CPAP Module 16, Section 1: Regulatory Time Limits (State, CMS, Commercial)
MODULE 16: TIMEFRAMES, TURNAROUND RULES & ESCALATIONS

Section 1: Regulatory Time Limits (State, CMS, Commercial)

Moving from the Pharmacy Pace to the Payer Clock: A Deep Dive into the Legal Timelines that Govern Prior Authorization.

SECTION 16.1

Regulatory Time Limits: The Foundation of PA Urgency

Understanding the legal and contractual clocks that dictate your workflow and advocacy.

16.1.1 The “Why”: Time is a Legal and Contractual Mandate

In your community pharmacy practice, time is a critical component of customer service. A patient waiting 30 minutes for a prescription is a service failure; a patient served in 5 minutes is a success. This “pharmacy pace” is driven by workflow efficiency, patient expectations, and a professional desire to provide prompt care. While important, this clock is largely self-imposed. When you transition into the world of prior authorization, the concept of time undergoes a fundamental transformation. The clock is no longer just a measure of good service; it is a legal, regulatory, and contractual mandate.

Every prior authorization request you manage is governed by a strict, non-negotiable timeline known as the Turnaround Time (TAT). These are not suggestions or goals; they are legally enforceable deadlines that health plans and Pharmacy Benefit Managers (PBMs) must meet. Failure to render a decision—an approval or a denial—within the specified TAT can result in significant consequences for the payer, including fines, sanctions from regulatory bodies like the Centers for Medicare & Medicaid Services (CMS), and loss of accreditation from bodies like the National Committee for Quality Assurance (NCQA) or URAC.

For you, the prior authorization pharmacist, understanding these timeframes is the absolute foundation of your role. It dictates the urgency of your work, empowers your advocacy, and provides the framework for escalation. Knowing that a standard Medicare Part D request has a 7-calendar-day deadline, or that an expedited request requires a decision within 72 hours, is not trivia. It is the core piece of intelligence that transforms you from a passive submitter of paperwork into an active manager of the process. You become the timekeeper for the patient, ensuring their case does not fall through the cracks and holding the payer accountable to their legal obligations. This section will provide a masterclass in these timelines, deconstructing the complex web of federal, state, and commercial rules that define the pace of prior authorization.

Retail Pharmacist Analogy: The DEA’s 72-Hour Rule for Emergency C-II Fills

Imagine a frantic physician calls your pharmacy on a Friday night. A post-operative patient is in severe, intractable pain, and the physician needs to phone in an emergency oral prescription for oxycodone. You immediately recognize this situation is governed by one of the most rigid rules in pharmacy practice: the DEA’s 72-hour rule for emergency Schedule II prescriptions.

Your entire mindset is now dictated by this external, legal clock. Let’s deconstruct your actions and how they directly translate to managing PA timeframes:

  • The Clock Starts Immediately: The moment you dispense a partial quantity of oxycodone based on that oral order, a 72-hour timer begins. This is not a pharmacy policy; it’s federal law. You are now legally obligated to obtain a hard copy, signed “cover” prescription from that prescriber within that 72-hour window. This is identical to how a PA clock starts the moment the payer receives a “clean” request with all necessary information.
  • Proactive Follow-Up is Required: You don’t just dispense the medication and hope the doctor remembers. You are professionally and legally responsible for the follow-up. You make a note, set a reminder, and on Monday morning, you or your staff are on the phone with the doctor’s office: “Hi, this is the pharmacist. I’m calling to follow up on the emergency oxycodone prescription for John Doe from Friday. We need the signed hard copy by tomorrow to be in compliance.” This is the exact same proactive advocacy you will use when a PA decision is nearing its deadline.
  • Documentation is Non-Negotiable: You document everything. The time of the doctor’s call, the reason for the emergency, your conversation, and the date you received the cover script. If you fail to get the script and the DEA audits you, “the doctor forgot” is not a defense. Your documentation is your only proof of due diligence. In the PA world, documenting your submission time, your follow-up calls, and the payer’s responses is your legal and clinical record.
  • Escalation Has a Protocol: If the 72 hours are about to expire and you still don’t have the script, you have a clear, mandated next step: you must report the failure to your local DEA office. This is a formal escalation process. Similarly, if a health plan violates a mandated TAT, there are formal grievance and appeals processes, up to and including reporting the plan to CMS or the state department of insurance.

