Nurse Practitioners to the Primary Care Shortage Rescue?

As the U.S. population grows and health insurance coverage expands, the demand for primary care is steadily increasing, giving rise to a shortage in primary care physicians (PCPs). In answer to this shortage, Kaiser Family Foundation (KFF) suggests filling the gap with increased use of nurse practitioners (NPs).

ACA Provisions

The Patient Protection and Affordable Care Act (P.L.111-148) (ACA) contributes to health coverage growth across the country and provides incentives to PCPs to address Health Professional Shortage Areas (HPSAs). Not only does the ACA offer a 10 percent Medicare payment bonus for five years to physicians and general surgeons practicing in HPSAs, the ACA also allows the HHS Secretary to award three-year grants to eligible entities to operate NP programs as part of a training demonstration program. Grant awardees will enroll and employ graduates of NP programs and provide one-year training for careers as PCPs in HPSAs. In 2012, HHS awarded $15 million in such grants to support 10 clinics.

Shortage

KFF notes that at least 58 million Americans reside in geographic areas or belong to population groups that are considered HPSAs, in which the supply of PCPs relative to the population falls below federally defined standards. The proportion of Americans living in HPSAs varies from state-to-state, with a little over 1 percent in Nebraska to 57 percent in Mississippi. In 19 states, the proportion is at least 20 percent and in six states, it exceeds 30 percent (Alabama, Arizona, the District of Columbia, Louisiana, Mississippi, and New Mexico). It is estimated that by 2020, there will be a shortage of 20,400 PCPs.

Power of NPs

NPs are registered nurses who have completed Master’s degrees or higher-level nursing degrees. Nearly 90 percent of all NPs are trained in primary care and able to prescribe medications. NPs are more likely to practice in urban and rural areas and serve a high proportion of uninsured patients and other vulnerable populations. Research shows that NPs can manage 80 to 90 percent of the same care provided by PCPs, although NPs achieve training in fewer years than PCPs (an average of six years of education and training versus 11 or 12 years, respectively).

Barriers

Unfortunately, there are some barriers to the extended use of NPs. Some states require NPs to have a regulated collaborative agreement with a PCP in order to provide patient care and limit NPs’ engagement in at least one element of NP practice, according to KFF. Only 20 states allow NPs to have full-practice authority.

In its 2011 report, “The Future of Nursing: Leading Change, Advancing Health,” the Institute of Medicine (IOM) specifically noted, “Remove scope-of-practice barriers” as one of its first recommendations to solve the PCP shortage. The IOM report called for a Federal Trade Commission (FTC) review of state regulations and for the Department of Justice (DOJ) to identify states with unjustified anticompetitive effects.

Highlight on Washington, DC: Prescription Drug Reporting, Licensing, and Exchange Laws Adopted in 2014

Pharmacists and other dispensers of controlled substances in the District of Columbia will have to provide specific information  to a new database on the substance prescribed and the person to whom the medication was prescribed under legislation adopted in 2014.  Another piece of legislation adopted by the City Council would regulate an additional nine professions including home health and assisted living administrators.  The Omnibus Health Regulation Amendment Act of 2013 would also require additional certification for dentists and dental facilities where anesthesia is administered.  Finally the City Council adopted legislation that provides definitions of key  phrases in the Health Benefit Exchange Authority Act of 2011.   Upcoming proposals having to do with health care will be treated differently in 2015, as the City Council is combining the Health Committee and the Human Services Committee.

Prescription Drug Monitoring Program

Effective February 22, 2014 dispensers of medications licensed by the District of Columbia will have to report information within 24 hours on each prescription  dispensed for a schedule II, III, IV or V controlled substance to the Prescription Drug Monitoring Program.  The patient’s name, address, date of birth, and gender as well as the dispenser’s and prescriber’s identification number, the date the prescription was written, the date the prescription was dispensed, the prescription number, the quantity dispensed, the source of payment and other information needs to be reported.  Hospitals, nursing facilities, hospices, and drug wholesalers are exempt from the act as are prescriptions provided by a licensed narcotic maintenance programs.

