Section 1877 of the Social Security Act (42 U.S.C. 1395nn) prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician or a member of the physician's immediate family has a financial relationship unless an exception applies.
Full Answer
Should all doctors prescribe generic drugs?
The ACP say all doctors should prescribe patients generic drugs rather than branded drugs, where possible. Conducted by members of the American College of Physicians’ (ACP) Clinical Guidelines Committee, the report is published in the Annals of Internal Medicine.
What is the law on gifts to physicians from industry?
The Patient Protection and Affordable Care Act of 2010 requires drug, device, and biologic companies to publicly report nearly all gifts or payments they make to physicians beginning in 2013. Academic institutions also may impose various restrictions on the interactions their faculty members or affiliated physicians have with industry.
Is it ethical for a doctor to write himself prescriptions?
According to Opinion 8.19 of the AMA Code of Medical Ethics, “physicians generally should not treat themselves or members of their immediate families.” The AMA cites the following reasons against the practice of physician self-prescribing: Professional objectivity may be...
Can a doctor receive compensation for prescribing manufacturers'drugs?
The Court of Appeals found that Dr. Brown was in violation of the Minnesota state statute that prohibits a physician from accepting compensation for prescribing a manufacturer's drugs.
Does Medicare pay for name brand drugs?
Medicare drug coverage covers generic and brand-name drugs. All plans must cover the same categories of drugs, but generally plans can choose which specific drugs are covered in each drug category. Plans have different monthly premiums.
What are the implications of the Medicare Modernization Act of 2003?
The 2003 Medicare Modernization Act (MMA) is considered one of the biggest overhauls of the Medicare program. It established prescription drug coverage and the modern Medicare Advantage program, among other provisions. It also created premium adjustments for low-income and wealthy beneficiaries.
Can the pharmacists substitute the brand name drug for a generic without the doctor's approval?
If doctors don't specify that the patient must get the brand-name product, pharmacists in California are allowed to substitute a generic as long as they tell the patient.
What is the name of the legislation that required MTM services to be a part of Medicare Part D?
The Patient Protection and Affordable Care Act (PL 111-148) authorized grants for “medication management services” in all practice settings (Section 3503), noting that such services will help manage chronic disease, reduce medical errors, and improve patient adherence to therapies while reducing acute-care costs and ...
What is the MMA law?
The Music Modernization Act (MMA) updates the copyright law to make statutory licensing more fair for creators and more efficient for digital music providers.
What was the purpose of the Durham Humphrey Amendment?
This amendment established the distinction between so-called legend (prescription) drugs and over the counter (nonprescription) drugs. The amendment also authorized the taking of prescriptions verbally, rather than in writing, and the refilling of prescriptions.
Which states have mandatory generic substitution laws?
State Action Twelve states and one territory require a pharmacist to replace a brand-name drug with a generic if all other prescribing requirements are met: Florida, Kansas, Kentucky, Massachusetts, Minnesota, Nevada, New Jersey, New York, Pennsylvania, Puerto Rico, Vermont and Washington.
Why might a doctor prescribe a brand name drug rather than a generic option?
The researchers found that doctors' willingness to prescribe a brand was associated with their acceptance of free food from drugmakers. They were also more likely to accept samples of brand-name drugs to hand out to their patients, too. The findings were just published online by JAMA Internal Medicine.
Can a generic drug always be substituted for a brand name drug?
No. Generic medications are just as effective as brand-name drugs. According to the FDA, drug makers must prove that generic medications can be substituted for brand-name drugs and offer the same benefits as their brand-name counterparts.
When did Part D become mandatory?
Medicare Part D Prescription Drug benefit The MMA also expanded Medicare to include an optional prescription drug benefit, “Part D,” which went into effect in 2006.
When was the Medicare Modernization Act passed?
December 8, 2003On December 8, 2003, the President signed into law Public Law 108-173, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003.
Which individual S may provide MTM services based on federal law?
CMS requires MTM plan sponsors to submit information about the MTM program each year, and plan sponsors must indicate which types of providers deliver MTM services within their plan by selecting one or more of the following provider types: Local pharmacist. Long-term care consultant pharmacist. Plan sponsor pharmacist.
What happens if a pharmacy doesn't fill a prescription?
If your pharmacy can’t fill your prescription as written, the pharmacist will give you a notice explaining how you or your doctor can call or write to your plan to ask for a coverage decision. If your health requires it, you can ask the plan for a fast coverage decision.
How long can you have opioids on Medicare?