Your mastery of the 72-hour rule—a high-stakes, time-sensitive, legally mandated process—is the perfect mental model for managing PA timelines. You already possess the core skills of tracking, documenting, and following up against a hard deadline. This module is about applying that same rigor to a different set of clocks: those set by CMS, state legislatures, and commercial contracts.

16.1.2 The Gold Standard: CMS Timelines for Medicare Part D

The Centers for Medicare & Medicaid Services (CMS) sets the rules for all Medicare plans, including Part D prescription drug plans. Because Medicare is the largest single payer in the United States, its regulations serve as the de facto “gold standard” for the industry. Many state laws and commercial plan policies are modeled directly on CMS guidelines. Therefore, mastering these timeframes is not just about learning one set of rules; it’s about learning the foundational language of the entire PA ecosystem.

CMS defines two primary categories for coverage requests (which includes prior authorizations): Standard and Expedited. The classification of a request is not arbitrary; it is determined by the clinical urgency of the patient’s situation. The timelines for these requests are measured in hours or calendar days and are strictly enforced.

Masterclass Table: CMS Medicare Part D Coverage Determination Timelines
Request Type CMS Definition of Urgency Maximum Turnaround Time (TAT) Critical Details & Pharmacist Insight
Standard Request A situation where applying the standard timeframe for a decision would not seriously jeopardize the patient’s life, health, or ability to regain maximum function. This is the default category.
7
Calendar Days
  • “Calendar Days” is Key: This is not business days. A request received on a Monday must have a decision by the following Monday. Weekends and holidays count. This is a common point of confusion for provider offices.
  • Clock Start: The 7-day clock starts the moment the plan receives the request for a coverage determination. If the plan needs more information, they can “stop the clock,” but they must notify the provider.
  • Your Role as Timekeeper: Document the exact date and time of your submission. Set a calendar reminder for yourself for Day 5 or 6 to proactively check the status if you haven’t heard back. Don’t wait for the deadline to pass.
Expedited (Fast) Request A situation where the plan determines that applying the standard timeframe could seriously jeopardize the patient’s life, health, or ability to regain maximum function. The request can be made by the member or their prescriber.
72
Hours
  • Prescriber Support is Crucial: If a prescriber makes or supports the request for expedition, the plan must grant it. This is a powerful tool. You must educate your providers on this point.
  • Clock is Ticking: 72 hours is three days. A request received at 9 AM on Tuesday is due by 9 AM on Friday. This requires constant monitoring.
  • The “24-Hour” Myth: Many providers believe there is a 24-hour rule. While some plans may process that quickly, the legal CMS mandate is 72 hours. It’s vital to manage expectations with providers and patients. If a plan uses the full 72 hours, they are still compliant.
The “Stop the Clock” Provision: A Critical Nuance

Payers have the ability to “stop the clock” on a PA review if they need additional clinical information from the prescriber to make a decision. However, they cannot do this silently. To stop the clock, the plan must:

  1. Promptly notify the prescriber (and sometimes the member) what specific information is needed.
  2. Document their attempt to contact the provider.

The clock resumes as soon as the requested information is provided. As a pharmacist, if a TAT deadline is approaching, one of your key questions when calling the payer must be: “Is this case pending for additional clinical information?” Often, the provider’s office is unaware that the plan has sent a fax or left a voicemail, and the case is in limbo. Your call can restart a stalled process.

These rules also apply to the first level of appeal. If a PA is denied, the member has the right to appeal the decision. The timelines for these appeals mirror the initial determination requests.

Masterclass Table: CMS Medicare Part D Redetermination (Appeal) Timelines
Appeal Type CMS Definition of Urgency Maximum Turnaround Time (TAT) Pharmacist Playbook
Standard Appeal The denial does not pose an immediate threat to the patient’s health.
7
Calendar Days

When a standard PA is denied, you have 60 days to file an appeal. The plan then has 7 calendar days from receipt of the appeal to provide a decision.

