008 legislation that authorized creation of a Prescription Drug Monitoring Program (“PMP” or “PDMP”). Although New Jersey’s PMP database has been collecting data for more than a year, the State has not yet issued implementing regulations to flesh out the details of the program beyond what the statute requires, such as the specific information and in what time frames pharmacies must make reports and the scope of interoperability agreements with other States. The Prescription Drug Monitoring Program Center of Excellence at the Heller School for Social Policy and Management at Brandeis University released “Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices” on September 20, 2012, which provides much for the State to consider as it moves forward.

As its title suggests, this White Paper aims to identify potential PDMP best practices, evaluate the evidence supporting labeling these as best practices, and survey the extent to which PDMPs throughout the country have adopted them.

After tracing PDMP development from its early roots in the 1980s and summarizing evidence suggesting that PDMPs are effective in improving the prescribing, and addressing the abuse, of controlled substances, the report identifies thirty-five potential best practices for these programs, including:

1. Standardizing data fields and formats across PDMPs to improve the comprehensiveness of data, comparability of data across states, and ease of integration with prescription information collected by potential PDMP collaborators, like Medicaid, the Indian Health Service, the Department of Veterans Affairs, and Department of Defense.

2. Reducing data collection intervals and moving toward real-time data collection to improve the utility of information collected for clinical practice and drug diversion investigations.

3. Integrating electronic prescribing with PDMP data collection to facilitate communication with electronic prescribers and facilitate monitoring of prescriptions as they are being issued as well as before and after they are dispensed.

4. Linking records to permit reliable identification of individuals (patients or prescribers), which is necessary for accurate analysis of trends and potential questionable behavior.

5. Determining validated and standardized criteria for possible questionable activity.

6. Conducting epidemiological analyses for use in surveillance, early warning, evaluation, and prevention to identify trends in prescribing and questionable behavior, which may inform public health objectives.

7. Providing continuous online access and automated reports to authorized users to encourage utilization.

8. Integrating PDMP reports with health information exchanges, electronic health records, and pharmacy dispensing systems to make it more efficient to access data.

9. Sending unsolicited reports and alerts to appropriate users based on data suggesting potentially questionable activity, such as doctor shopping or inappropriate prescribing.

10. Enacting and implementing interstate data sharing among PDMPs to address interstate diversion and doctor-shopping.

11. Securing funding independent of economic downturns, conflicts of interest, public policy changes, and changes in PDMP policies, such as from grants, licensing fees, general revenue, board funds, settlements, insurance fees, private donations, and asset forfeiture funds.

12. Conducting periodic review of PDMP performance to ensure efficient operations and to identify opportunities for improvement.

The authors noted, however, that good research evidence is not available to support the value of the vast majority of these potential best practices because “research in this area is scarce to nonexistent.” Thus, they suggested a prioritized research agenda with the goal of strengthening the evidence base for practices they believe have the greatest potential to enhance effectiveness of PMP databases and that can be studied using scientific techniques like randomized controlled trials or observational studies with comparison groups. Specifically, the report recommends focusing research and development on (a) data collection and data quality; (b) linking records to identify unique individuals; (c) unsolicited reporting and alerts; (d) valid and reliable criteria for questionable activity; (e) medical provider education, enrollment, and use of PDMP data, which includes the question of whether to require providers and dispensers to access the database; and (f) extending PDMP linkages to public health and safety.

The report makes valuable recommendations that will help guide policy makers as these programs continue to evolve. Despite its many strengths, however, the report gives short shrift to a critical area for ongoing monitoring — whether PMPs have a chilling effect that makes it more difficult for patients in pain to obtain appropriate, palliative care. Although this concern is mentioned in passing in various places in the report, it is not expressly incorporated into the authors’ conceptualization of how we should evaluate PDMP effectiveness. Indeed, it is dismissed as potentially overblown even though Appendix A to the report notes that twenty-three percent of Virginia doctors in a 2005 survey who believed their prescribing was being more closely monitored because of the PDMP “reported it had a negative impact on their ability to manage patients’ pain.” Admittedly, other studies summarized in the appendix found no chilling effect. But given the article’s critique of most studies as lacking empirical rigor and its call for more scientific study, it seems prudent to encourage empirical research to evaluate this concern. Recognizing that “an explicit goal of PDMPs is supporting access to controlled substances for legitimate medical use,” an August 20, 2012 [fee required to access] report from the Congressional Research Service suggested that “[a]ssessments of effectiveness may also take into consideration potential unintended consequences of PDMPs, such as limiting access to medications for legitimate use . . . .” (Although the August 20, 2012 CRS report does not appear to be available without charge on the internet, a July 10, 2012 version of this report is available here.)

With this caveat in mind, the Brandeis report undoubtedly is a valuable resource to policy makers and academics as they consider how to make the most appropriate and efficient use of PMPs. New Jersey can build on this knowledge base as it decides how to make use of its PMP. As the White Paper’s laundry list of potential best practices makes clear, the State has a plethora of options to research and consider. If New Jersey adopts the proposed regulations permitting electronic prescribing of controlled substances, for example, it should consider how it can integrate electronic CDS prescription records with its PMP. Given the statutory authorization to share data with other States, New Jersey also can learn from the experiences of States that are adopting standardized data formats and implementing interoperability agreements with other States.

The State also should evaluate the evidence that unsolicited reports increase the effectiveness of PMPs and whether legislation and/or regulations would be required to authorize their use in New Jersey. A related issue is what criteria to adopt to define potentially questionable behavior that would trigger an unsolicited report, which must balance the risks of false negative and false positive reports.

