| With the launch of a new Medicare prospective payment system, a flurry of federal regulatory initiatives, and a broad array of health care initiatives in the states, 1998 has been a year of major challenges for pharmacy in the public policy arena. |
"New challenges, new twists to old challenges, and never a dull moment in between." Thats how ASCP Director of Government Affairs Leigh Davitian sums up pharmacy-related public policy developments over the past 12 monthsa year marked both by a continuation of lobbying and regulatory battles begun in 1997 and a wide range of emergent battles on many fronts.
At the federal level, 1998 has seen Congress tackle thorny issues such as medical records confidentiality and managed care reform, while various agencies have implemented initiatives with significant long-term care implications, including a new Medicare nursing facility payment system that will have a far-reaching long-range impact on pharmacy providers and their patients. At the state level, the past 12 months have brought mixed news on long-standing collaborative practice initiatives, punctuated by a few breakthrough victories in areas such as cognitive services reimbursement and assisted living regulation.
Heres a rundown of some of the most important trends and developments in a fast-paced year of government affairs action.

Issue One: PPS
One of the biggest healthcare stories this yearand the main focus of ASCPs 1998 government affairs activitiesis the transition to a new Medicare nursing facility prospective payment system (PPS). Over the past 12 months, as federal health officials worked to get the new PPS up and running for the July 1 start-up date mandated by the Balanced Budget Act (BBA) of 1997, consultant pharmacists led efforts to sound the alarm about the serious patient care pitfalls inherent in the new system and the need for prompt PPS modifications to reduce those perils.
In her first address to ASCP members last November in Philadelphia, ASCP President Jan Allen identified the PPS challenge as the Societys top priority: "The PPS battle will largely determine the future quality of medication services for millions of elderly Americans," Allen said, putting the magnitude of the challenge in clear terms. "Whatever PPS policies ultimately emerge will be widely adopted by both public and private payers in every state and shape the practice of pharmacy in all sorts of capitated payment systems for many years to come," she noted.
Responding to Allens call for action, ASCP and its members have worked to keep the PPS issue in the spotlight through a variety of lobbying initiatives, including a letter-writing campaign at the Societys midyear conference in Orlando targeting hundreds of congressional offices, subsequent letter-writing initiatives that generated an additional 15,000 letters to members of Congress, and lobbying visits by ASCP members and leaders to more than 100 House and Senate offices.
The Societys campaign intensified when the Health Care Financing Administration (HCFA) unveiled its interim final PPS rule in May. ASCPs analysis of the rule identified several major problem areas. These flaws and concerns, which will be detailed in formal ASCP comments to HCFA this month, include payment rates inadequate to accommodate the medication needs of many residents, particularly those requiring higher-cost medications such as AIDS medications, I.V. and parenteral formulations, and many of the newer antibiotics and psychotropics; a payment update formula based on outdated pharmacy cost assumptions; and a resident classification system ill-designed to predict actual drug therapy costs. ASCPs comments will call on HCFA to mandate reporting of patient-specific medication use data on Section U of the Minimum Data Set (MDS)a vital step in developing geriatric-specific quality indicators for drug therapy and other essential quality-assurance tools far sooner than October 1999, as is currently planned.
Soon after the release of the interim final PPS rule, the Society sent HCFA officials the results of an independently conducted, ASCP-sponsored study presenting some of the most compelling evidence to date that inclusion of medication services in a payment system such as the Medicare PPS creates strong incentives for decreased use of medications considered to constitute optimal drug therapy for many disorders common in nursing facility populations (see July 1998 issue of The Consultant Pharmacist).
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Another focus of ASCPs public policy initiatives has centered on efforts by Congress to legislate national standards to protect the confidentiality of medical records and other patient information by August 1999 |
Y2K Bug Rears Its Head
Even as the Medicare payment system took flight on July 1, there were indications that implementation of the new PPS and other provisions of the BBA would not proceed exactly as planned, mainly because of the need for urgent action by HCFA and other federal agencies to address the "Year 2000" problem that threatens to paralyze key federal computer systems as soon as early 1999.
In late June, HCFA announced that implementation of BBA-mandated consolidated billing rules for Medicare Part B services provided in nursing facilities would be delayed indefinitely. In mid-July, Congress held a hearing to define strategies for averting a major Y2K disaster, while HCFA issued a memo indicating that several BBA provisionsa new home health PPS, physician and hospital payment updates, and otherswould likely be delayed pending resolution of the Y2K situation and related billing system challenges.
