Welcome to the new year! With a new year, comes new laws and regulations.
Recent polling suggests that 36% of Americans say healthcare is the top issue facing the United States. Expected, pending or soon to take effect regulations coming out of legislative sessions, from both Congress and individual states, will determine new opportunities and course corrections for the pharmacy industry.
The coming 2020 year is looking to shape the healthcare industry to become more consumerized and shoppable, allowing patients to compare prices and choose what works for their specific budget and type of care. Hopefully, these changes will lead to improved patient care and outcomes.
Following are the top 5 legislative issues affecting the pharmacy industry that you should keep an eye on.
1. Pharmacists Getting Provider Prescribing Privileges – Pharmacy and Medically Underserved Areas Enhancement Act
Millions of Americans lack adequate access to primary health care. Nearly half of all Americans have at least one chronic condition, and almost a quarter have two or more. As demand for healthcare increases, this problem is expected to get worse.
Medicare will add a projected 30 million more enrollees by 2040. The Affordable Care Act is expected to add 25 million more patients to the healthcare system, according to the Congressional Budget Office (CBO). And the Association of American Medical Colleges estimates there’ll be at least 90,000 fewer doctors than needed to meet demands.
With all of these increases in patient load, and a lack of doctors to serve these new patients, those in under-served populations will be the most impacted. Medically under-served communities, as designated by the Health Resources and Services Administration, have the greatest need for healthcare services.
Expanding the scope of practice for pharmacists is being considered in state legislatures and in Congress. This is especially true in states with large under-served communities. This bill addresses provider shortages and access issues so pharmacists may deliver care to Medicare beneficiaries living in federally defined under-served areas.
Pharmacists would be able to offer Medicare beneficiaries the same services that they are authorized to provide by their state pharmacy practice acts.
This follows similar paths taken by Nurse Practitioners and other healthcare professionals that have already been successful.
Under consideration is the practice of letting Medicare cover and reimburse for certain pharmacy services that are provided by a pharmacist in a shortage area that would otherwise be covered if provided by a physician.
State-licensed pharmacists with a B.S. Pharm or Pharm D degree who may have additional training or certificates would be able to participate, depending on state laws.
The Pharmacy and Medically Underserved Areas Enhancement Act (S 109), has the number of votes needed to pass legislation in the Senate, and the same bill, HR 592, is in the House of Representatives.
On the state level, many are considering allowing pharmacists to prescribe oral contraceptives, while other states allow them to dispense prescription treatments for common, non-chronic ailments. Virginia is considering allowing pharmacists to perform opioid abuse counseling. And tobacco cessation counseling by pharmacists is being considered in Pennsylvania.
Transparency on drug pricing legislation is changing the business of healthcare. As price transparency becomes a larger initiative and regulations continue to increase, there will be a ripple effect on healthcare costs and operations.
2. H. R. 3, the Lower Drug Costs Now Act
A proposal in the House, aiming for annual price negotiations for the top 250 most expensive drugs with 2 or fewer competitors, thiscx proposal includes an out-of-pocket cap of $2,000 on prescription drugs for Medicare beneficiaries and the disabled.
3. Importing Drugs from Abroad
The importation of prescription drugs from Canada is one of the most talked about healthcare topics in state legislative sessions.
No one knows exactly how much money could be saved by shipping drugs from Canada. Some lawmakers have claimed Canadian drugs are 30-50% cheaper. Others have said the US spends 30-190% more on prescription drugs than other countries.
Last July, the executive branch took its first steps toward allowing the import of certain drugs from Canada. The administration places the burden on states and manufacturers to prove that importing drugs does not pose a safety risk to patients and saves consumers money.
Colorado, Florida, Maine and Vermont have recently passed legislation allowing them to seek federal authorization to set up drug import programs. Officials in Colorado have passed a law requiring the state’s Health Care Policy & Financing Department to create a drug import program. Maine also approved legislation that directs its Health & Human Services Department to design a program and apply for federal approval. In Florida, lawmakers approved a plan for two programs: the first involves importing drugs from Canada, and the second to import prescription drugs from other countries as needed.
4. The Lowest Price Act
The Lowest Price Act blocks Medicare Advantage plan or Medicare Part D prescription drug plan providers gag clauses that prohibit pharmacists from informing Medicare patients of differences between their insurance copay and what the cash price without insurance would be. Pharmacists will now be able to help patients find better pricing for prescription meds by advising on other available options. This act was signed into law in October 2018 and becomes effective in 2020.
5. Drug Supply Chain Security Act (DSCSA)
The DSCSA was created so an electronic system could track and trace certain prescription drugs in the US. The Act aims to enhance compliance with current regulations that ensure the pharmaceutical integrity within the supply chain. By 2020, all Rx products covered under DSCSA must be serialized, and all transactions can only involve serialized product.
This is the start of a new year and decade. It’s around this time when most new laws take effect and when some laws no longer relevant are phased out.
What did you think of this list? Are any of the new laws presented more or less concerning for your pharmacy practice?