Prescription Drug and Health Care Spending (REG-117575-21)
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2021-11-29 2021-11-29 2021-11-29 2021-12-02 2021-12-02
IRS-2021-0016-0005 IRS-2021-0016-0003 IRS-2021-0016-0004 IRS-2021-0016-0007 IRS-2021-0016-0006
05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/IRS-2021-0016-0005 https://api.regulations.gov/v4/comments/IRS-2021-0016-0003 https://api.regulations.gov/v4/comments/IRS-2021-0016-0004 https://api.regulations.gov/v4/comments/IRS-2021-0016-0007 https://api.regulations.gov/v4/comments/IRS-2021-0016-0006
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Transparency is always great- especially in a system as convoluted as the current health care system! Many employer groups (whether self-insured or fully-insured) may not have access to the information below in order to provide this to the Department of HHS, Labor and Treasury:1.  The 50 most frequently dispensed brand prescription drugs;2.  The 50 costliest prescription drugs by total annual spending;3.  The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year;4.  Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; For this reason, we strongly encourage the Departments of Labor, HHS and Treasury to include language in the final rule which stipulates that the employer groups pharmacy benefits manager (PBM) and third party administrators (TPAs) must provide this information directly to their clients fee free - whether they are an employer group or health plan administrator - so that their clients and health plans may report it directly to the HHS. Treasury and Labor in order to remain compliant each year.  Absent this requirement, many employer groups (ours, for example), may not have this information and our PBMs and TPAs may charge us exorbitant fees to obtain it, which we may not have the funds to pay, the mechanism to do so under our existing PBM and TPA contracts, and if we do then the costs may be passed on to plan members in the form of higher premiums for those of us who are self insured.   Hello, I am a University of Virginia Batten student studying public policy. I am writing this public comment in support of the proposed rule to implement temporary transparency laws for group health plans and health insurance issuers. Making sure these health care providers report prescription drug spending will ensure that prescription drug prices will be lower. According to a study by Kaiser Family Foundation, nearly 25% of Americans who take prescription drugs struggle to afford their medication. Low-income families especially need to have lower medication prices to ensure that they do not have to make the impossible choice between food for their family or medication. Healthcare transparency is also important because it forces health care providers and professionals to take responsibility for their actions. With increased transparency and responsibility, these health care professionals are more likely to provide better care for their patients. Once patients know more about their health care themselves, they are also able to learn more about the medical and health care systems. This increased knowledge can also, hopefully, lead to better advocacy efforts on behalf of patients. If patients know more about their care, they are able to advocate for what they think may be best for their bodies along with medical advice. In conclusion, I support this proposed rule to increase transparency among group health plans and health insurance issuers. I appreciate the time set aside to read and consider this regulatory comment.  Drug prices have sky-rocketed across the United States, in turn increasing medical costs, premiums, and others. Several proposals focus on increasing visibility into how drug prices are set and decisions that lead to price increases; thus, potentially requiring drug companies to report price increases over a certain percentage and why that increase. Personally, I am in support of implementing transparency laws in order to ensure prescription drug prices are being regulated properly and efficiently.  One in ten brand drugs saw annual price increases of more than 20 percent (AHIP 2018). Additionally, from 2013-2017, 78% of drugs that saw a price increase were branded drugs (AHIP 2018).Generic prescription drugs during this period were also more likely to decrease in prices compared to branded prescription drugs (AHIP 2018). The IRS is issuing regulations that increase transparency by requiring group health plans and health insurance issuers in the group and individual markets to report information about prescription drugs and healthcare spending various departments. This regulation implements a reporting requirement for prescription drug costs and other medical expenses in order to better understand prescription drug pricing trends and impacts on premiums an out of pocket costs. Consumers could benefit from the reporting if plans and issuers are able to negotiate lower prescription drug prices. In turn, the reductions can result in a form of reduced premiums and out of pocket expenses. Transparency and lower drug prices not only hold companies accountable, but also can restore trust amongst patient in their healthcare providers. Lack of trust in the healthcare system is a large issue amongst minority communities. If patients trust that their healthcare providers are looking out for their best interests, they may be more likely to initiate or complete care and medications. Additionally, drug prices for medications are not provided through private insurers. Many Americans have private health insurance, so it is unclear the discrepancies they face. PBMs are well-intentioned but there are multiple negotiating prices with varying ranges of prices, thus there is little transparency in the supply chain about who gets what deal and how much of a deal