ASCP viewed these developments as a new window of opportunity to push for a broad rethinking of PPS policies. In July ASCP set about marshaling formation of a broad-based coalition to carry on the PPS lobbying battle. This new coalition, which includes the American Health Care Association, American Medical Directors Association, and other long-term care provider organizations, will work in the coming weeks to secure formal congressional sponsorship of legislation calling for an 18- to 24-month continuation of pre-PPS "pass-through" billing policies for medication services and other non-therapy ancillary services. "Such a delay is essential to allow more time for HCFA-funded studies to better define appropriate prospective payment levels and correct other PPS shortcomings that threaten to undermine the quality of medication services in the nations nursing facilities," Davitian says.
Recent developments regarding PPS implementation, while certainly unsettling to pharmacists and other provider groups, have raised hopes that positive policy changesan implementation slowdown, an extension of pass-through policies, perhaps a prompt move to develop "outlier" policies for higher-cost drug therapy servicesmay be within reach.
Confidentiality Legislation
Another focus of ASCPs public policy initiatives has centered on efforts by Congress to legislate national standards to protect the confidentiality of medical records and other patient information by August 1999, as mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. During the first six months of 1998, no fewer than six confidentiality proposals were circulating in Congress, key provisions of which are still under consideration as stand-alone bills or riders to other pieces of legislation.
One of the more restrictive confidentiality bills, Sen. Jim Jeffords (R-Vt.) "Health Care Personal Information Non-Disclosure Act" (S.1921), would limit exchange of medication information by or between pharmacists and other health care providers. From pharmacys perspective, the most dangerous proposal is the "Prescription Privacy Protection Act" introduced this spring by Rep. Jerrold Nadler (D-N.Y.). This bill (H.R.3756) would generally prohibit pharmacies, pharmacists, and pharmacy employees from sharing prescription data with "any person or governmental agency" except the prescribing physician without first obtaining the patients written permission.
If implemented as currently written, such restrictions would seriously impede clinical research, development of treatment protocols, and consultant pharmacists ability to quickly access and share essential patient care information with other members of the health care team, Davitian says.
Other medical records confidentiality measures were proposed in Congress as part of sweeping managed care reform packages introduced by Democrats and Republicans under the rubric of "Patients Bill of Rights." The GOP package drew attention for its proposal to permit the sale of patient data for legitimate health care activities, with no firm prohibition of subsequent dissemination for non-medical purposes. After the controversial provisions were widely publicized in the popular press, Republican leaders quickly scaled them back.
In an encouraging development, one version of the Patients Bill of Rights legislation (H.R.4250) containing confidentiality measures viewed by ASCP as both reasonable and workable was approved in the House in late July.
Last November in Philadelphia, ASCP Research and Education Foundation Executive Director Janice Feinberg updated reporters on findings in Phase II of the Fleetwood Project Research Initiative, a three-phase study to document and quantify the impact of consultant pharmacists services on drug therapy outcomes and overall health care costs. Also at that media briefing, the head of the Washington, D.C.-based Alliance for Aging Research announced that AAR would develop specific public policy recommendations to address a wide range of medication-related problems identified in Fleetwood Project Phase I. After months of work involving a national panel of experts in gerontology and geriatric drug therapy, AAR delivered its recommendations on June 9 at a briefing at the Capitol attended by senior legislative aides and staffers from 45 U.S. Senate offices. Joined by Feinberg, Sen. Bill Frist (R-Tenn.), and Richard Besdine, director of the Center on Aging at Georgetown University, AAR director Dan Perry released a report detailing the estimated $100 billion annual cost of medication problems and recommending action steps to be undertaken by federal and state agencies and the nations pharmacy schools. Augmenting the AAR report, ASCP representatives at the briefing distributed a second report highlighting consultant pharmacists activities in nursing facilities as a model for broader efforts to combat medication problems in assisted living facilities and other patient care settings, as well as among Medicare beneficiaries and community-dwelling seniors. To receive a copy of the ASCP report "ASCPs Prescription for Quality Care: Preventing Medication-Related Problems Among Older Americans"visit ASCPs web site (www.ascp.com). |
Anti-Dumping, Continuity of Care Bills
In recent weeks, ASCP has been lobbying aggressively for passage of two new bills in Congress that promise to reduce disruptive transfers and foster greater continuity of care for nursing facility residents.