First prescription fills for opioids. You may be limited to a 7-day supply or less if you haven’t recently taken opioids. Use of opioids and benzodiazepines at the same time.
What is formulary exception?
A formulary exception is a drug plan's decision to cover a drug that's not on its drug list or to waive a coverage rule. A tiering exception is a drug plan's decision to charge a lower amount for a drug that's on its non-preferred drug tier.
What is the purpose of a prescription drug safety check?
When you fill a prescription at the pharmacy, Medicare drug plans and pharmacists routinely check to make sure the prescription is correct, that there are no interactions, and that the medication is appropriate for you. They also conduct safety reviews to monitor the safe use of opioids ...
Does Medicare cover opioid pain?
There also may be other pain treatment options available that Medicare doesn’t cover. Tell your doctor if you have a history of depression, substance abuse, childhood trauma or other health and/or personal issues that could make opioid use more dangerous for you. Never take more opioids than prescribed.
Do you have to talk to your doctor before filling a prescription?
In some cases, the Medicare drug plan or pharmacist may need to first talk to your doctor before the prescription can be filled. Your drug plan or pharmacist may do a safety review when you fill a prescription if you: Take potentially unsafe opioid amounts as determined by the drug plan or pharmacist. Take opioids with benzodiazepines like Xanax®, ...
Does Medicare cover prescription drugs?
In most cases, the prescription drugs you get in a Hospital outpatient setting, like an emergency department or during observation services , aren't covered by Medicare Part B (Medical Insurance). These are sometimes called "self-administered drugs" that you would normally take on your own. Your Medicare drug plan may cover these drugs under certain circumstances.
What is the law that prohibits physicians from referring Medicare patients?
Current Law and Regulations. Section 1877 of the Social Security Act (42 U.S.C. 1395nn) prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician or a member of the physician's immediate family has a financial relationship unless an exception applies.
Where is the physician self referral law?
The physician self-referral law can be found in section 1877 of the Social Security Act (42 U.S.C. 1395nn). The regulations are located in Title 42 of the Code of Federal Regulations §411.350 – §411.389.
What is the prohibition on presenting a bill to anyone for DHS furnished?
It also prohibits an entity from presenting or causing to be presented a bill or claim to anyone for DHS furnished as a result of a prohibited referral . In addition, section 1903 (s) (42 U.S.C. 1396b) of the Social Security Act extends this referral prohibition to the Medicaid program.
Free Samples
Some physicians welcome visits from pharmaceutical salespeople, while other physicians prefer not to directly engage with industry representatives. If you decide to make your practice accessible to salespeople, you probably will be offered product samples.
Relationships With the Pharmaceutical and Medical Device Industries
Physician-industry collaboration can produce important medical advances. However, some pharmaceutical and device companies have used sham consulting agreements and other arrangements to buy physician loyalty to their products.
Transparency in Physician-Industry Relationships
Although some physicians believe that free lunches, subsidized trips, and gifts do not affect their medical judgment, research shows that these types of perquisites can influence prescribing practices.
Conflict-of-Interest Disclosures
Many of the relationships discussed in this brochure are subject to conflict-of-interest disclosure policies. Even if the relationships are legal, you may have an obligation to disclose their existence.
Continuing Medical Education
After finishing your formal graduate medical training, you will assume greater responsibility for your continuing medical education (CME) to maintain State licensure, hospital privileges, and board certification. Drug and device manufacturers sponsor many educational opportunities for physicians.
Why do doctors prescribe generic drugs?
In a new report, the American College of Physicians call for all doctors to prescribe generic medications over brand-name drugs, where possible, in order to improve treatment adherence and reduce health care spending.
What does the ACP say about generic drugs?
The ACP say all doctors should prescribe patients generic drugs rather than branded drugs, where possible. Conducted by members of the American College of Physicians’ (ACP) Clinical Guidelines Committee, the report is published in the Annals of Internal Medicine.
How much money is spent on generic drugs each year?
While the use of generic drugs has increased over time, the authors say that many health care providers continue to prescribe expensive brand-name drugs when cheaper generic alternatives are available – an issue that is likely to contributing to high health care costs; around $325 billion is spent on prescription drugs each year in the US.
How many people have used prescription drugs in the past 30 days?
Fast facts about prescription drug use. Around 48.7% of Americans have used at least one prescription drug in the past 30 days. More than 10% of Americans have used five or more prescription drugs in the past 30 days. In 2010, more than 75% of doctor’s visits results in a drug prescription.
How many people prefer generic drugs?
The authors cite a national survey that found, while most patients believed generic drugs were cheaper and better value than brand-name drugs, only 36% of Americans said they preferred to use them.