Similarly, the State may wish to explore the advantages and costs of moving toward a real-time database rather than its current design that requires dispensers to report at least twice per month. The Alliance of States with Prescription Monitoring Programs’ PMP Model Act 2010 Revision recommends that pharmacies submit data no more than seven days from when the script was dispensed, and Oklahoma is implementing real time reporting. (A recent study published in CMAJ found a 32.8% relative reduction among residents receiving social assistance in inappropriate prescriptions for opioids and a 48.6% reduction in inappropriate prescriptions for benzodiazepines within thirty months of implementation of a Canadian centralized database containing real-time prescription data.)

New Jersey also could study the experiences of various states like New York that are requiring certain prescribers and dispensers to register with the State’s PDMP and, in some cases, to check the database before authorizing or dispensing prescriptions for CDS. A research study underway in Utah may shed some light on whether mandating provider participation in PDMPs improves effectiveness.

In general, the State may wish to research how to strike the appropriate balance between educating prescribers, dispensers, and patients of the risks of prescription abuse and punishing those involved with diversion or abuse.

Because virtually all of these policy choices also involve substantial costs to research and implement, New Jersey might wish to pursue alternative sources of funding, such as grants available through the federal Harold Rogers Prescription Drug Monitoring Program or the National Association of State Controlled Substances Authorities.

Tags: Fraud and Abuse, Health Care Reform, Health Reform, Prescription Drugs

Electronic CDS Prescriptions Proposed in New Jersey

August 22, 2012 by Tara Adams Ragone · 1 Comment
Filed under: Health Reform, Prescription Drugs

More than two years ago, the Federal Drug Enforcement Administration (DEA) issued interim final regulations permitting practitioners to issue and pharmacists to fill electronic prescriptions for controlled dangerous substances (“CDS”) (see, e.g., 21 C.F.R. § 1306.08). Regulations of the New Jersey State Board of Medical Examiners (N.J.A.C. § 13:35-7.4A(g)-(h)) and Board of Pharmacy (N.J.A.C. § 13:39-7.11(h)-(i)) similarly permit electronic CDS prescriptions, subject to certain requirements. But the State’s CDS regulations do not currently permit electronic CDS prescriptions (N.J.A.C. § 13:45H-7.8).

On August 20, 2012, Eric T. Kanefsky, the Acting Director of New Jersey’s Department of Consumer Affairs (“DCA”), proposed regulations to resolve this regulatory inconsistency. DCA would add a new rule, N.J.A.C. § 13:45H-7.20, which would permit “[a]n individual practitioner [to] issue, and a pharmacist [to] accept for dispensing, an electronic prescription for a controlled dangerous substance, consistent with the requirements of this chapter and Federal law.” This proposed rule would define “electronic prescription” as “a prescription that is transmitted by a computer device in a secure manner, including computer-to-computer and computer-to-facsimile transmissions.” DCA also proposes to amend N.J.A.C. § 13:45H-7.8 to expressly permit an electronic prescription for Schedule II narcotics “[i]f permitted by Federal law, and in accordance with Federal requirements.”

These Federal requirements, set forth in 21 C.F.R. Parts 1300, 1304, 1306, and 1311, include provisions intended to balance the desire to permit the use of modern technology while “maintaining the closed system of controls on controlled substances dispensing” (75 Fed. Reg. 16236). Thus, if DCA ultimately adopts these rules, New Jersey prescribers and pharmacists seeking to exercise their option to issue or fill electronic prescriptions will need to ensure that they comply with all Federal rules, including, as DCA’s proposed rule reminds, a requirement for a third-party audit by a DEA-approved certification organization to verify that the technology used satisfies DEA security standards (see 21 C.F.R. § 1311.300).

In addition to “eliminating any confusion that may exist with respect to filling electronic prescriptions for controlled dangerous substances,” DCA also believes that “[e]lectronic prescriptions are more efficient and less susceptible to errors.” With proper controls and checks, electronic prescriptions can make it more difficult for patients to try to fill fraudulent prescriptions by, for example, forging doctor’s signatures on stolen prescription blanks or altering the dosage that the doctor prescribed. Electronic prescriptions also support other health care reform initiatives, including increasing the use of electronic medical records, which can facilitate improved care coordination.

The public may comment on DCA’s proposal until October 19, 2012. But given the potential advantages of electronic prescriptions and the strong controls required by Federal law to prevent their abuse, I would expect the comment to be light and these regulations to be adopted.

Tags: Drug & Device, Health Care Reform, Health Law, Health Reform, Prescription Drugs, State Initiatives

New Jersey, It’s Now or Federal

July 10, 2012 by Tara Adams Ragone · 2 Comments
Filed under: Health Law, New Jersey

It’s go time, New Jersey. Now that the Supreme Court has upheld the Affordable Care Act, New Jersey has to reignite efforts to implement health reform — or else the Federal government will step in to fill the gaps.

If New Jersey wishes to operate a state-based exchange (or to participate in a state partnership exchange) beginning in January 2014 (and avoid having HHS establish a federally-facilitated exchange in the State), it must submit a complete Exchange Blueprint no later than November 16, 2012. HHS then must approve or conditionally approve the State’s blueprint by January 1, 2013. See 45 C.F.R. § 155.105.

New Jersey’s Legislature passed Assembly Bill 2171 on March 15, 2012, which proposed creation of an exchange. But Governor Christie vetoed this bill in May, stating that it would be “imprudent . . . to create an exchange” until the Supreme Court rules on the constitutionality of the ACA. (He also identified substantive provisions of the bill that concerned him, such as the proposal to pay compensation of $50,000 to each exchange board member and to limit membership to those not directly involved in the healthcare industry.)

Now that the Supreme Court has issued its ruling upholding the ACA, Sen. Nia Gill (D-Essex) reportedly intends to reintroduce the vetoed exchange bill, which Christie has promised to veto again.