"The Nursing Home Patient Protection Act" (S.2308), introduced by Sen. Bob Graham (D-Fla.), would establish right-to-residency protections for Medicaid recipients, prohibiting forced transfers or discharges of residents who divest assets to achieve or maintain Medicaid eligibility. In addition to sending formal letters of endorsement to Graham and others in Congress, the Society is urging Graham to amend his bill to include similar anti-dumping protections for Medicare beneficiaries, many of whom will face a similar threat under the new nursing facility PPS.
ASCP is also working closely with the office of Sen. Barbara Mikulski(D-Md.) to secure congressional passage of her "Seniors Access to Continuity of Care Act." The bill (S.1997) would ensure that seniors who require hospitalization while residing in nursing facilities, assisted living facilities, or other long-term care settings can return to those settings after their hospital stay. Currently, many elderly patients enrolled in managed care plans are transferred against their wishes to a different facility after hospital discharge at the discretion of their sponsoring health plan.
ASCP Honors Government Affairs Supporters In a highlight of ASCPs 28th Annual Meeting and Exhibition in Philadelphia, the Society convened a special reception to honor all contributors to ASCP-PAC, the Societys political action committee; and the ASCP Capitol Fund, a legislative and regulatory lobbying fund established two years ago to help ensure that the Society always has adequate funds to mount crucial lobbying initiatives at the federal and state levels. John Ricci, a member of the ASCP Board of Directors, was honored as Political Contributor of the Year. President Jan Allen presented the Societys Award for Legislative Excellence to Sen. Rick Santorum (R-Penn.), a member of the Senate Special Committee on Aging and one of four senators who endorsed ASCP-backed BBA conference report language calling for a cautious approach to inclusion of pharmacy services in the Medicare nursing facility PPS. State Rep. Dennis OBrien, chairman of the Health and Human Services Committee of the Pennsylvania legislature, offered tips on effective grass-roots lobbying. A reception to honor 1998 political contributors is planned for this years ASCP Annual Meeting in Seattle. Rep. Jim McDermott (D-Wash.) has already committed to attend. "A strong ASCP-PAC and Capitol Fund enable the Society to cultivate strong allies and respond effectively to public policy challenges at both the state and federal levels," says Davitian. "The reception is our way of recognizing and thanking the many members whose support is critical to the Societys legislative and regulatory successes." For information on supporting ASCP-PAC and the ASCP Capitol Fund, contact Director of Government Affairs Leigh Davitian at 703-739-1316, ext. 141 (ldavitian@ascp.com), or Government Affairs Assistant Carrie Danuser at 703-739-1316, ext. 172 (cdanuser@ascp.com). |
A Mixed Bag from the FDA
Last November, President Clinton signed into law the sweeping Food and Drug Administration Modernization Act (FDAMA) of 1997, re-funding the agencys user-fee program, providing for expanded patient access to investigational drugs, and calling for other reforms to streamline the drug approval process and other FDA operations.
In addition to the broad reforms mandated by the FDAMA, the agency launched an initiative late last year to assert broad new regulatory jurisdiction over medication compounding practices, a move that drew stiff opposition from pharmacy organizations. Following months of comment-gathering and rancorous debate, pharmacists ability to compound medications for individual patient use, unfettered by FDA oversight, emerged intact. However, under final rules implemented this spring, state pharmacy boards will be required to enter into a "memorandum of understanding" providing for FDA regulation of interstate shipments of compounded products if such shipments account for more than 5% of a pharmacys total prescription volume. Compounding products that are commercially available "regularly or in inordinate amounts" is now prohibited, with the exception of preparations significantly modified to meet individual patient needs.
ASCP and all other pharmacy organizations strongly endorsed another FDA initiative early this year to mandate important labeling changes: new rules requiring manufacturers to present information on geriatric-specific drug effects, limitations, hazards, and monitoring considerations; uniform standards on type size and line spacing to make labels easier to read; and proposed revisions to over-the-counter label language directing consumers to "ask your doctor or pharmacist" for guidance on safe, effective use.
The OTC label changes will be implemented soon. The geriatric-use labeling requirements will initially apply to six drug classes (anticoagulants, cardiac drugs, nonsteroidal anti-inflammatories, oral hypoglycemic agents, and quinolone antibiotics); all prescription drugs will carry the geriatric-use information within five years. "Practitioners will find specific information regarding pharmacokinetic and pharmacodynamic actions of medications in the elderly especially useful in determining appropriate dosage levels," the Society commented in a letter to FDA; the comments also called the agencys attention to the need for new research to better delineate medication effects in the fast-growing population of patients aged 85 and older.

