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How the new Trump administration will affect everything from the ACA to the FDA.
From drug prices to regulations, President Donald Trump’s administration will have a big impact on pharmacy-and the entire health-care system.
ShutterstockWe're still only in the first 100 days, but already we're seeing radical shake-ups in the healthcare industry. These shake-ups are likely to continue, but Drug Topics is here to help you understand how the new adminstration is and will be affecting you and your patients. To help with that, we're taking a look at the Top 6 factors that you will need to be aware of going forward.
Up next: The top six factors that are likely to affect pharmacy businesses in 2017
1. Affordable Care Act reform
One of the issues that will demand “substantial effort” this year include advocating for appropriate reimbursement amid potential changes to the Affordable Care Act (ACA), Steven C. Anderson, president and CEO of the National Association of Chain Drug Stores (NACDS), wrote in a recent blog post. The National Community Pharmacists Association (NCPA) is primarily concerned about how ACA changes will affect Medicaid reimbursements. “We believe that prescription drug coverage must remain an essential benefit, and that large pharmacy networks, which include independent community pharmacies, should be maintained,” NCPA CEO B. Douglas Hoey, RPh, told Drug Topics.
“It’s also important that specific ACA provisions, such as continuing the progress made in improving Medicare Part D medication therapy management (MTM) programs; annual comprehensive medication reviews; efforts to further integrate pharmacists into the health care delivery system; and most importantly, pharmacy benefit manager (PBM) transparency requirement be kept.” Changes to Medicaid should keep the average manufacturer price (AMP) formula that is currently used to determine Medicaid reimbursements, Hoey added.
In addition, “robust oversight of managed care organizations is needed, including state inspection and audits of PBMs that administer the drug benefi t. If Medicaid is block- granted to the states, then we will also turn our attention to governors, who will have a much larger role in determining how the program is administered.” Mandatory mail order pharmacy requirements should also be prohibited in new ACA language pertaining to Medicaid, Hoey said.
2. Lower drug prices
Pharmaceutical manufacturers have been under fire for their high drug prices for at least the last two years, and President Trump has been one of the biggest critics on high prices-particularly for Medicare beneficiaries. He recently said that drugmakers are “getting away with murder” in terms of drug pricing.
“For Medicare, for Medicaid, we have to get prices way down, so that’s what we’re going to be talking about. We’re also going to be streamlining the process so that from your standpoint so that when you have a drug you can actually get it approved-if it works-instead of waiting for many, many years,” Trump said at a late January meeting with pharmaceutical manufacturers, including Merck and Johnson & Johnson, CNN reported.
“President Donald J. Trump has spoken out many occasions about his concerns with regard to this issue during his presidential campaign and since his Inauguration,” Hoey said. “While specific proposals have not been unveiled, the president has spoken favorably about Medicare Part D possibly being able to negotiate lower prescription drug prices and about the possible reimportation of drugs from Canada.”
3. Pharmacy benefit managers and remuneration fees
Any attempts to address rising drug costs must include the role that PBMs play in “extracting enormous profits from patients, payers, and pharmacies,” Hoey said. Direct and indirect remuneration (DIR) fees for the Medicare Part D program has “become the number one priority of independent community pharmacies over the last two years, and we were thankful that concerns we expressed to CMS [Centers for Medicare and Medicaid Services] and to members of Congress seem to have been taken into account,” NCPA said.
NCPA recommends that the Trump administration rely on CMS’s recent analysis, which found that DIR fees “do not reduce the cost of drugs for beneficiaries at the point of sale and tend to push seniors into the ‘donut hole’ or catastrophic phase of their coverage faster,” Hoey said. “CMS also asserted that Part D plans and PBMs favor using these post-point-of-sale price adjustments because it shifts their share of costsharing onto the beneficiaries and taxpayers.” CMS should finalize the ‘negotiated price’ guidance as proposed, to require fees be approximated at point-of-sale, and Congress should consider enacting bipartisan legislation to eliminate all retroactive pharmacy DIR fees or price concessions, Hoey said.
“We also would want the transparency provisions CMS established for Medicare Part D plans multisource generic prescription drugs under their maximum allowable costs (MAC) list to be maintained. Otherwise those hard-fought gains to provide more information about how the reimbursement criteria is established, and how frequently those reimbursement lists are updated could be an enormous setback,” Hoey stated.
4. Pharmacist provider status and Medicare
In January, the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592 and S. 109) was reintroduced in the House of Representatives and the Senate, after nearly being passed in last year’s Congressional session. The bills would allow underserved Medicare patients to receive certain services from pharmacists, in states in which pharmacists already are permitted to administer the functions. Nurse practitioners and physicians’ assistants currently can provide these services through Medicare.
If passed, pharmacists would be able to provide immunizations; help seniors manage chronic conditions such as diabetes, heart conditions, and asthma; conduct wellness or prevention testing; and help seniors take their medications correctly. “Pharmacists remain among the most highly trusted professionals. That, combined with their extensive education and accessibility, create tremendous opportunities for patient care,” Anderson said. “We hope the commonsense, bicameral, bipartisan legislation, which also generated a lot of support in the previous Congress, can pass both chambers and make it to President Trump’s desk for his signature,” Hoey said.
5. U.S. Representative Tom Price’s appointment as HHS Secretary
“As a member of the U.S. House of Representatives, Price (R-GA) has tended to mirror the approach of his Republican colleagues, which is to call for an easier drug approval process so that there would be more competition in the marketplace,” Hoey said.
In fact, at Price’s confirmation hearing, he signaled some willingness to look further into issues such as government negotiation of drug prices and reimportation, “a clear reflection that President Trump will naturally have the final say for his administration on these issues,” Hoey said.
Meanwhile, NACDS’ top priority is to translate Price’s high regard for affordability, accessibility, quality, innovation, responsiveness, and choices in health care reform into pro-patient and pro-pharmacy policies that “leverage the industry’s value while assuring its viability,” Anderson wrote. “Related issues that will demand substantial effort this year include advocating for appropriate reimbursement amid potential changes to the Affordable Care Act; for enactment of the pharmacist provider status legislation; for the Department of Defense’s implementation of the TRICARE pilot that was authorized late last year; and for remedies for the current application of [DIR] fees; among other issues.”
6. FDA reform:
President Trump is in favor of fewer government regulations at every agency, and this theme is expected to extend to the FDA. He issued an executive order calling for two regulations to be cut for every new one that is approved across agencies. In addition, President Trump said at the White House meeting with pharmacy executives, “We have to get rid of a tremendous number of regulations. I know you have some problems where you cannot even think about opening up new plants. You can’t get approval for the plant and then you can’t get approval to make the drugs.”
Fewer FDA regulations would eventually lead to a faster drug approval process and lower drug prices-hopefully driving more patients into pharmacies. “If approvals on a calendar basis were shortened, even by just two years, there are models that the contribution of development time to approval would mean less of a need for price increases and more exclusivity…those two years would reduce the development expenses and then with longer exclusivity, companies can recoup their R&D funds easier,” Joseph Gulfo, MD, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University in New Jersey and one of Trump’s reported candidates for FDA Commissioner, told Regulatory Focus.
However, for pharmacists, it is uncertain what the hands-offgovernment approach might mean for the ongoing implementation of the Drug Quality Security Act (DQSA), related to oversight over drug compounding as well as track-and-trace standards for the drug supply chain, Hoey said.