Strategy: Use the denial reason as your guide. If the denial was for “insufficient clinical information,” your appeal should focus on providing exactly what was missing. A well-constructed appeal can often be successful at this stage.
Expedited Appeal Upholding the denial could seriously jeopardize the patient’s life, health, or ability to regain maximum function.
72
Hours

This is your most powerful tool for urgent, denied medications. Again, if the prescriber states that the appeal needs to be expedited, the plan must comply.

Strategy: Do not just resubmit the same information. The appeal must present a clear, compelling argument for why the denial was incorrect or why the patient meets exception criteria. Often, this involves adding a peer-to-peer discussion between the prescriber and the plan’s medical director.

16.1.3 State Regulations: A Complex Patchwork of Rules

While CMS provides a strong federal baseline, it is not the only source of authority. Each state’s Department of Insurance (or equivalent regulatory body) has the power to enact its own laws governing health plans operating within its borders. This creates a complex patchwork of rules that can vary dramatically from one state to another. A foundational principle of healthcare law is that in cases of overlapping regulation, the stricter rule applies. This means if a state mandates a 48-hour TAT for expedited requests, a Medicare plan in that state cannot take the full 72 hours allowed by CMS; it must comply with the 48-hour state law.

This is one of the most challenging aspects of working in a national or large regional health system. The rules for a patient in California may be completely different from the rules for a patient in Texas. As a specialist, you must develop the skill of quickly identifying a patient’s plan type and location to determine which set of rules governs their case. The plan’s ID card and the denial letter itself are often your best clues.

Clinical Pearl: The “Prompt Response” Laws

Many states have enacted “prompt response” or “timely access” laws. While the specific timeframes vary, the intent is the same: to prevent payers from “sitting on” a request. These laws often differentiate between electronic, faxed, and telephonic submissions, sometimes providing shorter TATs for electronic PAs to encourage digital adoption. Knowing the specific law in your state is a massive advantage. Quoting the state statute in your communication with a plan can often accelerate a stalled review.

Masterclass Table: Illustrative Comparison of State PA Timeframe Laws (Hypothetical)

The following table is for illustrative purposes to demonstrate the variability you will encounter. These are not real statutes and you must verify the laws for your specific state of practice. However, the patterns are representative of the real-world regulatory landscape.

State Standard PA Request Expedited PA Request Unique State-Specific Provisions & Nuances
State A (e.g., California Model)
5
Business Days
72
Hours
  • Defines “business days” explicitly, excluding weekends and state holidays.
  • May have a shorter, 24-hour timeline for decisions on prescriptions for medical conditions that could cause imminent and serious harm.
  • Strong electronic PA (ePA) mandates, requiring health plans to accept and acknowledge ePA requests within a very short window (e.g., 1 business day).
State B (e.g., Texas Model)
3
Business Days
24
Hours
  • One of the most aggressive TATs in the country, placing significant pressure on payers.
  • Has specific rules for “Step Therapy” or “Fail First” protocols, often allowing a provider to override them under specific clinical circumstances, with a decision required within the expedited timeframe.
  • Requires payers to provide a direct toll-free number for providers to speak with a pharmacist or physician reviewer.
State C (e.g., New York Model)
72
Hours
24
Hours
  • Distinguishes between different types of reviews. A standard PA might have a 72-hour TAT, but a formulary exception request might have a longer timeframe.
  • Mandates that any denial notice must include the specific clinical rationale and instructions for how to appeal to the New York State Department of Financial Services.
  • Specifies the qualifications of the person reviewing the PA (e.g., must be a licensed pharmacist or physician).
State D (Federal Fallback) No specific state law No specific state law
  • In states without their own specific PA timeframe laws, commercial plans will typically default to their own internal policies, which are often based on NCQA/URAC accreditation standards.
  • For any federally regulated plan (Medicare, many ACA plans), the CMS rules (7 days / 72 hours) would be the prevailing standard.
  • This highlights the importance of not assuming a strict rule exists if you cannot find one. The payer’s contract and accreditation standards become the primary driver.