Congressional Site Visits
Helping ASCP members arrange visits by members of Congress to long-term care facilities is a substantial part of the Societys ongoing efforts to educate and keep legislators informed on critical initiatives such as the ongoing PPS campaign, efforts to win an expanded role for pharmacists as Medicare service providers, and other long-term care issues.
With support provided by the headquarters staff, ASCP members coordinated an unprecedented number of site visits over the past 12 months. Larry Galluzo toured one of his client long-term care facilities with Rep. Bob Portman (R-Ohio), a member of the House Ways and Means Committee. Dean Pedalino, 1997-98 ASCP-PAC Chairman, hosted Rep. Michael Bilirakis (R-Fla.) member of the Health and Environment Subcommittee of the House Commerce Committee. And in Maryland, Marvin Freedenberg accompanied Rep. Constance Morella (D-Md.) on a two-hour visit to a long-term care facility.
In a new twist to the site-visit program, ASCP coordinated a group visit designed to raise congressional awareness of the need to provide for appropriate pharmacist access to patients medical information as Congress works to legislate national confidentiality safeguards. Participants included legislative aides from the offices of Sens. Bob Bennett, Charles Grassley (R-Iowa), and Pat Leahy (D-Vt.), as well as two senior staffers to the Senate Special Committee on Aging. The visitors, some of whom were directly involved in drafting confidentiality bills currently pending in Congress, toured a long-term care pharmacy in the Baltimore area, then visited the Johns Hopkins Geriatric Center, where they saw firsthand why ready access and timely exchange of patient information is essential for prompt, proper patient care.
ASCP-PAC, the societys political action committee, also plays a key role in advancing pharmacys public policy agenda. This year, ASCP-PAC funds supported the attendance of Michigan ASCP member Ailene Eynon at a fund-raiser for Rep. Sander Levin (D-Mich.), a member of the powerful Ways and Means Committee. ASCP Region I Director Harlan Martin attended a fund-raiser for Rep. Bob Franks (R-N.J.), a member of several House committees.
For guidance or assistance in arranging a congressional site visit or supporting ASCP-PAC, contact Government Affairs Assistant Carrie Danuser at 703-739-1316, ext. 172 (cdanuser@ascp.com).
Reining in Drug Promotions
Pharmacy cried foul over an FDA "draft guidance" early this year regarding dissemination of information on drugs and other products by health care organizations receiving incentive-based rebates from product sponsors. The controversial document was widely viewed as an attempt by FDA to regulate drug promotions without going through the public review and comment process required for formal rule-making.
In written comments strongly criticizing the proposal, ASCP cautioned that such restrictions would work against consultant pharmacists efforts to protect elderly patients from geriatric-specific side effects not mentioned in product labeling and generally would hinder efforts to provide high-quality products at the lowest prices. "The mere granting of a rebate or discount does not establish either influence or control by a medical product sponsor over the content of communications by consultant pharmacists," the ASCP comments went on to emphasize. "For the FDA to assume that incentive-based rebates or discounts are tantamount to [sponsor] control of the professional decisions of consultant pharmacists challenges the fundamental independence and basic integrity of the profession."
Following heavy criticism from organized pharmacy, the FDA has indicated it will continue to explore issues surrounding drug promotions with an eye toward issuing a revised guidance document in the coming months.
A Busy Year for HCFA
Under the leadership of new Administrator Nancy-Ann Min DeParle, HCFA undertook several initiatives with implications for pharmacy providers this year.
Last December, as part of an administrative streamlining process, HCFA proposed revised pharmacy standards for Medicare- and Medicaid-certified hospitals. ASCP and other pharmacy organizations took issue with many aspects of the proposal, including its call for elimination of rules requiring the presence of a full-time, part-time, or consultant pharmacist and pharmacist supervision of all compounding and drug packaging. ASCP was particularly critical of proposals to shift most responsibility for detection and resolution of prescribing errors from pharmacists to nurses. After reviewing input from ASCP and other pharmacy and provider groups, HCFA extended the comment period; a final version of revised hospital Conditions of Participation may still be months away.
HCFA entered 1998 bolstered by increased funding for audits, inspections, prosecutions, and consumer education activities, which expand the HHS Office of the Inspector Generals (OIG) Operation Restore Trust crackdown on health care fraud and abuse into 12 additional states.
Intense scrutiny of home care providers has continued unabated this year. A six-month moratorium on Medicare certification of home care providers was followed by implementation of a new interim payment system widely criticized by home care providers as inequitable and unworkable.