Although the Governor could bypass the legislature by issuing an executive order establishing an exchange, Professor John Jacobi recently pointed out that Christie is limited in what he can accomplish on his own:

“There are some things he could do to get [an exchange] up and running, but New Jersey cannot spend money by executive order,” Jacobi said. Nor can Christie change state law without the Legislature, and that is what would be required if the two struggling and highly expensive state-run insurance programs, for small employers and individuals, are folded into the exchange, he said.

Given that Christie long has vowed not to let the federal government run an exchange in New Jersey and recently committed to complying with any deadlines imposed on States with respect to health care implementation, New Jersey’s legislative and executive branches should be able to work together to craft an exchange bill that will pass both houses and gain Christie’s signature. Indeed, Sen. Joseph Vitale (D-Middlesex), chair of the Senate Health, Human Services and Senior Services Committee, reportedly has committed to working with Christie’s administration to draft a new bill that the Governor can support. Enacting legal authority for the exchange is also among the requirements for the State to apply for a Level 2 Exchange Establishment grant. (HHS announced last week that it was adding ten additional opportunities for States to apply for exchange establishment funding.)

New Jersey also needs to turn its attention to the requirement in the ACA that non-grandfathered individual and small group plans both inside and outside of the exchanges offer essential health benefits (EHB). Although Section 1302 of the ACA requires the Secretary of HHS to define EHB (as long as EHB includes at least ten general categories itemized in the statute), HHS issued a bulletin in December 2011 indicating its intention to grant each State the flexibility to select a benchmark from certain existing health plans identified by HHS. HHS plans to require States to identify the selected benchmark plan for 2014 and 2015 in the third quarter of 2012 (that is, by September 30, 2012). If New Jersey does not designate a benchmark plan, HHS has said that the largest plan by enrollment in the largest product in the State’s small group market will be the default benchmark plan.

As I’ve previously blogged, HHS’s bulletin on EHB and subsequent FAQ leave many questions unanswered. New Jersey needs to evaluate the potential benchmarks identified by HHS and choose which to designate, which will demand careful attention to whether the benchmark plans include all of the ten categories required by the ACA and, if not, how the State will supplement the benchmarks to comply with federal requirements. Critical to this process is balancing the desire for comprehensive benefits with the need to keep premiums affordable.

New Jersey also needs to compare the potential benchmark plans with New Jersey’s insurance mandates. Section 1311(d)(3)(B) of the ACA requires States to defray the costs of State-mandated benefits in excess of EHB. For 2014 and 2015, however, HHS intends to create a transition period during which “if a State chooses a benchmark subject to State mandates -; such as a small group market plan — that benchmark would include those mandates in the State EHB package.” But if a State chooses a benchmark that does not include all of the State’s mandates, such as the Federal Employees Health Benefits Program, the State will be responsible for the costs of those mandates. HHS has indicated that it may exclude some State benefit mandates from State EHB packages for 2016 and beyond. New Jersey thus needs to evaluate the degree to which its mandates come within the EHB benchmark it selects.

Clearly, there is work to be done, but there is time, if used wisely.

Tags: ACA, Add new tag, Health Care Reform, Health Insurance Exchanges, Health Reform, HHS, New Jersey, State Initiatives, Uninsured

New Jersey’s Recent Efforts to Combat Prescription Drug Abuse

February 16, 2012 by Tara Adams Ragone · 10 Comments
Filed under: Prescription Drugs

New Jersey is adding to its arsenal of resources to investigate and combat prescription drug abuse and diversion.

On January 18, 2012, New Jersey’s new Attorney General, Jeffrey S. Chiesa, announced the launch of the State’s long-awaited Prescription Monitoring Program (“PMP”), which permits the State to monitor prescriptions for controlled substances. (I blogged last June about the passage of the statute authorizing the PMP, N.J.S.A. 45:1-45-1-52.) According to AG Chiesa, the PMP is “a powerful new tool in the State’s fight against the abuse and diversion of prescription drugs, and the often-heavy reimbursement costs of fraudulently-obtained prescription medication borne by health insurance companies, the State, and ultimately taxpayers.”

Before the PMP, investigators of inappropriate prescribing or usage patterns, absent timely and reliable complaints, had to pick which pharmacies, providers, or patients to investigate and then cobble together data from these various sources, looking for the proverbial needle in a haystack. It often took quite a bit of time and resources, not to mention a bit of luck, to find the evidence required to demonstrate diversion or abuse.

The PMP now centralizes these data in a searchable database maintained by the State’s Division of Consumer Affairs. Since September 1, 2011, the PMP has been collecting information from 2,000 pharmacies throughout the State every 15 days regarding the prescription sale of all drugs classified as controlled dangerous substances (CDS) and human growth hormone (HGH). As AG Chiesa explains, the PMP “database will help the Division of Consumer Affairs and other law enforcement agencies identify and investigate individuals and businesses suspected of fraudulently diverting controlled drugs for abuse. By highlighting the location, nature, and extent of abuse throughout the state, the information collected will also better inform our healthcare initiatives and addiction-treatment efforts.”

Investigators are not the only folks with access to this data. Beginning January 4, 2012, State-licensed prescribers and pharmacists may register to be able to access the PMP database to help inform their professional decision making with regard to current patients. Consumer affairs also will provide information garnered from the database to other law enforcement agencies and the professional licensing boards, as permitted by law.

By May 2012, the State intends to enhance and expand the PMP database to permit more sophisticated statistical analysis. According to the State:

When fully expanded, the NJPMP will generate reports on geographical areas with unusual CDS or HGH prescription activity during a specific time frame; identify practitioners in each county who prescribed the largest quantities of a specific drug during a given time period; and provide other information that can help identify and compare troubling patterns of CDS and HGH activity.

