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January 29, 2018

Preserving 340B Is Essential to Our Most Vulnerable Patients

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ORGANIZATIONS PROVIDING CARE TO MEDICALLY UNDERSERVED rely on the 340B Drug Pricing Program, and ASHP is committed to fighting ongoing threats to the program that could have serious consequences for our patients. ASHP has a long history of support for the 340B program, and many of our members have seen firsthand the benefits of the program to the patients they serve. As Congress considered overhauling the nation’s healthcare system last year, ASHP developed Principles on Healthcare Reform that included our support for the 340B program. We continue to collaborate with numerous stakeholders, including our longstanding partners at the American Hospital Association (AHA) and 340B Health, to prevent cuts to program eligibility and scope.

Last August, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that cuts Medicare Part B reimbursement for drugs purchased through the 340B program from ASP plus 6 percent to ASP minus 22.5 percent. Along with the AHA and many other like-minded stakeholders, ASHP submitted comments to CMS opposing the cuts. In addition to the comments, ASHP lobbied on Capitol Hill to garner signatures to a Dear Colleague Letter from Congress to CMS urging the agency not to go through with the cuts. During ASHP’s annual Legislative Day in September, over 100 ASHP members met with their members of Congress to discuss, among other issues, the importance of the 340B program to their organizations and the critical role it plays in their ability to provide care to the medically underserved.

In November, CMS finalized the rule, and the reimbursement cuts were set to begin this year. AHA has filed a lawsuit challenging CMS’s authority to impose the cuts on the federal 340B program, and ASHP is supportive of AHA’s efforts. We are extremely disappointed that the rule putting the cuts in effect was finalized, and we remain committed to advocating for overturning this rule.

To that end, ASHP supports legislation (H.R. 4392) that would block the CMS-imposed cuts. Sponsored by Representatives David McKinley (R-W.V.) and Mike Thompson (D-Calif.), the bill currently has 181 co-sponsors in the House. In addition to our letter of support, ASHP has created a grassroots letter of support for our members to send using our electronic letter-writing platform.

We know that there will be additional threats to the 340B program in 2018. For example, recently introduced legislation (H.R. 4710) would impose a two-year moratorium on disproportionate share hospitals applying to become covered entities within the federal 340B program. This bill would also require additional reporting requirements, including reporting of the number of insured patients, total cost of charity care provided, reimbursement for all drugs, and a listing of all third-party vendors associated with the 340B program. ASHP has strong concerns over this legislation, and we expressed our opposition in writing to the bill’s sponsors. Similar legislation (S. 2312), was introduced in the Senate, and ASHP will oppose that bill as well.

We expect to see additional legislation later this year. The House Energy and Commerce Committee last week released a report on the 340B Drug Pricing Program. The committee has been examining the structure, operation, and oversight of the program over the past two years through stakeholder meetings, committee hearings, and document collection. Further, Committee Chairman Greg Walden (R-Ore.) has stated that there will be legislative efforts to change the 340B program this year to focus on definition, transparency, and oversight. ASHP developed an issue brief summarizing that report and the potential legislative options that may result.

ASHP remains committed to supporting the 340B Drug Pricing Program, and we will continue to do so through assertive advocacy on Capitol Hill, grassroots advocacy, comments to federal agencies, and meetings with agency officials. Further, ASHP will continue working with other program supporters such as AHA and 340B Health to protect the program from threats, both legislative and regulatory.

Thanks so much for continuing to advocate on behalf of your patients and the profession, and for being a member of ASHP.



March 17, 2016

Medicare Project Helps Put Pharmacists in Primary Care

AN ONGOING MEDICARE demonstration program with a medication management component shows some hope of reducing healthcare costs through the use of team-based primary care services.

An analysis of first-year data from the Comprehensive Primary Care Initiative (CPCI), which started in the fall of 2012 and runs through this year, found that the cost savings to Medicare nearly equaled the $141 million in care-management incentives paid to the participating practice sites.

A report commissioned last year by the Centers for Medicare and Medicaid Services (CMS) called this finding “promising,” since savings weren’t expected during the program’s first year. But the report noted that the cost offsets varied by region and urged caution in interpreting the initial data.

