Another agency of the current Federal Government is taking actions to dismantle consumer protections with a new Administrative State. This time it is the Centers for Medicare and Medicaid Services (CMS), located in the Department of Health and Human Services (HHS). They propose to substitute generic drugs for brand drugs when consumers fill their doctors' prescriptions. Their proposal was only posted on January 24, 2019 and, in a relatively short period for Comments, the deadline for leaving a Comment including in opposition to these new-Federal Government proposals, is Tuesday, February 19, 2019.
Here are the complete Comments I left on https://www.regulations.gov on Sunday, February 17, 2019 in opposition to these particular proposals.
February 17, 2019
To: The Centers for Medicare and Medicaid Services (CMS),
Department of Health and Human Services (HHS).
https://www.regulations.gov
Re: Proposed Changes to ACA Benefits and Payments Parameters for 2020.
CMS-9926-P
To CMS, HHS:
These Comments are regarding your proposed addition to Regulations in 45 CFR, new proposed §§ 147.106(e)(5) and 148.122(g)(5), and wherever else the same proposed changes discussed in these Comments may be found in your proposals. Your proposed new regulations §§ 147.106(e)(5) and 148.122(g)(5) are published in 84 F.R. at pp. 313-314.
You advise in 84 F.R. at p. 234 that your proposed new § 147.106(e)(5), for example, would allow issuers of drug plans in all three markets -- individual, small group, and large group -- to allow changes to a formulary. (Although you do not define the term in your proposals, I understand from general usage by CMS/HHS that "formulary" in this context means a list of prescription drugs covered by a plan, a/k/a a drug list.)
The new additions you propose to existing law would be to allow issuers of plans covering prescription drugs to remove the equivalent of brand drugs from the formulary, i.e., from the plan of prescription drugs that are covered by the issuer. See, e.g., 84 F.R. at 234.
There are at least three obstacles to implementing these proposed new regulations as law. The three I would like to address in these Comments are (1) that the proposed new regulations are not a reasonable approach to the availability of prescription drugs to consumers who pay for prescription drug plans, or formularies; (2) that the proposed new regulations are a windfall to the issuers of plans covering prescription drugs, at the expense of consumer choice, and (3) that the term, "generic equivalent," is new and undefined, without so much as a reference I can find to the Federal Food and Drug Administration's process of testing and approving generic drugs for use by consumers.
First, the proposed new regulations are not a reasonable approach to the availability of prescription drugs to consumers who pay for prescription drug plans, or formularies. The goal of adding generic medical equivalents to prescription drug plans, or drug lists, could reasonably be accomplished without mentioning the removal of brand drugs from the formulary at all.
The real effect of proposed new regulations like §§ 147.106(e)(5) and 148.122(g)(5) is not to permit the addition of generic equivalent drugs to an issuer's list of covered drugs, but rather to permit the issuer to remove brand drugs from the issuer's list.
That in itself is an unreasonable change to the law and, moreover, it is not authorized by the enabling Congressional legislation in the first place. The clear purpose of the enabling statute was to foster consumer choice, not to limit consumer options, especially when it comes to prescription drugs.
That ties in to the second objection addressed in these Comments. The proposed new regulations, such as for example §§ 147.106(e)(5) and 148.122(g)(5), are an undeserved windfall for the makers of generic drugs, and at the expense of consumer choice. Lists of covered drugs are of course lists contained in plans for coverage of drugs. These plans are paid for by consumers in whole or in part including by the payment of deductibles and co-pays, and often paid for as well by a share of the premiums charged for coverage under these plans. Consumers have paid for the right to have their physicians and medicalcare providers prescribe drugs and to fill these prescriptions with brand drugs at the option or choice of the consumer, and not by the choice either of the pharmaceutical manufacturer or the issuer. For this reason as well, the proposed new regulations, including §§ 147.106(e)(5) and 148.122(g)(5), should not and cannot be adopted.
The third and final objection to proposed new regulations §§ 147.106(e)(5) and 148.122(g)(5) which will be addressed in these Comments is the undefined use of the phrase, "generic equivalent." This phrase is found in the proposed new authority to be conferred upon issuers to "add a generic equivalent to a formulary[.]" See, e.g., proposed new regulation § 147.106(e)(5), 84 F.R. at p. 314, and proposed new regulation § 148.122(g)(5), also in 84 F.R. at p. 314.