Both home care and durable medical equipment (DME) providers chafed as HCFA moved to implement BBA-mandated provisions requiring them to post surety bonds for $50,000 or 15% of total annual Medicare and Medicaid billings. In June, home health providers rejoiced at news from HCFA that implementation of HHA surety bond requirements would be delayed indefinitely, and DME providers are hopeful they will soon receive similar good news. Meanwhile, ASCP and other pharmacy groups continue to lobby in support of a bill introduced by Sen. Byron Dorgan (D-N.D.) and Rep. Marion Berry (D-Ark.) that would settle the issue once and for all by preventing HCFA through statute from implementing surety bond requirements.
HCFA also gained new authority this year to impose stiffer penalties on fraudulent Medicare and Medicaid providers: a one-year exclusion for submission of claims for excessive charges or unnecessary services or for failure to provide necessary services; a three-year exclusion for any misdemeanor fraud conviction; and a mandatory five-year exclusion for any federal, state, or local felony conviction involving fraud or controlled substances violationseven if government programs were not affected.
OIG Scrutinizes Nursing Facility Drug Use
In late 1997, the Department of Health and Human Services investigative arm, the Office of the Inspector General, released a series of three coordinated reports assessing progress in implementing medication-related provisions of nursing facility quality assurance provisions of the Omnibus Budget Reconciliation Acts of 1987 and 1990. In summing up its findings, OIG cited "lingering weaknesses and vulnerabilities" in provision of medication services, including continued use of drugs generally considered inappropriate for elderly patients, suboptimal prescribing and record-keeping, and a need for improved communication among pharmacists, physicians, and other health care team members.
ASCP seized upon the release of the reports as an opportunity to emphasize the need to make medication-related problems a focus of national public policy. "These reports call attention to a challenge that the nations consultant pharmacists, in cooperation with physicians, nurses, and other health care providers, have been addressing with considerable success for nearly 20 years," ASCP Executive Director R. Tim Webster said in response to media inquiries. He cited impressive data from Phase I of ASCPs Fleetwood Project (published in the October 13, 1997, issue of Archives of Internal Medicine) indicating that each year in U.S. nursing facilities, consultant pharmacists drug regimen review and related activities boost the rate of optimal drug therapy outcomes by 43% and yield estimated annual cost savings of $3.6 billion. "Already, a model is in place in the nations nursing facilities that allows consultant pharmacists to greatly reduce the incidence of medication-related problems. Public policy should expand that role into various other patient care settings," Webster said.
State Developments
As if federal policy-making werent active enough over the past 12 months, pharmacy-related public policy developments in the states have also been dynamicmarked both by an extension of trends that began in 1997 and attention to new issues.
All the activity has made for a bustling year for the ASCP Government Affairs Department, which has tracked more than 5,000 separate items of state legislation with provisions relevant to pharmacy providers, reports State Affairs Manager Brad Kile. Heres a look at some of the most important developments.
NTI Debate Continues
Continuing a trend last year that saw three states (North Carolina, Texas, and Virginia) enact new controls on generic substitution of "narrow therapeutic index" (NTI) drugs and other medications, proposed substitution restrictions came up for consideration this year in Alabama, Indiana, New Jersey, and Ohio, fueling debate over cost and quality issues surrounding therapeutic interchange programs. The New Jersey bill was tabled following a contentious debate in the state Senate in which opponents argued that decreased use of generics would cost the state $16 million a year in increased pharmacy program costs. The Ohio bill failed to advance out of committee, as did the Alabama bill. ASCP members helped secure the defeat of proposed NTI substitution restrictions in Indiana.
With more state legislatures wrestling with issues surrounding generic substitution practices, the FDA moved to offer assurances that health care providers can confidently substitute any FDA-approved generic for its branded equivalent without special lab tests or monitoring considerations. In a letter to FDA MedWatch program participants, the agency also emphasized the importance of "good communication between the patient and the health care provider, particularly with regard to medications that require frequent monitoring of performance."
Diabetes Care Coverage
Another of 1997s state legislative trends deepened in 1998, as seven statesAlabama, Alaska, Arizona, Illinois, Iowa, Mississippi, and Virginiaadopted new laws requiring all insurance and health plans to cover diabetes care equipment and supplies, as well as patient counseling and self-management training services. Under all these laws, reimbursement is contingent upon a physicians determination that such services are an essential component of optimal diabetes care and providers demonstration of appropriate skills and qualifications.
