| Course | NR 506 Health Care Policy |
|---|---|
| Week | 5 |
| Paper type | Rulemaking and implementation write-up |
| Length | About 1,170 words, 3 pages |
| Format | APA 7 student paper |
| School | Chamberlain University |
| Program | MSN |
| Updated | October 2026 |
Free sample paper for NR 506 Week 5
The 2020 Part D Rebate Rule From Proposal to Final Text: Medicaid Managed Care Dropped After 26,000 Comments, an Effective Date Moved Twice by the Agency and Then to 2032 by Congress, and Two Safe Harbors That Exist Only on Paper
Student Name
College of Nursing, Chamberlain University
NR 506: Health Care Policy
Instructor Name
Month Day, Year
The 2020 Part D Rebate Rule From Proposal to Final Text: Medicaid Managed Care Dropped After 26,000 Comments, an Effective Date Moved Twice by the Agency and Then to 2032 by Congress, and Two Safe Harbors That Exist Only on Paper
One Rule, and Why It Belongs to This Term
In Week 3, I followed the Affordable Insulin Now Act and noted that the version the House passed also pushed back, once more, a regulation about the rebates manufacturers pay Part D plans. This paper follows that regulation. It is the rule that the federal health department issued through its Office of Inspector General under the title "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees." It was proposed at 84 FR 2340 on February 6, 2019 (Department of Health and Human Services, 2019) and finalized at 85 FR 76666 on November 30, 2020 (Department of Health and Human Services, 2020).
The rule matters for insulin because insulin is among the drugs for which manufacturers pay large rebates to plans and pharmacy benefit managers after the sale, while the patient's cost-sharing at the counter is often based on the higher list price. The rule's premise was that moving those price reductions to the point of sale would lower what patients pay.
What the Rule Does
The federal anti-kickback statute makes it a crime to pay anything of value to induce purchases paid for by federal health programs. Regulatory safe harbors protect some common arrangements, and manufacturer rebates to plans had been protected under the discount safe harbor. The rule does three things. It removes that protection for rebates paid by manufacturers to Part D plan sponsors and the pharmacy benefit managers working for them. It creates a new safe harbor for price reductions that are passed through to the patient at the point of sale. And it creates a new safe harbor for fixed service fees that manufacturers pay to pharmacy benefit managers (Department of Health and Human Services, 2020).
Two Versions, Side by Side
The proposed and final texts differ in ways that change who the rule reaches and when.
Table 1
Proposed and Final Texts Compared
| Feature | Proposed rule, February 2019 | Final rule, November 2020 |
|---|---|---|
| Rebates excluded from the discount safe harbor | Rebates to Part D plan sponsors and to Medicaid managed care organizations, and pharmacy benefit managers acting for them | Rebates to Part D plan sponsors and their pharmacy benefit managers only; Medicaid managed care organizations removed |
| Point-of-sale safe harbor | Part D and Medicaid managed care | Part D and Medicaid managed care, kept |
| Effective date of the rebate exclusion | January 1, 2020 | January 1, 2022 |
| Effective date of the rest of the rule | Not separately proposed | January 29, 2021 |
Note. Compiled from the proposed rule, published at 84 FR 2340, and the final rule, published at 85 FR 76666.
Who Filed, Not How Many
The Department reported receiving responsive comments from approximately 26,000 distinct commenters, including individuals, drug manufacturers, pharmacies, pharmacy benefit managers, wholesalers, Part D plan sponsors, Medicaid managed care organizations and trade associations (Department of Health and Human Services, 2020). The number tells us the rule drew attention. The more useful question is which filers changed the text.
The change to Medicaid managed care came from a specific group of filers. According to the final rule, commenters, including Medicaid managed care organizations and those concerned with state Medicaid programs, argued that excluding managed care organizations but not fee-for-service Medicaid would treat the two parts of the same program differently and put managed care at a disadvantage, and several stressed that supplemental rebates are an important tool for states in controlling drug spending. The Department's response was brief: it was not finalizing the changes with respect to Medicaid managed care organizations, which addressed those concerns.