The report of the City Council’s Health Committee stated that this legislation is designed to “reduce the diversion of prescription drugs in an efficient and cost effective manner.” The committee reported that prescription drug abuse has become a nationwide problem with nearly one-third of people 12 years of age or older began abusing drugs by using a prescription drug for a non-medical purpose. Typically it will be pharmacists who will be checking the database and reporting data to the database and not physicians.  Pharmacists have the power to deny a request to fill a prescription, but without this database pharmacist have a difficult time obtaining information to make that decision.

Licensed Professionals

Dentists and dental facilities that administer anesthesia in the District of Columbia will have to obtain an additional certification under the provisions of the Omnibus Health Regulation Amendment Act of 2013, adopted on January 7, 2014 and effective on March 26, 2014.  In addition teachers of dentistry hygiene and dentistry will also have to be licensed in the District of Columbia.

While home health care agencies in the District  of Columbia have been licensed for a number of years they will now be required to provide both a skilled nursing services and a therapeutic services that includes physical, speech, or occupation therapy, medical social services, or personal care services. This definition will be in conformance with federal law and will minimize inconsistencies among oversight agencies, according to a report prepared by the City Council’s Health Committee on this legislation.

Home healthcare administrators, assisted living administrators, assistants in the practice of speech language pathology and audiology, as well as speech language pathology clinical fellows will need to be licensed. Prior to this legislation health professionals were regulated by 18 health occupation boards and four registration programs.

Health Insurance Exchange

The Better Prices, Better Quality, Better Choices for Health Care Coverage Amendment Act of 2014 provided key definitions for the regulation and operation of the District of Columbia’s health insurance exchange.  The Act would require insurers to offer plans at the bronze, silver and gold level on their exchange and require standardization of at least one plan at each metal level. The District of Columbia’s exchange acts more as a clearinghouse and contracts will all qualified health plans who want to offer insurance on their exchange instead of only offering pre-selected health plans with negotiated premiums prices, according to a Health Committee report.  The Act defines terms such as metal level, navigator, standardized plan, accurate attestation, prescription drug formularies, and essential health benefits.  The District of Columbia established its exchange with the Health Benefit Exchange Establishment Act of 2011.

Future Activity

The District of Columbia’s City Council may be more active in 2015 than it was in 2014.  It begins a new two year legislative session  on January 2, 2015, and the City Council will  be reducing the number of committees it has from ten to eight, according to a recent press release.  Most notably the Health and Human Services Committees will be combined into one committee which will be chaired by the former Chair of the Health Committee, Councilmember Yvette Alexander.  This combination could have a significant impact on how and what types of legislation will be adopted by the District of Columbia’s City Council on health care related issues in 2015 and 2016.

 

MAP 2015 Pre-Rulemaking Quality Measure Recommendations Open for Comment

The Measure Applications Partnership (MAP) published a list of recommendations for the CMS List of Measures under Consideration (MUC) for 2015, as well as accompanying draft reports detailing MAP’s process, approach, and considerations. The MAP recommendations are open for public comment until January 13, 2015.

List

As part of the annual pre-rulemaking review process, the federal government asks MAP, a public-private entity created by the National Quality Forum (NQF), to make recommendations to HHS regarding the selection of quality measures for the federal health care programs. In December 2014, MAP published CMS’ annual MUC for 2015, in order to engage in a public review and determine which of the reporting and payment measures add value, improve patient outcomes, or bring greater efficiency to the health care programs (see CMS’ 2015 pre-rulemaking list of quality and efficiency measures, December 3, 2014). The MUC list and the pre-rulemaking measure selection process is mandated by Section 1890A(a)(2) of the Social Security Act (SSA), as added by Section 3014 of the Affordable Care Act (ACA) (P.L. 111-148).