Since Wisconsin enacted the nations first comprehensive diabetes care coverage law in 1991, 20 states have passed such laws, creating new opportunities for pharmacists to assume an expanded role in caring for the estimated 16 million patients with diabetes.
Medicaid Formularies
Acting to encourage updating of Medicaid formularies that do not yet include recently developed antipsychotics, HCFA early this year sent all state Medicaid directors a letter emphasizing the benefits of the newer atypical agents over "older standard" therapies.
The letter, issued by HCFAs Center for Medicaid and State Operations, specifically mentions risperidone, olanzapine, and quetiapine. "Current knowledge indicates [that] side effects from these new antipsychotic drugs are much less severe than those of the older generation of drugs," use of which, HCFA warned, may lead to poor compliance and "revolving door" hospital re-admissions. "Short-term savings achieved in formulary budgets by not including the new medications may be more than offset by spending on inpatient care." HCFA also reminded Medicaid directors that prior authorization requests must be addressed within 24 hours and in emergency situations, the state must provide for pharmacy dispensing of at least a 72-hour emergency supply.
Off-Label Drug Uses
In a trend fueled by consumer backlash against managed care formulary restrictions, a growing number of states moved this year to require insurance companies and health plans to cover "off-label" uses of FDA-approved medications.
In the most notable of these initiatives, California Gov. Pete Wilson (R) signed into law a bill requiring health plans to continue to cover prescription drugs dropped from their formularies. The California bill, which took effect on July 1, also mandates that insurers provide, upon request, general information on what formularies are, disclosure of pharmacy and therapeutics committee records indicating the rationale for formulary decisions, prompt information regarding the formulary status of specific drugs, and full disclosure of health plan arrangements with physicians, pharmacists, or pharmacy benefits managers designed to promote formulary compliance.
According to a recent survey by health care consulting company Scott-Levin, 22 states have already enacted, or are considering, laws or regulations mandating insurance coverage of off-label uses. In Oregon, for example, the state has mandated that health plan enrollees who have prescription benefits cannot be denied coverage for drug uses not explicitly approved by the FDA; a similar proposal was considered this year in the Minnesota legislature. The California legislature considered a measure that would require coverage of off-label uses even if specific efficacy data are lacking. In New York, several bills to mandate coverage of experimental therapies for breast cancer and AIDS came up for consideration this year.
Access to Medical Information
Paralleling action at the federal level, four states moved this year to pass new laws limiting access to and exchange of patient medical records, with mixed results.
Following widely publicized media reports that two large chain pharmacies were selling patient-specific prescription information to a pharmacy benefit management company for use in marketing and compliance improvement efforts, legislators in New Jersey and Virginia introduced bills to tighten such uses. The Virginia bill was approved by both houses of the legislature but vetoed by the governor. The new Jersey bill is still pending.
Other confidentiality measures were introduced in Florida and Rhode Island. The Rhode Island bill, which rode a huge groundswell of popular support and was enacted without the governors signature, specifically lists pharmacists and pharmacy employees among the health care providers who are permitted appropriate access to patient information. The Florida bill died in committee.
"The American public is demanding assurances that sensitive medical information will not be exploited for purposes unrelated to health care, and we can expect more bills of this type to arise in the months ahead," Kile predicts.
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Oklahoma Makes Consultant Pharmacy a Key Part of the Assisted Living Quality Equation Last November, the ASCP Board of Directors approved model legislative language offering detailed guidance to assist states moving to develop or refine regulations for medication management in assisted living facilities. Key recommendations in ASCPs Assisted Living Model State Language include close involvement by consultant pharmacists in interdisciplinary care planning, medication monitoring, compliance counseling, resident education, pre-discharge counseling, and other quality assurance activities, as well as mandatory use of drug regimen review and other consultant pharmacist services at least quarterly for all residents requiring medication assistance. The language, intended for insertion in applicable sections of state laws governing assisted living regulations, has been forwarded to every governor and state legislature. Aggressive promotion of the model language by ASCP members is starting to pay off. Early this summer, the Oklahoma Board of Health adopted a regulation making consultant pharmacists services an integral part of assisted living quality assurance. The Oklahoma regulation, which went into effect June 25, stipulates that "medications shall be reviewed monthly by a registered nurse or pharmacist and quarterly by a consultant pharmacist." "This is a major victory for consultant pharmacy," says Kile, who gives much of the credit to ASCP Board member Alan Mason and other Oklahoma members who lobbied for insertion of the language during months of hearings and pharmacy board meetings. Says Kile: "Once members of the legislature became aware of the many benefits of these common-sense medication review requirements, convincing them to incorporate the language into the assisted living regulation was a surprisingly easy and straightforward process"an encouraging lesson for ASCP members pursuing similar assisted living language in Connecticut, Illinois, Maine, and other states. To receive a copy of ASCPs Assisted Living Model State Language, contact Kile at 703-739-1316, ext. 127 (bkile@ascp.com). |
Collaborative Practice
Pharmacists posted both big wins and discouraging setbacks this year in pursuit of expanded health care roles and broader reimbursement of their professional services. A major breakthrough in the cognitive services reimbursement arena came in May, when HCFA approved a Medicaid waiver authorizing Mississippi to pay pharmacists for providing disease management services to Medicaid recipients with asthma, coagulation disorders, diabetes, or dyslipidemia. The new program, whose implementation now awaits development of new credentialing mechanisms by the state pharmacy board, provides for Medicaid reimbursement of up to 12 pharmacy encounters per year, with payment expected to be set at $20$25 per encounter.