By using the PMP, investigators may more swiftly identify patients who are filling multiple prescriptions for CDS or providers who are authorizing large quantities of CDS. With this information, investigators may examine whether there are medically appropriate justifications for these prescriptions, or if this is evidence of diversion, abuse, or fraud. For example, the State’s press release recounts that investigators used the PMP to identify a patient who obtained a four-month supply of methadone and oxycodone in just over one month by presenting what are now believed to be fourteen forged prescriptions to three different pharmacies, and they made this discovery within a month of the abusive behavior.

To help the State maximize the potential of the PMP, AG Chiesa announced the “next step” in the State’s “comprehensive, statewide plan to fight the diversion and abuse of prescription drugs” — a reorganization and expansion of the Enforcement Bureau (“EB”) of the Division of Consumer Affairs. The EB is the investigative arm of the various state professional boards, including the State Board of Medical Examiners and Board of Pharmacy, which investigates potential professional misconduct by the licensees of these Boards. The AG plans to add investigators to the three investigative sections that play “a key role in the Division’s effort to curb prescription drug diversion and abuse” to permit the EB to develop expertise in identifying “the unlawful distribution and diversion of prescription medications.”

First, the AG plans to grow from 7 to 9 the number of undercover investigators in its drug diversion section, which investigates “cases related to the distribution and diversion of prescription drugs; indiscriminate prescribing and dispensing; prescription fraud; and enforcing the bans enacted by the Division of Consumer Affairs on so-called “bath salts” and other designer drugs.” Indeed, the State’s press release reports that one investigator has already been hired.

The AG also plans to add 4 pharmacist/investigators to the current 9 in the pharmacy inspection section, to inspect pharmacies and review security protocols to try to prevent theft of CDS.

It then will add three nurse/investigators to its quality of healthcare section, which currently has 7 registered nurses or other experienced investigators. By monitoring the quality of care provided by licensees primarily of the medical and nursing boards, this section often oversees investigations concerning “drug impairment and self-use by practitioners, and health insurance fraud.”

The AG also said that the 20 investigators in EB’s other 2 investigative sections will be available as needed to support the State’s efforts to fight prescription drug diversion.

There is much to applaud here. Public health demands increased efforts to curb prescription drug abuse and diversion. If used appropriately, these initiatives offer considerable promise — individuals, including practicing health care professionals, in need of substance abuse treatment can be identified in a more timely fashion; practitioners lacking adequate training in the prescribing of controlled substances can be required to take additional courses; and dishonest or dangerous practitioners can lose the privilege of licensure.

These initiatives also raise a number of policy and legal questions that need to be fleshed out. These include, just to identify a few:

How do we ensure patient privacy? Prescribing doctors and pharmacists must certify that they are accessing the database for a current patient, but how do we verify the truth of their certifications?
When will information be shared with other law enforcement entities?
New Jersey’s statute permits the State to enter interoperability agreements with other states so that each state may access the other’s data. When will other states be able to access New Jersey’s database?
The statute does not require prescribing doctors and pharmacists to access the database — should it, to better inform care decisions? (The Massachusetts Senate unanimously passed S. 2122recently, generally requiring doctors to check the State’s PMP database before prescribing a Schedule II or III narcotic drug to a patient for the first time. Not everyone, however, thinks it’s a wise proposal.)
Should New Jersey amend the PMP statute to permit non-prescribing substance abuse treatment providers, such as social workers or psychologists, to access the database?
How do we discern from the data which high volume prescribers may be too readily prescribing — or even complicit in diversion — and which are needed palliative care doctors who treat a disproportionate number of patients in chronic pain? It is critical that well-trained, ethical pain management doctors are not deterred from practicing their specialty by fear of being caught up in a protracted, potentially career-ending investigation. (Somewhat relatedly, the Florida Legislature recently killed a bill that would have prohibited doctors from writing prescriptions for controlled substances while arrested and awaiting trial on — but not yet convicted of — a charge relating to controlled substances.)
What public policy initiatives can be adopted to ensure that all patients with legitimate prescriptions for pain medication can get those prescriptions filled at local pharmacies?

I am encouraged by New Jersey’s continued efforts to combat the real and deadly challenges of prescription drug abuse and diversion, but I encourage balance in the implementation of these new tools so that patients suffering from pain are not denied appropriate palliative care. I am eager to work through these issues. Let’s start a dialogue. I welcome your ideas.

Tags: Health Care Reform, Health Reform, New Jersey, Prescription Drug Abuse, Prescription Drugs, Prescription Monitoring Program, State Initiatives

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

January 24, 2012 by Tara Adams Ragone · Leave a Comment
Filed under: Health Reform, State Initiatives

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

ASCs 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’

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

Legislators 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

Tags: Ambulatory Surgery Centers, Health Care Reform, Health Reform, New Jersey, one room, Quality Improvement, State Initiatives

Defining Essential Health Benefits

December 30, 2011 by Tara Adams Ragone · Leave a Comment
Filed under: Health Reform, Private Insurance

As many of us just finished scurrying to fulfill our children’s increasingly unrealistic holiday wish lists (my six year-old wanted a laptop and a phone — hah!), it’s a fitting time to step back and think about what is essential.

Section 2707 of the Affordable Care Act (ACA) requires all non-grandfathered health insurance coverage offered in the individual or small group markets beginning in 2014 to include essential health benefits (EHB). Section 1302 then largely leaves the task of defining this term to the Secretary of HHS, as long as EHB include these ten statutorily itemized general categories:

(A) Ambulatory patient services.
(B) Emergency services.
(C) Hospitalization.
(D) Maternity and newborn care.
(E) Mental health and substance use disorder services, including behavioral health treatment.
(F) Prescription drugs.
(G) Rehabilitative and habilitative services and devices.
(H) Laboratory services.
(I) Preventive and wellness services and chronic disease management.
(J) Pediatric services, including oral and vision care.