Can generic drugs be used as brand names?
Generic drugs can be ‘just as effective as brand-name counterparts’. On assessing the frequency of brand-name drug prescription, the authors found that – as expected – health care providers often prescribe brand-name drugs over the generic equivalents.
Who is the President of ACP?
Based on the findings of the report, ACP President Dr. Wayne J. Riley says: “ The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”.
What is required on a label?
Labeling typically requires that the patient name, drug name and strength, quantity provided, directions, date dispensed, and drug expiration date and lot number be affixed to the packaging. Everyone needs to follow these regulations to minimize their legal liability.
What is the role of a pharmacist in a recall?
1) Identifying each patient who is receiving or has received recalled medications. 2) Identifying the source of the medication. 3) Providing for the retrieval and safe disposal of medications subject to recall. 4) Providing for external reporting of medication product defects.
Where are controlled substances stored?
Controlled substances must be stored in a securely locked cabinet of substantial construction . Pharmacies have the option of storing controlled substances as set forth above, or concealing them by dispersal throughout their stock of non-controlled substances.
Can a physician write a prescription for a controlled substance?
The AMA sees no issue with a physician providing routine care for short-term, minor problems; however, except in emergencies, Self prescribing is not appropriate for physicians to write prescriptions for controlled substances (I, II, IV) for themselves or immediate family members.
Is additional security required by federal law?
Although not specifically required by Federal law or regulation, the following additional security measures are recommended to enhance the overall security of non-practitioners as well as practitioners in some situations…. Continue
Can a practitioner use a DEA agent?
A practitioner must not employ an agent or individual who has had his application for registration with the Drug Enforcement Administration (DEA) denied or revoked at any time, and who, as a result of his employment, will have access to controlled substances.
Can a pharmacy print a label without the information?
Each state requires that certain information be on a label of medications. Web-based software, such as MEDeRx, tracks each state’s specific requirements and will not allow your office to print a pharmacy label without the necessary information.
Legal Analysis
The above facts are adapted from US v Brown [1] and D.A.B. v Brown [2]. Dr. David Brown was one of the largest prescribers of Protropin, a genetically engineered human growth hormone made by Genentech and distributed in the US solely by Caremark, a home health care company. Over an 8-year period, Dr.
Conclusion
There are several causes of action against physicians for taking kickbacks. The federal government has a cause of action for violations of the Medicare/Medicaid statute. If a physician participating in a kickback scheme has Medicare or Medicaid patients, then the physician is subject to this law.
Questions for Discussion
Does receiving money from the pharmaceutical industry necessarily mean that a physician's medical judgment is compromised? Can you think of situations when no conflict of interest would arise?
Why is self prescribing bad for physicians?
The AMA cites the following reasons against the practice of physician self-prescribing: Professional objectivity may be compromised when an immediate family member or the physician is the patient; the physician’s personal feelings may unduly influence his or her professional medical judgment. Physicians may fail to probe sensitive areas ...
Why are family members reluctant to recommend another physician?
Family members may be reluctant to state their preference for another physician or decline a recommendation for fear of offending the physician.
Can a physician write prescriptions outside of the course of his or her medical practice?
Some states have laws that discipline a physician for prescriptions written outside the course of his or her medical practice, which could include self-prescriptions and prescriptions for those that do not have a documented patient-physician relationship.
Can a physician write a prescription for a controlled substance?
The AMA sees no issue with a physician providing routine care for short-term, minor problems; however, except in emergencies, Self prescribing is not appropriate for physicians to write prescriptions for controlled substances (I, II, IV) for themselves or immediate family members.
How many people died from prescription drugs in 2011?
The United States is in the midst of an unprecedented epidemic of prescription drug overdose deaths.1 More than 41,000 people died of drug overdoses in 2011, and most of these deaths (22,810) were caused by overdoses involving prescription drugs.2 Three-quarters of prescription drug overdose deaths in 2011 (16,917) involved a prescription opioid pain reliever (OPR), which is a drug derived from the opium poppy or synthetic versions of it such as oxycodone, hydrocodone, or methadone.3 The prescription drug overdose epidemic has not affected all states equally, and overdose death rates vary widely across states.
Can a physician prescribe a controlled substance?
“[A] physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any controlled substance to a person who the physician has never personally physically examined and diagnosed.”11
Is a prescription or drug order valid?
Provides a list of substances, including certain schedules, for which “[a] prescription or drug order . . . is not valid, unless it can be established that the prescription or order was based on a documented patient evaluation, including an examination.”32