The effective-date change came from another group. Many commenters, the rule reports, said that a January 1, 2020 date left too little time to rebuild systems and contracts, and some tied the problem to the timing of Part D plan bids. The Department explained that, after consulting CMS, it set January 1, 2022 for the rebate exclusion so that the 2020 bid cycle would not be disrupted (Department of Health and Human Services, 2020).
Two Dates, Then Several More
A rule has at least two dates: the day it is published and the day it takes effect. For this rule the second date kept moving. The final rule was published on November 30, 2020. Most of it was to take effect on January 29, 2021, and the rebate exclusion on January 1, 2022.
On March 22, 2021, following an order of the U.S. District Court for the District of Columbia, the Department gave notice that the new safe harbors and related provisions would not take effect until January 1, 2023 (Department of Health and Human Services, 2021). Congress then enacted a series of moratoria on implementing the rule, the most recent in section 11301 of the Inflation Reduction Act, which extended the moratorium to January 1, 2032. On December 29, 2023, the Department stayed the affected provisions until that date (Department of Health and Human Services, 2023). The rule is therefore final and published, but it has never taken effect.
The Objects the Rule Created
The rule created two new regulatory objects: a safe harbor for point-of-sale reductions in price, at 42 CFR 1001.952(cc), and a safe harbor for pharmacy benefit manager service fees, at 42 CFR 1001.952(dd). Both appear in the Code of Federal Regulations, and both are stayed. For a nurse advising a patient at the pharmacy counter, the practical meaning is simple: nothing in this rule currently changes what a Part D enrollee pays for insulin.
The history also explains why the rule kept appearing in unrelated legislation. Delaying it scores as federal savings in the budget, because the government's estimates projected that the rule would raise federal spending on Part D premiums. That made each delay a convenient offset for other spending, including, in the House-passed Affordable Insulin Now Act, the cost of capping insulin prices.
For advocates of lower insulin costs, the lesson of this rule is about sequence. A regulation that depends on how federal spending is scored can be undone without a single hearing, simply by being delayed to pay for something else. A cost-sharing limit written into statute, like the Medicare insulin cap, does not carry that weakness, which is one reason the brief in Week 2 asked Congress for a statutory limit rather than for another regulation.
References
Department of Health and Human Services. (2019). Fraud and abuse; removal of safe harbor protection for rebates involving prescription pharmaceuticals and creation of new safe harbor protection for certain point-of-sale reductions in price on prescription pharmaceuticals and certain pharmacy benefit manager service fees. Federal Register, 84, 2340-2363.
Department of Health and Human Services. (2020). Fraud and abuse; removal of safe harbor protection for rebates involving prescription pharmaceuticals and creation of new safe harbor protection for certain point-of-sale reductions in price on prescription pharmaceuticals and certain pharmacy benefit manager service fees. Federal Register, 85, 76666-76731.
Department of Health and Human Services. (2021). Fraud and abuse; removal of safe harbor protection for rebates involving prescription pharmaceuticals and creation of new safe harbor protection for certain point-of-sale reductions in price on prescription pharmaceuticals and certain pharmacy benefit manager service fees; additional delayed effective date. Federal Register, 86, 15132-15133.
Department of Health and Human Services. (2023). Action to delay effective date consistent with congressionally enacted moratorium. Federal Register, 88, 90125-90126.
What the NR 506 Week 5 assignment asks for
For Week 5 you follow one health policy from statute into regulation and practice. You will likely need the rule and its purpose, the proposed and final versions, public comments, changes made and why, implementation dates and the rule's effects, with APA. Choose one rule and explain why it matters to your topic. Compare proposed and final texts side by side. Describe comments by who filed them and which change they produced, using the agency's own stated reasons. Track every date, including delays. Name the regulatory objects the rule created. Draw a lesson about sequence or durability for advocates. Cite each version by its Federal Register page.