Process

The MAP reports detail the analysis algorithms that MAP used to evaluate the proposed quality measures. The measures were subjected to scrutiny by MAP staff through workgroup sessions, and by public comment. A key component of the MAP analysis was the early publication of the CMS measures so that stakeholders would be given an opportunity to comment on the measures and their perceived efficacy. The MAP recommendations were published alongside the MAP process and approach report. The accompanying spread sheet includes recommendations on individual measures and rationales for why MAP made the particular recommendations. MAP broke its recommendations down into several categories including: support, conditional support, do not support, encourage continued development, do not encourage further consideration, and insufficient information.

Measures that Matter

The reports include an explanation of how MAP is making progress by devoting attention to “measures that matter.” Specifically, MAP indicates that the MAP discussions and recommendations focus on particular quality measure characteristics “such as whether the measures assessed an important health issue (based on its prevalence, cost, or resulted in harm), addressed an opportunity for improvement in care quality or people’s health, or whether the measures had demonstrated an ability to change performance.” 

Implementation

The MAP recommendations also include suggestions about how the measures might be implemented in specific federal programs and with specific types of providers. The recommendations stress the importance maintaining measures that help consumers make decisions about where to obtain the best quality and highest value health care. Additionally, the recommendations indicate that measures should be aligned across different programs so that consumers can make reasonable comparisons regarding providers in different settings that may provide comparable services.

Omnicare Accused of Anti-Kickback Violations for Promoting Abbott’s Depakote®

A federal False Claims Act (FCA) lawsuit has been filed by the U.S. Department of Justice (DOJ) against Omnicare Inc., the nation’s largest provider of pharmaceuticals and pharmacy consulting services to nursing homes. The DOJ’s complaint alleges that Omnicare solicited and accepted millions of dollars in kickbacks from Abbott Laboratories to promote Abbott’s anti-epileptic drug, Depakote®, for controlling behavioral disturbances exhibited by dementia patients residing in nursing homes serviced by Omnicare.

Prior Settlement by Abbott

In May 2012, the United States, numerous individual states, and Abbott entered into a $1.5 billion global civil and criminal resolution that, among other things, resolved Abbott’s civil liability under the FCA for its unlawful promotion of Depakote for uses not approved as safe and effective by the FDA. The resolution, the second largest payment by a drug company, included a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also was made subject to court-supervised probation and reporting obligations for Abbott’s Chief Executive Officer and Board of Directors.

The DOJ’s Complaint

Federal regulations designed to protect nursing home residents from unnecessary drugs require nursing homes to retain consulting pharmacists. According to the DOJ’s complaint, Omnicare’s consulting pharmacists reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients. The complaint alleges that Omnicare used its influence over physicians in the nursing homes they serviced to secure kickbacks from pharmaceutical companies such as Abbott. The complaint further alleges that Omnicare:

  • disguised the kickbacks it received by accepting payments from Abbott described as “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend Depakote;
  • solicited contributions from Abbott and other pharmaceutical manufacturers to its Re*View program, which was not a “health management” or “educational” program as claimed by Omnicare, but simply a means by which Omnicare solicited kickbacks; and
  • entered into agreements with Abbott by which Omnicare was entitled to increasing levels of rebates based on the number of nursing home residents serviced and the amount of Depakote prescribed per resident.

Finally, the complaint alleges that Abbott funded Omnicare management meetings on Amelia Island, Florida, offered tickets to sporting events to Omnicare management, and made other payments to local Omnicare pharmacies.

Previous Omnicare Settlement

In June, 2014, Omnicare agreed to pay $124.24 million for allegedly offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to supply drugs to elderly Medicare and Medicaid beneficiaries. The settlement resolved allegations that Omnicare submitted false claims by entering into below-cost contracts to supply prescription medication and other pharmaceutical drugs to skilled nursing facilities and their resident patients to induce the facilities to select Omnicare as their pharmacy provider.

Whistleblower Suits

The DOJ filed its current complaint against Omnicare in two consolidated whistleblower lawsuits filed under the FCA in the Western District of Virginia. The cases are U.S. ex rel. Spetter v. Abbott Labs, Case No. 10-cv-00006 and U.S. ex rel. McCoyd v. Abbott Labs, Case No. 07-cv-00081.

The government’s complaint contains allegations only. There has been no determination of liability against Omnicare.