16.1.4 Commercial & Exchange Plans: Contracts and Accreditation

The third layer of complexity involves commercial health plans. These are typically employer-sponsored plans (fully-insured or self-funded) or plans purchased on the Affordable Care Act (ACA) marketplace. The TAT rules for these plans are a hybrid, governed by a combination of:

  1. State Law: The plan must, at a minimum, comply with the laws of the state in which it is regulated.
  2. The Employer/Payer Contract: A large employer may negotiate specific performance guarantees with its PBM, including stricter TATs than what state law requires. These are contractual obligations.
  3. Accreditation Standards (NCQA/URAC): This is the hidden driver of most commercial plan policies. To earn and maintain accreditation from bodies like NCQA and URAC, health plans must demonstrate that they have robust processes for utilization management, including policies for timely decision-making. While not laws themselves, these standards function as powerful industry regulations.
Deconstructing NCQA/URAC Influence

Accreditation is a mark of quality that health plans use to market themselves to employers and members. The standards set by these bodies are incredibly detailed and influential.

Accreditation Body Typical TAT Standard Impact on Pharmacy Workflow
NCQA (National Committee for Quality Assurance)
  • Urgent/Expedited: Within 72 hours of receipt of request.
  • Standard (Pre-service): Within 14 calendar days of receipt of request.

NCQA’s 14-day standard is longer than CMS’s 7-day rule. This is a critical distinction. For a commercial plan patient in a state with no specific law, the plan might legally take up to 14 days. This is a vital piece of information when setting expectations for a provider.

Advocacy Point: If a patient’s care is being delayed by a 14-day review, your argument for expedition becomes even more critical. You must clearly articulate why waiting two weeks would be detrimental to the patient’s health.
URAC
  • Urgent/Expedited: Within 72 hours of receipt of necessary information.
  • Standard (Pre-service): Within 15 business days of receipt of request.

URAC’s standards are similar to NCQA’s but often specify “business days,” which can extend the real-world timeline even further. This is a crucial detail to verify.

Investigative Work: The health plan’s website or the PA denial letter will often state if they are NCQA or URAC accredited. This is a clue that helps you understand the internal policies that are driving their timelines.

16.1.5 The Pharmacist’s Role: Timekeeper, Advocate, and Documentarian

Understanding this complex web of timelines is not an academic exercise. It directly translates into a set of core professional responsibilities that define an expert PA pharmacist. You must seamlessly integrate three roles into your daily workflow.

The Timekeeper

Your first job is to know the clock. For every PA you submit, you must know the applicable TAT. This requires a quick mental checklist:

  • Is this a Medicare plan? (CMS rules apply).
  • If not, what state is the plan regulated in? (Check state law).
  • Is it an urgent clinical situation? (Expedited rules apply).

You must have a system to track these deadlines. This could be a shared spreadsheet, a task manager, or features within your EMR. A simple entry like: “Doe, Jane – Xarelto PA – Submitted 10/15 @ 2pm – Standard CMS – Deadline 10/22 @ 2pm” is invaluable.

The Advocate

Knowing the deadline empowers your advocacy. You are no longer just asking for a favor; you are inquiring about a mandated obligation. Your communication becomes more confident and effective.

The Script (Approaching Deadline):
“Hello, my name is [Name], a pharmacist calling on behalf of patient Jane Doe. I submitted a standard prior authorization request for Xarelto on Monday, October 13th. Per CMS guidelines, a decision is due within 7 calendar days, which is this coming Monday. I am calling to confirm the case is being actively reviewed and to see if any additional information is needed to facilitate a timely decision.”

The Documentarian

Just as with the C-II emergency fill, documentation is your ultimate defense and tool. Every action related to a PA must be logged with a date and time.

  • Submission: Note the exact time, date, and method (portal, fax). Get a confirmation number.
  • Calls to Payer: Note time, date, name of representative, and a summary of the conversation.
  • Info Requests: Note when the payer requested more info and when your team provided it. This is crucial for tracking “stop the clock” events.

This meticulous trail is essential for appeals and escalations. It allows you to build a case demonstrating that you have met all your obligations and that the responsibility for a decision now rests solely with the payer.