Nearly 100 CPCI sites have implemented comprehensive medication management services.

The CPCI includes about 500 primary care practices in seven geographic regions. Each participating site receives per-member-per-month (PMPM) payments from CMS and other payers and may be eligible for additional shared-savings incentives.

Among the initiative’s requirements are that all participating sites implement one or more primary care strategies—comprehensive medication management, integrated behavioral health services, or patient self-management support services—as part of CPCI’s focus on population health.

Sites are encouraged, but not required, to implement all three of these strategies by the end of the demonstration project, according to CMS.

The most recent data from CMS indicate that nearly 100 CPCI sites have implemented comprehensive medication management services and 74 practices have brought at least one pharmacist onto the healthcare team to provide the services.

Katherine O’Neal

Katherine O’Neal

Clinical pharmacist Katherine O’Neal of OU Physicians, an internal medicine clinic affiliated with the University of Oklahoma School of Community Medicine in Tulsa, is one of those pharmacists.

“I am completely integrated into the clinic,” O’Neal said. “I do medication reconciliation and daily prescription reviews and medication monitoring for all medications prescribed in our clinic, and I provide support for medication use and self-management.”

She also works to resolve medication-related issues that occur during transitions in care and sees patients by referral to help them control chronic conditions such as diabetes, hypertension, chronic obstructive pulmonary disease, and dyslipidemia.

O’Neal is the internal medicine clinic’s only pharmacist and is onsite 4.5 days per week. Her position is funded through the University of Oklahoma College of Pharmacy, where she holds the titles assistant professor and adjunct associate professor.

Nearly a quarter of the pharmacists working at CPCI sites are funded through an academic appointment, according to CMS. About half have been directly hired by the practice group, and 14% work under contract. Other sources fund the remainder of the positions.

According to CMS, all of the CPCI sites that focus on medication management provide medication reconciliation services, and most also address medication coordination during care transitions and medication review and assessment. Nearly half have collaborative drug therapy management agreements in place.

Jessica Binz, director of clinical pharmacy education at the University of Arkansas for Medical Sciences—West Family Medical Center in Fort Smith, said her practice site participates in several quality initiatives, including CPCI.

The new payment mechanisms… are going to open up tremendous opportunities for pharmacists.

Binz practices under a collaborative drug therapy management agreement—known in Arkansas as a “written protocol”—and also works closely on medication-related issues with the transitions-of-care team.

“I do smoking cessation and medication management for smoking cessation as well,” Binz said. “We have an interdisciplinary team that works with patients that are interested in stopping smoking.”

Binz said the smoking-cessation program started last October and is going well. She said one of the positive trends is that her patients, many of whom have “issues with transportation,” find ways to get to their follow-up appointments.

All of the Medicare beneficiaries in the practice—about 650 people—are considered part of the CPCI population, Binz said. Overall, according to CMS, the CPCI practice sites are responsible for the care of about 2.7 million patients, including more than 400,000 Medicare and Medicaid beneficiaries.

F. Alison Gray

F. Alison Gray

F. Alison Gray, ambulatory care pharmacist at the Little Rock Family Practice Clinic in Arkansas, said she was initially brought into the CPCI-participating clinic to help patients reduce their medication costs, mostly by increasing the use of generics and ensuring that prescribing is aligned with each patient’s pharmacy plan.

After she found that the healthcare team was already doing a good job of keeping drug costs down, she turned her focus to warfarin management because it is “fairly straightforward” to implement and manage.

“Once I got that off the ground, then I moved on to diabetes education, which is really my passion,” said Gray, who worked with the clinic’s dietitian to develop a diabetes education program for patients.

“We have individual and group visits as well as a monthly support group that we have put together. And so far, it’s been pretty successful. We’ve seen some pretty good outcomes with patients,” Gray said.

Gray said she will be evaluating diabetes outcomes measures for CPCI. For warfarin-management patients, she is collecting data on their International Normalized Ratio (INR) values and examining whether patients are having their INR checked regularly.

Outcomes measures like these may help practice sites qualify for incentive payments from insurance programs that participate in the CPCI.

