BETHESDA, MD 15 April 2010—President Barack Obama on March 23 and 30 signed into law two pieces of legislation that have been widely described as the most sweeping changes to U.S. health care since the creation of Medicare and Medicaid in 1965.
The Patient Protection and Affordable Care Act, the longer of the two laws, refers to pharmacists and pharmacies several times.
In addition, that law in conjunction with the Health Care and Education Affordability Reconciliation Act of 2010 alter the calculation of pharmaceuticals’ average manufacturer price (AMP).
Kasey K. Thompson, vice president for policy, planning, and communication at ASHP, cautioned that many parts of the Patient Protection and Affordable Care Act cannot go into effect until the appropriate agencies write the related regulations.
He said ASHP was already planning to discuss regulations and federal funding for new programs with the agencies.
Many parts of the law refer to the safety and quality of medication use without stating "pharmacist," Thompson said. Nonetheless, this attention to medication use, he said, "creates an incredible opportunity for pharmacists to take a leadership role in helping their organizations."
Below is a summary of the laws’ sections that refer to pharmacists or pharmacies.
Medication therapy management. Patient Safety Research Center. By May 1, the Department of Health and Human Services (HHS) will launch a program that provides grants or contracts specifically to implement pharmacist-
provided medication therapy management (MTM) services.
These services will target persons who take four or more medications under a prescriber’s orders, receive any so-called high-risk medications, have two or more chronic diseases, or have undergone a transition of care likely to create a high risk of medication-related problems.
The law specifies 10 services that must be provided, at a minimum, under the program.
Nine of the services correspond to the "Medication Therapy Management Services Definition" approved in July 2004 by ASHP and 10 other national pharmacy organizations.
Grantees and contractors will have to submit a report on their activities. In turn, the HHS secretary will submit a report to Congress.
The law gives HHS the prerogative to fund the development of performance measures that assess the use and effectiveness of MTM services.
Medicare Part D. For the first time, MTM programs in Medicare Part D have required components.
Starting in 2013, the MTM services offered by sponsors of Part D prescription drug plans must include an annual comprehensive medication review and follow-up interventions as needed.
A pharmacist or other qualified provider is to undertake the medication review directly with the Part D enrollee or conduct it using telehealth technologies. The enrollee must receive a written or printed summary of the results of the review.
The law does not specify who must provide the follow-up interventions.
Center for Medicare and Medicaid Innovation. The soon-to-be-created innovation group at the Centers for Medicare and Medicaid Services will test payment and service-delivery models.
One of the innovative models that the HHS secretary may select to test is MTM services, such as those described in the new program from the Patient Safety Research Center, part of the Agency for Healthcare Research and Quality.
Health teams for patient-centered medical homes. Through grants to or contracts with state groups and Indian tribes, HHS will establish community-based health teams whose purpose is to support primary care practices in running patient-centered medical homes.
This model of care, according to the government, includes new payments for the "additional components" of patient-centered care.
The HHS-funded health teams may, but do not have to, include pharmacists.
But the teams must enable local primary care providers to give their patients access to pharmacist-delivered medication management services, including medication reconciliation. The teams must also provide a 24-hour transitional care program that includes medication reconciliation on admission to and discharge from hospitals, nursing homes, and other institutional settings.
No deadline is stated in the law for HHS to start this program.
Independence at home. HHS will conduct a demonstration program for Medicare to test a payment-incentive and service-delivery model in which physicians and nurse practitioners direct home-based primary care teams. Pharmacists are to be part of these teams.
All team members must have experience providing home-based primary care, make in-home visits, and be available 24 hours a day, 7 days a week, to carry out a Medicare beneficiary’s plan of care.
HHS must start this program by 2012.
New definition for AMP. Since mid-2007, pharmaceutical manufacturers have calculated their AMPs from the prices paid by wholesalers that sell to the retail pharmacy class of trade, including the mail-order sector.
The federal government has plans to use AMP as the basis of payments to pharmacies for Medicaid-covered generic medications.
Starting October 1, AMP will be based on the average price paid by wholesalers for drugs distributed to "retail community pharmacies"—defined as independent, chain, supermarket, and mass-merchandiser pharmacies—and by these pharmacies when they buy directly from the manufacturer.
Manufacturers will exclude from their calculations customary prompt-pay discounts and certain rebates and discounts.
Work-force issues. National commission. The new National Health Care Workforce Commission will annually assess the nation’s supply and distribution of health care workers, including pharmacists, and project demand for the next 10 and 25 years.
Another task is to assess the implications of the government’s Medicare and Medicaid graduate medical education policies.
Findings and recommendations will be reported to Congress and the executive branch.
Geriatrics specialists. HHS will give career-incentive awards to pharmacists and others who are pursuing an advanced degree in geriatrics or a related field at an accredited health professions school.
Advanced degrees in public health sciences. HHS will establish the United States Public Health Sciences Track at selected academic health centers to grant advanced degrees emphasizing team-based service, public health, epidemiology, and emergency preparedness and response.
One of the goals is to graduate at least 50 pharmacy students annually.
Waste reduction in Part D. The HHS secretary will ask pharmacists and others for ways to decrease the amount of outpatient prescription medications that goes to waste at long-term-care facilities.
At issue are the customary 30-day prescription refills for medications covered by Part D.
Sponsors of the prescription drug plans must make changes by 2012.
Accreditation for Part B. Pharmacies do not need accreditation this year to provide durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) under Medicare Part B.
But starting in 2011, pharmacies providing DMEPOS will need accreditation unless they meet the following criteria: recent annual billings of those items and services under Part B have been less than 5% of the pharmacy’s total sales, the pharmacy has been in good standing as a Part B supplier for at least five years, and the pharmacy agrees to submit material in support of an HHS-initiated audit.