How the NR 506 Week 5 example is put together
The opening links the rule to the insulin bill that delayed it. The purpose section explains the anti-kickback statute and how removing the safe harbor for manufacturer rebates to plans would push discounts to the pharmacy counter. Table 1 compares the proposed rule of February 2019 and the final rule of November 2020. The comments section reports that Medicaid managed care organizations and states won their exclusion and that systems concerns moved the date. The dates section follows the effective date through a March 2021 court-ordered delay and later legislative moratoria, including a 2023 notice. The objects section names the point-of-sale and pharmacy benefit manager safe harbors. The closing explains budget scoring and the lesson for advocates.
Reading the NR 506 Week 5 grading rubric
Rulemaking rubrics in NR 506 usually score accurate description of the rule, comparison of proposed and final versions, analysis of public comment, attention to implementation dates, understanding of the regulatory process and APA. Linking comments to changes is the row this paper earns most fully, by naming who filed each objection and quoting the agency's reason. The comparison is credited for a side-by-side table. Dates score because each delay has a source. Process understanding earns points for explaining safe harbors and budget scoring. The lesson for advocates is credited for being specific. Four Federal Register documents complete APA. Four Federal Register citations let the grader check every date.
NR 506 Week 5 help from the desk
The biggest single loss on this write-up is never leaving the enabling statute, answering a question about practice from a document never written to handle details. Another loss is counting comments without saying who filed them or what they changed. Students also skip the proposed version, assume a final rule is in effect or miss later delays. Proposed rules can be found in the Federal Register by docket number. A state board rule works the same way if its proposal and comments are public. You may say the agency got something wrong if you show why. Name the rule you want to follow, and an NR 506 rulemaking write-up can compare its versions.
Get a NR 506 Week 5 example written to your instructions
Send the Week 5 instructions and the rule your section assigned, or say which practice area matters to you and one with a full public record is selected for you, and the write-up arrives inside 24-48h with the first one free. Rules whose documentation turns out to be sparse are flagged before drafting starts rather than after.
More NR 506 papers and MSN samples
- NR 506 Week 1: Health Policy at Work Discussion Post
- NR 506 Week 2: Insulin Cost Policy Issue Brief
- NR 506 Week 3: Insulin Bill Legislative Process Paper
- NR 506 Week 4: Medicare Insulin Cap Policy Analysis
- NR 506 Week 6: Interest Group Analysis
- NR 506 Week 7: Policy Evaluation Write-up
- NR 506 Week 8: Policy Synthesis Paper
- NR 506NP Week 5: Reimbursement and Credentialing Write-up
- NR 505 Week 5: Noninferiority Trial Appraisal Paper
- NR 508 Week 5: Adverse Effect Analysis
- NR 504 Week 5: Two-Way Nursing Mentorship Plan
NR 506 Week 5 questions, answered
Where do I find the proposed version of a rule?
The federal rulemaking record is public and searchable, and a final rule cites its own proposed version near the top. Comments filed on it sit in the same docket, viewable by filer. State rules vary more, but most boards publish a notice with a comment period and keep what was submitted. A rule with no traceable proposal is usually guidance, which is worth knowing first.
My section wants a state board rule instead. Does the same structure work?
Mostly. State boards publish notices, take comment and adopt final language, so the two-version comparison holds even where the record is thinner. What differs is volume, since a state rule may draw a dozen submissions rather than thousands, which makes each one easier to describe and quote. Check whether the board publishes its reasoning, because some do not, and say so where that is true.
Is it acceptable to write that the agency got something wrong?
Yes, provided the criticism points at something. Saying that a definition excludes a group the statute named, and pointing at the comment that raised it and the response given, is analysis. Saying the agency was captured by industry, with no filing to point at, is not. What this rubric rewards is the difference between a documented objection and an attributed motive.
Where can I find a free NR 506 Week 5 sample paper?
Every part of the Week 5 paper on the 2020 Part D rebate rule, with the proposed and final texts, the commenters and their effects, the moving dates, the new safe harbors and four references, is shown here.
Why was the rebate rule delayed repeatedly in the NR 506 Week 5 paper?
Because delaying it scores as federal savings in the budget, so Congress used moratoria on it to pay for other legislation, beginning after a court-ordered delay in 2021.