The phrase used in this new proposed regulation is not limited to "medically equivalent." (Emphasis added.) Nor is it limited by reference, so far as I can find, to FDA-generic-approved medicines. Without such limitations, the proposed new authority to replace brand drugs on drug lists with "a generic equivalent" is overly broad and so it is meaningless. It would, for example, allow issuers and generic drug manufacturers to buy their way onto drug lists to add drugs that their own proprietary 'research' and support has 'determined' to be "a generic equivalent," without limitation to generic medicines already approved by the FDA. For this reason as well, the proposed new regulations, including §§ 147.106(e)(5) and 148.122(g)(5), provide no limiting guidelines and so are void and of no effect. They cannot validly be promulgated.
For each and all of these reasons, whether taken separately or together, the proposed new regulations, including §§ 147.106(e)(5) and 148.122(g)(5), cannot validly be promulgated as administrative regulations and, moreover, they are void and of no effect as new law.
Sincerely,
Dennis J. Wall
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REQUEST FOR INFORMATION FROM YOU REGARDING HEALTH CARE PROVIDERS ...
... BY YOUR DEPARTMENT OF JUSTICE'S ANTITRUST DIVISION, BY YOUR DEPARTMENT OF HEALTH AND HUMAN SERVICES, AND BY YOUR FEDERAL TRADE COMMISSION, if online, then before May 6, 2024.
All these Government agencies want to hear from all of us. We can submit our comments online or mail them. If we submit our comments online, we can use the Federal eRulemaking Portal at www.regulations.gov. Whether we submit our comments online or by mail, they want us to identify our comments by Docket No. ATR 102. (On the Federal Trade Commission's website, I noticed this number as well on the FTC website: Document ID FTC-2024-0022-0001. When I leave my comments online at www.regulations.gov, as I intend to do, I will use the Docket No. ATR 102 like they ask for, but I just wanted you to know in advance what you will see if you send your comments through the FTC's website.)
These people want to hear from everyone who has a stake in Health Care in this nation. They want to hear from stakeholders, whether or not the stakeholders also hold shares in the companies that hold themselves out as providing you with Health Care in this country.
We will address different aspects of this Request for Information ("RFI") as time goes on, but that is not because the RFI is very long; it isn't very long. It is only 12 pages long (11 pages, really, because the 12th and last page is only a signature page and does not have any text to read on it). Rather, you and I will take our time together to look over the RFI because the information these agencies are looking for is huge.
For example, the agencies list out 5 questions they are interested in, 4 specific questions and one last overall question that asks if there is anything else we would like to address that we haven't already told them about.
We will start with their first question, and they ask us to "identify, where possible, the question numbers your comments are intended to address." Question 1 asks about Effects of Consolidation.
If you are a patient – and who isn't at one time or another – they want to know how a transaction that involved your health care providers like home-and community-based services, health systems, nursing homes or ambulatory surgical centers to name a few, affected in any way the providers' costs for you to obtain care, or ...
... costs of health insurance coverage, medical debt and access to charity care, quality of clinical or non-clinical care, quality of the patient’s experience, access to and denials of care, language access, types of goods and services offered, safety, utilization of services, drug utilization, staffing levels, mix of providers and medical support staff, practices regarding prior authorizations, other utilization management, or reimbursement strategies, referral practices, site of service for procedures, ease of access to providers, patient billing, collections, financial assistance practices, access to or sharing of patient information, differences in these areas in rural compared to urban settings, and differences in areas for marginalized patient populations, including differences by race, ethnicity, gender, sexual orientation, income level, disability, Tribal status, or citizenship status.
Think they left anything out? Please remember that these are only examples of what you can talk to them about; they want to hear your experiences with these things, not somebody else's experiences.
Whatever we do in leaving our comments to provide them with information, they want us to remember this very important thing:
DO NOT include sensitive or confidential information in the comments including: social security numbers, dates of birth, driver’s license numbers or other state identification numbers, financial account information, sensitive health information, or competitively sensitive information. Comments will be posted on the Internet and made available to the public (subject to exceptions such as for personal privacy information of persons other than the submitter).
TO BE CONTINUED .... Please read the disclaimer. ©2024 Dennis J. Wall. All rights reserved.
Posted by Dennis J. Wall on April 23, 2024 at 05:44 AM in Comments on Proposed Rules, Health Insurance | Permalink | Comments (0)
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