The statute also directed that the scope of EHB must be “equal to the scope of benefits provided under a typical employer plan.” (For more background on EHB, see Timothy Jost’s recent blog post on Health Affairs.)

Given the complexity of establishing a national floor for coverage, it is not surprising that the statute was short on specifics, and stakeholders have been waiting for HHS to provide detailed guidance as 2014 gets closer and closer.

On December 16, 2011, the Center for Consumer Information and Insurance Oversight in HHS released a bulletin outlining HHS’s intended regulatory approach to defining EHB. After balancing “comprehensiveness, affordability, and State flexibility” along with input from various camps, HHS’s “intended regulatory approach utilizes a reference plan based on employer-sponsored coverage in the marketplace today, supplemented as necessary to ensure that plans cover each of the 10 statutory categories of EHB.” Specifically, HHS

intends to propose that EHB be defined by a benchmark plan selected by each State. The selected benchmark plan would serve as a reference plan, reflecting both the scope of services and any limits offered by a “typical employer plan” in that State . . . .

The bulletin identifies four benchmark plan types for 2014 and 2015 (HHS will assess the benchmark process for later years based on experience and feedback): (1) “the largest plan by enrollment in any of the three largest small group insurance products in the State’s small group market; (2) any of the largest three State employee health benefit plans by enrollment; (3) any of the largest three national FEHBP plan options by enrollment; or (4) the largest insured commercial non-Medicaid Health Maintenance Organization (HMO) operating in the State.” It also indicated HHS’ intent to propose a default benchmark plan if a State does not exercise its discretion to select its benchmark.

Under HHS’s intended regulatory framework, insurance providers could adopt the balance achieved by the State benchmark, but it must supplement the benchmark it if it does not include all ten ACA-required categories. HHS solicited comments regarding “options for supplementing missing categories.” HHS also intends to require plans to offer “benefits that are ‘substantially equal’ to the benefits of the benchmark plan selected by the State and modified as necessary to reflect the 10 coverage categories.” It wants to provide flexibility to adjust benefits as long as there is coverage in all ten categories, and the flexibility will be “subject to a baseline set of relevant benefits.”

This bulletin raises more questions than it answers. HHS itself seeks comment on a variety of issues, including the definition of habilitative services, what to require when a benchmark plan does not cover one of the ten statutory categories, or whether to permit substitutions between (and not only within) categories, subject to “a higher level of scrutiny.” What do terms like “substantially equal” or “higher level of scrutiny” mean in practice?

On a more macro level, the bulletin raises the classic tension between centralized, prescriptive programs and those that permit states flexibility. On the one hand, permitting state flexibility may ease states’ objections to federal interference with insurance regulation, and permit experimentation to reflect local circumstances. As the bulletin recognizes, all states have their own benefit mandates, so the less prescriptive the federal EHB definition, the lower the risk it will conflict with state-specific mandate requirements.

Yet with devolution comes the possibility that state decisions will frustrate the achievement of the ACA’s policy goals. It remains to be seen how HHS effectively will police the various state and local decision makers who will exercise this discretion to protect consumers from discriminatory behavior. How powerful will HHS’s oversight be? For example, HHS’s review of the scope of existing coverage of mental health and substance use disorder services revealed great variations in coverage. How much variation is acceptable? What is the substance of the “baseline set of relevant benefits” that is supposed to limit state discretion? What role will politics have in this state-by-state process?

These questions just scratch the surface and remind us how critical it is to engage in this debate. Jason Millman, writing for Politico, noted that consumer groups have not yet taken “the sky-is-falling position” in protest of HHS’s intended regulatory approach even though they have advocated for specific, federal requirements. The sky may not be falling, but there are important policy issues in play that will benefit from careful and deliberate airing. Comments on the bulletin must be submitted by January 31, 2012 to EssentialHealthBenefits@cms.hhs.gov.

Here’s to a new year in which more of us realize the essentials we all shouldn’t have to live without. Happy and safe holidays!

Tags: ACA, essential health benefits, Health Care Reform, Health Care Regulation, Health Reform, HHS, Pirvate insurance

Recent Comparative Studies of Health Systems

November 29, 2011 by Tara Adams Ragone · 1 Comment
Filed under: Recommended Reading

As America continues to wrestle with the thorny thicket of health care reform, there are a number of recent reports chronicling and comparing approaches to health care and health reform in different countries that are worth a read. For example:

The Organisation for Economic Co-operation and Development recently released Health at a Glance 2011: OECD Indicators, which provides “comparable data on different aspects of the performance of health systems in OECD countries.” The U.S. spends 2 ½ times more than the OECD average health expenditure per capita (which amounted to 17.4% of GDP in 2009). (OECD explores why in a separate addendum, “Why is Health Spending in the United States So High”.) Yet, with the exception of cancer care and acute care in hospitals, it is not clear Americans are getting improved quality for the greater expenditures. As reported by CQ HealthBeat and by the Commonwealth Fund, “hospital services cost much more in the United States and pharmaceutical prices are much higher compared to other countries;” “there are fewer practicing physicians per 1,000 population, fewer doctor consultations and shorter hospital stays;” “more CT scans, knee replacements, and Caesarean sections;” and “comparatively high hospital admission rates for preventable conditions like asthma, diabetes and hypertension.”