another person receives. Oregon has implemented an Rx Drug Transparency that requires health plans to report the top 25 drugs responsible for the greatest increase in plan spending, top 25 most costly prescription drugs, as well as the top 25 most frequently prescribed drugs. The National Academy for State Health Policy (NASHP) proposed legislation includes minimizing reporting burden with a common data set for reporting across states, detailed reporting requirements across the entire supply chain; and strong penalties for pharmaceutical companies that fail to report or submit insufficient reports. This allows for a greater understanding regarding pharmaceutical drug price increases in addition to drug impacts on health insurance plans. Orphan drugs and specialty drugs will need to be evaluated differently due to reporting differences and higher prices from lower numbers of potential patients. Will transparency laws be effective and how large of a burden will they impose on pharmaceutical industry and regulatory agencies? Will transparency laws truly lower out of pocket costs and premiums? Overall, I support the proposed rule. There should be more studies should be done to determine the economic impact on various entities. I believe the transparency laws will allow for pharmaceutical companies, pharmacies, practices, and other businesses will provide clarity to patients in addition to reduced out of pocket costs. Additionally, the recordkeeping and reporting requirements will increase for plans and issuers subject to these regulations; such as developing, building and maintaining information technology systems to report the required data. So, it is important to take this into consideration when implementing such regulations and the economic impact on various companies.  Creating efficient and transparent record keeping initiatives around health care costs and expenses and the pharmaceutical industry are effective tools needed to mitigate excessive spending and drug cost within the health care market. These tools can offer new opportunities that would promote innovative responses to lowering medical and pharmaceutical drug costs for consumers while still administering high quality standards of care and fostering innovative pharmaceutical drug developments. Health care and pharmaceutical drug prices have been an ever-growing issue that many individuals would like to see policy changes to address the financial burden of seeking medical care coverage. The final rules included in the provisions of the Internal Revenue Code and the Public Health Service Act in part issued from the Consolidated Appropriations Act of 2021 will provide a new layer of record keeping for medical and pharmaceutical entities that will share information about prescription drugs and health care spending costs identical to that of group health plans and health insured individual coverages. These new rules will offer reporting on a multitude of categories, most notably on the 50 most frequently issued prescription drugs, as well as reporting on the 50 most costly prescription drugs given the timeframe of an entities yearly spending. The importance behind these new methods offers transparency within the health care market around both prescription drugs and health care spending, which will ultimately create new rules and regulations that will go as far as reporting the impact on premiums through rebates and fees supported by pharmaceutical companies. This level of record keeping is of high importance because it is necessary when trying to identify key problem areas within the health care and pharmaceutical industry that creates an overwhelming financial burden on the people of the United States. These efforts bolster a larger initiative supported by President Joe Biden through a recent executive order that promotes competition within the United States economy in an effort enacted to fight industry concentration and market power abuse by preventing industry specific monopolies. This move will not only aid in policy changes but will help identify key areas of excessive pricing within the pharmaceutical industry further creating transparency in a free market with the goal of lowering consumer costs of health care and prescription drugs. These rules and regulations will also bolster larger initiatives to lower cost when seeking pharmaceutical drugs and health care through the implementation of the new No Surprises Act. The No Surprises Act will provide new protections for individuals that receive medical care specifically from out of network providers through in network medical facilities as deemed through the consumers medical care provider. The new rules provide innovative approaches to making pharmaceutical drugs and seeking medical care more accessible and affordable while promoting competition in the marketplace and fueling innovative research in pharmaceutical drug development. The new reporting and record keeping structures will also allow for a deeper understanding of where medical and pharmaceutical drug cost accrue to better help target key problem areas to provide additional benefits and support when seeking care. By allowing for more transparency on how costs are accumulated and accounted for within the medical industry, policymakers and consumers will be granted information needed to better understand medical cost to avoid surprise billing, as well as mitigating the risk of avoiding needed medical care due to excessive spending. The newly implemented reporting structures through the Consolidated Appropriations Act also allow for deeper accountability from medical care providers and pharmaceutical drug manufacturers when creating prices for medical care and pharmaceutical drug cost by openly reporting on cost line items that allow for consumers to make more informed decisions based on spending data.