CMS initially identified 31 payers that covered a substantial portion of the practice sites’ patients, agreed to contribute to PMPM payments, and, in some cases, offered pay-for-performance bonuses or other incentives to improve population health.

Marie Smith, assistant dean for practice and public policy at the University of Connecticut School of Pharmacy in Storrs, said the multipayer participation is an unusual cornerstone of the CPCI.

Smith explained that it’s difficult for practice sites to disrupt their processes to participate in individual initiatives by different payers. She said having payers working in concert, as they do in the CPCI, minimizes this problem.

But she said it’s the PMPM payments, which largely come from CMS, that have really boosted the CPCI by providing start-up funds for sites to hire the pharmacists and other staff needed to meet the program’s milestones. She contrasted that strategy to shared-savings incentives, which are generally paid out only after outcomes have been assessed and long after the care is delivered.

Smith spent six months during 2013 on faculty leave at the CMS Innovation Center, where she focused on creating a road map for the integration of clinical pharmacy services into CPCI practice sites. She said the near-universal existence of state collaborative practice laws in 2012 gave CMS staff the confidence that pharmacists would be able to work effectively under the CPCI model without running afoul of scope-of-practice regulations.

CMS’s implementation guidance for CPCI participants recommends that practices focusing on medication management include a clinical pharmacist on the healthcare team. According to CMS, the pharmacist should be involved in patient care either directly or by performing chart reviews and making therapy recommendations.

The pharmacist should also help the practice identify patients who are at high risk for poor health outcomes and would benefit from medication management. And, according to CMS, the pharmacist should participate in care team meetings and help develop processes to improve medication use and safety.

“It’s an exciting time to be in primary care because there’s so much experimentation going on,” Smith said. “The new payment mechanisms, I think, are going to open up tremendous opportunities for pharmacists.”

–By Kate Traynor, reprinted with permission from AJHP (March 15, 2016; volume 73, pages 346, 349, 350)

January 19, 2015

Pharmacists Praise New Medicare Billing Opportunities

Filed under: ASHP News,Clinical,Feature Stories,Provider Status,Uncategorized — Tags: , , , , — jmilford @ 5:12 pm

RECENT UPDATES TO THE INCIDENT-TO BILLING REQUIREMENTS from the Centers for Medicare and Medicaid Services (CMS) have created new opportunities for medical practices to be reimbursed for pharmacists’ patient care services.

“Change is happening,” said Sandra Leal, medical director of pharmacy at El Rio Community Health Center in Tucson, Arizona. “What’s exciting is that there is more consideration from CMS to have pharmacists participate in teams and to . . . bill with the physician,” she said.

Sandra_LealLeal said the new billing opportunities arise from clarifications from CMS on work done by nonphysician healthcare providers and language in the agency’s 2015 update to the physician fee schedule.

The fee schedule, released this past November, allows physicians to bill Medicare for unsupervised after-hours services provided by nonphysicians under Medicare’s chronic care management (CCM) and transitional care management (TCM) programs. The person who provides these services incident to a physician’s care need not be a direct employee of the medical practice, according to CMS.

TCM and CCM services involve face-to-face care and comprehensive follow-up, including medication therapy management, within a specific time frame.

CMS began reimbursing medical practices for TCM services in 2013, and Leal said her clinic participates in this program. She said in November that no decision had yet been made about providing CCM services.

“Our compliance officer is actually reviewing the language right now to see if it makes sense for us to be able to  participate,” she said.

The 2015 fee schedule doesn’t state outright that physicians can bill for pharmacists’ TCM and CCM services provided incident to the physician’s care.

Instead, the fee schedule refers to physicians’ clinical staff and the time spent by those nonphysician healthcare professionals in providing TCM and CCM services.

But a March 2014 letter from CMS Administrator Marilyn Tavenner affirmed that pharmacists are among the nonphysician healthcare providers for whom incident-to billing is permissible [see June 15, 2014, AJHP News].

CMS regulations for 2014 also specified that nonphysician healthcare professionals must meet state requirements for licensure and work within their state’s scope of practice regulations in order to participate in incident-to billing.