More good news came this summer, when Ohio overhauled its pharmacy practice act to include new language authorizing pharmacists to assume a variety of new patient care responsibilities under written "consult agreements" with physicians.
In a related development, ASCPs new Connecticut chapter played a crucial role in securing passage of a bill recognizing pharmacists as "qualified health care providers," laying a foundation for future patient care and reimbursement gains. In another important advance, Delaware pharmacists secured passage of a new law clearing the way for them to administer vaccines and other injectable medications, as well as to perform and interpret blood tests and other monitoring tests, under physician-approved protocols.
ASCP continued to arrange member testimony and provide legislative support to advance long-standing collaborative practice initiatives in New York and Pennsylvania, but no significant headway was achieved in either state.
In a deep disappointment to members of ASCPs Maryland chapter, a long-standing collaborative practice initiative in that state, which had appeared close to successful completion early this year, ended in defeat when provisions that had emerged intact from committee review were defeated on the House floor. A similar fate befell proposed collaborative practice provisions introduced in Colorado. And the Florida legislature shelved a bill that would have allowed consultant pharmacists to order and perform clinical and laboratory tests in nursing facilities contingent upon authorization by the facilitys medical director.
"Despite disappointing setbacks in these three states, the overall trend in the area of expanded practice authority for pharmacists continues to be generally positive," says Kile. With the addition of Ohio and South Carolina, 22 states now have legislation or regulations on the books granting pharmacists some degree of prescribing authority or expanded patient care duties under collaborative practice agreements with physicians; thats up from 17 states in 1997 and just seven in 1995. "Securing collaborative practice victories in more states will continue to be a major focus of our government affairs initiatives for the remainder of 1998 and into 1999," Kile adds.
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Showcasing the Value of Pharmacy Services
At last years annual meeting of the National Conference of State Legislatures (NCSL) in Philadelphia, ASCP helped set a new example for intraprofessional teamwork, joining with four other organizations the American Pharmaceutical Association, American Society of Health-System Pharmacists, National Pharmaceutical Council, and National Wholesale Druggists Associationto host a joint exhibit illustrating the enormous toll of medication-related problems and pharmacists key role in combating those problems. At this years NCSL meeting in Las Vegas, the list of groups participating in the Alliance for Pharmaceutical Care was expanded to include the Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, National Community Pharmacists Association, National Council of State Pharmacy Association Executives, and United States Pharmacopeial Convention. Representatives of the 10 groups had ample opportunities to interact with many of the 5,000 state legislators at the meeting, while joining together to stage an exhibit showcasing pharmacists many essential contributions to health care and the quality benefits and cost savings already realized in states permitting collaborative practice arrangements between pharmacists and physicians. The exhibit also featured pharmacist-conducted cholesterol, diabetes, respiratory, and cardiovascular screenings, as well as counseling on test results. |
Dual-Eligible Waivers
State requests for federal permission to experiment with new health care delivery approaches under HCFA waivers from Medicare and Medicaid requirements have dropped off sharply since 1995, but HCFA this year approved important waivers targeting geriatric populations in Florida, Maryland, and Wisconsin. The three states will receive federal grants totaling $450,000 to fund initiatives to coordinate and integrate health care services for "dual-eligibles"Medicare beneficiaries who also qualify for Medicaid benefits. According to HCFA estimates, the nations six million dual-eligibles comprise 17% of the Medicaid population but consume 35% of total Medicaid expenditures.