Strengthening Primary Care: Recent Reforms and Achievements in Australia, England, and the Netherlands, a recent report by Sharon Willcox, Geraint Lewis, and Jako Burgers of the Commonwealth Fund, evaluates efforts to improve access to, and the quality of, primary care in these countries– and suggests what the U.S. can learn from these initiatives. These countries have been focusing on three primary care reform strategies: promoting coordination of care, reforming primary care payment, and improving quality and access. As the abstract summarizes, “[q]uality improvement strategies include postgraduate training programs for family physicians, accreditation of general practitioner (GP) practices, and efforts to modify professional behaviors–for example, through clinical guideline development. Strategies for improving access include national performance targets, greater use of practice nurses, assured after-hours care, and medical advice telephone lines. All three countries have established midlevel primary care organizations both to coordinate primary care health services and to serve other functions, such as purchasing and population health planning. Better coordination of primary health care services is also the objective driving the use of patient enrollment in a single general practice. Payment reform is also a key element of English and Australian reforms, with both countries having introduced payment-for-quality initiatives. Dutch payment reform has stressed financial incentives for better management of chronic disease.”

Bradford H. Gray, Thomas Bowden, Ib Johansen, and Sabine Koch, also of the Commonwealth Fund, review the extent of adoption of “meaningful use” (as defined in federal regulations) in three countries with extensive experience with electronic health records, Denmark, New Zealand, and Sweden in Electronic Health Records: An International Perspective on “Meaningful Use.” Although these European countries have high levels of EHR adoption, they have not reached 100% meaningful use, with the greatest weakness being in information provided to patients. The authors suggest that the U.S. could learn from these experiences the value of “providing economic incentives to encourage adoption and designating an organization to take responsibility for standardization and interoperability.”

International Profiles of Health Care Systems: Australia, Canada, Denmark, England, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States, edited by Sarah Thomson, Robin Osborn, David Squires, and Sarah Jane Reed and published by the Commonwealth Fund, provides an overview of the health systems in these countries– including “health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations.”

The Commonwealth Fund also recently released results of an international study of patients with complex care needs in eleven countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the U.S. Although it identified significant care coordination issues, it found that “patients who have a medical home reported better coordination of care, fewer medical errors, and greater satisfaction with care than those without one.” In addition, the study also found “that patients in the United States are much more likely than those in 10 other high-income countries to forgo needed care because of costs and to struggle with medical debt.” 27% “were unable to pay or encountered serious problems paying medical bills in the past year, compared with between 1 percent and 14 percent of adults in the other countries,” and 42% did not see a doctor, fill a prescription, or receive recommended care. The authors conclude that “[t]he United States in particular has opportunities to learn from abroad-including the use of purchasing power to lower prices, payment innovations, and the use of information systems and care system redesign efforts that are under way in several countries.”

Of course, there are a variety of reasons the experiences in other countries may not take root in the United States. But we still should be aware of these efforts and critically evaluate whether we might transplant any of them as seeds of reform here.

Tags: Comparative Health Care, Cost Control, EMR, Health Care Reform, Health Economics, Health Reform, Meaningful Use, Primary Care, Quality Control, Recommended Reading

Rising Health Insurance Premiums: Don’t Let Yourself Be Spinned

October 4, 2011 by Tara Adams Ragone · Leave a Comment
Filed under: Health Benefit Costs, Private Insurance

It’s not surprising that opponents of health reform are capitalizing on the rather surprising findings of the Kaiser Family Foundation’s Employer Health Benefits 2011 Annual Survey that the average annual premiums for employer-sponsored health insurance increased 8 percent for single coverage and 9 percent for family coverage from 2010. These numbers don’t sound good.

But analysis by Jon Gabel, Senior Fellow at NORC at the University of Chicago, Roland McDevitt, Director of Health Research at Towers Watson, and Ryan Lore, Senior Associate at Towers Watson, which is summarized on the Commonwealth Fund Blog and will be detailed more fully in a forthcoming issue brief, shows that the vast majority of premium increases are not tied to health reform, and those that are relate to improved coverage. As the authors summarize:

[Our analysis] attributes only 1.8 percentage points of the 8 percent to 9 percent rise in premiums to the insurance reforms. Moreover, this marginal increase as a result of the reforms also means that families have better coverage that protects them from catastrophic health care costs as well as lower out-of-pocket costs for preventive services like colonoscopies and mammograms. It’s logical that improvements in the quality of the product would increase the cost of premiums and lower out-of-pocket costs to some degree.

This is not to minimize the impact of these increases. Any increase in premiums, especially in a challenging economy, warrants scrutiny. But rather than rush to judgment on data taken out of context by spinsters with a political agenda, we must continue to carefully consider the full panoply of facts and how they interrelate. While some premium increases in the group markets seem to be linked to health reform, are the benefits worth the costs?

For example, the study estimates that expanding coverage for adult children accounts for 0.9 percent of the premium increases and affects 91 percent of group policyholders; banning limits on lifetime maximum benefits is responsible for 0.5 percent in premium increases and impacts 53 percent of group policyholders; and requiring employers to offer certain preventive services without cost-sharing increases premiums by 0.4 percent and affects 24 percent of group policyholders. The total additional annual cost of the increased premiums tied to health reform amounts to $167 per policyholder in the group markets.

It is critical to explore whether these enhanced coverage options warrant increased premiums. While we do, we also should ensure the public is aware that there is more to the data than nearly 10 percent premium hikes so it does not get dizzy from the spin cycle.

Tags: cost, Cost Control, Health Benefit Costs, Health Care Reform, Health Reform, Premiums, Private Insurance

Community Based Medicaid ACOs in New Jersey: A Signature Away

July 10, 2011 by Tara Adams Ragone · 1 Comment
Filed under: Accountable Care Organization, Medicaid

Almost daily, there is a new article or study emphasizing the need for innovative reform to save Medicaid amidst growing threats of deep cuts to the already struggling program. New Jersey, as one of the states with the highest Medicaid spending per beneficiary in the country, is paying attention. And help may be on the way in the form of a medical home/safety net.