Betsy Bryant Shilliday, associate professor of medicine at the University of North Carolina (UNC) School of Medicine in Chapel Hill and assistant medical director for the UNC internal medicine clinic, said the reference to state law has greatly benefited her clinic.

That’s because North Carolina has established the clinical pharmacist practitioner (CPP) credential, an advanced practice designation conferred by the state’s pharmacy and medical boards.

Under North Carolina state law, CPPs are “approved to provide drug therapy management, including controlled substances, under the direction of, or under the supervision of a licensed physician.”

A March 2014 letter from CMS Administrator Marilyn Tavenner affirmed that pharmacists are among the nonphysician healthcare providers for whom incident-to billing is permissible.

A March 2014 letter from CMS Administrator Marilyn Tavenner affirmed that pharmacists are among the nonphysician healthcare providers for whom incident-to billing is permissible.

Shilliday said her regional Medicare carrier—or Medicare administrative contractor (MAC), as the entities are officially designated—recently agreed that CPP-certified pharmacists qualify for incident-to billing using higher-level Current Procedural Terminology (CPT) codes.

Specifically, she said, physicians can bill using CPT codes 99211–99214 for pharmacists’ incident-to services.

“This was my Christmas present. I’m like a kid in a candy store now,” Shilliday said in November.

Shilliday recalled that about a decade ago, her Medicare carrier allowed higher-level incident-to billing by pharmacists. But that changed when a different carrier assumed responsibility for the region.

At that time, she said, pharmacists’ services were restricted to the minimal evaluation and management CPT code, 99211, regardless of the time spent with the patient and the complexity of the patient’s condition or the medical decision-making involved in the visit.

“We’d been going along that path, providing very complex care but getting reimbursed very little,” Shilliday said.

“So it’s been very hard for us to justify to practices to hire more pharmacists, because we’re expensive. And our reimbursement rates are very low, especially if we’re in a high Medicare population clinic.”

She said the new ruling from the MAC will provide a better return on the clinic’s investment in pharmacists’ services. Her compliance office is also attempting to justify billing at the highest level, 99215.

“However, we’re happy to bill up to a 99214. It’s huge, it’s over three times what we are able to bill for a [99211] visit,” she said.

Shilliday said that although the CPP credentialing process for North Carolina pharmacists helped sway the Medicare carrier’s approval of higher-level billing, pharmacists in states without a similar advanced practice designation might also be able to use higher-paying CPT codes.

We’re happy to bill up to a 99214. It’s huge, it’s over three times what we are able to bill for a [99211] visit.

“I would very much explore it in another state as well and see how they interpret it. Because each Medicare carrier can interpret it differently,” she said.

Shilliday said she and her colleagues are exploring whether the clinic meets CMS’s requirements to bill for TCM and CCM services. She said potential problems with billing for these services include the need to obtain a written agreement from patients to receive the care.

Medicare coinsurance and deductibles apply to TCM and CCM services, which could pose an obstacle to patients’ acceptance of the services.

Shilliday and Leal welcomed the new opportunities for reimbursement of pharmacists’ patient care services. But they emphasized that incident-to billing is not a substitute for the recognition of pharmacists as healthcare providers under the Social Security Act.

Shilliday noted that her MAC’s previous refusal to allow higher-level billing for pharmacists’ incident-to services was based on the fact that CMS didn’t list pharmacists as recognized providers.

Leal explained that incident-to billing “only covers what the provider specifically asks for you to help with.”

If a physician refers a patient to a pharmacist for diabetes management, only those services are billable as incident to the physician’s service. This applies even if the pharmacist discovers during the encounter that the patient has uncontrolled hypertension or other problems and addresses those.

“You will [treat them], because that’s our clinical obligation. But for reimbursement purposes, you’re only able to do what the [physician] asks you to do,” Leal said.

Thus, to allow pharmacists broader opportunities to use their skills and be reimbursed for their work, “it’s very critical to get provider status,” Leal said.

 –By Kate Traynor, reprinted with permission from AJHP (Jan. 15, 2015; volume 72, pages 91-92)

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