In addition to $150,000 in start-up funds, each state is eligible for matching funds of up to $300,000 over a 12- to 18-month period. The Florida Department of Elder Affairs will apply its grant to integrate acute and long-term care services for dual-eligibles under its Long-Term Care Community Diversion Pilot Project. Maryland received two grants: one for development of a "social" health maintenance organization to integrate financing and delivery of Medicare and Medicaid health and social services; the other, to establish a managed care plan to help physically disabled dual-eligibles make the transition from nursing facilities to community-based care. Wisconsin will use its grant to coordinate services for both elderly and non-elderly long-term care patients, with Medicaid-covered services paid on a capitated basis.
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State News Capsules States took up a variety of health care issues and actions with important implications for pharmacy, in addition to those discussed elsewhere in this article. Some highlights: Wisconsin Gov. Tommy Thompson (D) signs into law a bill giving pharmacists new authority to administer certain drugs and vaccines. A similar bill is defeated in Maryland. Maine Gov. Angus King (I) appoints ASCP member Michael Fiori to sit on the Maine Commission to Study the Use of Pharmaceuticals in Long-Term Care, a new panel charged with exploring a wide range of coverage and payment issues, including Medicaid policies. Florida ASCP members help halt the advance of a budget proposal by Gov. Lawton Chiles (D) to implement a statewide competitive bidding program for all long-term care pharmacy services covered under Medicaid. West Virginia Pharmacists lobby successfully for a new law authorizing pharmacists to dispense larger-than-usual amounts of analgesics, including opioid medications and other Schedule II controlled substances, for management of intractable pain. Pennsylvania The first comprehensive audit of the states long-term care system reveals widespread problems. The governor orders corrective steps including an immediate overhaul of the complaint-response system. Ohio A federal audit of nursing facility reimbursement by the states Medicaid program has verified the results of a state investigation indicating overpayments to long-term care facilities totaling $34 million over a seven-year period, most due to duplicative or erroneous payments. California HCFA bars all new enrollments in Californias home-and community-based services waiver program, citing "severe deficiencies" including widespread inappropriate use of psychotropic drugs. New Jersey State health officials mandate that all elderly people be offered influenza and pneumococcal vaccinations at the time of nursing facility admission or hospital discharge. Kentucky The legislature considers a first-of-its-kind bill that would permit pharmacists to refuse to perform professional services on moral, ethical, or religious grounds and would prohibit disciplinary or discriminatory action against those making such claims of conscience. |
What's Ahead?
With the end of the year in sight, the ASCP government affairs staff and ASCP members are already mapping out strategies to tackle an ambitious slate of legislative and regulatory initiatives for the final months of 1998 and into 1999.
At the federal level, ASCP will seek to be a key player in guiding implementation of a far-ranging initiative recently announced by President Clinton to improve quality of care in the nations nursing facilities. In unveiling the planned initiative this summer, HCFA officials released a 900-page report to President Clinton assessing progress implementing a wide range of nursing facility quality improvements mandated under the Omnibus Budget Reconciliation Act of 1987. While acknowledging major strides in reducing once-rampant overutilization of psychotropic drugs in nursing facilities during the past decade, the report cited persistent problems in areas such as reduction of malnutrition and pressure ulcers, prevention of resident abuse and neglect, survey compliance, and fraud enforcement.
In the months ahead ASCP will also step up its efforts to advance a crucial initiative that began to take shape this year: a campaign involving the concerted efforts of all the nations major pharmacy organizations to amend the Social Security Act (SSA) to include pharmacists on the list of "bona fide" health care professionals permitted to directly bill the Medicare program for their professional services. "Early this year, ASCP made headway building a pharmacy-wide coalition to push for this long-overdue updating of SSA provider definitions," Davitian notes. "However, we were advised by several allies in Congress that with a major election cycle approaching this fall, the time was not right to move ahead. Once the elections are over, well be moving ahead full-steam."
At the state level, one of ASCPs top priorities will be continuing to work with legislators to draft new practice act language and further the advance of existing legislative proposals to give pharmacists expanded patient care responsibilities under collaborative practice arrangements with physicians, says Kile, who points out that collaborative practice initiatives are still very active in more than 20 states. "Were also going to continue to work with state chapters and individual members to promote our Assisted Living Model State Language to governors and legislatures across the country."
As it works to formulate public policy initiatives and strategies for the coming year, ASCP will be closely watching the outcome of congressional and gubernatorial elections less than two months from now. With a large number of congressional seats and 36 gubernatorial seats at stake, Kile notes, "the outcome of the November elections will set the tone of both federal and state health care public policy initiatives for years to come."