Showing promise, the medical home model of care is an oft proposed reform. As Mary Takach explains in the July 2011 edition of Health Affairs, “[a] patient-centered medical home is an enhanced model of primary care in which care teams, led by a primary care provider, attend to the multifaceted needs of patients and provide whole-person, comprehensive, coordinated, and patient-centered care.” (See “Reinventing Medicaid: State Innovations to Qualify and Pay for Patient-Centered Medical Homes Show Promising results,” Health Affairs, July 2011, 30(7):1325-34.)

According to the National Academy for State Health Policy, thirty-nine states are working to implement medical homes for Medicaid and CHIP participants, and New Jersey is one of them. In September 2010, Governor Christie signed Assembly Bill 226 into law, which established a three-year Medicaid medical home demonstration project that, at minimum, will include “primary care providers utilizing a multi-disciplinary team that provides patient-centered care coordination through the use of health information technology and chronic disease registries across the patient’s life-span and across all domains of the health care system and the patient’s community.” The statute requires that the payment system “be structured to reward quality and improved patient outcomes” and that Medicaid “[c]onsider payment methodologies that support care-coordination through multi-disciplinary teams, including payment for care of patients with chronic diseases and the elderly, and that encourage services such as: (a) patient or family education for patients with chronic diseases; (b) home-based services; (c) telephonic communication; (d) group care; (e) oral health examinations, when applicable; and (f) culturally and linguistically appropriate care.” You can learn about various medical home initiatives in New Jersey at the National Center for Medical Home Implementation web site.

Takach’s report focuses on seventeen states that have aligned “patient-centered medical home standards with incentive payments to support reform in the delivery of primary care” — Colorado, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and West Virginia.

Although these programs are in their infancy, Takach interprets limited early data from a few states as encouraging. Vermont, for example, documented that inpatient use had decreased twenty-one percent, with a corresponding twenty-two percent decrease in per person per month inpatient costs, and that emergency department use had decreased thirty-one percent, with a corresponding reduction of thirty-six percent in per person per month costs (although its second pilot community had what Takach describes as “mixed results”). Colorado similarly has seen decreases in its median Medicaid costs per patient for children.

Both Colorado and Oklahoma also have seen increases in participating providers since the medical home model started operating. In Oklahoma, more than 244 new physicians enrolled in Medicaid. Ninety-six percent of pediatricians now accept Medicaid in Colorado, up from only twenty percent before the program began. Increasing the number of Medicaid providers is critical, given national shortages of available primary care Medicaid providers.

As Takach summarizes:

Some of the early findings from Colorado and Oklahoma, which have statewide Medicaid initiatives, demonstrate that modest increases in payment aligned with quality improvement standards have not only resulted in promising trends for costs and quality, but have also greatly improved access to care. This is an important finding for other states as they consider how to meet the tremendous increase in demand for care that will result from the expansions to Medicaid in the Affordable Care Act of 2010.

But beyond a medical home, there needs to be a safety net for the most vulnerable urban populations who are, in a sense, medically homeless– and are, by EMTALA default, frequent utilizers of high cost emergency room services.

As this blog and other sources, including The New Yorker, have discussed, New Jersey is home to the Camden Coalition of Healthcare Providers, which describes itself as “a citywide organization of social workers, nurses, physicians, administrators, hospitals, health services organizations, and clinics that serve the health needs of Camden, New Jersey residents. [It] work[s] in a variety of settings — from small neighborhood based practices to hospital based offices — with the goal of improving the coordination and capacity of the healthcare system for residents of Camden.” Dr. Jeffrey Brenner has been leading this effort since 2002. His work offers promising program models for safety-net providers throughout the country to “improve the quality, capacity, and accessibility of the healthcare system for vulnerable populations.” Indeed, even though the budget bill signed by Governor Christie slashed Medicaid funding in New Jersey by $540 million, his Commissioner of Human Services has expressed continuing support for the Coalition’s pilot because it is seen as a smart reform that could save money while improving care. Newark and Trenton also have established citywide healthcare coalitions to improve medical care for their vulnerable, underserved residents. And we at the Center for Health and Pharmaceutical Law and Policy have worked closely with the Greater Newark Healthcare Coalition.

In a recent post on the Health Affairs blog, Dr. Brenner and Nikki Highsmith note that although the Camden Coalition “has had preliminary successes and offers potential long-term savings, such community-based endeavors are difficult to initiate and sustain without start-up financing, ground-level technical assistance, and buy-in from state and local policymakers, health plans, patients, and community members.” They thus call on CMS to “jump start investments in safety-net ACOs” by pursuing a national demonstration project to support programs similar to Camden’s pilot.

New Jersey is poised to be ready if CMS heeds this call for a national Safety Net ACO demonstration project because the Coalition and other New Jersey stakeholders, including Seton Hall Law Professor John Jacobi, have been active in advocating for a bill (S2443) authorizing geography-based Medicaid ACOs in New Jersey. As the Coalition’s web site summarizes:

The proposed New Jersey law would authorize a three-year Medicaid ACO demonstration project whereby community-based, non-profit coalitions can apply for recognition by the State of New Jersey as a Medicaid ACO. The applicants must propose a geographic focus and will need 100% of the [general] hospitals, 75% of the primary care providers, [four] behavioral health providers, and two community [organizations] from that geography on the board of the organization. The providers in the community will continue to receive their usual Medicaid payments and the ACO, if its providers meet quality benchmarks, would be eligible to receive shared savings payments, that can be distributed to participants based on a proposed gain sharing plan.

The proposed legislation specifically recognizes that patient-centered medical home models are one way, among others, to achieve coordination. On June 27, 2011, the Assembly and Senate passed S2443, and it is awaiting Governor Christie’s signature.

New Jersey’s proposed Medicaid ACOs go beyond Medical Homes. They are built on a foundation of sound primary care, but they offer the promise of reaching vulnerable populations in many settings, and of assuring that the right care is provided at the right location for people who are often left out of health reform efforts. The financing mechanisms provided by the bill awaiting the governor’s signature go some way towards financing these innovating community organizations, although, as Brenner and Highsmith point out, more needs to be done –particularly in the way of providing start-up funding for community providers.

Appropriately cultivated, patient-focused collaborations such as these may yield synergies in care and cost of a substantial scale. But another recent Health Affairs article suggests that adoption of the medical home may well develop at a slower pace in states, like New Jersey, where physicians tend to be organized in smaller practices. New Jersey’s Medicaid ACO pilot could help to accelerate the development of practice reformation in New Jersey — particularly if CMS provides the support advocated by Jeff Brenner and Nikki Highsmith.

It’s an exciting time for growth and innovation in the Garden State … if we just get that signature.

Tags: Accountable Care Organizations, ACO, Cost Control, Health Care Reform, Health Reform, Medicaid, Medicaid ACO, New Jersey, Quality Improvement, State Initiatives, The Greater Newark Healthcare Coalition

Moving the Battle of the Experts to the Hot Tub?

June 23, 2011 by Tara Adams Ragone · 1 Comment
Filed under: Health Law, Medical Malpractice

Michael Ricciardelli’s recent post concerning a judge-directed negotiation pilot program in the Bronx to facilitate early resolution of medical malpractice cases reminded me of another idea to improve our expensive, expert-deadlocked, malpractice litigation system: hot tubbing.

I first heard this term (related to litigation, that is) earlier this Spring when a former colleague shared an article by Bryan Finlay QC, head of the litigation practice at WeirFoulds LLP in Canada, and law student, Kristi Collins, that discusses hot tubbing as an example of a new tool for judges to use in managing evidence in complex litigation. According to this article, hot tubbing, also less colorfully referred to as concurrent evidence, refers to “a method of presenting expert evidence all at once by having the expert witnesses for both parties give testimony, answer questions, and fully discuss the expert evidence on one panel.” Finlay and Collins report that this practice originated in Australia in recent years and is gaining attention in Canada, the United Kingdom, and the United States.

Honorable Justice Peter McClellan, Chief Judge at Common Law, Supreme Court of New South Wales, Australia, describes the concurrent evidence process in a 2010 article in the Journal of Court Innovation:

Concurrent evidence is essentially a discussion chaired by the judge in which the various experts, the parties, the advocates and the judge engage in a cooperative endeavor to identify the issues and arrive where possible at a common resolution of them. Where resolution of issues is not possible, a structured discussion, with the judge as chairperson, allows the experts to give their opinions without the constraints of the adversarial process and in a forum which enables them to respond directly to each other. The judge is not confined to the opinion of one advisor but has the benefit of multiple advisors who are rigorously examined in public.

* * *

Conflict Resolution in Human Evolution

[Concurrent evidence] requires the experts retained by the parties to prepare a written report in the conventional fashion. The reports are exchanged and, as is now the case in many Australian courts, the experts are required to meet without the parties or their representatives to discuss those reports. . . . The experts are required to prepare a bullet-point document incorporating a summary of the matters upon which they agree, but, more significantly, matters upon which they disagree. The experts are sworn together and, using the summary of matters upon which they disagree, the judge settles an agenda with counsel for a “directed” discussion, chaired by the judge, of the issues in disagreement. The process provides an opportunity for each expert to place his or her view on a particular issue or sub-issue before the court. The experts are encouraged to ask and answer questions of each other. The advocates also may ask questions during the course of the discussion to ensure that an expert’s opinion is fully articulated and tested against a contrary opinion. At the end of the discussion, the judge will ask a general question to ensure that all of the experts have had the opportunity to fully explain their positions.

(To see how hot tubbing works in trials in Australia, you can watch a video narrated by Justice McClellan here.)

Hand-coloured woodprint by Samuel Coccius, Basle Switzerland 1566. August 7th many black globes moved before the sun at great speed and seemed to be fighting.

Finlay and Collins report that “[e]xperts tend to like the hot-tubbing method.” As they explain, “[t]he procedure allows them to more fully flesh-out and discuss their positions in, at least the beginning, a less adversarial way. They like the opportunity to pose questions to each other.” Justice McClellan agrees, reporting that “[t]he change in procedure has been met with overwhelming support from the experts and their professional organizations.” This can lead to a more collegial and less partisan and adversarial exchange among professional colleagues. This process may also reduce the likelihood that experts will take extreme positions, knowing that a colleague stands ready to challenge the basis for their statement.

Justice McClellan also relayed that “[a]lthough counsel may be hesitant about the process initially, [he has] heard little criticism once they have experienced it.”

Finders of fact, too, seem to like what hot tubbing offers. Justice McClellan, who has presided over numerous hot tubs, is an unabashed proponent:

From the decision-maker’s perspective, the opportunity to observe the experts in conversation with each other about the matter, together with the ability to ask and answer each others’ questions, greatly enhances the capacity of the judge to decide which expert to accept. Rather than have a person’s expertise translated or colored by the skill of the advocate, and as we know the impact of the advocate can be significant, the experts can express their views in their own words. There also are benefits which aid in the decision-writing process. Concurrent evidence allows for a well-organized transcript because each expert answers the same question at the same point in the proceeding. Read more

Tags: Concurrent Evidence, Expert Testimony, Health Care Reform, Health Law, Health Reform, Hot Tubbing, Litigation, Medical Malpractice Reform

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Moving the Battle of the Experts to the Hot Tub?

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